Company ยท US
Stat Medical Devices
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2023. Name variants (Inc, Corp, punctuation) are merged.
4510(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 |
|---|---|---|---|
| Sep 8, 2023 | K230310 | STAT Medical Device Lancing System Stat Medical Devices | QRK |
| Mar 21, 2023 | K222617 | EasyTouch Lancing Device Stat Medical Devices | QRK |
| Feb 15, 2023 | K223815 | ONE DROP Lancing Device Stat Medical Devices | QRK |
| Oct 2, 2009 | K092016 | SUPER-FINE PEN NEEDLE Stat Medical Devices, Inc. | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2009 | Stat Medical Devices, Inc. Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously. Terminated |
FMI | None listed |