[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FDY":3},{"classification":4,"mappedDevices":33,"similarCandidates":34,"relatedClassifications":147,"syncDates":748,"translation":32,"marketSummary":32,"recalls":755,"k510s":757,"pmas":759},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":31,"pma_count":31,"event_count":31,"total_record_count":31},4148,"FDY","Device, Measuring, For Panendoscope","1","876.1500","GU","Gastroenterology, Urology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":27,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"fei_number":17,"registration_number":26},[18,19,20,21,22,23,24,25],"3015225571","1721504","3006950086","3012536737","3015309643","3033589330","3008797804","3010665433",[18,19,20,21,22,23,24,25],"N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-31T02:00:42.235875+00:00",0,null,[],[35,55,66,82,95,108,118,126,133,140],{"medical_device_id":36,"generic_name":37,"class_classification":38,"jmdn_code":39,"name_similarity":40,"definition_similarity":31,"vector_similarity":41,"score":42,"id":36,"category_code":43,"category_name":44,"subcategory_name":45,"data_exist":46,"product_count":47,"company_count":48,"market_size":49,"market_size_unit":50,"growth_ratio":51,"average_price":52,"average_price_unit":53,"domestic_ratio":54},3463,"内視鏡用メジャ","Ⅰ","32053000",0.589744,0.75159,0.0325225,"器25","医療用鏡","医用内視鏡",true,4,3,0.1,"億円\u002F年",27.75,1.68,"万円\u002F個",99.6,{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":60,"definition_similarity":31,"vector_similarity":61,"score":62,"id":56,"category_code":63,"category_name":64,"subcategory_name":65,"data_exist":14,"product_count":32,"company_count":32,"market_size":32,"market_size_unit":32,"growth_ratio":32,"average_price":32,"average_price_unit":32,"domestic_ratio":32},2910,"隅角鏡","Ⅱ","11894000",0.125,0.751723,0.0163934,"器22","検眼用器具","検眼用品",{"medical_device_id":67,"generic_name":68,"class_classification":38,"jmdn_code":69,"name_similarity":70,"definition_similarity":31,"vector_similarity":71,"score":72,"id":67,"category_code":73,"category_name":74,"subcategory_name":75,"data_exist":46,"product_count":76,"company_count":77,"market_size":78,"market_size_unit":50,"growth_ratio":79,"average_price":80,"average_price_unit":53,"domestic_ratio":81},3917,"人工血管用サイザ","70490000",0.428571,0.65244,0.016129,"器07","内臓機能代用器","生体内移植器具",8,7,0.03,-33.67,1.88,96.6,{"medical_device_id":83,"generic_name":84,"class_classification":38,"jmdn_code":85,"name_similarity":86,"definition_similarity":31,"vector_similarity":87,"score":88,"id":83,"category_code":43,"category_name":44,"subcategory_name":45,"data_exist":46,"product_count":89,"company_count":90,"market_size":91,"market_size_unit":50,"growth_ratio":92,"average_price":93,"average_price_unit":53,"domestic_ratio":94},3483,"内視鏡固定具","37090030",0.363636,0.649126,0.015873,64,32,6.65,172.2,12.81,12.8,{"medical_device_id":96,"generic_name":97,"class_classification":38,"jmdn_code":98,"name_similarity":99,"definition_similarity":31,"vector_similarity":100,"score":88,"id":96,"category_code":63,"category_name":64,"subcategory_name":65,"data_exist":46,"product_count":101,"company_count":102,"market_size":103,"market_size_unit":50,"growth_ratio":104,"average_price":105,"average_price_unit":106,"domestic_ratio":107},4399,"瞳孔計","13236000",0.0217391,0.743895,14,10,0.78,61.57,1274,"円\u002F個",0.8,{"medical_device_id":109,"generic_name":110,"class_classification":58,"jmdn_code":111,"name_similarity":112,"definition_similarity":31,"vector_similarity":113,"score":114,"id":109,"category_code":115,"category_name":116,"subcategory_name":117,"data_exist":14,"product_count":32,"company_count":32,"market_size":32,"market_size_unit":32,"growth_ratio":32,"average_price":32,"average_price_unit":32,"domestic_ratio":32},3148,"内視鏡挿入形状検出装置用プログラム","70161012",0.322034,0.642319,0.015625,"プ01","疾病診断用プログラム","プログラム",{"medical_device_id":119,"generic_name":120,"class_classification":38,"jmdn_code":121,"name_similarity":31,"definition_similarity":31,"vector_similarity":122,"score":114,"id":119,"category_code":123,"category_name":124,"subcategory_name":65,"data_exist":14,"product_count":125,"company_count":125,"market_size":32,"market_size_unit":32,"growth_ratio":32,"average_price":32,"average_price