[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FZS":3},{"classification":4,"mappedDevices":347,"similarCandidates":348,"relatedClassifications":422,"syncDates":798},{"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":340,"updated_at":341,"recall_count":342,"latest_recall_date":343,"k510_count":344,"pma_count":345,"event_count":346},3167,"FZS","Curette, Surgical, General Use","1","878.4800","SU","General, Plastic Surgery","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":338,"product_code":6,"review_panel":10,"gmp_exempt_flag":338,"third_party_flag":338,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":338,"medical_specialty_description":11,"summary_malfunction_reporting":339},{"k_number":17,"fei_number":32,"registration_number":251},[18,19,20,21,22,23,24,25,26,27,28,29,30,31],"K842701","K892521","K875292","K831367","K854888","K891888","K803178","K932493","K902000","K854899","K891334","K831119","K890366","K871925",[13,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250],"3017980495","1000306276","4486","3005693456","3004788213","3005349543","2245304","3018094310","3045853999","3003424264","3022862651","3001084743","3008004502","1000443015","3002807072","1000521467","3006487092","3003775395","3022320321","3007185216","3004028763","3008911114","3009822485","3003473212","1222188","3003772581","1000143502","3003694247","3003052153","3008501922","3006142527","3012267976","1000114355","3005734757","3038187464","3007589150","3003431869","2523865","2511556","3015895045","1317628","3023155873","3009995358","3008110533","3007264034","3003249645","3004095748","3007728266","1000405819","3005194291","3002834291","3008808049","3016825318","3010071016","1923569","3005641619","3007137643","1000632857","3012995405","3002750084","3002806575","3003597504","3008770252","3006554912","1000168975","3005726885","3030644259","3009027787","3003675041","3007648354","3000183921","3005695838","3012966183","1000136191","3002902165","3002786339","3000286616","6827","3011371465","1000160162","3012120772","3009513193","3031564283","3007221462","3002808001","3015972835","3002807156","3003697160","1000347621","3004216008","3002806773","3002806315","2183650","3010606097","3002807988","3006561161","5870","3033526648","3004608878","3010687973","3013557562","3008782585","3032747418","3002807421","3005180920","3002409980","3013358456","3013194153","1000123297","3003807268","3003015552","3010097171","3010041511","3037407500","3003944071","1000159990","3000280067","3017352116","1000139987","3004499989","1000208866","3006803771","3005587147","3014334038","1412854","3011689956","1000124817","4476","3006509795","3008571754","3002807091","3042940336","3021519357","1000221916","3036795921","3002904345","3005440795","2521453","3010055973","3005528784","1417592","3016069968","1219518","3006765019","1000525271","3010405304","3008285983","3004001706","3005809810","3039103971","1000402972","3009340886","3002808145","3015351976","1038671","3008338766","2434839","3002806862","3002631673","3546","3002807646","3002806452","3034688516","3033536312","3003435550","3008902714","3002808043","3004705187","3016032497","1825034","3029082594","1000111204","3005649458","3004971305","3001408183","4498","3023657851","1000127001","3005182241","3010123256","3012494290","3003418325","3010041420","3002315844","1216677","3004215117","3002807183","1000388472","3002807214","3007663067","1421101","3005083075","1000477302","1000194896","3003499455","1000