[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HEF":3},{"classification":4,"mappedDevices":81,"similarCandidates":82,"relatedClassifications":148,"syncDates":162},{"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":76,"updated_at":77,"recall_count":78,"latest_recall_date":79,"k510_count":78,"pma_count":78,"event_count":80},3391,"HEF","Binder, Breast","1","880.5160","HO","General Hospital","4","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":73,"product_code":6,"review_panel":10,"gmp_exempt_flag":74,"third_party_flag":73,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":73,"medical_specialty_description":11,"summary_malfunction_reporting":75},{"fei_number":18,"registration_number":66},[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65],"3008863514","3007817069","3006609021","3004755469","3014407894","3016707060","3019888059","1043644","3006227741","3005855077","1000641183","3014457829","3000206450","3004024638","3012895304","1000132035","3014144875","3004511024","1417592","3012408006","1926174","3003052290","3003255844","3006010416","2938604","3008023310","1038963","3008114969","3045174673","3017633586","3008973893","3006076154","3003905499","1214422","1525724","3043051412","3013498096","3006121457","3010359088","3004134970","3007740574","3026020435","3005748481","3007076137","3013180212","3012971326","3003855936",[19,20,21,23,24,25,26,27,28,29,30,32,33,35,36,37,38,39,67,42,43,44,45,46,68,47,48,49,69,51,52,53,54,55,56,57,70,58,71,59,72,60,61,62,63,64,65],"1225157","1057079","9616086","9617045","9616933","9612388","N","Y","Eligible","2026-08-18T05:52:50.955415+00:00","2026-08-18T22:05:38.961415+00:00",0,null,3,[],[83,91,98,104,112,118,124,130,136,142],{"medical_device_id":84,"generic_name":85,"class_classification":86,"jmdn_code":87,"name_similarity":88,"definition_similarity":78,"vector_similarity":89,"score":90},3279,"胸部画像診断・放射線治療用患者体位固定具","Ⅰ","40899000",0.0921053,0.581777,0.0269162,{"medical_device_id":92,"generic_name":93,"class_classification":94,"jmdn_code":95,"name_similarity":78,"definition_similarity":78,"vector_similarity":96,"score":97},268,"ゲル充填人工乳房","Ⅳ","36197000",0.602573,0.0163934,{"medical_device_id":99,"generic_name":100,"class_classification":86,"jmdn_code":101,"name_similarity":102,"definition_similarity":78,"vector_similarity":103,"score":97},3922,"血液回路遮断器具","70548000",0.193548,0.389665,{"medical_device_id":105,"generic_name":106,"class_classification":107,"jmdn_code":108,"name_similarity":109,"definition_similarity":78,"vector_similarity":110,"score":111},644,"挿入器付後房レンズ","Ⅲ","35658400",0.0212766,0.599217,0.016129,{"medical_device_id":113,"generic_name":114,"class_classification":86,"jmdn_code":115,"name_similarity":116,"definition_similarity":78,"vector_similarity":117,"score":111},3833,"呼吸ガス混合器","36327009",0.178571,0.367657,{"medical_device_id":119,"generic_name":120,"class_classification":94,"jmdn_code":121,"name_similarity":78,"definition_similarity":78,"vector_similarity":122,"score":123},43,"ヘパリン使用大静脈カニューレ","34904200",0.59142,0.015873,{"medical_device_id":125,"generic_name":126,"class_classification":86,"jmdn_code":127,"name_similarity":128,"definition_similarity":78,"vector_similarity":129,"score":123},3925,"呼吸ガスミキサ","70563000",0.15625,0.383336,{"medical_device_id":131,"generic_name":132,"class_classification":94,"jmdn_code":133,"name_similarity":78,"definition_similarity":78,"vector_similarity":134,"score":135},41,"ヘパリン使用冠動脈カニューレ","34896200",0.58654,0.015625,{"medical_device_id":137,"generic_name":138,"class_classification":86,"jmdn_code":139,"name_similarity":140,"definition_similarity":78,"vector_similarity":141,"score":135},4191,"ギプスカッタ用刃","15774000",0.153846,0.406704,{"medical_device_id":143,"generic_name":144,"class_classification":94,"jmdn_code":145,"name_similarity":78,"definition_similarity":78,"vector_similarity":146,"score":147},49,"ヘパリン使用心室カニューレ","35891200",0.58239,0.0153846,[149,153,156,159],{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"FSD","Binder, Abdominal",5,{"product_code":154,"device_name":155,"device_class":8,"k510_count":152},"KMO","Binder, Elastic",{"product_code":157,"device_name":158,"device_class":8,"k510_count":78},"FQK","Binder, Perineal",{"product_code":160,"device_name":161,"device_class":8,"k510_count":78},"MDR","Binder, Medical, Therapeutic",{"510k":163,"classification":164,"enforcement":165,"event":166,"pma":167,"warning_letter":168},"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","2026-08-19T04:07:02.603+00:00"]