_unit":32,"domestic_ratio":32},4380,"不等像視診断計","11391000",0.743582,"医06","視力表及び色盲検査表",1,{"medical_device_id":127,"generic_name":128,"class_classification":58,"jmdn_code":129,"name_similarity":130,"definition_similarity":31,"vector_similarity":131,"score":132,"id":127,"category_code":43,"category_name":44,"subcategory_name":45,"data_exist":14,"product_count":32,"company_count":32,"market_size":32,"market_size_unit":32,"growth_ratio":32,"average_price":32,"average_price_unit":32,"domestic_ratio":32},1715,"ビデオ軟性膵管鏡","70143000",0.163636,0.727871,0.0153846,{"medical_device_id":134,"generic_name":135,"class_classification":58,"jmdn_code":136,"name_similarity":137,"definition_similarity":31,"vector_similarity":138,"score":132,"id":134,"category_code":43,"category_name":44,"subcategory_name":45,"data_exist":14,"product_count":139,"company_count":125,"market_size":32,"market_size_unit":32,"growth_ratio":32,"average_price":32,"average_price_unit":32,"domestic_ratio":32},1788,"内視鏡挿入形状検出装置","70161000",0.32,0.681168,5,{"medical_device_id":141,"generic_name":142,"class_classification":38,"jmdn_code":143,"name_similarity":31,"definition_similarity":31,"vector_similarity":144,"score":145,"id":141,"category_code":63,"category_name":64,"subcategory_name":146,"data_exist":14,"product_count":139,"company_count":47,"market_size":32,"market_size_unit":32,"growth_ratio":32,"average_price":32,"average_price_unit":32,"domestic_ratio":32},3403,"近点距離計","12821000",0.724341,0.0151515,"生体検査用機器",[148,156,163,170,177,184,190,197,204,211,217,224,230,236,242,249,255,261,266,273,278,283,288,295,301,306,312,318,323,329,335,341,346,352,357,362,368,373,377,382,387,392,398,403,408,414,419,423,428,433,437,442,447,452,456,460,464,468,473,477,482,486,491,497,502,506,510,515,519,523,527,531,535,540,545,549,553,557,561,565,569,573,577,581,584,588,592,596,600,604,608,612,616,620,625,629,633,637,641,645,650,654,657,661,665,669,673,677,680,684,689,693,698,702,705,710,713,716,720,723,727,731,734,737,740,745],{"product_code":149,"device_name":150,"device_class":151,"medical_specialty":10,"k510_count":152,"pma_count":31,"event_count":153,"recall_count":154,"device_name_ja":155},"GCJ","Laparoscope, General & Plastic Surgery","2",1426,83077,274,"腹腔鏡（一般外科・形成外科用）",{"product_code":157,"device_name":158,"device_class":151,"medical_specialty":10,"k510_count":159,"pma_count":31,"event_count":160,"recall_count":161,"device_name_ja":162},"NAY","System, Surgical, Computer Controlled Instrument",165,136068,248,"コンピュータ制御手術用器械システム",{"product_code":164,"device_name":165,"device_class":151,"medical_specialty":10,"k510_count":166,"pma_count":31,"event_count":167,"recall_count":168,"device_name_ja":169},"FGB","Ureteroscope And Accessories, Flexible\u002FRigid",115,6470,27,"軟性・硬性尿管鏡及び付属品",{"product_code":171,"device_name":172,"device_class":151,"medical_specialty":10,"k510_count":173,"pma_count":31,"event_count":174,"recall_count":175,"device_name_ja":176},"FDF","Colonoscope And Accessories, Flexible\u002FRigid",113,76673,25,"大腸内視鏡およびその附属品（軟性・硬性）",{"product_code":178,"device_name":179,"device_class":151,"medical_specialty":10,"k510_count":180,"pma_count":31,"event_count":181,"recall_count":182,"device_name_ja":183},"FED","Endoscopic Access Overtube, Gastroenterology-Urology",102,1305,12,"内視鏡挿入補助用オーバーチューブ（消化器・泌尿器科用）",{"product_code":185,"device_name":186,"device_class":151,"medical_specialty":10,"k510_count":187,"pma_count":31,"event_count":188,"recall_count":76,"device_name_ja":189},"FET","Endoscopic Video Imaging System\u002FComponent, Gastroenterology-Urology",100,60698,"内視鏡用ビデオ画像観察装置（消化器・尿路用）",{"product_code":191,"device_name":192,"device_class":151,"medical_specialty":10,"k510_count":193,"pma_count":31,"event_count":194,"recall_count":195,"device_name_ja":196},"OCX","Endoscopic Irrigation\u002FSuction System",93,258,18,"内視鏡用洗浄吸引システム",{"product_code":198,"device_name":199,"device_class":151,"medical_specialty":10,"k510_count":200,"pma_count":31,"event_count":201,"recall_count":202,"device_name_ja":203},"FAJ","Cystoscope And Accessories, Flexible\u002FRigid",92,10265,22,"膀胱鏡及び付属品（軟性\u002F硬性）",{"product_code":205,"device_name":206,"device_class":151,"medical_specialty":10,"k510_count":207,"pma_count":31,"event_count":208,"recall_count":209,"device_name_ja":210},"FBK","Endoscopic