Company · US
Owen Mumford USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2023. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KZH | Introducer, Syringe Needle | 9 |
| FMI | Needle, Hypodermic, Single Lumen | 7 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 5 |
| FMF | Syringe, Piston | 4 |
| LKY | Device, External Penile Rigidity | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| KXP | Stent, Vaginal | 1 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 2023 | K223854 | Unistik® ShieldLock, Unistik VacuFlip Owen Mumford, Ltd., GB | JKA |
| Jun 27, 2023 | K231124 | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) Owen Mumford, Ltd., GB | FMK |
| Nov 3, 2022 | K222168 | Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Sing Owen Mumford, Ltd., GB | FMK |
| Oct 25, 2022 | K222303 | Unistik® Pro Owen Mumford, Ltd., GB | FMK |
| Oct 3, 2022 | K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets Owen Mumford, Ltd., GB | QRL |
| Sep 7, 2022 | K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G Owen Mumford, Ltd., GB | FMK |
| Aug 12, 2022 | K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile si Owen Mumford, Ltd., GB | FMK |
| Sep 17, 2021 | K210399 | Unifine SafeControl Owen Mumford, Ltd., GB | FMI |
| Jul 11, 2018 | K173881 | Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G Owen Mumford, Ltd., GB | FMI |
| Jun 24, 2016 | K152339 | Unifine Pentips/ Unifine Pentips Plus Owen Mumford, Ltd., GB | FMI |
| Oct 15, 2012 | K122837 | AUTOJECT 2 FOR GLASSY SYRINGE Owen Mumford, Ltd., GB | KZH |
| Nov 13, 2001 | K013362 | AUTOJECT 2 Owen Mumford USA, Inc. | KZH |
| Aug 2, 2001 | K011951 | EZ SYRINGE Owen Mumford, Ltd. | FMF |
| Mar 6, 2000 | K000482 | MODIFICATION TO AUTOJECT MINI Owen Mumford, Ltd. | KZH |
| Nov 10, 1999 | K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) Owen Mumford USA, Inc. | KZH |
| Jan 8, 1999 | K983994 | UNIFINE Owen Mumford USA, Inc. | FMF |
| Dec 21, 1998 | K983974 | OWEN MUMFORD 3ML AUTOPEN Owen Mumford USA, Inc. | FMF |
| Dec 4, 1998 | K982275 | RAPPORT V.T.D. Owen Mumford USA, Inc. | LKY |
| Nov 25, 1998 | K983045 | AMIELLE Owen Mumford USA, Inc. | KXP |
| Dec 4, 1997 | K973899 | UNIFINE PENTIPS Owen Mumford USA, Inc. | FMI |
| Sep 26, 1997 | K971443 | RAPPORT V.T.D. Owen Mumford USA, Inc. | LKY |
| Nov 8, 1995 | K953735 | AUTOJECT MINI Owen Mumford USA, Inc. | KZH |
| Aug 11, 1995 | K945660 | AUTOJECT 2 Owen Mumford USA, Inc. | KZH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2021 | Owen Mumford USA, Inc. Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover. Open, Classified |
FMI | K152339 |
| Jul 17, 2019 | Owen Mumford USA, Inc. Petfine Auto Injector, REF 3310VET Open, Classified |
KZH | K945660 |
| Jul 17, 2019 | Owen Mumford USA, Inc. Autoject EI, REF AJ1310 Open, Classified |
KZH | K945660 |
| Nov 6, 2017 | Owen Mumford USA, Inc. Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles.
Product Usage:
Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen inject Terminated |
FMI | K152339 |
| Nov 6, 2017 | Owen Mumford USA, Inc. Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles.
Product Usage:
Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen inject Terminated |
FMI | K152339 |
| Jul 15, 2015 | Owen Mumford USA, Inc. Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01,
The product is a non-sterile automatic subcutaneous injection device which delivers ins Terminated |
FMF | K983974 |
| Apr 2, 2015 | Owen Mumford USA, Inc. Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010
The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor. Terminated |
KZH | K945660 |