Huntleigh Healthcare - FDA 510(k) Cleared Devices

Huntleigh Healthcare, is a leading global provider of diagnostic and monitoring medical devices, with a manufacturing facility in Surrey, GB. Now part of the Arjo family, the company specializes in innovative solutions for vascular care, fetal monitoring, and patient monitoring. Huntleigh has operated for over 40 years, serving healthcare professionals across more than 100 countries.

The company has received 2 FDA 510(k) clearances from 2 total submissions, with all submissions focused on Cardiovascular devices. Clearances span from 2005 to 2013. Notable cleared devices include the DOPPLEX ABILITY and MEDILOG DARWIN HOLTER ANALYSIS systems. The company is currently inactive in FDA submissions, with no clearances recorded in more than a decade.

Huntleigh's product portfolio encompasses handheld Dopplers, vascular assessment systems, fetal Dopplers and monitors under the Sonicaid brand, and patient monitoring solutions via the Smartsigns range. The company is recognized for world-leading brands including Dopplex, Sonicaid, and Smartsigns, reflecting decades of expertise in diagnostic and monitoring technologies.

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

510(k) submissions have been managed by Tuv America, Inc. as regulatory consultant.