Injection Needle, Gastroenterology-Urology",89,565,42,"内視鏡用注射針（消化器・泌尿器用）",{"product_code":212,"device_name":213,"device_class":151,"medical_specialty":10,"k510_count":214,"pma_count":31,"event_count":215,"recall_count":182,"device_name_ja":216},"FDS","Gastroscope And Accessories, Flexible\u002FRigid",76,71783,"胃鏡及び付属品（軟性・硬性）",{"product_code":218,"device_name":219,"device_class":151,"medical_specialty":10,"k510_count":220,"pma_count":31,"event_count":221,"recall_count":222,"device_name_ja":223},"OCZ","Endoscopic Grasping\u002FCutting Instrument, Non-Powered",74,2206,21,"内視鏡用把持鉗子・切開器具（非電動式）",{"product_code":225,"device_name":226,"device_class":151,"medical_specialty":10,"k510_count":227,"pma_count":31,"event_count":228,"recall_count":48,"device_name_ja":229},"ODC","Endoscope Channel Accessory",72,644,"内視鏡チャンネル用アクセサリ",{"product_code":231,"device_name":232,"device_class":151,"medical_specialty":10,"k510_count":233,"pma_count":31,"event_count":234,"recall_count":47,"device_name_ja":235},"OCW","Endoscopic Tissue Approximation Device",70,3113,"内視鏡的組織近接デバイス",{"product_code":237,"device_name":238,"device_class":151,"medical_specialty":10,"k510_count":239,"pma_count":31,"event_count":240,"recall_count":47,"device_name_ja":241},"OWN","Confocal Optical Imaging",62,1515,"共焦点光学画像化装置",{"product_code":243,"device_name":244,"device_class":151,"medical_specialty":10,"k510_count":245,"pma_count":31,"event_count":246,"recall_count":247,"device_name_ja":248},"FEB","Accessories, Cleaning, For Endoscope",57,5020,40,"内視鏡用洗浄アクセサリ",{"product_code":250,"device_name":251,"device_class":151,"medical_specialty":10,"k510_count":252,"pma_count":31,"event_count":253,"recall_count":48,"device_name_ja":254},"GCT","Light Source, Endoscope, Xenon Arc",47,2311,"キセノンアーク内視鏡用光源",{"product_code":256,"device_name":257,"device_class":151,"medical_specialty":10,"k510_count":258,"pma_count":31,"event_count":259,"recall_count":139,"device_name_ja":260},"FDX","Endoscopic Cytology Brush",44,694,"内視鏡用細胞診ブラシ",{"product_code":262,"device_name":263,"device_class":151,"medical_specialty":10,"k510_count":258,"pma_count":31,"event_count":264,"recall_count":102,"device_name_ja":265},"ODG","Endoscopic Ultrasound System, Gastroenterology-Urology",15940,"内視鏡的超音波システム（消化器・泌尿器用）",{"product_code":267,"device_name":268,"device_class":151,"medical_specialty":10,"k510_count":269,"pma_count":31,"event_count":270,"recall_count":271,"device_name_ja":272},"FBN","Choledochoscope And Accessories, Flexible\u002FRigid",43,2281,9,"軟性\u002F硬性胆道鏡及び附属品",{"product_code":274,"device_name":275,"device_class":151,"medical_specialty":10,"k510_count":269,"pma_count":31,"event_count":276,"recall_count":102,"device_name_ja":277},"OCY","Endoscopic Guidewire, Gastroenterology-Urology",1623,"内視鏡用ガイドワイヤ（消化器・泌尿器用）",{"product_code":279,"device_name":280,"device_class":151,"medical_specialty":10,"k510_count":281,"pma_count":31,"event_count":77,"recall_count":31,"device_name_ja":282},"LYK","Angioscope",41,"アンジオスコープ",{"product_code":284,"device_name":285,"device_class":151,"medical_specialty":10,"k510_count":247,"pma_count":31,"event_count":286,"recall_count":125,"device_name_ja":287},"MPA","Endoilluminator",269,"内視鏡用照明装置",{"product_code":289,"device_name":290,"device_class":151,"medical_specialty":10,"k510_count":291,"pma_count":31,"event_count":292,"recall_count":293,"device_name_ja":294},"FDT","Duodenoscope And Accessories, Flexible\u002FRigid",35,23723,38,"十二指腸鏡及び付属品（軟性・硬性）",{"product_code":296,"device_name":297,"device_class":151,"medical_specialty":10,"k510_count":298,"pma_count":31,"event_count":299,"recall_count":139,"device_name_ja":300},"FCW","Light Source, Fiberoptic, Routine",31,2950,"内視鏡用ファイバオプチック光源",{"product_code":302,"device_name":303,"device_class":151,"medical_specialty":10,"k510_count":168,"pma_count":31,"event_count":304,"recall_count":125,"device_name_ja":305},"FER","Anoscope And Accessories",81,"肛門鏡及び附属品",{"product_code":307,"device_name":308,"device_class":151,"medical_specialty":10,"k510_count":168,"pma_count":31,"event_count":309,"recall_count":310,"device_name_ja":311},"OCT","Anti Fog Solution And