[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DWS":3},{"classification":4,"mappedDevices":555,"similarCandidates":556,"relatedClassifications":630,"syncDates":646},{"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":548,"updated_at":549,"recall_count":550,"latest_recall_date":551,"k510_count":552,"pma_count":553,"event_count":554},6020,"DWS","Instruments, Surgical, Cardiovascular","1","870.4500","CV","Cardiovascular","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":546,"product_code":6,"review_panel":10,"gmp_exempt_flag":546,"third_party_flag":546,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":546,"medical_specialty_description":11,"summary_malfunction_reporting":547},{"k_number":17,"fei_number":89,"registration_number":403},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"K840305","K881392","K864461","K851834","K841468","K761161","K810890","K861745","K820258","K851140","K851152","K960144","K790124","K851825","K892804","K875016","K890432","K881796","K934727","K771026","K823764","K781336","K791370","K760136","K851833","K960143","K882367","K882479","K791710","K760645","K823094","K801393","K891000","K792576","K760646","K760624","K780567","K882981","K883135","K760792","K850394","K851832","K830471","K955689","K960139","K890707","K881717","K900379","K780247","K894738","K896307","K800122","K792088","K760087","K822829","K802079","K831455","K833547","K761328","K760648","K813284","K771625","K760791","K022238","K964445","K874960","K760351","K893436","K962771","K844584","K821569",[13,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402],"3005349543","3009763019","3004545991","3002807072","3001584317","2020394","3003915875","3014615697","3013938829","1522875","3023190433","3002565916","3007410669","3002807111","3017540705","3002806517","1220648","1000405819","3033589330","4417","3002806575","3003597504","2025816","3002806685","3007475226","1000136191","3002902165","3002539629","3001451326","3000286616","3011371465","1000160162","3003644849","5870","3002807421","3003015552","3003944071","6082","3003761012","1000124817","3036795921","2183744","3013846070","3003320928","3005809810","3012434811","3033536312","3003888652","3001286223","3013750125","3013288201","3012536737","1000179044","3005698350","3029082594","3005649458","3002807982","2522007","3002807056","6166","3012448339","1047843","1416666","3009703496","1421101","2027111","3006950086","1000116158","4442","1519227","1000119305","2916714","3002808264","3015309643","3013497507","3005593675","3009750712","1721504","3001665800","3005276402","3005693456","2245304","3002558692","3019455","3009051888","3003094851","3003803182","3011642792","3015924373","5639","3006897899","3015895045","3014201171","3008770252","3006554912","3003370911","2017865","2649622","1000165971","6362","1000307733","3002806315","3002807988","3010687973","1220477","3006548402","3009959868","3035678069","3005969827","1000112968","3010041511","1000453845","3008237805","1412854","3015225571","4476","3004369356","3004961578","3005304066","3006125446","3000204839","3004579427","3007334784","3009340886","3042278955","3002806816","3002807395","3005182241","3002534070","1713910","1935627","3004215117","3002807214","3014579161","3003687489","3000718472","3003696170","1036836","2020550","3942","3004053982","3002378832","2518902","4486","3003244954","1625519","3022862651","3015451162","3010407203","3002808360","3003040625","3003477135","3004028763","3003120742","3007135583","2183319","2183570","2523865","1000138054","1000306431","3000206435","3007137643","1000307813","3010235355","1721676","3002750084","1721251","3007648354","3002707083","2025587","3004111573","1643817","1000306139","3008238512","1000512168","3005273623