17 results
·
22ms
·
Sources: EU EUDAMED, US FDA
UNICLIP SURGICAL CLIP APPLIER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EPISTAXIS NASAL BALLOON CATHETER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST
FDA 510(k)
FDA Class 2
·Radiology
3M UNIVERSAL ELECTROSURGICAL PAD
FDA Adverse Event
Injury
·3M HEALTH CO·Product code GEI·January 14, 2013
ENRHYTHM DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·December 14, 2010
OMINIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·July 1, 2014
ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2017
ORTHOPEDIC SALVAGE SYSTEM AXLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2017
ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2017
ORTHOPEDIC SALVAGE SYSTEM STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2017
ORTHOPEDIC SALVAGE SYSTEM TIBIAL BASEPLATE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2017
ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2017
ORTHOPEDIC SALVAGE SYSTEM STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2017
ORTHOPEDIC SALVAGE SYSTEM RESURFACING FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2017
ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2017
ORTHOPEDIC SALVAGE SYSTEM LOCKING PIN
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 13, 2017
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021