Accessories, Endoscopy",178,2,"内視鏡用曇り止め液及び附属品",{"product_code":313,"device_name":314,"device_class":151,"medical_specialty":10,"k510_count":315,"pma_count":31,"event_count":316,"recall_count":310,"device_name_ja":317},"FFS","Image, Illumination, Fiberoptic, For Endoscope ",26,338,"内視鏡用光ファイバ照明装置",{"product_code":319,"device_name":320,"device_class":151,"medical_specialty":10,"k510_count":175,"pma_count":31,"event_count":321,"recall_count":310,"device_name_ja":322},"FCX","Insufflator, Automatic Carbon-Dioxide For Endoscope",523,"内視鏡用自動二酸化炭素送気装置",{"product_code":324,"device_name":325,"device_class":151,"medical_specialty":10,"k510_count":326,"pma_count":31,"event_count":327,"recall_count":310,"device_name_ja":328},"FAM","Sigmoidoscope And Accessories, Flexible\u002FRigid",24,53,"軟性・硬性S状結腸鏡及び附属品",{"product_code":330,"device_name":331,"device_class":151,"medical_specialty":10,"k510_count":326,"pma_count":31,"event_count":332,"recall_count":333,"device_name_ja":334},"FJL","Resectoscope",934,33,"レゼクトスコープ",{"product_code":336,"device_name":337,"device_class":151,"medical_specialty":10,"k510_count":338,"pma_count":31,"event_count":339,"recall_count":182,"device_name_ja":340},"NLM","Laparoscope, General & Plastic Surgery, Reprocessed",23,467,"再製造腹腔鏡（一般外科・形成外科用）",{"product_code":342,"device_name":343,"device_class":151,"medical_specialty":10,"k510_count":222,"pma_count":31,"event_count":344,"recall_count":139,"device_name_ja":345},"FEQ","Pump, Air, Non-Manual, For Endoscope",1303,"内視鏡用非手動式送気ポンプ",{"product_code":347,"device_name":348,"device_class":8,"medical_specialty":10,"k510_count":349,"pma_count":31,"event_count":350,"recall_count":31,"device_name_ja":351},"FCO","Box, Battery, Rechargeable",20,101,"充電式バッテリーボックス",{"product_code":353,"device_name":354,"device_class":151,"medical_specialty":10,"k510_count":349,"pma_count":31,"event_count":355,"recall_count":31,"device_name_ja":356},"FDA","Enteroscope And Accessories",787,"小腸内視鏡及び附属品",{"product_code":358,"device_name":359,"device_class":151,"medical_specialty":10,"k510_count":349,"pma_count":31,"event_count":360,"recall_count":47,"device_name_ja":361},"ODE","Endoscopic Suture\u002FPlication System, Gastroesophageal Reflux Disease (Gerd)",356,"内視鏡的縫合\u002F縫縮システム（胃食道逆流症用）",{"product_code":363,"device_name":364,"device_class":151,"medical_specialty":10,"k510_count":365,"pma_count":31,"event_count":366,"recall_count":77,"device_name_ja":367},"FBO","Cystourethroscope",19,275,"膀胱尿道鏡",{"product_code":369,"device_name":370,"device_class":151,"medical_specialty":10,"k510_count":195,"pma_count":31,"event_count":371,"recall_count":31,"device_name_ja":372},"GCM","Endoscope, Rigid",1464,"硬性内視鏡",{"product_code":374,"device_name":375,"device_class":151,"medical_specialty":10,"k510_count":195,"pma_count":31,"event_count":168,"recall_count":31,"device_name_ja":376},"ODA","Endoscopic Central Control Unit","内視鏡用中央制御装置",{"product_code":378,"device_name":379,"device_class":151,"medical_specialty":10,"k510_count":195,"pma_count":31,"event_count":380,"recall_count":31,"device_name_ja":381},"ODD","Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula",126,"内視鏡的逆行性胆管膵管造影カニューレ",{"product_code":383,"device_name":384,"device_class":151,"medical_specialty":10,"k510_count":385,"pma_count":31,"event_count":304,"recall_count":31,"device_name_ja":386},"FHO","Pneumoperitoneum Needle",15,"気腹針",{"product_code":388,"device_name":389,"device_class":151,"medical_specialty":10,"k510_count":101,"pma_count":31,"event_count":390,"recall_count":139,"device_name_ja":391},"GCI","Laryngoscope, Endoscope",1653,"喉頭鏡内視鏡",{"product_code":393,"device_name":394,"device_class":151,"medical_specialty":10,"k510_count":395,"pma_count":31,"event_count":396,"recall_count":139,"device_name_ja":397},"GCP","Endoscope, Ac-Powered And Accessories",13,692,"交流電源式内視鏡及び附属品",{"product_code":399,"device_name":400,"device_class":151,"medical_specialty":10,"k510_count":182,"pma_count":31,"event_count":401,"recall_count":125,"device_name_ja":402},"NVE","Washer, Cleaner, Automated, Endoscope",264,"内視鏡自動洗浄装置",{"product_code":404,"device_name":405,"device_class":151,"medical_specialty":10,"k510_count":182,"pma_count":31,"event_count":406,"recall_count":31,"device_name_ja":407},"ODF","Mini Endoscope, Gastroenterology-Urology",28,"消化器・泌尿器用ミニ内視鏡",{"product_code":409,"device_name":410,"device_class":151,"medical_specialty":10,"k510_count":411,"pma_count":31,"event_count":412,"recall_count":31,"device_name_ja":413},"FDC","Resectoscope, Working Element",11,434,"レゼクトスコープ用作動部",{"product_code":415,"device_name":416,"device_class":151,"medical_specialty":10,"k510_count":411,"pma_count":31,"event_count":417,"recall_count":125,"device_name_ja":418},"NZA","Accessories, Germicide, Cleaning, For Endoscopes",90,"内視鏡用殺菌洗浄剤",{"product_code":420,"device_name":421,"device_class":151,"medical_specialty":10,"k510_count":411,"pma_count":31,"event_count":195,"recall_count":31,"device_name_ja":422},"OTJ","Laparoscopic Single Port Access Device","腹腔鏡下単孔式アクセスデバイス",{"product_code":424,"device_name":425,"device_class":151,"medical_specialty":10,"k510_count":102,"pma_count":31,"event_count":426,"recall_count":76,"device_name_ja":427},"FGA","Kit, Nephroscope",95,"腎鏡キット",{"product_code":429,"device_name":430,"device_class":151,"medical_specialty":10,"k510_count":102,"pma_count":31,"event_count":431,"recall_count":31,"device_name_ja":432},"OCV","Endoscope Holder",6,"内視鏡保持装置",{"product_code":434,"device_name":435,"device_class":151,"medical_specialty":10,"k510_count":271,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":436},"GCS","Endoscope, Battery-Powered And Accessories","バッテリー式内視鏡及び附属品",{"product_code":438,"device_name":439,"device_class":151,"medical_specialty":10,"k510_count":271,"pma_count":31,"event_count":440,"recall_count":31,"device_name_ja":441},"NTN","Led Light Source",268,"LED光源装置",{"product_code":443,"device_name":444,"device_class":151,"medical_specialty":10,"k510_count":271,"pma_count":31,"event_count":445,"recall_count":365,"device_name_ja":446},"NWB","Endoscope, Accessories, Narrow Band Spectrum",13808,"狭帯域スペクトル内視鏡アクセサリ",{"product_code":448,"device_name":449,"device_class":151,"medical_specialty":10,"k510_count":271,"pma_count":31,"event_count":450,"recall_count":47,"device_name_ja":451},"PEA","Endoscope, Accessories, Image Post-Processing For Color Enhancement",608,"内視鏡用色彩強調画像後処理アクセサリ",{"product_code":453,"device_name":454,"device_class":151,"medical_specialty":10,"k510_count":271,"pma_count":31,"event_count":233,"recall_count":125,"device_name_ja":455},"PLL","Submucosal Injection Agent","粘膜下注入剤",{"product_code":457,"device_name":458,"device_class":151,"medical_specialty":10,"k510_count":76,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":459},"QSM","System, Surgical, Computer Controlled Instrument, Remanufactured","再製造コンピュータ制御手術用器具システム",{"product_code":461,"device_name":462,"device_class":151,"medical_specialty":10,"k510_count":77,"pma_count":31,"event_count":168,"recall_count":31,"device_name_ja":463},"GDB","Endoscope, Fiber Optic","ファイバースコープ式内視鏡",{"product_code":465,"device_name":466,"device_class":151,"medical_specialty":10,"k510_count":431,"pma_count":31,"event_count":76,"recall_count":31,"device_name_ja":467},"FHX","Jelly, Lubricating, For Transurethral Surgical Instrument","経尿道的手術器具用潤滑ゼリー",{"product_code":469,"device_name":470,"device_class":8,"medical_specialty":10,"k510_count":431,"pma_count":31,"event_count":471,"recall_count":31,"device_name_ja":472},"MNK","Endoscopic Bite Block",158,"内視鏡用バイトブロック",{"product_code":474,"device_name":475,"device_class":151,"medical_specialty":10,"k510_count":431,"pma_count":31,"event_count":125,"recall_count":125,"device_name_ja":476},"OCU","Endoscopic Storage Cover","内視鏡保管用カバー",{"product_code":478,"device_name":479,"device_class":151,"medical_specialty":10,"k510_count":139,"pma_count":31,"event_count":480,"recall_count":31,"device_name_ja":481},"FBP","Telescope, Rigid, Endoscopic",125,"硬性内視鏡用テレスコープ",{"product_code":483,"device_name":484,"device_class":151,"medical_specialty":10,"k510_count":139,"pma_count":31,"event_count":417,"recall_count":202,"device_name_ja":485},"GCQ","Endoscope, Flexible","軟性内視鏡",{"product_code":487,"device_name":488,"device_class":151,"medical_specialty":10,"k510_count":139,"pma_count":31,"event_count":489,"recall_count":31,"device_name_ja":490},"ODB","Endoscopic Contamination Prevention Sheath",46,"内視鏡汚染防止シース",{"product_code":492,"device_name":493,"device_class":151,"medical_specialty":10,"k510_count":47,"pma_count":31,"event_count":494,"recall_count":495,"device_name_ja":496},"FDE","Laparoscopy