7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterilization Pouches and Reels
FDA 510(k)
FDA Class 2
·General Hospital
ABL800 FLEX with AQURE connectivity
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PANTHERA N POWDER FREE BLACK NITRILE GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CRE ESOPHAGEAL/PYLORIC/COLONIC WIREGUIDED BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code KNQ·November 19, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
BIOFINITY TORIC
FDA Adverse Event
Injury
·COOPERVISION MANUFACTURING, LTD.·Product code LPM·July 19, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025