[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FIZ":3},{"classification":4,"mappedDevices":44,"similarCandidates":45,"relatedClassifications":117,"syncDates":326},{"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":15,"gmp_exempt_flag":14,"raw":16,"created_at":39,"updated_at":40,"recall_count":41,"latest_recall_date":42,"k510_count":43,"pma_count":41,"event_count":41},1235,"FIZ","Meter, Conductivity, Non-Remote","2","876.5820","GU","Gastroenterology, Urology","1","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":36,"product_code":6,"review_panel":10,"gmp_exempt_flag":36,"third_party_flag":36,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":37,"medical_specialty_description":11,"summary_malfunction_reporting":38},{"k_number":18,"fei_number":32,"registration_number":35},[19,20,21,22,23,24,25,26,27,28,29,30,31],"K050812","K881098","K020909","K981294","K871708","K920810","K020908","K955298","K853735","K780932","K201765","K992431","K150657",[33,34],"1720309","3003884198",[33,34],"N","Y","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-18T22:05:38.961415+00:00",0,null,13,[],[46,54,62,70,77,84,91,97,104,110],{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":41,"vector_similarity":52,"score":53},2529,"治療点検索測定器","Ⅱ","31109000",0.230769,0.676831,0.0322665,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":59,"definition_similarity":41,"vector_similarity":60,"score":61},702,"透析液導電率測定装置","Ⅲ","34998000",0.192308,0.672187,0.0312805,{"medical_device_id":63,"generic_name":64,"class_classification":65,"jmdn_code":66,"name_similarity":67,"definition_similarity":41,"vector_similarity":68,"score":69},3414,"コントラスト感度測定装置","Ⅰ","70092000",0.325581,0.604352,0.0163934,{"medical_device_id":71,"generic_name":72,"class_classification":57,"jmdn_code":73,"name_similarity":74,"definition_similarity":41,"vector_similarity":75,"score":76},438,"伝達麻酔用カテーテル","35795009",0.255319,0.510569,0.016129,{"medical_device_id":78,"generic_name":79,"class_classification":49,"jmdn_code":80,"name_similarity":81,"definition_similarity":41,"vector_similarity":82,"score":83},2545,"低周波治療器・鍼電極低周波治療器・治療点検索測定器組合せ理学療法機器","70622000",0.11811,0.665935,0.015873,{"medical_device_id":85,"generic_name":86,"class_classification":49,"jmdn_code":87,"name_similarity":88,"definition_similarity":41,"vector_similarity":89,"score":90},1604,"純音オージオメータ","37503000",0.0851064,0.652224,0.015625,{"medical_device_id":92,"generic_name":93,"class_classification":65,"jmdn_code":94,"name_similarity":95,"definition_similarity":41,"vector_similarity":96,"score":90},3971,"非能動型接触鍼","70613001",0.215686,0.571691,{"medical_device_id":98,"generic_name":99,"class_classification":49,"jmdn_code":100,"name_similarity":101,"definition_similarity":41,"vector_similarity":102,"score":103},1422,"脈拍数計","70061000",0.205128,0.607084,0.0153846,{"medical_device_id":105,"generic_name":106,"class_classification":49,"jmdn_code":107,"name_similarity":108,"definition_similarity":41,"vector_similarity":109,"score":103},1496,"非観血血圧モニタ","31681000",0.0666667,0.650146,{"medical_device_id":111,"generic_name":112,"class_classification":49,"jmdn_code":113,"name_similarity":114,"definition_similarity":41,"vector_similarity":115,"score":116},1553,"テレメトリー式心電受信モジュール","37176000",0.0909091,0.648734,0.0151515,[118,122,126,130,134,138,142,146,150,154,158,161,165,168,172,175,179,182,186,189,192,195,199,202,205,208,212,215,218,221,224,227,231,234,237,240,243,247,250,254,257,260,263,266,269,272,275,278,281,284,287,290,293,296,299,302,305,308,311,314,317,320,323],{"product_code":119,"device_name":120,"device_class":8,"k510_count":121},"KOC","Accessories, Blood