Kit",250,118,"腹腔鏡検査キット",{"product_code":498,"device_name":499,"device_class":8,"medical_specialty":10,"k510_count":47,"pma_count":31,"event_count":500,"recall_count":139,"device_name_ja":501},"FEM","Accessories, Photographic, For Endoscope (Exclude Light Sources)",693,"内視鏡用写真撮影用アクセサリ（光源を除く）",{"product_code":503,"device_name":504,"device_class":151,"medical_specialty":10,"k510_count":47,"pma_count":31,"event_count":310,"recall_count":125,"device_name_ja":505},"FGS","Carrier, Sponge, Endoscopic","内視鏡用スポンジキャリア",{"product_code":507,"device_name":508,"device_class":151,"medical_specialty":10,"k510_count":47,"pma_count":31,"event_count":315,"recall_count":31,"device_name_ja":509},"GCL","Esophagoscope, General & Plastic Surgery","食道鏡（一般・形成外科用）",{"product_code":511,"device_name":512,"device_class":8,"medical_specialty":10,"k510_count":47,"pma_count":31,"event_count":513,"recall_count":326,"device_name_ja":514},"MNL","Accessories, Cleaning Brushes, For Endoscope",661,"内視鏡用洗浄ブラシ",{"product_code":516,"device_name":517,"device_class":151,"medical_specialty":10,"k510_count":47,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":518},"QZB","Software Controlled Endoscope And Instrument Holder","ソフトウェア制御内視鏡・器具保持装置",{"product_code":520,"device_name":521,"device_class":151,"medical_specialty":10,"k510_count":48,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":522},"FCC","Endoscopic Magnetic Retriever","内視鏡用磁性異物摘出器",{"product_code":524,"device_name":525,"device_class":151,"medical_specialty":10,"k510_count":48,"pma_count":31,"event_count":77,"recall_count":31,"device_name_ja":526},"FCR","Light Source, Photographic, Fiberoptic","光ファイバー式撮影用光源",{"product_code":528,"device_name":529,"device_class":8,"medical_specialty":10,"k510_count":48,"pma_count":31,"event_count":195,"recall_count":31,"device_name_ja":530},"FCY","Bulb, Inflation, For Endoscope","内視鏡用送気球",{"product_code":532,"device_name":533,"device_class":151,"medical_specialty":10,"k510_count":48,"pma_count":31,"event_count":209,"recall_count":31,"device_name_ja":534},"FEC","Obturator, For Endoscope","内視鏡用閉鎖子",{"product_code":536,"device_name":537,"device_class":151,"medical_specialty":10,"k510_count":48,"pma_count":31,"event_count":538,"recall_count":125,"device_name_ja":539},"FFZ","Cord, Electric, For Endoscope",56,"内視鏡用電気コード",{"product_code":541,"device_name":542,"device_class":151,"medical_specialty":10,"k510_count":48,"pma_count":31,"event_count":543,"recall_count":31,"device_name_ja":544},"FGC","Urethroscope",1760,"尿道鏡",{"product_code":546,"device_name":547,"device_class":151,"medical_specialty":10,"k510_count":48,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":548},"GCO","Endoscope, Mirror","ミラー式内視鏡",{"product_code":550,"device_name":551,"device_class":151,"medical_specialty":10,"k510_count":48,"pma_count":31,"event_count":195,"recall_count":338,"device_name_ja":552},"NWU","Endoscope Introducer Kit","内視鏡導入器キット",{"product_code":554,"device_name":555,"device_class":151,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":47,"recall_count":31,"device_name_ja":556},"FAK","Panendoscope (Gastroduodenoscope)","汎用内視鏡（胃十二指腸鏡）",{"product_code":558,"device_name":559,"device_class":151,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":560},"FAN","Sigmoidoscope, Rigid, Electrical","電気式硬性S状結腸鏡",{"product_code":562,"device_name":563,"device_class":8,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":310,"recall_count":125,"device_name_ja":564},"FCP","Box, Battery, Pocket","携帯用電池ボックス",{"product_code":566,"device_name":567,"device_class":8,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":125,"recall_count":31,"device_name_ja":568},"FDZ","Attachment, Eyepiece, For Insertion Of Prescription Lens","処方レンズ挿入用接眼アタッチメント",{"product_code":570,"device_name":571,"device_class":8,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":89,"recall_count":31,"device_name_ja":572},"FEA","Attachment, Teaching, For Endoscope","内視鏡用教育用アタッチメント",{"product_code":574,"device_name":575,"device_class":8,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":365,"recall_count":310,"device_name_ja":576},"FEI","Instrument, Special Lens, For Endoscope","内視鏡用特殊レンズ器具",{"product_code":578,"device_name":579,"device_class":8,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":271,"recall_count":31,"device_name_ja":580},"FFY","Adaptor, Bulbs, Miscellaneous, For