Contract Pharma8d
FDA Grants 510(k) Clearance for Fresenius Kabi’s Adaptive Nomogram
The U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance for Fresenius Kabi’s Adaptive Nomogram, an ...
Healio23h
FDA grants 510(k) clearance to AI Optics’ handheld retinal imaging system
The FDA has granted 510(k) clearance to AI Optics’ Sentinel Camera, a handheld retinal imaging system that captures ...
Business Wire9d
Fresenius Kabi Receives FDA 510(k) Clearance for Adaptive Nomogram, Enhancing Plasma Collection Efficiency with the Aurora Xi Plasmapheresis System
announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Adaptive Nomogram - an alternate algorithm that will be available in the Aurora Xi ...
Business Wire1mon
Simpson Interventions Announces both IDE approval from FDA for Acolyte™ Catheter System and 510(k) clearance for its Shadow Catheter™, adds Board Member
Additionally, the company also announced that its Shadow Catheter™ has received 510(k) clearance from the FDA. The Acolyte ... must have an approved IDE prior to studies being initiated.