28 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLYCARBOXYLATE CEMENT
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TirboLOX-L Lumbar IBFD
FDA 510(k)
FDA Class 2
·Orthopedic
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 31, 2015
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·November 23, 2016
S3 ROLLER PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010
3 TO 1 REDUCTION DRIVE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 14, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 16, 2017
S3 ROLLER PUMP MODULE AND CONSOLE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR·Product code DTQ·March 24, 2010
3-TO-1 REDUCTION DRIVE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHMAND·Product code DTQ·December 14, 2011
STOCKERT S3 CONSOLE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011
STOCKERT S3 CONSOLE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011
MENTOR SMOOTH ROUND HIGH PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·January 30, 2019
PANORAMA CENTRAL STATION
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·January 29, 2013
LOW PROFILE SELF-TAPPING BONE SCREW 6.5MM X 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·February 8, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·July 24, 2014
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016