15 results · 28ms · Sources: EU EUDAMED, US FDA

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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