[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LBN":3},{"classification":4,"mappedDevices":35,"similarCandidates":36,"relatedClassifications":108,"syncDates":113},{"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":30,"updated_at":31,"recall_count":32,"latest_recall_date":33,"k510_count":34,"pma_count":32,"event_count":34},5551,"LBN","Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene","2","874.3495","EN","Ear, Nose, Throat","1","",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":29},{"k_number":18,"fei_number":20,"registration_number":25},[19],"K822367",[21,22,23,24],"1045254","3003495548","3018094310","3017636737",[21,26,23,24],"9612501","Y","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[37,45,52,59,66,73,80,87,94,101],{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":32,"vector_similarity":43,"score":44},628,"人工全耳小骨","Ⅲ","35674000",0.482143,0.832973,0.0327869,{"medical_device_id":46,"generic_name":47,"class_classification":40,"jmdn_code":48,"name_similarity":49,"definition_similarity":32,"vector_similarity":50,"score":51},631,"局所人工耳小骨","35690000",0.360656,0.765741,0.0322581,{"medical_device_id":53,"generic_name":54,"class_classification":40,"jmdn_code":55,"name_similarity":56,"definition_similarity":32,"vector_similarity":57,"score":58},634,"全人工側頭下顎関節","36042000",0.315068,0.716586,0.0305789,{"medical_device_id":60,"generic_name":61,"class_classification":40,"jmdn_code":62,"name_similarity":63,"definition_similarity":32,"vector_similarity":64,"score":65},620,"全人工手関節","33705000",0.274194,0.713936,0.0294181,{"medical_device_id":67,"generic_name":68,"class_classification":40,"jmdn_code":69,"name_similarity":70,"definition_similarity":32,"vector_similarity":71,"score":72},569,"全人工股関節","36315000",0.283333,0.698204,0.0275298,{"medical_device_id":74,"generic_name":75,"class_classification":40,"jmdn_code":76,"name_similarity":77,"definition_similarity":32,"vector_similarity":78,"score":79},677,"尿道用チューブ補綴材","35279000",0.206349,0.738999,0.0273897,{"medical_device_id":81,"generic_name":82,"class_classification":40,"jmdn_code":83,"name_similarity":84,"definition_similarity":32,"vector_similarity":85,"score":86},615,"全人工足関節","32837000",0.246154,0.704259,0.0270468,{"medical_device_id":88,"generic_name":89,"class_classification":40,"jmdn_code":90,"name_similarity":91,"definition_similarity":32,"vector_similarity":92,"score":93},599,"人工顎関節","35943000",0.246575,0.699981,0.0262796,{"medical_device_id":95,"generic_name":96,"class_classification":40,"jmdn_code":97,"name_similarity":98,"definition_similarity":32,"vector_similarity":99,"score":100},670,"耳用補綴材","35262000",0.20339,0.709644,0.0252525,{"medical_device_id":102,"generic_name":103,"class_classification":40,"jmdn_code":104,"name_similarity":105,"definition_similarity":32,"vector_similarity":106,"score":107},519,"非吸収性ステープルライン補強材料","70435000",0.215909,0.699605,0.0243939,[109],{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"ETA","Replacement, Ossicular Prosthesis, Total",39,{"510k":114,"classification":115,"enforcement":116,"event":117,"pma":118,"warning_letter":119},"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"]