Data / Medical devices / Temporary, Internal Use Hemostatic
Temporary, Internal Use Hemostatic (POD): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Temporary, Internal Use Hemostatic (product code POD, Class 2, 21 CFR 878.4454). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on March 18, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- POD
- Device class
- 2
- Regulation
- 878.4454
- Medical specialty
- General, Plastic Surgery
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Mexico | 1 |
| India | 1 |
| Dominican Republic | 1 |
Makers of Temporary, Internal Use Hemostatic
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 3 | March 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 3 | March 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Z-Medica, LLC | North Haven, CT, United States | Manufacturer, Repackager or relabeler | 3 | March 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Z-Medica, LLC | Wallingford, CT, United States | Manufacturer, Repackager or relabeler | 3 | March 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Advamedica Inc. | Cambridge, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | January 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Beeken Biomedical LLC | Newton, MA, United States | Complaint file establishment, Specification developer | 1 | September 25, 2019 | 0 | 1 | 0 | api.fda.gov |
| Axio Biosolutions Pvt Ltd | Ahmedabad Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benefit Coatings, Inc. | Stratford, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medsorb Dominicana, S.A. | San Pedro De Macoris, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weslacova | North Wilkesboro, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.