Cardio Flow has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its FreedomFlow Orbital Atherectomy Peripheral Platform. The platform deploys a modern action mechanism ...

OSI Systems has announced FDA 510k clearance of Enhanced Flow Meter Visualization, which is used in anesthesia delivery alongside the company’s BleaseSirius Anesthesia System, according to a company ...

The FDA granted 510 (k) clearance to the Bonhawa High Flow Oxygen Therapy system for patients with respiratory insufficiency, according to a manufacturer-issued press release.Key features of the ...

EnteraLoc Flow was granted 510 (k) clearance (Rx Only) by the FDA in 2021. “We’re very pleased with the FDA’s decision,” said Keith Smith, CEO of Vonco Products.

The 58 unique serial numbers to look out for can be found on the FDA's recall database entry. The products in question were distributed between June 2, 2020 and February 15, 2022.