22 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Auto Folding Scooter, S21F
FDA 510(k)
FDA Class 2
·Physical Medicine
SELICOR, MODELS A100 & D100
FDA 510(k)
FDA Class 2
·Physical Medicine
Journey II XR Knee Instrument
FDA 510(k)
FDA Class 2
·Orthopedic
OXF UNI CMNTLS TIB SZ F LM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·October 24, 2018
OXFORD PH3 CEMENTLESS FEM SZ L
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·October 24, 2018
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 16, 2011
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
UNKNOWN TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 2, 2017
UNKNOWN KNEE FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 2, 2017
UNKNOWN TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 2, 2017
UNKNOWN KNEE TIBIAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 2, 2017
Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory
FDA Enforcement
Class II
·Terminated·Avanos Medical, Inc.·November 16, 2022
UNKNOWN BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 2, 2017
UNKNOWN FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 2, 2017
UNKNOWN KNEE BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 2, 2017
UNKNOWN TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 2, 2017
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·May 15, 2014
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·May 15, 2014
UNKNOWN KNEE FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 2, 2017