12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XENON(TM) PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000
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
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·November 29, 2010
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·January 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 3, 2014
BIOMET COBALT-CHROME FEMORAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDI·April 7, 2017
VITEK®2 GP TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LQL·July 11, 2018