8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
GAMMA RADIATION STERILIZED ALCOHOL PREP PADS
FDA 510(k)
FDA Unclassified
·Unknown
15-INCH (38CM) COLOR LCD MONITOR CDL1566A
FDA 510(k)
FDA Class 2
·Radiology
Mozec NC-Rx PTCA Baloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·December 13, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
KAPPA 700 DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·October 7, 2010
ADMIRAL XTREME
FDA Adverse Event
Injury
·INVATEC SPA·Product code LIT·December 6, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012