[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QSY":3},{"classification":4,"mappedDevices":300,"similarCandidates":301,"relatedClassifications":385,"syncDates":386,"translation":297,"marketSummary":297,"recalls":393,"k510s":395,"pmas":476},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":294,"updated_at":295,"recall_count":296,"latest_recall_date":297,"k510_count":298,"pma_count":296,"event_count":299},1744,"QSY","Hemostatic Wound Dressing Without Thrombin Or Other Biologics","U","","Unknown","SU","1","To temporarily control bleeding and cover external wounds.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":292,"product_code":6,"review_panel":11,"gmp_exempt_flag":292,"third_party_flag":292,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":12,"life_sustain_support_flag":292,"medical_specialty_description":10,"summary_malfunction_reporting":293},{"k_number":17,"fei_number":145,"registration_number":262},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144],"K103641","K080532","K220566","K070520","K180893","K092552","K070010","K130324","K072900","K091795","K071936","K133121","K172155","K904488","K910059","K120958","K160679","K202830","K090100","K090620","K072681","K051955","K153582","K103245","K172324","K220525","K102742","K213652","K222909","K033291","K080818","K101257","K021062","K082601","K161274","K112215","K040283","K021581","K901564","K143466","K211570","K142363","K893123","K982638","K080210","K111163","K033666","K213413","K072328","K063190","K160130","K180152","K080648","K072890","K151204","K081183","K240097","K123387","K143462","K110386","K240454","K060409","K121485","K090026","K102459","K093729","K140573","K132105","K093593","K061079","K090780","K070175","K230589","K250319","K040208","K253017","K093519","K091194","K150916","K240713","K181641","K161013","K112864","K122886","K223495","K050769","K092357","K061767","K112800","K210751","K072474","K030946","K071578","K102944","K072486","K132333","K101097","K910080","K013390","K232216","K070211","K061722","K023298","K021678","K010933","K071519","K030334","K102965","K032986","K190012","K182811","K965034","K120782","K251700","K160578","K112961","K080097","K140313","K043050","K150963","K113560","K192667","K192671","K102546","K253609","K140757","K183622",[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],"3002422294","3008162665","3027517726","1000127185","1038758","2245304","3034735187","3044819802","1721504","3011088743","3017391151","1250045","3003898360","3005461046","3021841055","3001186500","3000215273","3010256218","2183319","1000114185","3002565916","3011657181","3038718579","3012888343","3006082230","1000306431","3004512585","3007867940","3004728227","1219313","3003775072","3031563325","3033589330","3026322855","3045855232","1000219637","3007215524","3004957256","3015525200","3006113097","3009317711","3007788086","3008298053","3004111573","3015422337","1643817","3031288561","3007225047","3016844359","3045158005","3008559295","3015219237","3006324197","1213643","3015205402","3022104448","1000512168","3002806457","3015437221","1220477","3002807310","3004740112","3010155661","3003015552","2244725","3002468371","3015225571","3002807113","3014136088","1417592","3007829657","3003188818","3023316","3002806830","3002808227","3005460813","3012777736","3001436772","3003646540","3007583554","3012536737","3005674475","3003737899","3006580788","3006619672","3007735241","3010123105","1526711","1000120505","1625425","3002807038","1047843","3009348684","3006260740","3007663067","3003259710","3006950086","3005761322","3004050854","3005378067","3011400126","3004138549","1018233","3003395204","3010862763","3003767891","1450662","3025413691","1000237915","3015309643","3005853033","3004545959","3002807112","3003058448","3005747797","3010878315",[146,148,150,151,152,153,155,156,157,158,160,161,163,164,263,167,168,169,170,264,172,175,176,177,265,178,179,180,182,266,183,267,184,268,185,186,187,188,189,192,190,269,191,193,194,195,196,270,197,198,199,200,201,204,205,271,206,207,208,210,212,272,273,274,214,215,216,275,218,276,277,220,221,222,225,226,278,227,279,280,229,230,231,232,233,235,237,238,239,240,281,282,283,242,284,285,243,286,244,245,246,247,248,251,287,252,253,288,255,256,289,290,291,258,154,261],"3010864832","1054811","1424263","3032534","2032098","9616067","2135152","1066421","1058584","2032542","8043838","9680794","3011137372","1061124","9681465","2135339","1223089","8021832","9617592","3027815","9612051","9680091","9611590","1423662","9614493","9680271","2029275","3009756327","8043396","N","Ineligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",0,null,127,19,[],[302,311,320,329,336,344,352,361,369,377],{"medical_device_id":303,"generic_name":304,"class_classification":305,"jmdn_code":306,"name_similarity":307,"definition_similarity":308,"vector_similarity":309,"score":310},1100,"ヒトトロンビン含有ゼラチン使用吸収性局所止血材","Ⅳ","35895324",0.19802,0.102439,0.717555,0.0313188,{"medical_device_id":312,"generic_name":313,"class_classification":314,"jmdn_code":315,"name_similarity":316,"definition_similarity":317,"vector_similarity":318,"score":319},2565,"止血ナイフ","Ⅱ","36136000",0.166667,0.0897436,0.710593,0.0290309,{"medical_device_id":321,"generic_name":322,"class_classification":323,"jmdn_code":324,"name_similarity":325,"definition_similarity":326,"vector_similarity":327,"score":328},500,"二次治癒ハイドロゲル創傷被覆・保護材","Ⅲ","34082003",0.211765,0.163043,0.666154,0.0286935,{"medical_device_id":330,"generic_name":331,"class_classification":305,"jmdn_code":332,"name_similarity":316,"definition_similarity":333,"vector_similarity":334,"score":335},176,"コラーゲン使用吸収性局所止血材","35895200