10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
RelieVRx (Pico G3)
FDA 510(k)
FDA Class 2
·Neurology
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·June 8, 2017
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
FDA 510(k)
FDA Class 2
·Cardiovascular
PROFEMUR® GLADIATOR® Cemented Classic Stem
FDA 510(k)
FDA Class 2
·Orthopedic
GLIDEWELL HT IMPLANT Ø5.0 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 18, 2025
EPIC II
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS·Product code FNL·June 25, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·September 16, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS·Product code MKJ·September 3, 2014
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026