10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
OPTI 110/12/50 HSG
FDA 510(k)
FDA Class 1
·Radiology
JUGGERKNOT 1.4MM SHORT W/NDLS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBI·March 7, 2013
Estremo Citieffe Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
ZEGRA POSTURE TRAINER
FDA 510(k)
FDA Unclassified
·Unknown
JUGGERKNOT 1.4MM SHORT W / NEEDLES
FDA Adverse Event
Injury
·BIOMET SPORTS MEDICINE·Product code MBI·October 3, 2011
PINNACLE SECTOR II CUP 54MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code LPH·April 30, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 10, 2012
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 3, 2010
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
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024