[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HNX":3},{"classification":4,"mappedDevices":142,"similarCandidates":143,"relatedClassifications":216,"syncDates":335,"translation":342,"marketSummary":348,"recalls":362,"k510s":364,"pmas":376},{"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":136,"updated_at":137,"recall_count":138,"latest_recall_date":139,"k510_count":140,"pma_count":138,"event_count":141},998,"HNX","Depressor, Orbital","1","886.4350","OP","Ophthalmic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":134,"product_code":6,"review_panel":10,"gmp_exempt_flag":134,"third_party_flag":134,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":134,"medical_specialty_description":11,"summary_malfunction_reporting":135},{"k_number":17,"fei_number":20,"registration_number":105},[18,19],"K951702","K951701",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104],"6749","3013576617","3015177648","3000264417","1211998","3003772581","3029990829","3005734757","3003951061","1000160458","3013602181","3007589150","3009465247","1317628","3002807111","3015972897","1000306431","6750","1720747","1000231766","1923569","3007137643","3002809378","3002808441","3012995405","3002445546","3002750084","3008770252","3006677911","3009027787","3004571672","1000136191","3003408840","3009513193","3003644849","1000307733","3042228518","3005747797","3012733432","3019924","1000246164","3000280067","3010041511","3013002167","2521877","3003289411","3017857440","3006550126","3005528784","3011110913","1417592","3004001706","3007334784","3012037425","3031231776","2434839","3008114965","3004475955","3012185136","1045379","3012375451","3005548740","3005595283","3007714917","3008342610","3003039352","3003418325","3004215117","3001180016","3002809480","1421101","3006380247","3010383847","1000119305","2916714","2242450","3004049923","3013398127","1000115048","1221934","3002806863","3004216008","1000140363","3030451558",[106,22,23,24,107,108,25,109,27,29,31,32,33,36,110,111,39,41,42,45,48,49,50,51,112,113,114,54,55,115,57,59,60,63,64,116,117,118,65,119,120,121,67,122,68,123,69,70,71,72,124,73,125,74,75,76,77,126,78,79,80,127,81,82,83,85,86,87,88,128,91,129,130,92,93,131,95,96,97,132,98,100,133,104],"9617768","8043441","8040381","9680620","1934420","3005941719","9615659","1056350","1932180","8040278","1058726","8040382","9616245","9680718","9612075","1313525","1836161","9616250","8043816","3011137372","2029015","1421879","9611516","2031962","2529846","8021817","9612297","2029275","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:48.620842+00:00",0,null,2,11,[],[144,152,159,167,174,181,188,195,203,209],{"medical_device_id":145,"generic_name":146,"class_classification":147,"jmdn_code":148,"name_similarity":149,"definition_similarity":138,"vector_similarity":150,"score":151},4266,"眼窩圧迫子","Ⅰ","16465000",1,0.836251,0.0327869,{"medical_device_id":153,"generic_name":154,"class_classification":147,"jmdn_code":155,"name_similarity":156,"definition_similarity":138,"vector_similarity":157,"score":158},4241,"舌圧子","14066000",0.4,0.691138,0.0322581,{"medical_device_id":160,"generic_name":161,"class_classification":162,"jmdn_code":163,"name_similarity":164,"definition_similarity":138,"vector_similarity":165,"score":166},629,"人工眼窩縁","Ⅲ","35677000",0.242424,0.6116,0.03125,{"medical_device_id":168,"generic_name":169,"class_classification":147,"jmdn_code":170,"name_similarity":171,"definition_similarity":138,"vector_similarity":172,"score":173},4258,"水晶体圧出器","12318000",0.222222,0.607735,0.030303,{"medical_device_id":175