Company ยท US
Facet Technologies, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2024. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2024 | K232912 | Facet Aurora Reusable Lancet Base Facet Technologies, LLC | QRL |
| Feb 13, 2023 | K223370 | NeatNick Heel Safety Lancet Facet Technologies, LLC | FMK |
| Nov 28, 2022 | K223099 | Facet Manatee Reusable Lancing Base Facet Technologies, LLC | QRL |
| Nov 18, 2022 | K222539 | Facet Blood Lancets Facet Technologies, LLC | QRL |
| Jul 15, 2022 | K221433 | Facet 28G Universal Lancet Facet Technologies, LLC | QRK |
| Jul 29, 2014 | K141749 | CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT Facet Technologies, LLC | FMI |
| May 13, 2014 | K140568 | CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT Facet Technologies, LLC | FMI |
| Jan 23, 2014 | K133100 | CAREFINE PEN NEEDLE Facet Technologies | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2008 | Facet Technologies Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets, Distributed by: Chain Drug Consortium, LLC, Boca Raton Terminated |
FMK | None listed |