119305","3002807264","3002807464","2916714","3003914946","2183449","3008439467","1035236","1000115048","3009746061","3016965929","3013497507","3002808264","3012507533","3027262786","3035708926","3043226252","3003510542","3013503739","3003448211","3003058448","3005747797","1000140363",[13,252,253,33,254,37,39,40,41,43,44,45,49,255,256,50,51,52,257,258,54,259,260,55,57,261,63,60,262,64,263,264,67,265,68,69,71,72,74,76,266,80,82,267,83,84,85,86,87,268,88,89,90,91,269,270,271,272,94,95,273,96,274,275,98,99,100,276,101,277,102,278,104,105,279,280,109,281,111,282,283,113,114,115,116,118,284,285,286,287,288,289,290,125,126,128,130,131,132,133,135,137,291,292,139,140,146,142,144,293,145,150,152,294,154,155,156,295,157,296,158,297,298,162,299,300,164,165,301,167,169,302,170,303,171,172,173,174,175,304,176,178,179,305,180,306,182,181,307,184,185,186,187,188,308,189,195,309,196,197,198,200,310,201,311,312,202,313,203,314,206,207,315,316,317,209,318,211,212,213,214,215,217,218,319,320,222,321,223,224,322,323,324,231,325,326,233,327,328,234,235,237,329,330,238,239,331,241,242,243,332,333,244,245,246,334,335,336,337],"8010298","1054986","2084346","9680026","1722511","9614986","9611278","9680889","8010099","8010257","9614062","1057425","9680059","8010935","9616246","1422507","1057946","3027615","1123010","3008132398","1424263","8010273","9610612","2032098","9611262","1056350","1055890","2087382","2436906","9613926","1932180","9611610","9680837","8031525","8040278","9611274","9710524","9680260","9611579","2431166","9615857","8043368","3007597038","9611827","8010374","1833986","9613079","9680718","9612086","1313525","1836161","9616250","9612278","8010155","8043816","3011137372","9610905","9611062","1424785","8044030","1421879","8010591","8043496","1722824","8040233","8010665","1646747","8010547","2249529","9680890","2529846","8040179","9680519","9611390","1030489","8030607","9612420","2248030","9611112","9611102","8010890","3005067367","9612074","9680735","8044098","1424478","N","Eligible","2026-08-18T05:52:50.955415+00:00","2026-08-18T22:05:38.961415+00:00",3,"2025-01-22",14,0,71,[],[349,357,365,373,380,387,394,402,408,415],{"medical_device_id":350,"generic_name":351,"class_classification":352,"jmdn_code":353,"name_similarity":354,"definition_similarity":345,"vector_similarity":355,"score":356},953,"汎用冷凍手術ユニット","Ⅲ","11067000",0.386364,0.631275,0.0302135,{"medical_device_id":358,"generic_name":359,"class_classification":360,"jmdn_code":361,"name_similarity":362,"definition_similarity":345,"vector_similarity":363,"score":364},2867,"単回使用眼科用鋭ひ","Ⅱ","32772002",0.288889,0.714697,0.0287873,{"medical_device_id":366,"generic_name":367,"class_classification":368,"jmdn_code":369,"name_similarity":370,"definition_similarity":345,"vector_similarity":371,"score":372},3797,"単回使用汎用サージカルドレープ","Ⅰ","35531000",0.425532,0.613008,0.0276294,{"medical_device_id":374,"generic_name":375,"class_classification":360,"jmdn_code":376,"name_similarity":377,"definition_similarity":345,"vector_similarity":378,"score":379},3171,"単回使用電動剥離器","71048002",0.290323,0.649955,0.0275264,{"medical_device_id":381,"generic_name":382,"class_classification":368,"jmdn_code":383,"name_similarity":384,"definition_similarity":345,"vector_similarity":385,"score":386},3822,"単回使用クラスⅠ処置キット","33961001",0.277778,0.620115,0.0251821,{"medical_device_id":388,"generic_name":389,"class_classification":352,"jmdn_code":390,"name_similarity":391,"definition_similarity":345,"vector_similarity":392,"score":393},535,"単回使用クラスⅢ処置キット","33961003",0.267857,0.618223,0.0239316,{"medical_device_id":395,"generic_name":396,"class_classification":397,"jmdn_code":398,"name_similarity":399,"definition_similarity":345,"vector_similarity":400,"score":401},191,"単回使用クラスⅣ処置キット","Ⅳ","33961004",0.272727,0.615563,0.0236894,{"medical_device_id":403,"generic_name":404,"class_classification":360,"jmdn_code":405,"name_similarity":399,"definition_similarity":345,"vector_similarity":406,"score":407},2265,"単回使用クラスⅡ処置キット","33961002",0.613233,0.0229915,{"medical_device_id":409,"generic_name":410,"class_classification":368,"jmdn_code":411,"name_similarity":412,"definition_similarity":345,"vector_similarity":413,"score":414},4009,"歯科用キュレット","31904000",0.264706,0.734878,0.0163934,{"medical_device_id":416,"generic_name":417,"class_classification":360,"jmdn_code":418,"name_similarity":419,"definition_similarity":345,"vector_similarity":420,"score":421},2554,"一般的電気手術器","70647000",0.365854,0.596874,0.015873,[423,427,431,435,439,443,447,451,455,459,462,466,470,474,478,482,486,490,494,498,501,505,508,512,516,520,523,526,529,533,537,541,544,548,552,555,558,562,565,568,571,574,578,581,585,588,591,594,597,601,604,607,610,613,616,619,622,625,628,631,635,638,641,644,647,650,653,656,659,662,666,669,672,675,678,681,684,687,690,693,696,699,702,705,708,711,714,717,720,723,726,729,732,735,738,741,744,747,750,753,756,759,762,765,768,771,774,777,780,783,786,789,792,795],{"product_code":424,"device_name":425,"device_class":8,"k510_count":426},"GAA","Needle, Aspiration And Injection, Disposable",107,{"product_code":428,"device_name":429,"device_class":8,"k510_count":430},"GEN","Forceps, General & Plastic Surgery",104,{"product_code":432,"device_name":433,"device_class":8,"k510_count":434},"GAD","Retractor",100,{"product_code":436,"device_name":437,"device_class":8,"k510_count":438},"FSM","Tray, Surgical, Instrument",76,{"product_code":440,"device_name":441,"device_class":8,"k510_count":442},"HTD","Forceps",73,{"product_code":444,"device_name":445,"device_class":8,"k510_count":446},"KDC","Instrument, Surgical, Disposable",67,{"product_code":448,"device_name":449,"device_class":8,"k510_count":450},"KDD","Kit, Surgical Instrument, Disposable",62,{"product_code":452,"device_name":453,"device_class":8,"k510_count":454},"FZT","Cutter, Surgical",52,{"product_code":456,"device_name":457,"device_class":8,"k510_count":458},"GDM","Needle, Aspiration And Injection, Reusable",48,{"product_code":460,"device_name":461,"device_class":8,"k510_count":458},"GES","Blade, Scalpel",{"product_code":463,"device_name":464,"device_class":8,"k510_count":465},"MDM","Instrument, Manual, Surgical, General Use",44,{"product_code":467,"device_name":468,"device_class":8,"k510_count":469},"GEC","Brush, Scrub, Operating-Room",37,{"product_code":471,"device_name":472,"device_class":8,"k510_count":473},"GEA","Cannula, Surgical, General & Plastic Surgery",36,{"product_code":475,"device_name":476,"device_class":8,"k510_count":477},"GDJ","Clamp, Surgical, General & Plastic Surgery",32,{"product_code":479,"device_name":480,"device_class":8,"k510_count":481},"GDF","Guide, Needle, Surgical",28,{"product_code":483,"device_name":484,"device_class":8,"k510_count":485},"GDX","Scalpel, One-Piece",26,{"product_code":487,"device_name":488,"device_class":8,"k510_count":489},"FTY","Tape, Measuring, Rulers And