Owen Mumford USA, Inc.
Marietta, GA, US
OWEN MUMFORD USA, INC. appears in FDA device records in Marietta, GA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Owen Mumford USA, Inc. between 1995 and 2001. The busiest year on record is 1998, with 3. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 2 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 2 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K013362 | AUTOJECT 2 | KZH | Substantially Equivalent | |
| K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) | KZH | Substantially Equivalent | |
| K983994 | UNIFINE | FMF | Substantially Equivalent | |
| K983974 | OWEN MUMFORD 3ML AUTOPEN | FMF | Substantially Equivalent | |
| K982275 | RAPPORT V.T.D. | LKY | Substantially Equivalent | |
| K983045 | AMIELLE | KXP | Substantially Equivalent | |
| K973899 | UNIFINE PENTIPS | FMI | Substantially Equivalent | |
| K971443 | RAPPORT V.T.D. | LKY | Substantially Equivalent | |
| K953735 | AUTOJECT MINI | KZH | Substantially Equivalent | |
| K945660 | AUTOJECT 2 | KZH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1058602 | 1000219614 | OWEN MUMFORD USA, INC. | 1755 W Oak Commons Ct, MARIETTA, GA 30062 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IODComponents, Exercise
- LKYDevice, External Penile Rigidity
- KCMDropper, Ent
- GXBEsthesiometer
- IONExerciser, Non-Measuring
- KZHIntroducer, Syringe Needle
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- FMINeedle, Hypodermic, Single Lumen
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- KXPStent, Vaginal
- FMFSyringe, Piston
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2078-2021 | Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover. | Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles. | Class II | Open, Classified | |
| Z-0264-2020 | Petfine Auto Injector, REF 3310VET | There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107 | Class II | Open, Classified | |
| Z-0263-2020 | Autoject EI, REF AJ1310 | There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107 | Class II | Open, Classified | |
| Z-0382-2018 | 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 injectors. | Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal. | Class II | Terminated | |
| Z-0381-2018 | 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 injectors. | Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal. | Class II | Terminated | |
| Z-2082-2015 | 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 insulin. | The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection. | Class II | Terminated | |
| Z-1366-2015 | 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. | The syringe carrier is missing components: a damper and spring. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain