11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AP X-RAY TUBE ANGULATION DEVICE
FDA 510(k)
FDA Class 1
·Radiology
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
VANGUARD COMPLETE KNEE SYSTEM, TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 23, 2018
VANGUARD COMPLETE KNEE SYSTEM, FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 23, 2018
VANGUARD TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 23, 2018
BREEZE2
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 15, 2014
KAPPA 900 DR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code DXY·October 31, 2012
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 24, 2010
BD SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 13, 2019
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024