Owen Mumford, Ltd.
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories4
Latest Approval2023-06-30
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K223854 | Unistik® ShieldLock, Unistik VacuFlip | JKA | 2023-06-30 | View |
| 510(k) | K231124 | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) | FMK | 2023-06-27 | View |
| 510(k) | K222168 | Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler | FMK | 2022-11-03 | View |
| 510(k) | K222303 | Unistik® Pro | FMK | 2022-10-25 | View |
| 510(k) | K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | QRL | 2022-10-03 | View |
| 510(k) | K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G | FMK | 2022-09-07 | View |
| 510(k) | K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets | FMK | 2022-08-12 | View |
| 510(k) | K210399 | Unifine SafeControl | FMI | 2021-09-17 | View |
| 510(k) | K173881 | Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G | FMI | 2018-07-11 | View |
| 510(k) | K152339 | Unifine Pentips/ Unifine Pentips Plus | FMI | 2016-06-24 | View |
No matching devices.