","3004608878","3008782585","3032747418","3043543260","2182208","1000112877","3002862271","3002806450","3002406063","3011111237","3002802903","3014334038","3002806755","3012226300","3005440795","3004365956","1000136269","1417592","3021680161","1000525271","3002855321","3004001706","1928237","3031231776","2434839","3002806862","3008902714","3002287318","1417485","3007207906","3017636737","3003434195","3010052483","3013784566","3016096142","1000132370","3011706110","3002807754","3003499455","6892","1000517719","3002807464","3008592544","1450662","1000115048","1000136478","3015398570","1450428","2126670","3011636272","3003448211","3004216008","3005747797","1000159424","1720929","1000518731","1000393132","3010197700","3003772581","3015173212","3003052153","3012267976","3003431869","1317628","1720747","3006441280","3015970743","1923569","3016408131","3003988575","3000335778","1000219637","3005726885","3003675041","3000183921","3002786339","3003882387","3008998256","3001236905","3010034765","2183787","1043214","3015542130","1000123297","2246552","3000280067","3010531069","3006516512","3002808335","3042940336","3000206455","3002807010","1000514656","3010055973","3005528784","3002806934","1921846","3000717902","3003826419","3011175548","3002807041","3002631673","3546","1118880","3002808043","3012185136","2011171","3010455030","3010699884","1000111204","1000123180","4498","3002806486","2015691","3009265194","1000208624","3003418325","5906","2242352","3007290840","3007773213","6032","3008388245","3000178338","3002807264","3003322138","3005687633","7282","1000125147","3008595179","3012507533","3002902735","3004605321","3035708926","3000717741","3003955307","1000140363",[13,404,405,406,407,408,91,409,95,96,97,410,411,412,98,99,100,102,413,414,415,104,106,416,417,108,418,111,419,420,112,119,120,421,122,422,423,424,128,425,130,426,427,428,131,132,134,429,430,431,135,432,433,136,434,435,139,140,141,436,143,144,147,437,438,150,151,152,153,154,155,156,439,440,159,161,441,163,164,165,166,167,442,171,443,173,174,444,176,177,178,180,181,182,445,446,447,448,449,450,451,183,184,186,452,187,453,454,188,455,456,193,457,194,458,196,197,200,203,204,459,460,207,461,462,212,213,463,214,464,465,466,217,467,220,221,468,223,469,470,471,224,226,227,228,472,473,474,232,475,234,235,476,236,237,238,477,241,244,245,246,478,479,480,251,253,254,481,256,482,483,484,485,257,486,487,259,260,261,488,489,490,491,265,266,268,269,270,272,492,275,277,493,494,495,279,496,497,280,281,283,284,287,498,288,289,290,499,292,294,295,296,500,501,502,298,503,299,300,504,505,506,507,508,302,509,510,511,308,512,309,513,312,514,313,314,515,315,320,516,322,323,517,518,325,327,328,519,520,521,522,330,332,333,334,523,335,338,339,524,525,342,526,527,343,346,347,348,350,528,352,353,529,530,355,359,360,362,531,364,532,365,369,371,372,373,533,534,374,535,536,379,380,382,383,537,384,538,539,386,540,388,391,541,542,543,392,395,396,398,399,544,401,545],"9616538","9611502","2084346","2320762","1320468","8010386","8010528","8010099","8010422","9615005","9616088","8010851","9612030","1123010","8010273","9610612","8010405","8010769","8010300","8040278","2431166","1123137","8010395","1836161","9613083","1649833","9611283","3011137372","9680518","9617604","1063481","8010372","2244478","1530504","1066959","1647149","9680519","9611112","1424478","1319639","9614062","1649914","9616246","9614093","8031015","1057946","8010235","9616972","9611262","1055890","9611814","9611274","9710524","9610557","1058584","8010374","8010254","9680718","9616250","1061124","8010591","8010871","1646747","3008500478","1124841","1723241","8039053","2028523","9611813","2029275","8044098","8010298","1054241","1060680","8043769","3005941719","9680515