Calipers",23,{"product_code":491,"device_name":492,"device_class":8,"k510_count":493},"LRP","Tray, Surgical",22,{"product_code":495,"device_name":496,"device_class":8,"k510_count":497},"EMF","Knife, Surgical",21,{"product_code":499,"device_name":500,"device_class":8,"k510_count":497},"HTZ","Instrument, Cutting, Orthopedic",{"product_code":502,"device_name":503,"device_class":8,"k510_count":504},"FZX","Guide, Surgical, Instrument",19,{"product_code":506,"device_name":507,"device_class":8,"k510_count":504},"KAM","Cannula, Sinus",{"product_code":509,"device_name":510,"device_class":8,"k510_count":511},"LRW","Scissors, General, Surgical",18,{"product_code":513,"device_name":514,"device_class":8,"k510_count":515},"GDZ","Handle, Scalpel",16,{"product_code":517,"device_name":518,"device_class":8,"k510_count":519},"HRQ","Hemostat",15,{"product_code":521,"device_name":522,"device_class":8,"k510_count":519},"MCZ","Suture Removal Kit",{"product_code":524,"device_name":525,"device_class":8,"k510_count":344},"GDO","Applier, Surgical, Clip",{"product_code":527,"device_name":528,"device_class":8,"k510_count":344},"HXD","Clamp",{"product_code":530,"device_name":531,"device_class":8,"k510_count":532},"GEG","Elevator, Surgical, General & Plastic Surgery",12,{"product_code":534,"device_name":535,"device_class":8,"k510_count":536},"DWO","Needle, Biopsy, Cardiovascular",11,{"product_code":538,"device_name":539,"device_class":8,"k510_count":540},"GDG","Hook, Surgical, General & Plastic Surgery",10,{"product_code":542,"device_name":543,"device_class":8,"k510_count":540},"HTC","Pliers, Surgical",{"product_code":545,"device_name":546,"device_class":8,"k510_count":547},"HTR","Rasp",9,{"product_code":549,"device_name":550,"device_class":8,"k510_count":551},"FSH","Tray, Surgical, Needle",8,{"product_code":553,"device_name":554,"device_class":8,"k510_count":551},"FZW","Expander, Surgical, Skin Graft",{"product_code":556,"device_name":557,"device_class":8,"k510_count":551},"GAB","Needle, Suturing, Disposable",{"product_code":559,"device_name":560,"device_class":8,"k510_count":561},"GAH","Stylet, Surgical, General & Plastic Surgery",7,{"product_code":563,"device_name":564,"device_class":8,"k510_count":561},"GDI","Dissector, Surgical, General & Plastic Surgery",{"product_code":566,"device_name":567,"device_class":8,"k510_count":561},"GEE","Brush, Biopsy, General & Plastic Surgery",{"product_code":569,"device_name":570,"device_class":8,"k510_count":561},"LRY","Punch, Surgical",{"product_code":572,"device_name":573,"device_class":8,"k510_count":561},"MJG","Device, Percutaneous, Biopsy",{"product_code":575,"device_name":576,"device_class":8,"k510_count":577},"GDH","Gouge, Surgical, General & Plastic Surgery",6,{"product_code":579,"device_name":580,"device_class":8,"k510_count":577},"GFI","Osteotome, Manual",{"product_code":582,"device_name":583,"device_class":8,"k510_count":584},"GAF","Spatula, Surgical, General & Plastic Surgery",5,{"product_code":586,"device_name":587,"device_class":8,"k510_count":584},"GCZ","Retainer, Surgical",{"product_code":589,"device_name":590,"device_class":8,"k510_count":584},"GDL","Needle, Suturing, Reusable",{"product_code":592,"device_name":593,"device_class":8,"k510_count":584},"GEJ","Carrier, Ligature",{"product_code":595,"device_name":596,"device_class":8,"k510_count":584},"HCF","Instrument, Ligature Passing And Knot