9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SURGICAL EYE SHIELD
FDA 510(k)
FDA Class 2
·Ophthalmic
XLIF
FDA UDI
Nuvasive, Inc.·00887517724625·Alt L4-5 Annulus Cutter, 6x18mm Angled
INVISALIGN SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TUBAL OCCLUSION INSERTER/LAPAROSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·April 30, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·October 5, 2012
3-0 VICRYL SH
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·July 29, 2010
Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017