Data / Medical devices / United States / Novabay Pharmaceuticals, Inc
Novabay Pharmaceuticals, Inc: FDA-registered device maker in Emeryville, CA, United States, 3 510(k) clearances
Novabay Pharmaceuticals, Inc is registered with the FDA (registration 3006218807) in Emeryville, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 29, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006218807
- Address
- 2000 Powell Street, Suite 1150, Emeryville, CA, United States, 94608
- Owner or operator
- NovaBay Pharmaceuticals, Inc (10039889)
- Roles
- Manufacturer
- First device listed
- November 12, 2015
- Registered through
- 2026
- Brand names listed
- NeutroPhase, PhaseOne Skin and Wound Cleanser, intelliCase
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Manufacturer | accessdata.fda.gov |
| Case, Contact Lens | LRX | 2 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 29, 2015 | K143351 | iCase Contact Lens Case | LRX | Substantially Equivalent | Novabay Pharmaceuticals, Inc. | accessdata.fda.gov |
| August 8, 2012 | K113820 | NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER | FRO | Substantially Equivalent | Novabay Pharmaceuticals | accessdata.fda.gov |
| May 20, 2008 | K081009 | NEUTROPHASE | KMF | Substantially Equivalent | Novabay Pharmaceuticals | accessdata.fda.gov |
Compare with other makers
Updated April 29, 2015. 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.