40 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EASY X-TRAC SYSTEM
FDA 510(k)
FDA Class 1
·Dental
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
FDA 510(k)
FDA Class 2
·Radiology
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS
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
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·March 27, 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
TRIAGE TOX DRUG SCREEN PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DIO·May 23, 2017
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
HEARTSTART XL + DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 28, 2013
MENTOR
FDA Adverse Event
Injury
·Product code FWM·June 10, 2008
UNKNOWN DEPUY PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·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