[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-ISM":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":103,"syncDates":134},{"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":15,"raw":16,"created_at":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":30,"event_count":30},4540,"ISM","Pylon, Post Surgical","1","890.3025","PM","Physical Medicine","4","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":23,"product_code":6,"review_panel":10,"gmp_exempt_flag":24,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"fei_number":18,"registration_number":21},[19,20],"1000123590","1000357070",[20,22],"2950684","N","Y","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-18T22:05:38.961415+00:00",1,"2017-03-08",0,[],[33,41,49,56,63,69,76,82,89,96],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":30,"vector_similarity":39,"score":40},4268,"鈎","Ⅰ","35105000",0.36,0.5981,0.0303658,{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":30,"vector_similarity":47,"score":48},2264,"手術用タンプ","Ⅱ","32873000",0.375,0.571043,0.0290832,{"medical_device_id":50,"generic_name":51,"class_classification":36,"jmdn_code":52,"name_similarity":53,"definition_similarity":30,"vector_similarity":54,"score":55},3794,"手術用被覆・保護材","34654000",0.321429,0.590707,0.0287829,{"medical_device_id":57,"generic_name":58,"class_classification":36,"jmdn_code":59,"name_similarity":60,"definition_similarity":30,"vector_similarity":61,"score":62},4190,"手術用のこぎり","13448001",0.409091,0.47481,0.0163934,{"medical_device_id":64,"generic_name":65,"class_classification":36,"jmdn_code":66,"name_similarity":67,"definition_similarity":30,"vector_similarity":68,"score":62},4225,"幽門セパレータ","13543000",0.15625,0.630568,{"medical_device_id":70,"generic_name":71,"class_classification":44,"jmdn_code":72,"name_similarity":73,"definition_similarity":30,"vector_similarity":74,"score":75},1968,"喉頭切開術後用チューブ","12292020",0.135135,0.607906,0.016129,{"medical_device_id":77,"generic_name":78,"class_classification":44,"jmdn_code":79,"name_similarity":80,"definition_similarity":30,"vector_similarity":81,"score":75},2849,"電動式手術用のこぎり","13448022",0.392857,0.46366,{"medical_device_id":83,"generic_name":84,"class_classification":44,"jmdn_code":85,"name_similarity":86,"definition_similarity":30,"vector_similarity":87,"score":88},2252,"手術用パッキング","13886000",0.384615,0.534662,0.015873,{"medical_device_id":90,"generic_name":91,"class_classification":92,"jmdn_code":93,"name_similarity":46,"definition_similarity":30,"vector_similarity":94,"score":95},514,"手術用メッシュ","Ⅲ","16048003",0.531327,0.015625,{"medical_device_id":97,"generic_name":98,"class_classification":44,"jmdn_code":99,"name_similarity":100,"definition_similarity":30,"vector_similarity":101,"score":102},2371,"植込み用注射筒","43989000",0.0487805,0.581032,0.0153846,[104,108,112,115,119,122,125,128,131],{"product_code":105,"device_name":106,"device_class":8,"k510_count":107},"ITG","Bandage, Cast",37,{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"IPG","Shoe, Cast",6,{"product_code":113,"device_name":114,"device_class":8,"k510_count":111},"IPM","Cover, Limb",{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"IQM","Splint, Temporary Training",3,{"product_code":120,"device_name":121,"device_class":8,"k510_count":28},"IQP","Rotator, Transverse",{"product_code":123,"device_name":124,"device_class":8,"k510_count":28},"ISR","Band Or Belt, Pelvic Support",{"product_code":126,"device_name":127,"device_class":8,"k510_count":30},"IQO","Device, Prosthesis Alignment",{"product_code":129,"device_name":130,"device_class":8,"k510_count":30},"NDA","Helmet, Cranial, For Protective Use",{"product_code":132,"device_name":133,"device_class":8,"k510_count":30},"NHF","Monitor, Orthotic\u002FProsthetic",{"510k":135,"classification":136,"enforcement":137,"event":138,"pma":139,"warning_letter":140},"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"]