Circuit, Hemodialysis",182,{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"FJI","Dialyzer, Capillary, Hollow Fiber",131,{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"KPO","Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",123,{"product_code":131,"device_name":132,"device_class":8,"k510_count":133},"FJK","Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",77,{"product_code":135,"device_name":136,"device_class":8,"k510_count":137},"FKQ","System, Dialysate Delivery, Central Multiple Patient",61,{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"LIF","Dialyzer Reprocessing System",57,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"FKP","System, Dialysate Delivery, Single Patient",50,{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"FJG","Dialyzer, Parallel Flow",36,{"product_code":151,"device_name":152,"device_class":8,"k510_count":153},"FIB","Protector, Transducer, Dialysis",35,{"product_code":155,"device_name":156,"device_class":8,"k510_count":157},"FIN","Tank, Holding, Dialysis",18,{"product_code":159,"device_name":160,"device_class":8,"k510_count":157},"MQS","System, Hemodialysis, Access Recirculation Monitoring",{"product_code":162,"device_name":163,"device_class":8,"k510_count":164},"FHS","Dialyzer, Single Coil",12,{"product_code":166,"device_name":167,"device_class":8,"k510_count":164},"FKR","Subsystem, Proportioning",{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"FIL","System, Dialysate Delivery, Single Pass",8,{"product_code":173,"device_name":174,"device_class":8,"k510_count":171},"FKH","Solution-Test Standard-Conductivity, Dialysis",{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"FIR","Pump, Blood, Extra-Luminal",7,{"product_code":180,"device_name":181,"device_class":8,"k510_count":178},"MSE","Hemodialyzer, Re-Use, Low Flux",{"product_code":183,"device_name":184,"device_class":8,"k510_count":185},"FIF","Set, Dialysis, Single Needle With Uni-Directional Pump",6,{"product_code":187,"device_name":188,"device_class":12,"k510_count":185},"FKG","Tray, Start\u002FStop (Including Contents), Dialysis",{"product_code":190,"device_name":191,"device_class":8,"k510_count":185},"FLB","Meter, Conductivity, Induction, Remote Type",{"product_code":193,"device_name":194,"device_class":8,"k510_count":185},"MNV","Strip, Dialysate Ph Indicator",{"product_code":196,"device_name":197,"device_class":8,"k510_count":198},"FIH","Pump, Infusion Or Syringe, Extra-Luminal",5,{"product_code":200,"device_name":201,"device_class":8,"k510_count":198},"FJF","Detector, Air Bubble",{"product_code":203,"device_name":204,"device_class":8,"k510_count":198},"FJT","Intracatheter, Dialysis",{"product_code":206,"device_name":207,"device_class":8,"k510_count":198},"FKJ","Filter, Blood, Dialysis",{"product_code":209,"device_name":210,"device_class":8,"k510_count":211},"FIG","Clamp, Tubing, Blood, Automatic",4,{"product_code":213,"device_name":214,"device_class":8,"k510_count":211},"FJD","Detector, Leak, Blood",{"product_code":216,"device_name":217,"device_class":8,"k510_count":211},"FKY","Connector, Tubing, Dialysate",{"product_code":219,"device_name":220,"device_class":8,"k510_count":211},"FLC","Station, Dialysis Control, Negative Pressure Type",{"product_code":222,"device_name":223,"device_class":8,"k510_count":211},"KXM","System Accessories, Extracorporeal",{"product_code":225,"device_name":226,"device_class":8,"k510_count":211},"ODX","Autonomous Extracorporeal Blood Leak Detector\u002FAlarm",{"product_code":228,"device_name":229,"device_class":8,"k510_count":230},"FID","Tubing, Dialysate",3,{"product_code":232,"device_name":233,"device_class":8,"k510_count":230},"FJB","Detector, Dialysate