Medical Device Manufacturer · US , Mchenry , IL

Welch Allyn, Inc. - FDA 510(k) Cleared Devices

111 submissions · 111 cleared · Since 1977

111

Total

111

Cleared

Denied

Welch Allyn, Inc. is a medical device manufacturer based in McHenry, US. The company specializes in patient monitoring and diagnostic equipment for healthcare settings.

Welch Allyn has maintained a strong FDA 510(k) regulatory record since 1977. The company has received 111 FDA 510(k) clearances from 111 total submissions. Cardiovascular monitoring devices represent the dominant category in recent clearances, including the Connex vital signs monitor series and central station systems. The company's latest clearance in 2025 demonstrates continued regulatory activity and product innovation.

Recent cleared devices span multiple therapeutic areas, including ophthalmic imaging systems and anesthesiology diagnostic equipment. The Connex platform and related monitoring solutions form a core product line. The company also offers specialized diagnostic cardiology and retinal imaging systems for clinical use.

Explore the complete regulatory history, device names, product codes, and clearance dates in the database to review Welch Allyn's full submission record and cleared device portfolio.

FDA 510(k) Regulatory Record - Welch Allyn, Inc.

111 devices

1-12 of 111