18 results
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29ms
·
Sources: EU EUDAMED, US FDA
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
FDA 510(k)
FDA Class 2
·Neurology
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
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
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
5.0MM CANNULATED VA LOCKING SCREW/90MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·April 29, 2013
MAESTRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBB·April 26, 2011
PCA II PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code MEA·July 23, 2008
E.CAM, SYMBIA E
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·April 16, 2013
PRESIDIO 10 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
PRESIDIO 18 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014