38 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARCHITECT BNP ASSAY, MODEL 8K28
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
FDA 510(k)
FDA Class 2
·Anesthesiology
AUTO-DRIVE LAG SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TESS HUM INSERT TH 6 DIA36 S1
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code KWS·March 7, 2017
TESS HUMERAL INSERT TH 8 DIA36 S0
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code KWS·February 15, 2017
TESS HUMERAL REVERSED INLAY 036 S1 12MM
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·February 9, 2017
TESS HUMERAL INSERT TH 6 DIA36 S0
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code KWS·February 15, 2017
CUSTOM REVERSE HUMERAL LINER
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·February 27, 2017
TESS GLEN BASEPLATE S0
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·May 25, 2016
TESS HUMERAL REVERSE COROLLA S0
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·November 18, 2016
UNKNOWN TESS GLENOID COMPONENT
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·July 7, 2017
TESS HUM INSERT TH 6 DIA36 S0
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code KWS·May 10, 2017
UNKNOWN TESS HUMERAL INSERT
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·June 1, 2017
EXTRACTSCR F/TIBIAL+FEM NAILS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 16, 2013
MULTIPOLAR BIPOLAR CUP LINER
FDA Adverse Event
Malfunction
·ZIMMER·Product code JDI·March 14, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·June 13, 2008
FATHOM GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - FREMONT·Product code DQX·June 16, 2011
TESS HUMERAL INSERT TH 8 DIA36 S0
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code KWS·February 17, 2017
TESS HUMERAL INSERT TH 6 DIA36 S0
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·January 25, 2017
TESS HUM INSERT TH 6 DIA36 S0
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·February 6, 2017