[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-EXE":3},{"classification":4,"mappedDevices":126,"similarCandidates":127,"relatedClassifications":199,"syncDates":234},{"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":119,"updated_at":120,"recall_count":121,"latest_recall_date":122,"k510_count":123,"pma_count":124,"event_count":125},6662,"EXE","Protector, Ostomy","1","876.5900","GU","Gastroenterology, Urology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":117,"product_code":6,"review_panel":10,"gmp_exempt_flag":117,"third_party_flag":117,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":117,"medical_specialty_description":11,"summary_malfunction_reporting":118},{"k_number":17,"fei_number":21,"registration_number":106},[18,19,20],"K770982","K760927","K904233",[22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"1000339531","3003902312","3027517726","1000522686","3002807315","3009655869","3006787036","3016758972","3015414875","3003172243","3045058049","3000719502","1220581","3003264198","3011247798","3015300984","1000219637","3007441619","3003348807","3003565456","3034669683","3000206450","3031184338","3006131984","3016452400","3015219237","3015821396","3014195785","3031582434","3015332213","3044921221","3006121457","3013557562","3014461810","3016675012","3011987967","3010372554","3015140199","3013530901","3011558220","3015865915","3030446844","3006582718","3011689956","3012502601","3013298431","3012034017","3027514586","3011814545","3010580321","3013564290","1480288","3012421607","3013863160","3008432385","3011270181","3013180212","3006609021","2023344","3044150131","3010961310","3012465068","3016426850","3004610510","3014579161","3030733800","3008806809","3015142802","3014666579","3021632375","3008244559","3030226295","3011191255","1119193","3012706495","3011495142","3037918935","3014404707","3017448136","1000317571","3043226252","3004216008","3015140210","3007417132",[23,24,26,27,107,108,28,29,109,30,32,34,36,37,39,40,42,44,45,46,47,110,111,48,49,112,50,51,52,113,114,53,54,55,56,115,57,58,59,60,61,62,63,65,66,67,68,69,70,116,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,104,105],"3006358042","8022978","9681410","9710641","9618003","8040278","2320961","2530957","1058584","1225157","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",4,"2025-01-22",3,0,32248,[],[128,136,143,150,158,165,172,179,185,191],{"medical_device_id":129,"generic_name":130,"class_classification":131,"jmdn_code":132,"name_similarity":133,"definition_similarity":124,"vector_similarity":134,"score":135},4418,"再使用可能な指保護具","Ⅰ","42050000",0.30303,0.665385,0.0315136,{"medical_device_id":137,"generic_name":138,"class_classification":131,"jmdn_code":139,"name_similarity":140,"definition_similarity":124,"vector_similarity":141,"score":142},4417,"単回使用指保護具","35073000",0.294118,0.657114,0.0305789,{"medical_device_id":144,"generic_name":145,"class_classification":131,"jmdn_code":146,"name_similarity":147,"definition_similarity":124,"vector_similarity":148,"score":149},3309,"放射線防護用顔面防護具","38363000",0.3125,0.652659,0.030478,{"medical_device_id":151,"generic_name":152,"class_classification":153,"jmdn_code":154,"name_similarity":155,"definition_similarity":124,"vector_similarity":156,"score":157},2253,"創傷保護リング","Ⅱ","44273000",0.233333,0.669843,0.0297619,{"medical_device_id":159,"generic_name":160,"class_classification":153,"jmdn_code":161,"name_similarity":162,"definition_similarity":124,"vector_similarity":163,"score":164},2647,"歯科矯正用長期粘膜保護材","70738000",0.229167,0.658918,0.028624,{"medical_device_id":166,"generic_name":167,"class_classification":131,"jmdn_code":168,"name_similarity":169,"definition_similarity":124,"vector_similarity":170,"score":171},3650,"ストーマ用洗浄キット","37716000",0.21875,0.652325,0.0272222,{"medical_device_id":173,"generic_name":174,"class_classification":131,"jmdn_code":175,"name_similarity":176,"definition_similarity":124,"vector_similarity":177,"score":178},4068,"短期的使用歯科矯正用粘膜保護材","70735000",0.211538,0.656398,0.0266314,{"medical_device_id":180,"generic_name":181,"class_classification":131,"jmdn_code":182,"name_similarity":124,"definition_similarity":124,"vector_similarity":183,"score":184},3794,"手術用被覆・保護材","34654000",0.71018,0.0163934,{"medical_device_id":186,"generic_name":187,"class_classification":131,"jmdn_code":188,"name_similarity":124,"definition_similarity":124,"vector_similarity":189,"score":190},4249,"アプライヤ","16446000",0.686748,0.016129,{"medical_device_id":192,"generic_name":193,"class_classification":194,"jmdn_code":195,"name_similarity":196,"definition_similarity":124,"vector_similarity":197,"score":198},183,"癒着防止吸収性バリア","Ⅳ","34212000",0.0384615,0.668712,0.015625,[200,204,208,211,214,218,222,225,228,231],{"product_code":201,"device_name":202,"device_class":8,"k510_count":203},"EXB","Collector, Ostomy",102,{"product_code":205,"device_name":206,"device_class":8,"k510_count":207},"EZQ","Pouch, Colostomy",6,{"product_code":209,"device_name":210,"device_class":8,"k510_count":207},"EZR","Cement, Stomal Appliance, Ostomy",{"product_code":212,"device_name":213,"device_class":8,"k510_count":123},"FON","Bag, Drainage, With Adhesive, Ostomy",{"product_code":215,"device_name":216,"device_class":8,"k510_count":217},"GDS","Bag, Stomal",2,{"product_code":219,"device_name":220,"device_class":8,"k510_count":221},"EXA","Selector, Size, Ostomy",1,{"product_code":223,"device_name":224,"device_class":8,"k510_count":221},"EZS","Appliance, Colostomy, Disposable",{"product_code":226,"device_name":227,"device_class":8,"k510_count":124},"EXG","Bag, Urine Collecting, Ureterostomy",{"product_code":229,"device_name":230,"device_class":8,"k510_count":124},"EXH","Bag, Urinary, Ileostomy",{"product_code":232,"device_name":233,"device_class":8,"k510_count":124},"PQE","Ostomy Care Kit",{"510k":235,"classification":236,"enforcement":237,"event":238,"pma":239,"warning_letter":240},"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"]