Huntleigh Healthcare , Ltd. - FDA 510(k) Cleared Devices

Huntleigh Healthcare, Ltd. is a leading global provider of innovative medical devices for vascular assessment and treatment, fetal monitoring, and patient monitoring. A proud member of the Arjo family, the company operates with a manufacturing facility in Cardiff, United Kingdom, and serves healthcare professionals across more than 100 countries with over 40 years of clinical expertise.

The company has received 8 FDA 510(k) clearances from 8 total submissions since 2006, with no denied submissions. Huntleigh's cleared devices span Obstetrics & Gynecology, Cardiovascular, and Anesthesiology categories. The latest clearance in 2025 confirms the company remains actively engaged in FDA regulatory pathways and product innovation.

Huntleigh's portfolio includes world-renowned brands such as Dopplex handheld Dopplers, Sonicaid fetal monitoring systems, Hydroven intermittent pneumatic compression devices, and Smartsigns patient monitoring solutions. The company specializes in vascular assessment tools, fetal Dopplers and monitors, and comprehensive patient monitoring platforms ranging from handheld to advanced modular systems.

Explore the complete list of device names, product codes, and FDA 510(k) clearance dates in the regulatory database.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.