Product code QSY · Class U
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
4510(k)s in 12 months (127 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QSY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtrade Products , Ltd. | 14 | 0 |
| Z-Medica Corporation | 10 | 0 |
| Hem Con Medical Technologies, Inc. | 9 | 0 |
| Hemostasis, LLC | 5 | 0 |
| Hemcon, Inc. | 4 | 0 |
| Lifescience Plus, Inc. | 4 | 0 |
| Advamedica, Inc. | 3 | 0 |
| Biolife, LLC | 3 | 0 |
| Calgon Vestal Div. | 3 | 0 |
| Cresilon, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2026 | K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) Lifescience Plus, Inc. | QSY |
| Feb 26, 2026 | K251700 | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm ( Speciality Fibres and Materials Limited, GB | QSY |
| Dec 15, 2025 | K250319 | MFUSE (MS001) Machina Medical, Inc. | QSY |
| Dec 12, 2025 | K253609 | TRAUMAGEL® 2.0 Hemostatic Gel Cresilon, Inc. | QSY |
| Aug 14, 2024 | K240713 | TRAUMAGEL® Cresilon, Inc. | QSY |
| May 22, 2024 | K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) Ushare Medical, Inc., CN | QSY |
| Apr 19, 2024 | K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) Incore Co., Ltd., KR | QSY |
| Mar 15, 2024 | K240454 | RESPONDER® Polysaccharide Hemostat Starch Medical, Inc. | QSY |
| Dec 4, 2023 | K220525 | RESPONDER Polysaccharide Hemostat Starch Medical, Inc. | QSY |
| Nov 17, 2023 | K230589 | Celox Rapid X-Ray Gauze Medtrade Products , Ltd., GB | QSY |
| Sep 1, 2023 | K213413 | Hemostatic Dressing Jiangsu Newvalue Medical Products Co., Ltd., CN | QSY |
| Jun 28, 2023 | K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) Cresilon, Inc. | QSY |
| May 2, 2023 | K223495 | Zeolite Hemostatic Cotton Hangzhou Zeo-Innov Life Technology Co., Ltd., CN | QSY |
| Apr 7, 2023 | K222909 | Axiostat Gauze Advamedica, Inc. | QSY |
| Feb 2, 2023 | K210751 | S.E.A.L. Hemostatic Wound Spray Bc3 Technologies, Inc. | QSY |
| Jul 29, 2022 | K220566 | Vascette HP (hemostatic pad) Koag, LLC | QSY |
| Feb 10, 2022 | K211570 | Zeolite Hemostatic Gauze Hangzhou Zeo-Innov Life Technology Co., Ltd., CN | QSY |
| Apr 15, 2021 | K202830 | Axiostat Patch Advamedica, Inc. | QSY |
| Aug 28, 2020 | K192671 | Hemostatic Xerogel Sponge Solaplus Biotech Co., Ltd., CN | QSY |
| Dec 18, 2019 | K190012 | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid Medtrade Product, Ltd., GB | QSY |
| Dec 2, 2019 | K183622 | NasalCEASE and BleedCEASE Les Laboratoires Brothier S.A., FR | QSY |
| Oct 25, 2019 | K192667 | gel-e Flex+ gel OTC Gel-E, Inc. | QSY |
| Aug 29, 2019 | K182811 | gel-e Flex+ Gel-E, Inc. | QSY |
| Dec 24, 2018 | K181641 | QuikClot Radial Z-Medica, LLC | QSY |
| Sep 19, 2018 | K180893 | IHM Technology Bandage Protege Biomedical | QSY |
| Jun 22, 2018 | K180152 | gel-e Flex Gel-E, Inc. | QSY |
| Apr 12, 2018 | K172155 | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing Statguard, LLC | QSY |
| Feb 23, 2018 | K172324 | Axiostat Chitosan Hemostatic Dressing Advamedica, Inc. | QSY |
| Jan 18, 2017 | K161274 | Bondiloxs Topical Hemostatic Granules Medtrade Products , Ltd., GB | QSY |
| Nov 29, 2016 | K161013 | InnoSEAL Hemostatic Pad Innotherapy, Inc., KR | QSY |
| Aug 8, 2016 | K160679 | WoundClot9 Core Scientific Creation , Ltd., IL | QSY |
| Jun 29, 2016 | K160578 | Nustat XR Beeken Biomedical, LLC | QSY |
| Jun 29, 2016 | K160130 | BloodSTOP iX Battle Matrix Lifescience Plus, Inc. | QSY |
| May 25, 2016 | K153582 | Prometheus ChitoGauze XR PRO Hem Con Medical Technologies, Inc. | QSY |
| Nov 10, 2015 | K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO Hem Con Medical Technologies, Inc. | QSY |
| Nov 5, 2015 | K150963 | AnsCare ChitoClot Pad Benq Materials Corporation, TW | QSY |
| Jul 31, 2015 | K151204 | HEMO-Bandage Coreleader Biotech Co., Ltd., TW | QSY |
| Jun 8, 2015 | K143466 | Hemogrip Patch Remedium Technologies, Inc. | QSY |
| May 8, 2015 | K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) Benq Materials Corporation, TW | QSY |
| Jan 9, 2015 | K142363 | NUSTAT, NUSTAT XR Beeken Biomedical | QSY |
| Nov 24, 2014 | K140573 | WOUNDCLOT HEMOSTATIC GAUZE Core Scientific , Ltd., IL | QSY |
| Jul 28, 2014 | K140313 | STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM Coag Medical, LLC | QSY |
| Jul 17, 2014 | K140757 | D2 HEMOSTANTIC DRESSING Z-Medica, LLC | QSY |
| Jun 25, 2014 | K132333 | BONDILOXS TOPICAL HEMOSTATIC DRESSING Medtrade Products , Ltd., GB | QSY |
| May 22, 2014 | 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 | QSY |
| Apr 3, 2014 | K132105 | PERCLOT TOPICAL Cryolife, Inc. | QSY |
| Jul 9, 2013 | K130324 | STATSEAL DISC Biolife, LLC | QSY |
| Apr 12, 2013 | K123387 | QUIKCLOT HEMOSTATIC DRESSING Z-Medica, LLC | QSY |
| Mar 20, 2013 | K120782 | INTERVENTIONAL HEMOSTATIC BANDAGE Z-Medica Corporation | QSY |
| Nov 15, 2012 | K122886 | NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING Hemostasis, LLC | QSY |
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