,"generic_name":176,"class_classification":147,"jmdn_code":177,"name_similarity":178,"definition_similarity":138,"vector_similarity":179,"score":180},4269,"眼窩固定鈎","35314001",0.333333,0.596566,0.0301587,{"medical_device_id":182,"generic_name":183,"class_classification":162,"jmdn_code":184,"name_similarity":185,"definition_similarity":138,"vector_similarity":186,"score":187},531,"外眼眼窩インプラント","70442000",0.210526,0.593509,0.0279843,{"medical_device_id":189,"generic_name":190,"class_classification":147,"jmdn_code":191,"name_similarity":192,"definition_similarity":138,"vector_similarity":193,"score":194},4265,"眼球固定鈎","13381001",0.171429,0.617695,0.0279212,{"medical_device_id":196,"generic_name":197,"class_classification":198,"jmdn_code":199,"name_similarity":200,"definition_similarity":138,"vector_similarity":201,"score":202},2911,"眼圧減圧器","Ⅱ","15048000",0.0681818,0.610882,0.0153846,{"medical_device_id":204,"generic_name":205,"class_classification":198,"jmdn_code":206,"name_similarity":207,"definition_similarity":138,"vector_similarity":208,"score":202},2923,"家庭用温熱式指圧代用器","70980000",0.232558,0.519506,{"medical_device_id":210,"generic_name":211,"class_classification":162,"jmdn_code":212,"name_similarity":213,"definition_similarity":138,"vector_similarity":214,"score":215},797,"デスフルラン用麻酔薬気化器","36979000",0.0576923,0.605109,0.0149254,[217,221,225,229,233,237,241,244,248,251,255,258,262,266,269,272,275,278,281,284,287,290,293,296,299,302,305,308,311,314,317,320,323,326,329,332],{"product_code":218,"device_name":219,"device_class":8,"k510_count":220},"HMX","Cannula, Ophthalmic",77,{"product_code":222,"device_name":223,"device_class":8,"k510_count":224},"HNN","Knife, Ophthalmic",54,{"product_code":226,"device_name":227,"device_class":8,"k510_count":228},"HNR","Forceps, Ophthalmic",44,{"product_code":230,"device_name":231,"device_class":8,"k510_count":232},"HNY","Cystotome",20,{"product_code":234,"device_name":235,"device_class":8,"k510_count":236},"HNF","Scissors, Ophthalmic",15,{"product_code":238,"device_name":239,"device_class":8,"k510_count":240},"HRH","Trephine, Manual, Ophthalmic",12,{"product_code":242,"device_name":243,"device_class":8,"k510_count":141},"HNC","Specula, Ophthalmic",{"product_code":245,"device_name":246,"device_class":8,"k510_count":247},"HNL","Probe, Lachrymal",10,{"product_code":249,"device_name":250,"device_class":8,"k510_count":247},"HNQ","Hook, Ophthalmic",{"product_code":252,"device_name":253,"device_class":8,"k510_count":254},"HNH","Ring, Ophthalmic (Flieringa)",7,{"product_code":256,"device_name":257,"device_class":8,"k510_count":254},"HOE","Caliper, Ophthalmic",{"product_code":259,"device_name":260,"device_class":8,"k510_count":261},"HND","Spatula, Ophthalmic",6,{"product_code":263,"device_name":264,"device_class":8,"k510_count":265},"HNJ","Punch, Corneo-Scleral",3,{"product_code":267,"device_name":268,"device_class":8,"k510_count":265},"HNW","Dilator, Lachrymal",{"product_code":270,"device_name":271,"device_class":8,"k510_count":265},"HOB","Clamp, Muscle, Ophthalmic",{"product_code":273,"device_name":274,"device_class":8,"k510_count":265},"HOD","Clamp, Eyelid, Ophthalmic",{"product_code":276,"device_name":277,"device_class":8,"k510_count":140},"HNA","Spud, Ophthalmic",{"product_code":279,"device_name":280,"device_class":8,"k510_count":140},"HNI","Retractor, Ophthalmic",{"product_code":282,"device_name":283,"device_class":8,"k510_count":140},"HNM","Needle, Ophthalmic Suturing",{"product_code":285,"device_name":286,"device_class":8,"k510_count":140},"HNZ","Curette, Ophthalmic",{"product_code":288,"device_name":289,"device_class":8,"k510_count":140},"HOC","Clip, Iris