[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MNE":3},{"classification":4,"mappedDevices":55,"similarCandidates":56,"relatedClassifications":127,"syncDates":178},{"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":50,"updated_at":51,"recall_count":52,"latest_recall_date":53,"k510_count":54,"pma_count":52,"event_count":54},3425,"MNE","Orthosis, Moldable, Supportive, Skin Protective","1","890.3475","PM","Physical Medicine","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":48,"product_code":6,"review_panel":10,"gmp_exempt_flag":48,"third_party_flag":48,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":48,"medical_specialty_description":11,"summary_malfunction_reporting":49},{"k_number":17,"fei_number":20,"registration_number":44},[18,19],"K940132","K780391",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"3004116526","3044150131","3006943846","3008648418","3042641165","3003565456","3009710062","3014527896","3020284548","3010220187","3033813891","1026765","3031582434","3043089668","3009757062","1000227792","3036773435","2431069","3010097863","3003610251","3015090419","3019387924","3030541417",[21,22,23,24,25,28,29,30,31,45,32,33,34,35,46,37,38,39,40,41,47,42,43],"9710641","2431499","9613183","N","Eligible","2026-08-18T05:52:50.955415+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,[],[57,65,72,79,86,94,100,108,114,121],{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":52,"vector_similarity":63,"score":64},3809,"成形型副木","Ⅰ","36204000",0.163265,0.677373,0.0306792,{"medical_device_id":66,"generic_name":67,"class_classification":60,"jmdn_code":68,"name_similarity":69,"definition_similarity":52,"vector_similarity":70,"score":71},3807,"真空成形型式副木","35358000",0.142857,0.66565,0.0277569,{"medical_device_id":73,"generic_name":74,"class_classification":60,"jmdn_code":75,"name_similarity":76,"definition_similarity":52,"vector_similarity":77,"score":78},3661,"保護栓","70280000",0.25,0.519543,0.0163934,{"medical_device_id":80,"generic_name":81,"class_classification":82,"jmdn_code":83,"name_similarity":76,"definition_similarity":52,"vector_similarity":84,"score":85},2132,"保護用オーバーチューブ","Ⅱ","70334000",0.609142,0.016129,{"medical_device_id":87,"generic_name":88,"class_classification":89,"jmdn_code":90,"name_similarity":91,"definition_similarity":52,"vector_similarity":92,"score":93},170,"手術用吸収性メッシュ","Ⅳ","16048004",0.101695,0.665124,0.015873,{"medical_device_id":95,"generic_name":96,"class_classification":60,"jmdn_code":97,"name_similarity":98,"definition_similarity":52,"vector_similarity":99,"score":93},4068,"短期的使用歯科矯正用粘膜保護材","70735000",0.194444,0.600019,{"medical_device_id":101,"generic_name":102,"class_classification":103,"jmdn_code":104,"name_similarity":105,"definition_similarity":52,"vector_similarity":106,"score":107},507,"コラーゲン使用吸収性創傷被覆・保護材","Ⅲ","34615200",0.0410959,0.658687,0.015625,{"medical_device_id":109,"generic_name":110,"class_classification":82,"jmdn_code":111,"name_similarity":112,"definition_similarity":52,"vector_similarity":113,"score":107},2647,"歯科矯正用長期粘膜保護材","70738000",0.188406,0.607343,{"medical_device_id":115,"generic_name":116,"class_classification":89,"jmdn_code":117,"name_similarity":118,"definition_similarity":52,"vector_similarity":119,"score":120},260,"体内用吸収性合成・炭素繊維補綴材","33473204",0.127451,0.654349,0.0153846,{"medical_device_id":122,"generic_name":123,"class_classification":82,"jmdn_code":124,"name_similarity":125,"definition_similarity":52,"vector_similarity":126,"score":120},3194,"骨盤臓器脱用ペッサリー","34149002",0.186441,0.610868,[128,132,136,140,144,148,152,156,159,163,166,169,172,175],{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"IQI","Orthosis, Limb Brace",52,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"ILH","Splint, Hand, And Components",36,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"ITQ","Joint, Knee, External Brace",15,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"ILG","Stocking, Elastic",8,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"KNP","Orthosis, Corrective Shoe",7,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"ITM","Cage, Knee",5,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"ILE","Sling, Arm, Overhead Supported",3,{"product_code":157,"device_name":158,"device_class":8,"k510_count":54},"LQX","Device, Finger-Sucking",{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"IOY","Support, Arm",1,{"product_code":164,"device_name":165,"device_class":8,"k510_count":162},"ITS","Joint, Hip, External Brace",{"product_code":167,"device_name":168,"device_class":8,"k510_count":162},"ITW","Joint, Ankle, External Brace",{"product_code":170,"device_name":171,"device_class":8,"k510_count":162},"OHI","Orthosis, Foot Drop",{"product_code":173,"device_name":174,"device_class":8,"k510_count":162},"PMV","Orthosis, Limb, For Back Pain",{"product_code":176,"device_name":177,"device_class":8,"k510_count":162},"QDT","Shoe With Adjustable Sole Units",{"510k":179,"classification":180,"enforcement":181,"event":182,"pma":183,"warning_letter":184},"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"]