Owen Mumford, Ltd. - FDA 510(k) Cleared Devices

Owen Mumford, Ltd. is a global medical device manufacturer with over 70 years of experience designing and manufacturing innovative healthcare solutions. The company specializes in drug delivery systems, blood collection devices, and safety lancets for both clinical and home use. Owen Mumford operates with a manufacturing facility in Marietta, US, and serves healthcare professionals and patients worldwide.

The company has received 13 FDA 510(k) clearances from 13 total submissions, spanning from 2000 to 2023. Owen Mumford's cleared devices focus primarily on General Hospital applications, including safety lancets, autoinjectors, syringes, and venepuncture systems. This regulatory track record reflects the company's sustained commitment to device innovation and safety standards across multiple therapeutic areas.

Notable product lines include the Unistik® safety lancet series, Unifine pen needles, and AUTOJECT autoinjectors-devices widely used in diabetes management and blood sampling. The company's portfolio also encompasses specialized heel incision lancets for neonatal and pediatric applications, demonstrating expertise in patient-centered design for vulnerable populations.

Owen Mumford's regulatory activity concluded in 2023. For detailed information on specific device names, product codes, and individual clearance dates, consult the FDA 510(k) database.

510(k) submissions have been managed by Owen Mumford USA, Inc. as regulatory consultant.