Data / Medical devices / United States / Hydrofera, LLC.
Hydrofera, LLC.: FDA-registered device maker in Manchester, CT, United States, 4 510(k) clearances
Hydrofera, LLC. is registered with the FDA (registration 3019543072) in Manchester, CT, United States. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 6, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019543072
- Address
- 8 Progress Drive --, Manchester, CT, United States, 06042
- Owner or operator
- HYDROFERA, LLC. (9028346)
- Roles
- Repackager or relabeler
- First device listed
- March 24, 1998
- Registered through
- 2026
- Brand names listed
- BACTERIOSTATIC NASAL, Hydrofera Blue Classic, Hydrofera Blue READY Antibacterial Foam Dressing, Hydrofera Blue Ready - Border, Hydrofera Blue Ready Transfer, Hydrofera Blue Transfer, Hydrofera Ear Wick, Hydrofera Femoral Wick and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon, Epistaxis | EMX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Repackager or relabeler | accessdata.fda.gov |
| Ear Wick | KCN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal | EFQ | U | Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 6, 2019 | K190268 | Hydrofera Blue READY - Border | FRO | Substantially Equivalent | Hydrofera, LLC | accessdata.fda.gov |
| January 2, 2014 | K130670 | HYDROFERA BLUE PU BACTERIOSTATIC DRESSING | FRO | Substantially Equivalent | Hydrofera, LLC | accessdata.fda.gov |
| January 11, 2002 | K013462 | HYDROFERA BACTERIOSTATIC WOUND DRESSING | FRO | Substantially Equivalent | Hydrofera, LLC | accessdata.fda.gov |
| February 13, 1998 | K974316 | HYDROFERA FEMORAL WICK | EFQ | Substantially Equivalent | Hydrofera, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Gauze/Sponge, Internal
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Ear Wick
- All makers of Dressing, Wound, Drug
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Balloon, Epistaxis
Updated November 6, 2019. 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.