[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MVA":3},{"classification":4,"mappedDevices":91,"similarCandidates":92,"relatedClassifications":165,"syncDates":170},{"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":85,"updated_at":86,"recall_count":87,"latest_recall_date":88,"k510_count":89,"pma_count":87,"event_count":90},4332,"MVA","Orthosis, Cranial","2","882.5970","NE","Neurology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":83,"product_code":6,"review_panel":10,"gmp_exempt_flag":83,"third_party_flag":83,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":83,"medical_specialty_description":11,"summary_malfunction_reporting":84},{"k_number":17,"fei_number":61,"registration_number":78},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60],"K011433","K001167","K000861","K180568","K023572","K193383","K063133","K003630","K141842","K021221","K111609","K020448","K103362","K223238","K030669","K111247","K201426","K133397","K241957","K013700","K013719","K063395","K013452","K213587","K003035","K140353","DEN980001","K001669","K021594","K012007","K230444","K070694","K022273","K042385","K090341","K010273","K013458","K012830","K203134","K041215","K220681","K012920","K012804",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77],"3005021665","1000560772","3042028951","3003404025","3003895329","3003355324","3015259854","1831680","3045077481","1721652","3038871395","3000215614","3001967835","1215709","1000222089","1000246715",[62,63,79,64,80,66,69,68,70,71,72,81,74,75,82,77],"2030829","3003603920","2032381","1058152","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",0,null,43,13,[],[93,101,109,116,124,130,138,145,152,159],{"medical_device_id":94,"generic_name":95,"class_classification":96,"jmdn_code":97,"name_similarity":98,"definition_similarity":87,"vector_similarity":99,"score":100},3181,"頭蓋形状矯正ヘルメット","Ⅱ","62265003",0.342105,0.753582,0.0325225,{"medical_device_id":102,"generic_name":103,"class_classification":104,"jmdn_code":105,"name_similarity":106,"definition_similarity":87,"vector_similarity":107,"score":108},4205,"頭蓋骨用バー","Ⅰ","10520001",0.380952,0.609634,0.0322665,{"medical_device_id":110,"generic_name":111,"class_classification":96,"jmdn_code":112,"name_similarity":113,"definition_similarity":87,"vector_similarity":114,"score":115},2853,"単回使用頭蓋骨用バー","10520002",0.25,0.589305,0.0310245,{"medical_device_id":117,"generic_name":118,"class_classification":119,"jmdn_code":120,"name_similarity":121,"definition_similarity":87,"vector_similarity":122,"score":123},596,"頭蓋骨固定用クランプ","Ⅲ","70500000",0.235294,0.609466,0.0310096,{"medical_device_id":125,"generic_name":126,"class_classification":119,"jmdn_code":127,"name_similarity":121,"definition_similarity":87,"vector_similarity":128,"score":129},611,"頭蓋用レジン様化合物","16131000",0.57649,0.0297095,{"medical_device_id":131,"generic_name":132,"class_classification":133,"jmdn_code":134,"name_similarity":135,"definition_similarity":87,"vector_similarity":136,"score":137},1085,"吸収性頭蓋骨固定用クランプ","Ⅳ","70500004",0.177778,0.58547,0.0282194,{"medical_device_id":139,"generic_name":140,"class_classification":104,"jmdn_code":141,"name_similarity":142,"definition_similarity":87,"vector_similarity":143,"score":144},4064,"歯列矯正用チンキャップ","41067000",0.193548,0.572793,0.0278261,{"medical_device_id":146,"generic_name":147,"class_classification":104,"jmdn_code":148,"name_similarity":149,"definition_similarity":87,"vector_similarity":150,"score":151},4306,"整形外科用リーマ","35297001",0.166667,0.578365,0.0264808,{"medical_device_id":153,"generic_name":154,"class_classification":96,"jmdn_code":155,"name_similarity":156,"definition_similarity":87,"vector_similarity":157,"score":158},2633,"歯列矯正用帯環","38734000",0.172414,0.560527,0.0248534,{"medical_device_id":160,"generic_name":161,"class_classification":96,"jmdn_code":162,"name_similarity":156,"definition_similarity":87,"vector_similarity":163,"score":164},2630,"歯列矯正用チューブ","31759000",0.556426,0.0247253,[166],{"product_code":167,"device_name":168,"device_class":8,"k510_count":169},"OAN","Orthosis, Cranial, Laser Scan",23,{"510k":171,"classification":172,"enforcement":173,"event":174,"pma":175,"warning_letter":176},"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"]