FDA Product Code
FDA Product Code QSY — Clearance Directory
- Device Class
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- Assigned Panel
- Unknown
510(k) Clearances — 127 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | 2026-04-30 | Traditional | PDF ↗ |
| K251700 | 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 | Traditional | PDF ↗ |
| K250319 | MFUSE (MS001) | Machina Medical, Inc. | 2025-12-15 | Traditional | PDF ↗ |
| K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 2025-12-12 | Special | PDF ↗ |
| K240713 | TRAUMAGEL® | Cresilon, Inc. | 2024-08-14 | Traditional | PDF ↗ |
| K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | Ushare Medical, Inc. | 2024-05-22 | Traditional | PDF ↗ |
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. | 2024-04-19 | Traditional | PDF ↗ |
| K240454 | RESPONDER® Polysaccharide Hemostat | Starch Medical, Inc. | 2024-03-15 | Special | PDF ↗ |
| K220525 | RESPONDER Polysaccharide Hemostat | Starch Medical, Inc. | 2023-12-04 | Traditional | PDF ↗ |
| K230589 | Celox Rapid X-Ray Gauze | Medtrade Products , Ltd. | 2023-11-17 | Traditional | PDF ↗ |
| K213413 | Hemostatic Dressing | Jiangsu Newvalue Medical Products Co., Ltd. | 2023-09-01 | Traditional | PDF ↗ |
| K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon, Inc. | 2023-06-28 | Traditional | PDF ↗ |
| K223495 | Zeolite Hemostatic Cotton | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2023-05-02 | Traditional | PDF ↗ |
| K222909 | Axiostat Gauze | Advamedica, Inc. | 2023-04-07 | Traditional | PDF ↗ |
| K210751 | S.E.A.L. Hemostatic Wound Spray | Bc3 Technologies, Inc. | 2023-02-02 | Traditional | PDF ↗ |
| K220566 | Vascette HP (hemostatic pad) | Koag, LLC | 2022-07-29 | Traditional | PDF ↗ |
| K211570 | Zeolite Hemostatic Gauze | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2022-02-10 | Traditional | PDF ↗ |
| K202830 | Axiostat Patch | Advamedica, Inc. | 2021-04-15 | Traditional | PDF ↗ |
| K192671 | Hemostatic Xerogel Sponge | Solaplus Biotech Co., Ltd. | 2020-08-28 | Traditional | PDF ↗ |
| K190012 | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid | Medtrade Product, Ltd. | 2019-12-18 | Traditional | PDF ↗ |
| K183622 | NasalCEASE and BleedCEASE | Les Laboratoires Brothier S.A. | 2019-12-02 | Traditional | PDF ↗ |
| K192667 | gel-e Flex+ gel OTC | Gel-E, Inc. | 2019-10-25 | Special | PDF ↗ |
| K182811 | gel-e Flex+ | Gel-E, Inc. | 2019-08-29 | Traditional | PDF ↗ |
| K181641 | QuikClot Radial | Z-Medica, LLC | 2018-12-24 | Traditional | PDF ↗ |
| K180893 | IHM Technology Bandage | Protege Biomedical | 2018-09-19 | Traditional | PDF ↗ |
| K180152 | gel-e Flex | Gel-E, Inc. | 2018-06-22 | Traditional | PDF ↗ |
| K172155 | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | Statguard, LLC | 2018-04-12 | Traditional | PDF ↗ |
| K172324 | Axiostat Chitosan Hemostatic Dressing | Advamedica, Inc. | 2018-02-23 | Traditional | PDF ↗ |
| K161274 | Bondiloxs Topical Hemostatic Granules | Medtrade Products , Ltd. | 2017-01-18 | Traditional | PDF ↗ |
| K161013 | InnoSEAL Hemostatic Pad | Innotherapy, Inc. | 2016-11-29 | Traditional | PDF ↗ |
| K160679 | WoundClot9 | Core Scientific Creation , Ltd. | 2016-08-08 | Traditional | PDF ↗ |
| K160578 | Nustat XR | Beeken Biomedical, LLC | 2016-06-29 | Traditional | PDF ↗ |
| K160130 | BloodSTOP iX Battle Matrix | Lifescience Plus, Inc. | 2016-06-29 | Traditional | PDF ↗ |
| K153582 | Prometheus ChitoGauze XR PRO | Hem Con Medical Technologies, Inc. | 2016-05-25 | Traditional | PDF ↗ |
| K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO | Hem Con Medical Technologies, Inc. | 2015-11-10 | Traditional | PDF ↗ |
