POD
6 FDA 510(k) clearances · Product code
310 daysmedian time to decision
471 days90th percentile
6clearances measured
FDA profile
- Official device name
- Temporary, Internal Use Hemostatic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4454
- Medical specialty
- General, Plastic Surgery
- Flags
- Life-sustaining
- FDA definition
- Intended to control severely bleeding wounds
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QuikClot Control+ Hemostatic Device (K243553) | Teleflex Medical | 2025-03-18 |
| Ax-Surgi Surgical Hemostat (K213198) | Advamedica, Inc. | 2023-01-05 |
| QuikClot Control+ Hemostatic Dressing (K220971) | Z-Medica, LLC | 2022-12-14 |
| QuikClot Control+ (K200167) | Z-Medica, LLC | 2020-04-23 |
| NuStat (K183190) | Beeken Biomedical, LLC | 2019-09-25 |
| D2 Dressing (DEN160012) | Z-Medica, LLC | 2017-06-30 |
Track POD automatically
Every clearance here is in the API, with alerts when new ones post.