Data / Medical devices / United States / Nordic Pharma, Inc.
Nordic Pharma, Inc.: FDA-registered device maker in Berwyn, PA, United States, 1 510(k) clearance and 1 PMA approval
Nordic Pharma, Inc. is registered with the FDA (registration 3011965331) in Berwyn, PA, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated December 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011965331
- Address
- 1205 Westlakes Drive Suite 275, Berwyn, PA, United States, 19312
- Owner or operator
- Amring Pharmaceuticals Inc. (10056388)
- Roles
- Specification developer
- First device listed
- April 2, 2024
- Registered through
- 2026
- Brand names listed
- LACRIFILL® Canalicular Gel, Temp
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Surgical, Viscoelastic | LZP | 3 | Specification developer | accessdata.fda.gov |
| Plug, Punctum | LZU | U | Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 23, 2022 | K222164 | Visant Medical Canalicular Plug | LZU | Substantially Equivalent | Visant Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 16, 1998 | P960011 | BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID | LZP | 33 | October 3, 2022 | accessdata.fda.gov |
Compare with other makers
Updated December 23, 2022. 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.