Data / Medical devices / United States / Kericure Medical
Kericure Medical: FDA-registered device maker in Land O Lakes, FL, United States, 2 510(k) clearances
Kericure Medical is registered with the FDA (registration 3010131715) in Land O Lakes, FL, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010131715
- Address
- 24327 Oaks Blvd, Land O Lakes, FL, United States, 34639
- Owner or operator
- KeriCure Medical (10043631)
- Roles
- Specification developer
- First device listed
- March 6, 2013
- Registered through
- 2026
- Brand names listed
- Advanced Seal Liquid Bandage, Advanced Seal Wound Barrier, Advanced Shield Chronic Wound Barrier, Advanced Shield Hydrogel Wound Barrier, Advanced Shield MAX Wound Barrier, Field Shield Hydrogel Wound Dressing, Field Shield PRO Wound Dressing, Field Shield Wound Dressing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Specification developer | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | 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 |
|---|---|---|---|---|---|---|
| July 18, 2024 | K212521 | Field Shield Wound Dressing | FRO | Substantially Equivalent | Kericure, Inc. | accessdata.fda.gov |
| August 7, 2014 | K131384 | KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE | KMF | Substantially Equivalent | Kericure, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bandage, Liquid
- All makers of Bandage, Liquid, Skin Protectant
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Updated July 18, 2024. 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.