Endoscope","内視鏡用バルブアダプタ",{"product_code":582,"device_name":583,"device_class":151,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":195,"recall_count":31,"device_name_ja":386},"FHP","Needle, Pneumoperitoneum, Simple",{"product_code":585,"device_name":586,"device_class":151,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":587},"FTI","Lamp, Endoscope, Incandescent","内視鏡用白熱ランプ",{"product_code":589,"device_name":590,"device_class":151,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":139,"recall_count":125,"device_name_ja":591},"GCF","Proctoscope","直腸鏡",{"product_code":593,"device_name":594,"device_class":151,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":310,"recall_count":31,"device_name_ja":595},"KGD","Scissors For Cystoscope","膀胱鏡用剪刀",{"product_code":597,"device_name":598,"device_class":151,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":139,"recall_count":31,"device_name_ja":599},"NBG","Marker, Colon","大腸マーカー",{"product_code":601,"device_name":602,"device_class":151,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":603},"NEQ","Device, Telemedicine, Robotic","遠隔医療用ロボット装置",{"product_code":605,"device_name":606,"device_class":151,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":310,"recall_count":31,"device_name_ja":607},"PCV","Endoscopic Leak Tester","内視鏡漏水検知装置",{"product_code":609,"device_name":610,"device_class":151,"medical_specialty":10,"k510_count":310,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":611},"SFE","Endoscopic Video Imaging System \u002F Software Component For Real Time Video Augmentation","内視鏡用ビデオ画像システム／リアルタイム映像強調用ソフトウェアコンポーネント",{"product_code":613,"device_name":614,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":310,"recall_count":31,"device_name_ja":615},"FAL","Panendoscope (Urethroscope)","汎用内視鏡（尿道鏡）",{"product_code":617,"device_name":618,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":291,"recall_count":31,"device_name_ja":619},"FCQ","Light Source, Incandescent, Diagnostic","診断用白熱光源",{"product_code":621,"device_name":622,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":623,"recall_count":31,"device_name_ja":624},"FDP","Apparatus, Pneumoperitoneum, Automatic",124,"自動気腹装置",{"product_code":626,"device_name":627,"device_class":8,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":125,"recall_count":31,"device_name_ja":628},"FEJ","Attachment, Binocular, For Endoscope","内視鏡用双眼アタッチメント",{"product_code":630,"device_name":631,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":310,"recall_count":431,"device_name_ja":632},"GCW","Transformer, Endoscope","内視鏡用トランスフォーマー",{"product_code":634,"device_name":635,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":31,"recall_count":125,"device_name_ja":636},"KDM","Sigmoidoscope, Rigid, Non-Electrical","非電動式硬性S状結腸鏡",{"product_code":638,"device_name":639,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":310,"recall_count":31,"device_name_ja":640},"KDO","Rongeur, Cystoscopic, Hot","電気焼灼式膀胱鏡用ロンジュール",{"product_code":642,"device_name":643,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":310,"recall_count":31,"device_name_ja":644},"KYH","Endoscope, Ophthalmic","眼科用内視鏡",{"product_code":646,"device_name":647,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":648,"recall_count":31,"device_name_ja":649},"MFJ","Device, Endoscopic Suturing",842,"内視鏡用縫合器",{"product_code":651,"device_name":652,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":653},"NWS","Kit, Choledochoscope, Flexible And Rigid","軟性・硬性胆道鏡キット",{"product_code":655,"device_name":186,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":139,"recall_count":125,"device_name_ja":656},"OCS","内視鏡用ビデオ画像システム／構成部品（消化器・泌尿器用）",{"product_code":658,"device_name":659,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":431,"recall_count":31,"device_name_ja":660},"PGU","Spatial Imaging For Display Of Endoscope Position","内視鏡位置表示用空間イメージング装置",{"product_code":662,"device_name":663,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":298,"recall_count":31,"device_name_ja":664},"PUP","Endoscope Maintenance System","内視鏡メンテナンスシステム",{"product_code":666,"device_name":667,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":668},"QGY","Mobile \u002F Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera","手術用・内視鏡用カメラ設定制御モバイル\u002Fタブレットソフトウェアアプリケーション",{"product_code":670,"device_name":671,"device_class":151,"medical_specialty":10,"k510_count":125,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":672},"SHU","Appendiceal Scope And Accessories, Flexible","軟性虫垂鏡及び付属品",{"product_code":674,"device_name":675,"device_class":8,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":310,"recall_count":31,"device_name_ja":676},"EXZ","Equipment, Photographic, For Physiologic Function Monitor","生理機能モニタ用写真撮影装置",{"product_code":678,"device_name":679,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":32},"FBI","Rongeur, Cystoscopic",{"product_code":681,"device_name":682,"device_class":8,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":395,"recall_count":31,"device_name_ja":683},"FCZ","Tube, Smoke Removal, Endoscopic","内視鏡用排煙チューブ",{"product_code":685,"device_name":686,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":687,"recall_count":31,"device_name_ja":688},"FDR","Sphyncteroscope",299,"括約筋鏡",{"product_code":690,"device_name":691,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":125,"recall_count":31,"device_name_ja":692},"FDW","Esophagoscope, Rigid, Gastro-Urology","硬性食道鏡（消化器・泌尿器用）",{"product_code":694,"device_name":695,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":696,"recall_count":31,"device_name_ja":697},"FTJ","Colonoscope, General & Plastic Surgery",223,"一般・形成外科用大腸内視鏡",{"product_code":699,"device_name":700,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":125,"recall_count":31,"device_name_ja":701},"GCG","Peritoneoscope","腹腔鏡",{"product_code":703,"device_name":704,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":32},"GCH","Mediastinoscope, Diagnostic",{"product_code":706,"device_name":707,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":708,"recall_count":125,"device_name_ja":709},"GCK","Gastroscope, General & Plastic Surgery",39,"汎用・形成外科用胃鏡",{"product_code":711,"device_name":712,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":32},"GCN","Endoscope, Prism",{"product_code":714,"device_name":715,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":32},"NKZ","Endoilluminator, Reprocessed",{"product_code":717,"device_name":718,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":125,"recall_count":31,"device_name_ja":719},"NLX","Needle, Pneumoperitoneum, Spring Loaded, Reprocessed","気腹用バネ式穿刺針（再製造品）",{"product_code":721,"device_name":722,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":32},"NMY","Needle, Endoscopic, Reprocessed",{"product_code":724,"device_name":725,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":310,"recall_count":31,"device_name_ja":726},"NWT","Endoscopic Cholangiogram Kit","内視鏡的胆管造影キット",{"product_code":728,"device_name":729,"device_class":8,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":125,"recall_count":31,"device_name_ja":730},"PHT","Basin For Endoscope Reprocessing","内視鏡再処理用浸漬槽",{"product_code":732,"device_name":733,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":32},"PPE","Nephroscope Set",{"product_code":735,"device_name":736,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":32},"PTQ","Endoscopic Magnetic Retriever, Exempt",{"product_code":738,"device_name":739,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":32},"PTR","Scissors For Cytoscope, Exempt",{"product_code":741,"device_name":742,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":743,"recall_count":31,"device_name_ja":744},"PTS","Endoscopic Grasping\u002FCutting Instrument, Non-Powered, Exempt",349,"内視鏡用把持切開器具（非電動式・届出免除）",{"product_code":746,"device_name":747,"device_class":151,"medical_specialty":10,"k510_count":31,"pma_count":31,"event_count":31,"recall_count":31,"device_name_ja":32},"SBX","Software For Endoscopy Procedure Metrics",{"510k":749,"classification":750,"enforcement":751,"event":752,"pma":753,"warning_letter":754},"2026-08-31T02:00:43.975+00:00","2026-08-31T02:00:42.972+00:00","2026-08-31T02:00:43.715+00:00","2026-08-31T04:01:28.676+00:00","2026-08-31T02:00:44.255+00:00","2026-08-20T03:28:02.95+00:00",{"items":756,"total":31},[],{"items":758,"total":31},[],{"items":760,"total":31},[]]