Evenflo Company, Inc. - FDA 510(k) Cleared Devices

Evenflo Company, Inc. is a baby gear manufacturer specializing in car seats, strollers, and infant care products. The company operates with a manufacturing facility in Canton, Ohio, and has served families for over 100 years since its founding in the 1920s.

Evenflo holds 8 FDA 510(k) clearances from 8 total submissions, with no denied submissions on record. The company's regulatory focus centers on Obstetrics & Gynecology devices, which represent the majority of its FDA submissions. Clearances span from 2001 to 2010, reflecting the company's historical involvement in breast pump innovation and infant feeding safety.

The company's cleared device portfolio includes breast pumps and related lactation products, along with dental devices for infants. Notable cleared devices demonstrate Evenflo's commitment to maternal and infant health through FDA-regulated medical devices.

This company profile reflects historical FDA 510(k) records. For detailed device names, product codes, and specific clearance dates, explore the full submission database.

510(k) submissions have been managed by Underwriters Laboratories, Inc. as regulatory consultant.