Owen Mumford USA, Inc.
Owen Mumford USA, Inc. holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2001, with 7 FDA device recalls on record.
Top product codes for Owen Mumford USA, Inc.
FDA recalls by Owen Mumford USA, Inc.
- Z-2078-2021 — Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
- Z-0264-2020 — Petfine Auto Injector, REF 3310VET
- Z-0263-2020 — Autoject EI, REF AJ1310
- 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.
- 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.
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Owen Mumford USA, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.