","9617601","1422634","3032534","1055236","1056350","8043404","2134285","9611610","1056553","9612773","8043467","1640201","1058726","9611827","9613079","9612086","1313525","8010877","9610905","8043496","8010697","8010665","2030598","2133928","8043548","3010162973","1319660","1423537","8010168","1649139","9611617","1223651","2248180","8010370","9612074","9611281","9611278","8010257","9611616","9611273","8043895","9616227","1424263","3007507973","9611503","1932180","9610621","2640138","1226015","2030624","9612278","8010155","8010704","1421879","2184009","8040233","2249529","1724474","3010202439","2529846","8010269","9616662","8010376","3005067367","1649395","N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",20,"2025-05-14",71,0,837,[],[557,565,573,580,587,595,603,609,616,623],{"medical_device_id":558,"generic_name":559,"class_classification":560,"jmdn_code":561,"name_similarity":562,"definition_similarity":553,"vector_similarity":563,"score":564},4337,"歯科用インプラント手術器具","Ⅰ","70965001",0.333333,0.689316,0.0312805,{"medical_device_id":566,"generic_name":567,"class_classification":568,"jmdn_code":569,"name_similarity":570,"definition_similarity":553,"vector_similarity":571,"score":572},1167,"マイクロ波メス用能動器具","Ⅲ","71082003",0.306452,0.679511,0.0296703,{"medical_device_id":574,"generic_name":575,"class_classification":560,"jmdn_code":576,"name_similarity":577,"definition_similarity":553,"vector_similarity":578,"score":579},4334,"骨手術用器械","70962001",0.237288,0.70332,0.027109,{"medical_device_id":581,"generic_name":582,"class_classification":560,"jmdn_code":583,"name_similarity":584,"definition_similarity":553,"vector_similarity":585,"score":586},4335,"脊椎手術用器械","70963001",0.254237,0.677684,0.0265845,{"medical_device_id":588,"generic_name":589,"class_classification":590,"jmdn_code":591,"name_similarity":592,"definition_similarity":553,"vector_similarity":593,"score":594},2239,"手術用クリップ","Ⅱ","37406000",0.25,0.665881,0.0239598,{"medical_device_id":596,"generic_name":597,"class_classification":598,"jmdn_code":599,"name_similarity":600,"definition_similarity":553,"vector_similarity":601,"score":602},225,"心血管用ステント","Ⅳ","34179000",0.425,0.610512,0.0163934,{"medical_device_id":604,"generic_name":605,"class_classification":568,"jmdn_code":606,"name_similarity":607,"definition_similarity":553,"vector_similarity":608,"score":602},967,"物質併用処置用能動器具","70668000",0.171429,0.723467,{"medical_device_id":610,"generic_name":611,"class_classification":560,"jmdn_code":612,"name_similarity":613,"definition_similarity":553,"vector_similarity":614,"score":615},4312,"エア式骨手術器械","70960000",0.163934,0.715816,0.016129,{"medical_device_id":617,"generic_name":618,"class_classification":598,"jmdn_code":619,"name_similarity":620,"definition_similarity":553,"vector_similarity":621,"score":622},97,"心臓血管縫合補助具","70290100",0.320755,0.637899,0.015873,{"medical_device_id":624,"generic_name":625,"class_classification":590,"jmdn_code":626,"name_similarity":627,"definition_similarity":553,"vector_similarity":628,"score":629},1599,"光学式眼内寸法測定装置","70096000",0.315789,0.568772,0.015625,[631,635,639,643],{"product_code":632,"device_name":633,"device_class":8,"k510_count":634},"MWS","Stabilizer, Heart",4,{"product_code":636,"device_name":637,"device_class":8,"k510_count":638},"NQG","Stabilizer, Heart, Non-Compression, Reprocessed",3,{"product_code":640,"device_name":641,"device_class":8,"k510_count":642},"LXN","Probe, Test, Heart-Valve",2,{"product_code":644,"device_name":645,"device_class":8,"k510_count":553},"OFA","Cardiovascular Surgical Instruments Tray",{"510k":647,"classification":648,"enforcement":649,"event":650,"pma":651,"warning_letter":652},"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"]