72 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
FDA 510(k)
FDA Class 2
·Immunology
RONGEUR #3 BLUMENTHAL 90 DEG
FDA UDI
W.H. Holden, Inc.·D928100825030·
CABLE INTERFACE 1/4” BIFURCATED PLUGS TO 6
FDA UDI
Datascope Corp.·10607567113845·CABLE INTERFACE 1/4” BIFURCATED PLUGS TO 6
METAL SCREW ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
FETALGARD LITE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYMBIA T-SERIES
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013
E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·May 31, 2013
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
FDA Enforcement
Class III
·Terminated·Advanced Sterilization Products·December 11, 2013
E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES
FDA Adverse Event
Injury
·SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP·Product code KPS·August 3, 2012
E.CAM, SYMBIA E
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·July 13, 2012
E.CAM, SYMBIA E
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·May 16, 2013
FORCE FX-8C GENERATOR (SHANGHAI)
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·April 17, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 10, 2011
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICRO TYPING SYSTEMS, INC.·Product code KSZ·July 24, 2008
NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX
FDA Adverse Event
Death
·ATRICURE, INC.·Product code OCL·November 13, 2018
E.COM, SYMBIA E
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012
E.CAM
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014
OT VITA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 20, 2010
OT VITA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 24, 2011
OT VITA ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 12, 2012