| K150963 | AnsCare ChitoClot Pad | Benq Materials Corporation | 2015-11-05 | Traditional | PDF ↗ |
| K151204 | HEMO-Bandage | Coreleader Biotech Co., Ltd. | 2015-07-31 | Traditional | PDF ↗ |
| K143466 | Hemogrip Patch | Remedium Technologies, Inc. | 2015-06-08 | Traditional | PDF ↗ |
| K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) | Benq Materials Corporation | 2015-05-08 | Traditional | PDF ↗ |
| K142363 | NUSTAT, NUSTAT XR | Beeken Biomedical | 2015-01-09 | Traditional | PDF ↗ |
| K140573 | WOUNDCLOT HEMOSTATIC GAUZE | Core Scientific , Ltd. | 2014-11-24 | Traditional | PDF ↗ |
| K140313 | STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM | Coag Medical, LLC | 2014-07-28 | Traditional | PDF ↗ |
| K140757 | D2 HEMOSTANTIC DRESSING | Z-Medica, LLC | 2014-07-17 | Traditional | PDF ↗ |
| K132333 | BONDILOXS TOPICAL HEMOSTATIC DRESSING | Medtrade Products , Ltd. | 2014-06-25 | Traditional | PDF ↗ |
| K133121 | CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT | Sam Medical Products | 2014-05-22 | Traditional | PDF ↗ |
| K132105 | PERCLOT TOPICAL | Cryolife, Inc. | 2014-04-03 | Traditional | PDF ↗ |
| K130324 | STATSEAL DISC | Biolife, LLC | 2013-07-09 | Traditional | PDF ↗ |
| K123387 | QUIKCLOT HEMOSTATIC DRESSING | Z-Medica, LLC | 2013-04-12 | Traditional | PDF ↗ |
| K120782 | INTERVENTIONAL HEMOSTATIC BANDAGE | Z-Medica Corporation | 2013-03-20 | Traditional | PDF ↗ |
| K122886 | NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING | Hemostasis, LLC | 2012-11-15 | Special | PDF ↗ |
| K121485 | GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING | Hemcon Medical Technologies Europe, Ltd. | 2012-08-21 | Traditional | PDF ↗ |
| K112864 | SOFTSEAL-C | Chitogen, Inc. | 2012-08-02 | Traditional | PDF ↗ |
| K113560 | CELOX GAUZE PRO | Medtrade Products , Ltd. | 2012-08-01 | Traditional | PDF ↗ |
| K120958 | POSISEP AND POSISEP X HEMOSTAT DRESSINGS | Hemostasis, LLC | 2012-07-25 | Traditional | PDF ↗ |
| K112800 | SUNTOUCH TOPICAL HEMOSTATIC DRESSING | Huizhou Foryou Medical Devices Co., Ltd. | 2012-05-23 | Traditional | PDF ↗ |
| K112215 | HEMCON HEMOSTATIC GEL | Hemcon Medical Technologies Europe, Ltd. | 2012-04-12 | Traditional | PDF ↗ |
| K101257 | ADVANCED TRAUMA DRESSING (ATD) | Nanosys, Inc. | 2011-12-01 | Traditional | PDF ↗ |
| K112961 | CLO-SURPLUS P.A.D. | Scion Cardio-Vascular, Inc. | 2011-10-31 | Special | PDF ↗ |
| K102944 | CORELEADER HEMO-PAD MODEL CPII 02030 | Coreleader Biotech Co., Ltd. | 2011-09-07 | Traditional | PDF ↗ |
| K103641 | GUARDACARE | Hem Con Medical Technologies, Inc. | 2011-06-16 | Traditional | PDF ↗ |
| K111163 | CHITOGAUZE FUSION | Hem Con Medical Technologies, Inc. | 2011-05-17 | Special | PDF ↗ |
| K110386 | CELOX RAPID GAUZE | Medtrade Products , Ltd. | 2011-05-10 | Traditional | PDF ↗ |
| K103245 | CELSTAT | Baxter Healthcare Corp | 2011-03-23 | Traditional | PDF ↗ |
| K102742 | NASAL CEASE | Catalina, Inc. | 2011-02-02 | Traditional | PDF ↗ |
| K102965 | CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI | Medtrade Products , Ltd. | 2010-12-08 | Traditional | PDF ↗ |
| K102459 | NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE | Hemostasis, LLC | 2010-12-03 | Traditional | PDF ↗ |
| K102546 | CHITOGAUZE | Hem Con Medical Technologies, Inc. | 2010-11-17 | Special | PDF ↗ |
| K101097 | CALGAESEAL MODEL: CAS | Bz Medical, Inc. | 2010-09-22 | Traditional | PDF ↗ |
| K093729 | GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I | Hemcon Medical Technologies Europe, Ltd. | 2010-06-08 | Traditional | PDF ↗ |
