8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DYNASTY GC 12550 (GELL/CELL)
FDA 510(k)
FDA Class 1
·Physical Medicine
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376321646·Offset Connector, Side-Loading, 10mm
ORTHO-PRO CANNULATED BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Stryker Infrared Fluorescence (IRF) Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·December 22, 2010
TRIATHLON PS FEM COMPONENT, CEMENTED
FDA Adverse Event
Malfunction
·HOWMEDICA INTERNATIONAL S. DE R.L.,·Product code JWH·January 8, 2013
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·HEARTWARE, INC·Product code DSQ·July 17, 2014
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019