[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HRH":3},{"classification":4,"mappedDevices":212,"similarCandidates":213,"relatedClassifications":286,"syncDates":406},{"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":205,"updated_at":206,"recall_count":207,"latest_recall_date":208,"k510_count":209,"pma_count":210,"event_count":211},825,"HRH","Trephine, Manual, Ophthalmic","1","886.4350","OP","Ophthalmic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":203,"product_code":6,"review_panel":10,"gmp_exempt_flag":203,"third_party_flag":203,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":203,"medical_specialty_description":11,"summary_malfunction_reporting":204},{"k_number":17,"fei_number":30,"registration_number":154},[18,19,20,21,22,23,24,25,26,27,28,29],"K843048","K931792","K861825","K022843","K862524","K864520","K843646","K860648","K771866","K812723","K873918","K781411",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153],"6749","3002867000","3013576617","3003244954","3015177648","3000264417","3013421458","3010487482","1211998","3004028763","3003772581","3004598675","3005734757","3003951061","1000555370","3004858034","1000138054","2523865","1000114185","3015895045","1317628","3002443341","1000306431","6750","1720747","1000231766","3002834291","3002808441","3002445546","3002750084","3008770252","3006677911","3009027787","3004571672","3007648354","1000136191","1643817","3003046678","1920664","3003408840","3009513193","3003860739","3013466775","1000307733","3042228518","3004216008","1926681","3002807988","3005370013","5870","3033526648","3010687973","3012733432","1043214","1000112877","3002807310","3002409980","3013358456","3010155661","1000246164","3000280067","3010041511","1000112968","3012341472","3010399422","3014334038","3003536766","3005765014","3003289411","3005304066","3017857440","3006550126","3009298127","3003860763","1000136269","3005528784","3011110913","1417592","3016069968","3001967056","3011499367","3005809810","1928237","3031231776","3008338766","3015218018","3546","1000484830","3004475955","3012185136","1045379","3007317099","3002090132","1000111204","3002806816","1526711","3008342610","3003039352","1047843","3003418325","3004215117","3001180016","3002809480","3027556548","1421101","3006380247","3008719017","4324","3010383847","1000194896","1000119305","3002808293","3006234591","2242450","1000306694","3018071447","1000115048","3003032798","3013503739","3003448211","3005747797","1000140363","3030451558",[155,156,33,34,157,35,36,158,37,38,159,39,160,161,162,163,42,44,46,50,164,165,166,55,57,61,62,167,63,64,168,169,65,170,67,171,69,72,71,73,172,173,75,174,77,79,81,82,83,175,84,86,176,88,89,177,92,178,95,96,179,97,180,181,182,183,184,101,185,103,104,102,186,106,107,108,109,110,187,111,188,112,113,189,114,190,115,191,116,118,119,120,192,121,122,193,194,123,126,127,128,129,130,131,134,135,195,196,136,137,139,197,143,198,144,146,148,199,200,149,201,202,153],"8010298","9617768","1319639","1054241","8040381","8040263","1226587","8010099","9680620","8010694","1934420","1054811","1055236","9615659","1056350","1055890","1932180","3008812251","8040278","2132732","2431166","9615857","8043368","3012833022","1058726","8040382","9616245","9680718","9612075","1313525","1836161","9616250","2028661","8043816","3011137372","9611283","9680518","2244478","1421879","8043496","2031962","2529846","8021817","9614107","2029275","3005067367","8044098","1835993","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",1,"2013-07-10",12,0,23,[],[214,222,230,237,244,251,257,264,271,278],{"medical_device_id":215,"generic_name":216,"class_classification":217,"jmdn_code":218,"name_similarity":219,"definition_similarity":210,"vector_similarity":220,"score":221},4176,"手動式角膜トレパン","Ⅰ","14148001",0.470588,0.835063,0.0327869,{"medical_device_id":223,"generic_name":224,"class_classification":225,"jmdn_code":226,"name_similarity":227,"definition_similarity":210,"vector_similarity":228,"score":229},2841,"単回使用手動式角膜トレパン","Ⅱ","14148012",0.355556,0.823449,0.032002,{"medical_device_id":231,"generic_name":232,"class_classification":217,"jmdn_code":233,"name_similarity":234,"definition_similarity":210,"vector_similarity":235,"score":236},4175,"骨トレパン","14147000",0.290323,0.7086,0.0280428,{"medical_device_id":238,"generic_name":239,"class_classification":225,"jmdn_code":240,"name_similarity":241,"definition_similarity":210,"vector_similarity":242,"score":243},1836,"眼科用針","70200000",0.323529,0.64238,0.0266314,{"medical_device_id":245,"generic_name":246,"class_classification":217,"jmdn_code":247,"name_similarity":248,"definition_similarity":210,"vector_similarity":249,"score":250},4179,"水晶体嚢切開刀","34984000",0.297297,0.65365,0.0264912,{"medical_device_id":252,"generic_name":253,"class_classification":217,"jmdn_code":254,"name_similarity":248,"definition_similarity":210,"vector_similarity":255,"score":256},4270,"眼科用開創器","70943000",0.639215,0.