8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
X-CUBE 50, X-CUBE 60
FDA 510(k)
FDA Class 2
·Radiology
EECP THERAPY SYSTEM, MODEL TS3
FDA Adverse Event
Injury
·VASOMEDICAL, INC.·Product code DRN·December 30, 2002
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER
FDA 510(k)
FDA Class 2
·Cardiovascular
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 27, 2022
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 30, 2008
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 23, 2011
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC·Product code FPA·July 11, 2013