8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
FDA 510(k)
FDA Class 2
·Neurology
UNK
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014
SOUNDVASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INVIDOS
FDA 510(k)
FDA Class 2
·Radiology
EXTERNAL NEUROSTIMULATOR, UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·April 29, 2013
RESERVOIR 3CC
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 26, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·July 23, 2008
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