[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-IWR":3},{"classification":4,"mappedDevices":49,"similarCandidates":50,"relatedClassifications":120,"syncDates":157},{"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":43,"updated_at":44,"recall_count":45,"latest_recall_date":46,"k510_count":47,"pma_count":45,"event_count":48},3350,"IWR","Holder, Syringe, Lead","1","892.6500","RA","Radiology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":41,"product_code":6,"review_panel":10,"gmp_exempt_flag":41,"third_party_flag":41,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":41,"medical_specialty_description":11,"summary_malfunction_reporting":42},{"k_number":17,"fei_number":22,"registration_number":38},[18,19,20,21],"K872656","K811688","K934549","K863936",[23,24,25,26,27,28,29,30,31,32,33,34,35,36,37],"3003808764","3043047788","3004491626","3009088444","3029900933","3020824984","2182762","3005579300","2518443","1048735","3013070673","3003350319","3004216008","3010141508","3012690638",[23,24,39,25,26,27,28,29,40,31,32,30,33,36,37],"8040278","3034521","N","Eligible","2026-08-18T05:52:50.955415+00:00","2026-08-18T22:05:38.961415+00:00",0,null,4,1,[],[51,59,66,73,81,88,95,101,107,113],{"medical_device_id":52,"generic_name":53,"class_classification":54,"jmdn_code":55,"name_similarity":56,"definition_similarity":45,"vector_similarity":57,"score":58},3674,"カテーテル等保持用ホルダ","Ⅰ","15735000",0.25,0.683208,0.0306792,{"medical_device_id":60,"generic_name":61,"class_classification":54,"jmdn_code":62,"name_similarity":63,"definition_similarity":45,"vector_similarity":64,"score":65},3754,"持針器","12726010",0.259259,0.646061,0.03031,{"medical_device_id":67,"generic_name":68,"class_classification":54,"jmdn_code":69,"name_similarity":70,"definition_similarity":45,"vector_similarity":71,"score":72},3610,"汎用注射筒","13929001",0.228571,0.68196,0.0294624,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":45,"vector_similarity":79,"score":80},1844,"血液ガス検体採取用注射筒","Ⅱ","16785000",0.266667,0.638616,0.0294372,{"medical_device_id":82,"generic_name":83,"class_classification":54,"jmdn_code":84,"name_similarity":85,"definition_similarity":45,"vector_similarity":86,"score":87},3642,"歯科用シリンジ","35970011",0.296296,0.62685,0.0286935,{"medical_device_id":89,"generic_name":90,"class_classification":54,"jmdn_code":91,"name_similarity":92,"definition_similarity":45,"vector_similarity":93,"score":94},3854,"再使用可能な歯科用シリンジ","35970021",0.222222,0.648107,0.0284455,{"medical_device_id":96,"generic_name":97,"class_classification":54,"jmdn_code":98,"name_similarity":56,"definition_similarity":45,"vector_similarity":99,"score":100},3611,"血管造影用注射筒","15286000",0.63541,0.0283816,{"medical_device_id":102,"generic_name":103,"class_classification":54,"jmdn_code":104,"name_similarity":56,"definition_similarity":45,"vector_similarity":105,"score":106},3613,"麻酔用注射筒","35387001",0.637305,0.0279734,{"medical_device_id":108,"generic_name":109,"class_classification":54,"jmdn_code":110,"name_similarity":92,"definition_similarity":45,"vector_similarity":111,"score":112},3620,"ガラス注射筒","70202000",0.641216,0.0270516,{"medical_device_id":114,"generic_name":115,"class_classification":54,"jmdn_code":116,"name_similarity":117,"definition_similarity":45,"vector_similarity":118,"score":119},3615,"精密投与皮下注射用注射筒","35904000",0.217391,0.627711,0.0251821,[121,125,129,133,136,140,144,147,151,154],{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"KPY","Shield, Protective, Personnel",25,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"EAK","Screen, Leaded, Operator Radiation Protector",7,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"EAJ","Apron, Leaded",6,{"product_code":134,"device_name":135,"device_class":8,"k510_count":132},"IWS","Shield, Eye, Radiological",{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"IWP","Radiographic Protective Glove",5,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"IWQ","Curtain, Protective, Radiographic",3,{"product_code":145,"device_name":146,"device_class":8,"k510_count":143},"IWX","Barrier, Control Panel, X-Ray, Movable",{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"IWT","Shield, Gonadal",2,{"product_code":152,"device_name":153,"device_class":8,"k510_count":48},"IWO","Apron, Protective",{"product_code":155,"device_name":156,"device_class":8,"k510_count":48},"IWW","Shield, Vial",{"510k":158,"classification":159,"enforcement":160,"event":161,"pma":162,"warning_letter":163},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]