",0.128205,0.695746,0.0285948,{"medical_device_id":337,"generic_name":338,"class_classification":323,"jmdn_code":339,"name_similarity":340,"definition_similarity":341,"vector_similarity":342,"score":343},1150,"腹部開放創用ドレッシングキット","47406003",0.205128,0.117647,0.663732,0.0274972,{"medical_device_id":345,"generic_name":346,"class_classification":323,"jmdn_code":347,"name_similarity":348,"definition_similarity":349,"vector_similarity":350,"score":351},1094,"単回使用陰圧創傷治療システム","58202003",0.159574,0.118644,0.68771,0.0271062,{"medical_device_id":353,"generic_name":354,"class_classification":355,"jmdn_code":356,"name_similarity":357,"definition_similarity":358,"vector_similarity":359,"score":360},3988,"止血器","Ⅰ","70678000",0.169231,0.125,0.66508,0.0267427,{"medical_device_id":362,"generic_name":363,"class_classification":355,"jmdn_code":364,"name_similarity":365,"definition_similarity":366,"vector_similarity":367,"score":368},3794,"手術用被覆・保護材","34654000",0.147059,0.171171,0.6822,0.0261986,{"medical_device_id":370,"generic_name":371,"class_classification":323,"jmdn_code":372,"name_similarity":373,"definition_similarity":374,"vector_similarity":375,"score":376},1072,"陰圧創傷治療システム","20395000",0.151163,0.122807,0.683947,0.0259893,{"medical_device_id":378,"generic_name":379,"class_classification":323,"jmdn_code":380,"name_similarity":381,"definition_similarity":382,"vector_similarity":383,"score":384},509,"植皮部・採皮部創傷被覆・保護材","15319000",0.141026,0.1375,0.662352,0.0235424,[],{"510k":387,"classification":388,"enforcement":389,"event":390,"pma":391,"warning_letter":392},"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","2026-08-20T03:28:02.95+00:00",{"items":394,"total":296},[],{"items":396,"total":298},[397,404,408,412,417,420,424,428,432,435,439,443,446,450,454,458,462,465,468,472],{"k_number":93,"device_name":398,"applicant":399,"decision_date":400,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"BloodSTOP iX Trauma Matrix (TM-iX-20)","Lifescience Plus, Inc.","2026-04-30","Traditional","SESE","Summary",{"k_number":131,"device_name":405,"applicant":406,"decision_date":407,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm  (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm  (FG100701); Ganymede-X 25cm","Speciality Fibres and Materials Limited","2026-02-26",{"k_number":91,"device_name":409,"applicant":410,"decision_date":411,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"MFUSE (MS001)","Machina Medical, Inc.","2025-12-15",{"k_number":142,"device_name":413,"applicant":414,"decision_date":415,"clearance_type":416,"decision_code":402,"statement_or_summary":403},"TRAUMAGEL® 2.0 Hemostatic Gel","Cresilon, Inc.","2025-12-12","Special",{"k_number":97,"device_name":418,"applicant":414,"decision_date":419,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"TRAUMAGEL®","2024-08-14",{"k_number":74,"device_name":421,"applicant":422,"decision_date":423,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)","Ushare Medical, Inc.","2024-05-22",{"k_number":117,"device_name":425,"applicant":426,"decision_date":427,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Hemoblock_S (Prescription); Hemoblock_S (OTC)","Incore Co., Ltd.","2024-04-19",{"k_number":78,"device_name":429,"applicant":430,"decision_date":431,"clearance_type":416,"decision_code":402,"statement_or_summary":403},"RESPONDER® Polysaccharide Hemostat","Starch Medical, Inc.","2024-03-15",{"k_number":43,"device_name":433,"applicant":430,"decision_date":434,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"RESPONDER Polysaccharide Hemostat","2023-12-04",{"k_number":90,"device_name":436,"applicant":437,"decision_date":438,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Celox Rapid X-Ray Gauze","Medtrade Products , Ltd.","2023-11-17",{"k_number":65,"device_name":440,"applicant":441,"decision_date":442,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Hemostatic Dressing","Jiangsu Newvalue Medical Products Co., Ltd.","2023-09-01",{"k_number":45,"device_name":444,"applicant":414,"decision_date":445,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)","2023-06-28",{"k_number":102,"device_name":447,"applicant":448,"decision_date":449,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Zeolite Hemostatic Cotton","Hangzhou Zeo-Innov Life Technology Co., Ltd.","2023-05-02",{"k_number":46,"device_name":451,"applicant":452,"decision_date":453,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Axiostat Gauze","Advamedica, Inc.","2023-04-07",{"k_number":107,"device_name":455,"applicant":456,"decision_date":457,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"S.E.A.L. Hemostatic Wound Spray","Bc3 Technologies, Inc.","2023-02-02",{"k_number":20,"device_name":459,"applicant":460,"decision_date":461,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Vascette HP (hemostatic pad)","Koag, LLC","2022-07-29",{"k_number":58,"device_name":463,"applicant":448,"decision_date":464,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Zeolite Hemostatic Gauze","2022-02-10",{"k_number":35,"device_name":466,"applicant":452,"decision_date":467,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Axiostat Patch","2021-04-15",{"k_number":140,"device_name":469,"applicant":470,"decision_date":471,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"Hemostatic Xerogel Sponge","Solaplus Biotech Co., Ltd.","2020-08-28",{"k_number":127,"device_name":473,"applicant":474,"decision_date":475,"clearance_type":401,"decision_code":402,"statement_or_summary":403},"OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid","Medtrade Product, Ltd.","2019-12-18",{"items":477,"total":296},[]]