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