QSY · Hemostatic Wound Dressing Without Thrombin Or Other Biologics
· Class U
Overview
| Product Code | QSY |
|---|---|
| Device Name | Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Device Class | Class U |
| Review Panel |
Identification
To temporarily control bleeding and cover external wounds.
Recent Cleared Devices (20 of 127)
Showing 20 most recent of 127 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | Apr 30, 2026 | SESE |
| 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 | Feb 26, 2026 | SESE |
| K250319 | MFUSE (MS001) | Machina Medical, Inc. | Dec 15, 2025 | SESE |
| K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | Dec 12, 2025 | SESE |
| K240713 | TRAUMAGEL® | Cresilon, Inc. | Aug 14, 2024 | SESE |
| K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | Ushare Medical, Inc. | May 22, 2024 | SESE |
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. | Apr 19, 2024 | SESE |
| K240454 | RESPONDER® Polysaccharide Hemostat | Starch Medical, Inc. | Mar 15, 2024 | SESE |
| K220525 | RESPONDER Polysaccharide Hemostat | Starch Medical, Inc. | Dec 4, 2023 | SESE |
| K230589 | Celox Rapid X-Ray Gauze | Medtrade Products , Ltd. | Nov 17, 2023 | SESE |
| K213413 | Hemostatic Dressing | Jiangsu Newvalue Medical Products Co., Ltd. | Sep 1, 2023 | SESE |
| K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon, Inc. | Jun 28, 2023 | SESE |
| K223495 | Zeolite Hemostatic Cotton | Hangzhou Zeo-Innov Life Technology Co., Ltd. | May 2, 2023 | SESE |
| K222909 | Axiostat Gauze | Advamedica, Inc. | Apr 7, 2023 | SESE |
| K210751 | S.E.A.L. Hemostatic Wound Spray | Bc3 Technologies, Inc. | Feb 2, 2023 | SESE |
| K220566 | Vascette HP (hemostatic pad) | Koag, LLC | Jul 29, 2022 | SESE |
| K211570 | Zeolite Hemostatic Gauze | Hangzhou Zeo-Innov Life Technology Co., Ltd. | Feb 10, 2022 | SESE |
| K202830 | Axiostat Patch | Advamedica, Inc. | Apr 15, 2021 | SESE |
| K192671 | Hemostatic Xerogel Sponge | Solaplus Biotech Co., Ltd. | Aug 28, 2020 | SESE |
| K190012 | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid | Medtrade Product, Ltd. | Dec 18, 2019 | SESE |
Top Applicants
- Medtrade Products , Ltd. — 13 clearances
- Hem Con Medical Technologies, Inc. — 9 clearances
- Z-Medica Corporation — 7 clearances
- Hemostasis, LLC — 5 clearances
- Hemcon, Inc. — 4 clearances