0250352,{"medical_device_id":258,"generic_name":259,"class_classification":217,"jmdn_code":260,"name_similarity":261,"definition_similarity":210,"vector_similarity":262,"score":263},3887,"眼科診療・処置用椅子","15723000",0.269231,0.633563,0.023259,{"medical_device_id":265,"generic_name":266,"class_classification":217,"jmdn_code":267,"name_similarity":268,"definition_similarity":210,"vector_similarity":269,"score":270},3901,"眼科用鏡","32707000",0.363636,0.577003,0.016129,{"medical_device_id":272,"generic_name":273,"class_classification":225,"jmdn_code":274,"name_similarity":275,"definition_similarity":210,"vector_similarity":276,"score":277},2560,"電動式角膜トレパン","14148022",0.238095,0.766914,0.015873,{"medical_device_id":279,"generic_name":280,"class_classification":281,"jmdn_code":282,"name_similarity":283,"definition_similarity":210,"vector_similarity":284,"score":285},523,"眼科手術用クリップ","Ⅲ","32814000",0.34375,0.606803,0.015625,[287,291,295,299,303,307,311,315,318,322,325,329,333,336,339,342,346,349,352,355,358,361,364,367,370,373,376,379,382,385,388,391,394,397,400,403],{"product_code":288,"device_name":289,"device_class":8,"k510_count":290},"HMX","Cannula, Ophthalmic",77,{"product_code":292,"device_name":293,"device_class":8,"k510_count":294},"HNN","Knife, Ophthalmic",54,{"product_code":296,"device_name":297,"device_class":8,"k510_count":298},"HNR","Forceps, Ophthalmic",44,{"product_code":300,"device_name":301,"device_class":8,"k510_count":302},"HNY","Cystotome",20,{"product_code":304,"device_name":305,"device_class":8,"k510_count":306},"HNF","Scissors, Ophthalmic",15,{"product_code":308,"device_name":309,"device_class":8,"k510_count":310},"HNC","Specula, Ophthalmic",11,{"product_code":312,"device_name":313,"device_class":8,"k510_count":314},"HNL","Probe, Lachrymal",10,{"product_code":316,"device_name":317,"device_class":8,"k510_count":314},"HNQ","Hook, Ophthalmic",{"product_code":319,"device_name":320,"device_class":8,"k510_count":321},"HNH","Ring, Ophthalmic (Flieringa)",7,{"product_code":323,"device_name":324,"device_class":8,"k510_count":321},"HOE","Caliper, Ophthalmic",{"product_code":326,"device_name":327,"device_class":8,"k510_count":328},"HND","Spatula, Ophthalmic",6,{"product_code":330,"device_name":331,"device_class":8,"k510_count":332},"HNJ","Punch, Corneo-Scleral",3,{"product_code":334,"device_name":335,"device_class":8,"k510_count":332},"HNW","Dilator, Lachrymal",{"product_code":337,"device_name":338,"device_class":8,"k510_count":332},"HOB","Clamp, Muscle, Ophthalmic",{"product_code":340,"device_name":341,"device_class":8,"k510_count":332},"HOD","Clamp, Eyelid, Ophthalmic",{"product_code":343,"device_name":344,"device_class":8,"k510_count":345},"HNA","Spud, Ophthalmic",2,{"product_code":347,"device_name":348,"device_class":8,"k510_count":345},"HNI","Retractor, Ophthalmic",{"product_code":350,"device_name":351,"device_class":8,"k510_count":345},"HNM","Needle, Ophthalmic Suturing",{"product_code":353,"device_name":354,"device_class":8,"k510_count":345},"HNX","Depressor, Orbital",{"product_code":356,"device_name":357,"device_class":8,"k510_count":345},"HNZ","Curette, Ophthalmic",{"product_code":359,"device_name":360,"device_class":8,"k510_count":345},"HOC","Clip, Iris Retractor",{"product_code":362,"device_name":363,"device_class":8,"k510_count":207},"HOF","Burr, Corneal, Manual",{"product_code":365,"device_name":366,"device_class":8,"k510_count":207},"NGY","Cannula, Trocar, Ophthalmic",{"product_code":368,"device_name":369,"device_class":8,"k510_count":210},"HMZ","Trabeculotome",{"product_code":371,"device_name":372,"device_class":8,"k510_count":210},"HNB","Spoon, Ophthalmic",{"product_code":374,"device_name":375,"device_class":8,"k510_count":210},"HNE","Snare, Enucleating",{"product_code":377,"device_name":378,"device_class":8,"k510_count":210},"HNG","Rongeur, Lachrymal Sac",{"product_code":380,"device_name":381,"device_class":8,"k510_count":210},"HNK","Probe, Trabeculotomy",{"product_code":383,"device_name":384,"device_class":8,"k510_count":210},"HNP","Introducer, Sphere",{"product_code":386,"device_name":387,"device_class":8,"k510_count":210},"HNS","Expressor",{"product_code":389,"device_name":390,"device_class":8,"k510_count":210},"HNT","Erisophake",{"product_code":392,"device_name":393,"device_class":8,"k510_count":210},"HOA","Compressor, Orbital",{"product_code":395,"device_name":396,"device_class":8,"k510_count":210},"MXY","Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal",{"product_code":398,"device_name":399,"device_class":8,"k510_count":210},"NLA","Knife, Ophthalmic, Reprocessed",{"product_code":401,"device_name":402,"device_class":8,"k510_count":210},"PZG","Surgical Eye Tray",{"product_code":404,"device_name":405,"device_class":8,"k510_count":210},"QDV","Iol Tray",{"510k":407,"classification":408,"enforcement":409,"event":410,"pma":411,"warning_letter":412},"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"]