10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SUPERIOR BATH, MODEL 6300
FDA 510(k)
FDA Class 2
·Physical Medicine
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·June 29, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·April 29, 2013
HUDSON/MODIFIED TRINKLE ATTACH
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·April 26, 2011
VOYAGER RX CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·July 23, 2008
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·May 7, 2010
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·April 11, 2011
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