Company ยท US
Alafair Biosciences, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2025. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 22, 2025 | K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) Alafair Biosciences | JXI |
| Jul 18, 2025 | K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) Alafair Biosciences | OWW |
| Jul 17, 2025 | K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) Alafair Biosciences | JXI |
| Jun 14, 2024 | K240817 | VersaWrap Alafair Biosciences, Inc. | OWW |
| Nov 2, 2023 | K232029 | VersaWrap Nerve Protector Alafair Biosciences, Inc. | JXI |
| Oct 29, 2021 | K213163 | VersaWrap Alafair Biosciences, Inc. | FTM |
| Mar 9, 2021 | K203600 | VersaWrap Alafair Biosciences, Inc. | FTM |
| Sep 14, 2020 | K201631 | VersaWrap Nerve Protector Alafair Biosciences, Inc. | JXI |
| Mar 6, 2020 | K200311 | VersaWrap Tendon Protector Alafair Biosciences, Inc. | FTM |
| Jun 10, 2016 | K160364 | VersaWrap Tendon Protector Alafair Biosciences, Inc. | OWW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||