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News about "FDA 510k clearance"
StimLabs Secures FDA 510(k) Clearance for Umbilical Cord-Derived Wound Care Sheet Device
StimLabs, a regenerative medicine company focused on advancing wound care solutions, has received 510(k) clearance from the US Food and Drug Administration (FDA) for Theracor, the first human umbilical cord-derived medical device available in sheet form.
FDA 510(k) Clearance | 01/01/2026 | By Darshana | 160
ManaMed Secures FDA Clearance for Next-Generation Tubeless Compression System, PlasmaFlow X
ManaMed, a US-based global leader in orthopedic mobility and post-operative rehabilitation equipment, has received FDA 510(k) clearance for PlasmaFlow X, its next-generation tubeless sequential compression system designed to redefine recovery and enhance patient comfort.
FDA 510(k) Clearance | 21/10/2025 | By Dineshwori | 218
FX Shoulder Solutions Secures FDA Clearance for Full-Wedge Augmented Glenoid Baseplates
This clearance brings the total number of glenoid baseplate options to 18, providing a variety of solutions for surgeons addressing bone loss, defects, or complicated glenoid morphologies.
FDA 510k Clearance | 17/05/2024 | By Abha | 573
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