[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KHJ":3},{"classification":4,"mappedDevices":93,"similarCandidates":94,"relatedClassifications":168,"syncDates":197},{"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":15,"raw":16,"created_at":86,"updated_at":87,"recall_count":88,"latest_recall_date":89,"k510_count":90,"pma_count":91,"event_count":92},6991,"KHJ","Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)","2","874.3620","EN","Ear, Nose, Throat","1","",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":83,"product_code":6,"review_panel":10,"gmp_exempt_flag":84,"third_party_flag":84,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":84,"medical_specialty_description":11,"summary_malfunction_reporting":85},{"k_number":18,"fei_number":52,"registration_number":77},[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],"K120220","K970910","K991324","K150594","K033796","K974311","K060561","K122561","K972700","K013243","K051911","K953013","K051487","K080022","K081531","K003855","K911503","K070093","K132198","K060878","K062280","K103047","K082245","K002972","K932176","K121360","K161000","K232646","K982294","K043035","K964484","K982870","K001148",[53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"3014334038","3003407669","1000113735","3003418325","1000393132","3018094310","3002807315","3002340648","3002768455","1048735","3002806953","3003495548","1928237","3013840437","3009403363","1037007","3009217531","3011050570","3017636737","1045254","3004450973","1416980","3003790304","3006306415",[53,78,56,57,58,59,62,63,65,79,66,67,68,80,69,70,71,72,81,82,73,74,75,76],"1835959","1052728","2135225","1531062","9612501","Y","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",2,"2025-01-22",33,0,23,[],[95,103,110,117,125,133,140,147,154,161],{"medical_device_id":96,"generic_name":97,"class_classification":98,"jmdn_code":99,"name_similarity":100,"definition_similarity":91,"vector_similarity":101,"score":102},259,"人工耳・鼻・喉用吸収性補綴材","Ⅳ","33310204",0.222222,0.719086,0.0306792,{"medical_device_id":104,"generic_name":105,"class_classification":98,"jmdn_code":106,"name_similarity":107,"definition_similarity":91,"vector_similarity":108,"score":109},222,"合成心血管パッチ","35273100",0.225806,0.678937,0.03031,{"medical_device_id":111,"generic_name":112,"class_classification":98,"jmdn_code":113,"name_similarity":114,"definition_similarity":91,"vector_similarity":115,"score":116},271,"合成人工硬膜","70511000",0.285714,0.651631,0.029214,{"medical_device_id":118,"generic_name":119,"class_classification":120,"jmdn_code":121,"name_similarity":122,"definition_similarity":91,"vector_similarity":123,"score":124},2788,"歯科用高分子系仮封材料","Ⅱ","70870002",0.246753,0.645737,0.0277778,{"medical_device_id":126,"generic_name":127,"class_classification":128,"jmdn_code":129,"name_similarity":130,"definition_similarity":91,"vector_similarity":131,"score":132},485,"ポリアミド縫合糸","Ⅲ","38847000",0.2,0.653739,0.0261449,{"medical_device_id":134,"generic_name":135,"class_classification":128,"jmdn_code":136,"name_similarity":137,"definition_similarity":91,"vector_similarity":138,"score":139},1013,"医薬品含有高分子系歯科小窩裂溝封鎖材","31780003",0.224719,0.642049,0.0256039,{"medical_device_id":141,"generic_name":142,"class_classification":128,"jmdn_code":143,"name_similarity":144,"definition_similarity":91,"vector_similarity":145,"score":146},1023,"医薬品含有歯科裏層用高分子系材料","70863003",0.211765,0.646246,0.0255617,{"medical_device_id":148,"generic_name":149,"class_classification":128,"jmdn_code":150,"name_similarity":151,"definition_similarity":91,"vector_similarity":152,"score":153},1027,"医薬品含有歯科用高分子系仮封材料","70870003",0.213483,0.64262,0.0253205,{"medical_device_id":155,"generic_name":156,"class_classification":120,"jmdn_code":157,"name_similarity":158,"definition_similarity":91,"vector_similarity":159,"score":160},2771,"歯科用支台築造材料","38789000",0.188406,0.643815,0.0229885,{"medical_device_id":162,"generic_name":163,"class_classification":98,"jmdn_code":164,"name_similarity":165,"definition_similarity":91,"vector_similarity":166,"score":167},153,"合成吸収性縫合糸","70409000",0.151515,0.686701,0.016129,[169,173,177,181,185,189,193],{"product_code":170,"device_name":171,"device_class":8,"k510_count":172},"MIB","Elastomer, Silicone Block",45,{"product_code":174,"device_name":175,"device_class":8,"k510_count":176},"MIX","System, Vocal Cord Medialization",17,{"product_code":178,"device_name":179,"device_class":8,"k510_count":180},"NHB","Polymer, Ear, Nose And Throat, Synthetic, Absorbable",16,{"product_code":182,"device_name":183,"device_class":8,"k510_count":184},"FWN","Prosthesis, Larynx (Stents And Keels)",10,{"product_code":186,"device_name":187,"device_class":8,"k510_count":188},"MIC","Implant, Muscle, Pectoralis",8,{"product_code":190,"device_name":191,"device_class":8,"k510_count":192},"JOF","Polymer, Ent Synthetic, Porous Polyethylene",6,{"product_code":194,"device_name":195,"device_class":8,"k510_count":196},"ESH","Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane",1,{"510k":198,"classification":199,"enforcement":200,"event":201,"pma":202,"warning_letter":203},"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"]