545 results
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60ms
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Sources: EU EUDAMED, US FDA
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
FDA Recall
Terminated
·Signal Medical Corporation·Product code JWH·September 30, 2014
Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement.
FDA Recall
Terminated
·Signal Medical Corporation·Product code LPH·September 23, 2014
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
FDA Enforcement
Class II
·Terminated·Signal Medical Corporation·October 29, 2014
QUATROLOC FEMORAL STEM WITHOUT LATERAL SHOULDER
FDA Adverse Event
Injury
·WHITESIDE BIOMECHANICS (NOW SIGNAL MEDICAL CORP.)·Product code KWY·September 16, 2009
EVIS EXERA II VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FAJ·June 4, 2020
VIDEO SYSTEM
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·November 30, 2020
R SERIES DEFIRBILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 11, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 27, 2009
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 5, 2009
1700 SEMI AUTOMATIC DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 7, 2009
4K CAMERA HEAD
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·October 20, 2020
HIGH DEFINITION LCD MONITOR
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·January 31, 2021
PD1400 DEFIBRILLATOR/PACEMAKER
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code LDD·June 26, 2007
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 27, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 29, 2006
VISERA ELITE XENON LIGHT SOURCE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code NWB·January 7, 2021
VISERA ELITE VIDEO SYSTEM CENTER
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·January 7, 2021
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP·Product code GEI·September 2, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 17, 2007
PD1400 DEFIBRILLATOR/PACEMAKER
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code LDD·July 3, 2007