7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ROTAGYM
FDA 510(k)
FDA Class 2
·Physical Medicine
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
FDA 510(k)
FDA Class 1
·General Hospital
ERCHONIA ALLAY
FDA 510(k)
FDA Class 2
·Physical Medicine
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 27, 2014
12/14 ARTICUL 40MM M SPEC+5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·November 15, 2012
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 9, 2015
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