Facet Technologies, LLC
Medical device manufacturer in Atlanta, GA.
8510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K232912 | Facet Aurora Reusable Lancet BaseQRL · Traditional | 01/25/2024SE |
| K223370 | NeatNick Heel Safety LancetFMK · Traditional | 02/13/2023SE |
| K223099 | Facet Manatee Reusable Lancing BaseQRL · Traditional | 11/28/2022SE |
| K222539 | Facet Blood LancetsQRL · Traditional | 11/18/2022SE |
| K221433 | Facet 28G Universal LancetQRK · Traditional | 07/15/2022SE |
| K141749 | Carefine Pen Needle Family Including Quintapoint and SuperpointFMI · Special | 07/29/2014SE |
| K140568 | Carefine Pen Needle with Quintapoint and SuperpointFMI · Special | 05/13/2014SE |
| K133100 | Carefine Pen NeedleFMI · Traditional | 01/23/2014SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0174-2009 | Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing…The Alternate Site Cap was not included in the package as indicated on the labeling. | 07/18/2008Terminated |