15 results
·
28ms
·
Sources: EU EUDAMED, US FDA
MODEL 330 SCREENING AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STLASE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COBALT CHROME FEMORAL HEAD SZ 28 3.5MM 12/14 SHORT NECK
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JDI·December 15, 2016
COCR HEAD SHORT NECK DIA28/-3. 5 MM 12/14
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDI·May 10, 2016
BIOMET COBALT-CHROME FEMORAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·March 17, 2017
COBALT CHROME FEMORAL HEAD
FDA Adverse Event
Death
·BIOMET FRANCE S.A.R.L.·Product code JDI·August 31, 2017
CORONARY SINUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·January 11, 2013
PINNACLE SECTOR II CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 29, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 3, 2014
BIOMET COBALT-CHROME FEMORAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDI·April 7, 2017
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·March 18, 2014
SEE H10
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018
VITEK® 2 AST-N334 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·September 10, 2018
VITEK® 2 AST-GN09 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·September 5, 2018