[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-JCE":3},{"classification":4,"mappedDevices":69,"similarCandidates":70,"relatedClassifications":144,"syncDates":307},{"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":63,"updated_at":64,"recall_count":65,"latest_recall_date":66,"k510_count":67,"pma_count":65,"event_count":68},6270,"JCE","Solution, Isotonic","1","864.4010","PA","Pathology","4","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":60,"product_code":6,"review_panel":10,"gmp_exempt_flag":61,"third_party_flag":60,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":60,"medical_specialty_description":11,"summary_malfunction_reporting":62},{"k_number":18,"fei_number":26,"registration_number":58},[19,20,21,22,23,24,25],"K792101","K831200","K761183","K761174","K761170","K801506","K842722",[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],"3001106688","3008264111","3013632692","3042896810","3014257280","3009547954","3010374920","3008264242","3006365273","3012314549","2022807","3005592623","3015495690","3045030541","3003103936","1181121","3011715922","3031180757","3005460813","1831312","3004016977","3017830316","3022106572","3017970519","1625587","1210083","3025413691","3012309743","3015745029","3004857344","3008174888",[59,27,28,29,30,31,32,33,34,35,36,37,38,39,40,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57],"1125908","N","Y","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",0,null,7,21,[],[71,79,86,94,101,109,116,123,130,137],{"medical_device_id":72,"generic_name":73,"class_classification":74,"jmdn_code":75,"name_similarity":76,"definition_similarity":65,"vector_similarity":77,"score":78},2379,"心筋保護液用フィルタ","Ⅱ","70525000",0.27027,0.575006,0.0294691,{"medical_device_id":80,"generic_name":81,"class_classification":74,"jmdn_code":82,"name_similarity":83,"definition_similarity":65,"vector_similarity":84,"score":85},2248,"局所管理生理食塩液含有創傷被覆・保護材","37298002",0.173077,0.637554,0.0293805,{"medical_device_id":87,"generic_name":88,"class_classification":89,"jmdn_code":90,"name_similarity":91,"definition_similarity":65,"vector_similarity":92,"score":93},1048,"歯科用う蝕除去液","Ⅲ","38783000",0.230769,0.575123,0.0289916,{"medical_device_id":95,"generic_name":96,"class_classification":89,"jmdn_code":97,"name_similarity":98,"definition_similarity":65,"vector_similarity":99,"score":100},501,"二次治癒生理食塩液含有創傷被覆・保護材","37298003",0.166667,0.600244,0.0289495,{"medical_device_id":102,"generic_name":103,"class_classification":104,"jmdn_code":105,"name_similarity":106,"definition_similarity":65,"vector_similarity":107,"score":108},3604,"薬液用両刃針","Ⅰ","70196000",0.186047,0.585163,0.0285425,{"medical_device_id":110,"generic_name":111,"class_classification":104,"jmdn_code":112,"name_similarity":113,"definition_similarity":65,"vector_similarity":114,"score":115},3728,"薬液調整用器具","70381000",0.238095,0.563272,0.0274254,{"medical_device_id":117,"generic_name":118,"class_classification":74,"jmdn_code":119,"name_similarity":120,"definition_similarity":65,"vector_similarity":121,"score":122},1577,"炭酸ガス炭素同位体比分析装置","70082000",0.142857,0.580402,0.0266106,{"medical_device_id":124,"generic_name":125,"class_classification":74,"jmdn_code":126,"name_similarity":127,"definition_similarity":65,"vector_similarity":128,"score":129},2397,"人工心肺用プライミング溶液フィルタ","36080000",0.152542,0.572028,0.0263889,{"medical_device_id":131,"generic_name":132,"class_classification":104,"jmdn_code":133,"name_similarity":134,"definition_similarity":65,"vector_similarity":135,"score":136},3696,"採液針","70324000",0.3,0.508943,0.0163934,{"medical_device_id":138,"generic_name":139,"class_classification":74,"jmdn_code":140,"name_similarity":141,"definition_similarity":65,"vector_similarity":142,"score":143},2164,"血液・医薬品用加温器","10447000",0.290323,0.55082,0.016129,[145,149,153,156,160,164,167,170,173,176,180,184,187,191,194,198,201,204,207,210,213,217,220,223,226,229,232,235,238,241,244,247,250,253,256,259,262,265,268,271,274,277,280,283,286,289,292,295,298,301,304],{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"PPM","General Purpose Reagent",16,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"IFP","Formalin, Neutral Buffered",15,{"product_code":154,"device_name":155,"device_class":8,"k510_count":152},"KEM","Agent, Clearing",{"product_code":157,"device_name":158,"device_class":8,"k510_count":159},"KEO","Formulations, Paraffin, All",11,{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"KDX","Solution, Decalcifier, Acid Containing",8,{"product_code":165,"device_name":166,"device_class":8,"k510_count":163},"LDZ","Fixative, Alcohol Containing",{"product_code":168,"device_name":169,"device_class":8,"k510_count":67},"IGG","Formaldehyde (Formalin, Formol)",{"product_code":171,"device_name":172,"device_class":8,"k510_count":67},"JCC","Ph Buffer",{"product_code":174,"device_name":175,"device_class":8,"k510_count":67},"KEQ","Media, Mounting, Water Soluble",{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"LEB","Mounting Media",5,{"product_code":181,"device_name":182,"device_class":8,"k510_count":183},"LDW","Fixative, Acid Containing",4,{"product_code":185,"device_name":186,"device_class":8,"k510_count":183},"LEA","Preservative, Cytological",{"product_code":188,"device_name":189,"device_class":8,"k510_count":190},"IGM","Solution, Carnoy'S",3,{"product_code":192,"device_name":193,"device_class":8,"k510_count":190},"KEP","Media, Mounting, Oil Soluble",{"product_code":195,"device_name":196,"device_class":8,"k510_count":197},"IFH","Solution, Zenker'S",2,{"product_code":199,"device_name":200,"device_class":8,"k510_count":197},"IFQ","Formulations, Mercuric Chloride For Tissue",{"product_code":202,"device_name":203,"device_class":8,"k510_count":197},"IGC","Formalin-Saline",{"product_code":205,"device_name":206,"device_class":8,"k510_count":197},"IGE","Solution, Formalin Ammonium Bromide",{"product_code":208,"device_name":209,"device_class":8,"k510_count":197},"IGN","Fluid, Bouin'S",{"product_code":211,"device_name":212,"device_class":8,"k510_count":197},"KEL","Adhesive, Albumin-Based",{"product_code":214,"device_name":215,"device_class":8,"k510_count":216},"IER","Polyethylene Glycol (Carbowax)",1,{"product_code":218,"device_name":219,"device_class":8,"k510_count":216},"IFI","Sprays, Synthetic, Smear",{"product_code":221,"device_name":222,"device_class":8,"k510_count":216},"IFT","Glutaraldehyde",{"product_code":224,"device_name":225,"device_class":8,"k510_count":216},"IFZ","Gelatin For Specimen Adhesion",{"product_code":227,"device_name":228,"device_class":8,"k510_count":216},"IGB","Solution, Formalin-Sodium Acetate",{"product_code":230,"device_name":231,"device_class":8,"k510_count":216},"IGF","Solution, Formalin-Alcohol-Acetic Acid",{"product_code":233,"device_name":234,"device_class":8,"k510_count":216},"IJZ","Oil, Clearing",{"product_code":236,"device_name":237,"device_class":8,"k510_count":216},"LDX","Fixative, Metallic Containing",{"product_code":239,"device_name":240,"device_class":8,"k510_count":216},"LDY","Fixative, Formalin-Containing",{"product_code":242,"device_name":243,"device_class":8,"k510_count":65},"HZI","Acid, Osmic",{"product_code":245,"device_name":246,"device_class":8,"k510_count":65},"IAL","Iodine (Tincture)",{"product_code":248,"device_name":249,"device_class":8,"k510_count":65},"IAM","Solution, Lugol'S",{"product_code":251,"device_name":252,"device_class":8,"k510_count":65},"IAT","Syrup, Gum, Apathy'S",{"product_code":254,"device_name":255,"device_class":8,"k510_count":65},"IAW","Collodion",{"product_code":257,"device_name":258,"device_class":8,"k510_count":65},"IAY","Colchicine",{"product_code":260,"device_name":261,"device_class":8,"k510_count":65},"IBB","Phytohemaglutinin M",{"product_code":263,"device_name":264,"device_class":8,"k510_count":65},"IEX","Gelatin",{"product_code":266,"device_name":267,"device_class":8,"k510_count":65},"IEZ","Celloidin",{"product_code":269,"device_name":270,"device_class":8,"k510_count":65},"IFF","Solution, Decalcifier, Electrolytic",{"product_code":272,"device_name":273,"device_class":8,"k510_count":65},"IFJ","Fixative, Richardson Glycol",{"product_code":275,"device_name":276,"device_class":8,"k510_count":65},"IFL","Polyethylene Glycol Preservative",{"product_code":278,"device_name":279,"device_class":8,"k510_count":65},"IFN","Solution, Orth'S",{"product_code":281,"device_name":282,"device_class":8,"k510_count":65},"IFO","Solution, Newcomer'S",{"product_code":284,"device_name":285,"device_class":8,"k510_count":65},"IFS","Solution, Helly",{"product_code":287,"device_name":288,"device_class":8,"k510_count":65},"IFY","Gelatin-Formalin",{"product_code":290,"device_name":291,"device_class":8,"k510_count":65},"IGD","Solution, Formol Calcium",{"product_code":293,"device_name":294,"device_class":8,"k510_count":65},"IGK","Solution, Clarke'S",{"product_code":296,"device_name":297,"device_class":8,"k510_count":65},"JCB","Detergent",{"product_code":299,"device_name":300,"device_class":8,"k510_count":65},"KDY","Agent, Chelating For Decalcification",{"product_code":302,"device_name":303,"device_class":8,"k510_count":65},"KEE","Osmium Tetroxide",{"product_code":305,"device_name":306,"device_class":8,"k510_count":65},"KEF","Paraformaldehyde",{"510k":308,"classification":309,"enforcement":310,"event":311,"pma":312,"warning_letter":313},"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"]