Tying",{"product_code":598,"device_name":599,"device_class":8,"k510_count":600},"FSP","Loupe, Diagnostic\u002FSurgical",4,{"product_code":602,"device_name":603,"device_class":8,"k510_count":600},"GAE","Snare, Surgical",{"product_code":605,"device_name":606,"device_class":8,"k510_count":600},"GEF","Applier, Staple, Surgical,",{"product_code":608,"device_name":609,"device_class":8,"k510_count":600},"HBT","Applier, Hemostatic Clip",{"product_code":611,"device_name":612,"device_class":8,"k510_count":600},"HXR","Spatula, Orthopedic",{"product_code":614,"device_name":615,"device_class":8,"k510_count":600},"LWK","Razor, Surgical",{"product_code":617,"device_name":618,"device_class":8,"k510_count":342},"GFJ","Mallet, Surgical, General & Plastic Surgery",{"product_code":620,"device_name":621,"device_class":8,"k510_count":342},"HTF","Curette",{"product_code":623,"device_name":624,"device_class":8,"k510_count":342},"HWM","Osteotome",{"product_code":626,"device_name":627,"device_class":8,"k510_count":342},"HXL","Mallet",{"product_code":629,"device_name":630,"device_class":8,"k510_count":342},"LRZ","Screwdriver, Surgical",{"product_code":632,"device_name":633,"device_class":8,"k510_count":634},"FHM","Apparatus, Suturing, Stomach And Intestinal",2,{"product_code":636,"device_name":637,"device_class":8,"k510_count":634},"FZO","Chisel, Surgical, Manual",{"product_code":639,"device_name":640,"device_class":8,"k510_count":634},"GAC","Rasp, Surgical, General & Plastic Surgery",{"product_code":642,"device_name":643,"device_class":8,"k510_count":634},"GDR","Saw, Manual And Accessories",{"product_code":645,"device_name":646,"device_class":8,"k510_count":634},"GED","Brush, Dermabrasion, Manual",{"product_code":648,"device_name":649,"device_class":8,"k510_count":634},"GEO","File, Surgical, General & Plastic Surgery",{"product_code":651,"device_name":652,"device_class":8,"k510_count":634},"JYC","Cannula, Ear",{"product_code":654,"device_name":655,"device_class":8,"k510_count":634},"LXZ","Guard, Instrument",{"product_code":657,"device_name":658,"device_class":8,"k510_count":634},"LYV","Label Or Tag, Sterile",{"product_code":660,"device_name":661,"device_class":8,"k510_count":634},"PIR","Mercy Tape 2d And 3d Models",{"product_code":663,"device_name":664,"device_class":8,"k510_count":665},"FHR","Needle, Gastro-Urology",1,{"product_code":667,"device_name":668,"device_class":8,"k510_count":665},"FTX","Mirror, General & Plastic Surgery",{"product_code":670,"device_name":671,"device_class":8,"k510_count":665},"FZY","Hammer, Surgical",{"product_code":673,"device_name":674,"device_class":8,"k510_count":665},"GDN","Knife, Amputation",{"product_code":676,"device_name":677,"device_class":8,"k510_count":665},"JYD","Chisel, Mastoid",{"product_code":679,"device_name":680,"device_class":8,"k510_count":665},"KIK","Hook, Bone",{"product_code":682,"device_name":683,"device_class":8,"k510_count":665},"LSA","Vise, Bench, Surgical",{"product_code":685,"device_name":686,"device_class":8,"k510_count":665},"LXK","Scrapper, Skin Specimen",{"product_code":688,"device_name":689,"device_class":8,"k510_count":665},"MAW","Marker, Suture Identification",{"product_code":691,"device_name":692,"device_class":8,"k510_count":665},"OJU","Skin Prep Tray",{"product_code":694,"device_name":695,"device_class":8,"k510_count":665},"QQO","Cranial Measurement