| K093593 | CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO | Medtrade Products Limited | 2010-01-20 | Traditional | PDF ↗ |
| K093519 | MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET | Medtrade Products , Ltd. | 2010-01-14 | Traditional | PDF ↗ |
| K090780 | MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE | Medtrade Products , Ltd. | 2009-11-20 | Traditional | PDF ↗ |
| K091795 | MEDTRADE PRODUCTS CELOX TRAUMA GAUZE | Medtrade Products , Ltd. | 2009-11-20 | Traditional | PDF ↗ |
| K092552 | CLO-SURPLUS P.A.D. | Scion Cardio-Vascular, Inc. | 2009-09-04 | Traditional | PDF ↗ |
| K092357 | CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 | Hem Con Medical Technologies, Inc. | 2009-08-25 | Special | PDF ↗ |
| K091194 | ALGISEAL PAD | Evolution Medical Technologies, LLC | 2009-05-18 | Traditional | PDF ↗ |
| K090620 | QUIKCLOT INTEVENTIONAL, MODEL P/N 182 | Z-Medica Corporation | 2009-04-08 | Traditional | PDF ↗ |
| K090026 | CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009-03-31 | Traditional | PDF ↗ |
| K090100 | SOFTSEAL-STF | Chitogen, Inc. | 2009-03-11 | Traditional | PDF ↗ |
| K080210 | PRO QR ADVANCED FORMULA POWDER | Biolife, LLC | 2009-02-10 | Traditional | PDF ↗ |
| K080532 | BENACEL, MODELS C-001, C-002 AND C-005 | Unicare Biomedical, Inc. | 2008-11-12 | Traditional | PDF ↗ |
| K082601 | UltraClot, UltraClot OTC | Emergency Medical Devices, LLC | 2008-10-09 | Traditional | PDF ↗ |
| K072486 | MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC | Hem Con Medical Technologies, Inc. | 2008-08-06 | Traditional | PDF ↗ |
| K080097 | MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET | Medtrade Products , Ltd. | 2008-07-09 | Traditional | PDF ↗ |
| K081183 | WOUNDSTAT | Traumacure, Inc. | 2008-06-19 | Traditional | PDF ↗ |
| K080818 | HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING | Hem Con Medical Technologies, Inc. | 2008-05-15 | Traditional | PDF ↗ |
| K080648 | TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE | Ore-Medix, LLC | 2008-05-07 | Traditional | PDF ↗ |
| K072328 | MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT | Medtrade Products , Ltd. | 2007-12-21 | Traditional | PDF ↗ |
| K072890 | STASILON FR | Entegrion, Inc. | 2007-12-10 | Traditional | PDF ↗ |
| K072681 | BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE | Lifescience Plus, Inc. | 2007-11-02 | Traditional | PDF ↗ |
| K072900 | EXCELARREST FOAM | Hemostasis, LLC | 2007-10-26 | Special | PDF ↗ |
| K070520 | PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) | Biolife, LLC | 2007-10-23 | Traditional | PDF ↗ |
| K072474 | QUIKCLOT EX | Z-Medica Corporation | 2007-10-16 | Traditional | PDF ↗ |
| K071578 | BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17 | Lifescience Plus, Inc. | 2007-09-27 | Traditional | PDF ↗ |
| K071936 | WOUNDSTAT, MODEL TC1001 | Traumacure, Inc. | 2007-08-23 | Traditional | PDF ↗ |
| K063190 | SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC | Noble Fiber Technologies, Inc. | 2007-08-21 | Traditional | PDF ↗ |
| K071519 | HEMCON CHITOFLEX-SURGICAL DRESSING | Hemcon, Inc. | 2007-08-06 | Traditional | PDF ↗ |
| K070175 | AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC | Medtrade Products , Ltd. | 2007-07-25 | Traditional | PDF ↗ |
| K070211 | TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM | Hemostasis, LLC | 2007-04-05 | Traditional | PDF ↗ |
| K070010 | QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER | Z-Medica Corporation | 2007-01-25 | Special | PDF ↗ |
Product code QSY · · Unknown. Data: openFDA.