Level",{"product_code":235,"device_name":236,"device_class":8,"k510_count":230},"FJZ","Declotting Tray, Kit (Including Contents)",{"product_code":238,"device_name":239,"device_class":8,"k510_count":230},"FKI","Set, Dialyzer Holder",{"product_code":241,"device_name":242,"device_class":8,"k510_count":230},"FLA","Monitor, Temperature, Dialysis",{"product_code":244,"device_name":245,"device_class":8,"k510_count":246},"FKB","Connector, Blood Tubing, Infusion T",2,{"product_code":248,"device_name":249,"device_class":8,"k510_count":246},"LLB","System, Blood, Extracorporeal And Accessories",{"product_code":251,"device_name":252,"device_class":8,"k510_count":253},"FIJ","System, Dialysate Delivery, Recirculating, Single Pass",1,{"product_code":255,"device_name":256,"device_class":8,"k510_count":253},"FIW","Alarm, Pillow Pressure",{"product_code":258,"device_name":259,"device_class":8,"k510_count":253},"FJC","Detector, Blood Level",{"product_code":261,"device_name":262,"device_class":8,"k510_count":253},"FKD","Canister, Coil",{"product_code":264,"device_name":265,"device_class":8,"k510_count":253},"FKL","Insert, Pump, Blood",{"product_code":267,"device_name":268,"device_class":8,"k510_count":253},"KQQ","Tubing, Dialysate (And Connector)",{"product_code":270,"device_name":271,"device_class":8,"k510_count":253},"LRI","Ph Meter For Dialysis Hydrogen Ion Concentration",{"product_code":273,"device_name":274,"device_class":8,"k510_count":253},"NTZ","Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator",{"product_code":276,"device_name":277,"device_class":12,"k510_count":41},"FIA","Chair, Dialysis, Unpowered, Without Scales",{"product_code":279,"device_name":280,"device_class":8,"k510_count":41},"FIK","System, Dialysate Delivery, Recirculating",{"product_code":282,"device_name":283,"device_class":8,"k510_count":41},"FIS","Flowmeter, Dialysate",{"product_code":285,"device_name":286,"device_class":8,"k510_count":41},"FJA","Manometer, Water",{"product_code":288,"device_name":289,"device_class":8,"k510_count":41},"FJJ","Dialyzer, Twin Coil",{"product_code":291,"device_name":292,"device_class":8,"k510_count":41},"FJP","Adaptor, Y",{"product_code":294,"device_name":295,"device_class":12,"k510_count":41},"FKE","Tie, Dialysis",{"product_code":297,"device_name":298,"device_class":12,"k510_count":41},"FKF","Gun, Tie, Dialysis",{"product_code":300,"device_name":301,"device_class":8,"k510_count":41},"FKM","Adaptor, Fistula",{"product_code":303,"device_name":304,"device_class":8,"k510_count":41},"KQR","Detector, Air Or Foam",{"product_code":306,"device_name":307,"device_class":12,"k510_count":41},"MON","System, Hemodialysis, Remote Accessories",{"product_code":309,"device_name":310,"device_class":8,"k510_count":41},"NNG","Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed",{"product_code":312,"device_name":313,"device_class":8,"k510_count":41},"PEV","Dialysis Administration Kit",{"product_code":315,"device_name":316,"device_class":8,"k510_count":41},"PPH","Single Needle With Uni-Directional Pump Kit",{"product_code":318,"device_name":319,"device_class":8,"k510_count":41},"PPI","Hemodialysis Tray (Not A Start\u002FStop Kit)",{"product_code":321,"device_name":322,"device_class":8,"k510_count":41},"PPL","Single Needle (Co-Axial Flow) Dialysis Kit",{"product_code":324,"device_name":325,"device_class":8,"k510_count":41},"PRO","Anti-Regurgitation Blood Tubing Kit",{"510k":327,"classification":328,"enforcement":329,"event":330,"pma":331,"warning_letter":332},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]