35 results
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31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCLAIM TOTAL ELBOW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040018606·Facebow .045 #2 90mm
MACROPOREMX MANDIBULAR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BECKMAN COULTER DNASE B CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
ARCHITECT C16000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·April 16, 2013
MCGHAN
FDA Adverse Event
Injury
·Product code FWM·June 10, 2008
LCS COMPLETE FEM POR R MED
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·April 6, 2011
COMPR 12MM IM HMRL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·April 1, 2019
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