27 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPIN ROLLERE
FDA 510(k)
FDA Class 1
·Physical Medicine
PAO VALUE
FDA 510(k)
FDA Class 2
·General Hospital
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
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
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013
INTEGRATED APD SET W/CASSETTE3 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 7, 2011
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 23, 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
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016
SENSOR, LOW LEVEL II
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 16, 2010