Retractor",{"product_code":291,"device_name":292,"device_class":8,"k510_count":149},"HOF","Burr, Corneal, Manual",{"product_code":294,"device_name":295,"device_class":8,"k510_count":149},"NGY","Cannula, Trocar, Ophthalmic",{"product_code":297,"device_name":298,"device_class":8,"k510_count":138},"HMZ","Trabeculotome",{"product_code":300,"device_name":301,"device_class":8,"k510_count":138},"HNB","Spoon, Ophthalmic",{"product_code":303,"device_name":304,"device_class":8,"k510_count":138},"HNE","Snare, Enucleating",{"product_code":306,"device_name":307,"device_class":8,"k510_count":138},"HNG","Rongeur, Lachrymal Sac",{"product_code":309,"device_name":310,"device_class":8,"k510_count":138},"HNK","Probe, Trabeculotomy",{"product_code":312,"device_name":313,"device_class":8,"k510_count":138},"HNP","Introducer, Sphere",{"product_code":315,"device_name":316,"device_class":8,"k510_count":138},"HNS","Expressor",{"product_code":318,"device_name":319,"device_class":8,"k510_count":138},"HNT","Erisophake",{"product_code":321,"device_name":322,"device_class":8,"k510_count":138},"HOA","Compressor, Orbital",{"product_code":324,"device_name":325,"device_class":8,"k510_count":138},"MXY","Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal",{"product_code":327,"device_name":328,"device_class":8,"k510_count":138},"NLA","Knife, Ophthalmic, Reprocessed",{"product_code":330,"device_name":331,"device_class":8,"k510_count":138},"PZG","Surgical Eye Tray",{"product_code":333,"device_name":334,"device_class":8,"k510_count":138},"QDV","Iol Tray",{"510k":336,"classification":337,"enforcement":338,"event":339,"pma":340,"warning_letter":341},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":343,"definition_ja":139,"commentary_ja":344,"model_name":345,"source_hash":346,"reviewed_by":139,"reviewed_at":139,"created_at":347,"updated_at":347},"眼窩圧排子","本品は眼科手術において眼窩内の組織を圧排し、術野を確保するために用いられる器具です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分とされています。これは、安全性・有効性を担保するための一般的な規制のみで十分と判断される、リスクの低い医療機器であることを意味します。","claude-sonnet-5","97beb567ac7fff937d0279fd6f6c01efbcb19fe45c73173ec8ff43119c5aa457","2026-08-24T01:56:53.662172+00:00",{"product_code":6,"summary_ja":349,"stats":350,"stats_hash":360,"model_name":345,"created_at":361,"updated_at":361},"510(k)の累計届出は2件、参入企業数は1社で、直近5年間の届出実績は確認されていません。不具合報告は累計約10件で、その大半がMalfunction（不具合）であり、傷害報告が1件含まれていますが死亡報告は確認されていません。回収については累計0件で、クラスI（最重篤）を含め該当する事例は確認されていません。",{"pma":351,"k510":352,"as_of":354,"events":355,"recalls":357,"top_problems":359},{"latest":139,"originals":138,"supplements":138},{"total":140,"last5y":138,"latest":353,"applicants":149},"1995-05-12","2026-08",{"death":138,"other":138,"total":141,"injury":149,"last5y":138,"malfunction":247,"latest_month":356},"2019-09",{"total":138,"last5y":138,"latest":139,"class_i":138,"class_ii":138,"class_iii":138,"top_root_causes":358},[],[],"5e6c39d9d3236c4b08ed32b7333527fc6f54fd00e884a02fead6b72e1df0af96","2026-08-24T04:32:35.506862+00:00",{"items":363,"total":138},[],{"items":365,"total":140},[366,371],{"k_number":18,"device_name":367,"applicant":368,"decision_date":353,"clearance_type":369,"decision_code":370,"statement_or_summary":139},"FMS HIGH FLOW ARTHRO-SHEATH","Future Medical Systems, Inc.","Traditional","SN",{"k_number":19,"device_name":372,"applicant":368,"decision_date":373,"clearance_type":369,"decision_code":374,"statement_or_summary":375},"FMS ARTHRO-CUTTER","1995-05-09","SESE","Statement",{"items":377,"total":138},[]]