Software",{"product_code":697,"device_name":698,"device_class":8,"k510_count":345},"FZR","Contractor, Surgical",{"product_code":700,"device_name":701,"device_class":8,"k510_count":345},"GAI","Stripper, Vein, Reusable",{"product_code":703,"device_name":704,"device_class":8,"k510_count":345},"GAJ","Stripper, Vein, Disposable",{"product_code":706,"device_name":707,"device_class":8,"k510_count":345},"HSO","Saw",{"product_code":709,"device_name":710,"device_class":8,"k510_count":345},"HTE","Elevator",{"product_code":712,"device_name":713,"device_class":8,"k510_count":345},"HXT","Tape, Orthopedic",{"product_code":715,"device_name":716,"device_class":8,"k510_count":345},"HYA","Forceps, Wire Holding",{"product_code":718,"device_name":719,"device_class":8,"k510_count":345},"KAN","Chisel, Nasal",{"product_code":721,"device_name":722,"device_class":8,"k510_count":345},"KCE","Cannulae, Bronchial",{"product_code":724,"device_name":725,"device_class":8,"k510_count":345},"MIJ","Needle, Tumor Localization",{"product_code":727,"device_name":728,"device_class":8,"k510_count":345},"NJZ","Extractor, Vein",{"product_code":730,"device_name":731,"device_class":8,"k510_count":345},"NLK","Needle, Biopsy, Cardiovascular, Reprocessed",{"product_code":733,"device_name":734,"device_class":8,"k510_count":345},"NMU","Needle, Gastro-Urology, Reprocessed",{"product_code":736,"device_name":737,"device_class":8,"k510_count":345},"NNA","Biopsy Device, Percutaneous, Reprocessed",{"product_code":739,"device_name":740,"device_class":8,"k510_count":345},"NNC","Needle, Aspiration And Needle, Reprocessed",{"product_code":742,"device_name":743,"device_class":8,"k510_count":345},"OJH","Orthopedic Tray",{"product_code":745,"device_name":746,"device_class":8,"k510_count":345},"OJT","Aspiration Tray",{"product_code":748,"device_name":749,"device_class":8,"k510_count":345},"OJV","Single Use Instrument Tray",{"product_code":751,"device_name":752,"device_class":8,"k510_count":345},"PKE","Laparoscopic Cholecystectomy Kit",{"product_code":754,"device_name":755,"device_class":8,"k510_count":345},"PPP","Disposable Joint Aspiration\u002FInjection Kit",{"product_code":757,"device_name":758,"device_class":8,"k510_count":345},"PXN","Basic Set-Up Tray",{"product_code":760,"device_name":761,"device_class":8,"k510_count":345},"PXO","Bone Marrow Biopsy Tray",{"product_code":763,"device_name":764,"device_class":8,"k510_count":345},"PXP","Breast Biopsy \u002F Localization Tray",{"product_code":766,"device_name":767,"device_class":8,"k510_count":345},"PXS","Cholecystectomy Kit",{"product_code":769,"device_name":770,"device_class":8,"k510_count":345},"PXV","General Purpose Instrument Tray",{"product_code":772,"device_name":773,"device_class":8,"k510_count":345},"PXW","Herniorraphy Kit",{"product_code":775,"device_name":776,"device_class":8,"k510_count":345},"PXX","Incision Tray",{"product_code":778,"device_name":779,"device_class":8,"k510_count":345},"PXZ","Laparascopic Sphincterotomy Kit",{"product_code":781,"device_name":782,"device_class":8,"k510_count":345},"PYA","Liver Biopsy Kit",{"product_code":784,"device_name":785,"device_class":8,"k510_count":345},"PYB","Minor Surgical Procedures Tray",{"product_code":787,"device_name":788,"device_class":8,"k510_count":345},"PYD","Pelviscopy Kit",{"product_code":790,"device_name":791,"device_class":8,"k510_count":345},"PYF","Sterile Puncture Tray",{"product_code":793,"device_name":794,"device_class":8,"k510_count":345},"PYH","Surgical Retractor Kit",{"product_code":796,"device_name":797,"device_class":8,"k510_count":345},"QMX","Label Or Tag, Non-Sterile",{"510k":799,"classification":800,"enforcement":801,"event":802,"pma":803,"warning_letter":804},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]