Data / Medical devices / United States / Lavior Pharma Inc.
Lavior Pharma Inc.: FDA-registered device maker in Hallandale Beach, FL, United States, 1 510(k) clearance
Lavior Pharma Inc. is registered with the FDA (registration 3022133572) in Hallandale Beach, FL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 26, 2012. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3022133572
- Address
- 1250 E Hallandale Beach Blvd Ste 302, Hallandale Beach, FL, United States, 33009
- Owner or operator
- Lavior Pharma Inc. (10086490)
- Roles
- Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- November 14, 2022
- Registered through
- 2027
- Brand names listed
- Advanced Dermal Barrier Cream, Advanced Diabetic Wound Hydrogel, Advanced Itch & Irritation Barrier Cream, Advanced MultiCare Hydrogel, Advanced Post-Procedure Barrier Gel, Diabetic Itch Shield Skin Barrier Cream, Diabetic Skin Barrier Cream, Diabetic Wound Hydrogel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer for export | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Specification developer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | 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 |
|---|---|---|---|---|---|---|
| October 26, 2012 | K122325 | SKINTEMP II | KGN | Substantially Equivalent | Human Biosciences, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated October 26, 2012. 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.