7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Urine Collection Tube
FDA 510(k)
FDA Class 1
·Microbiology
BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTERNALBRACE LIGAMENT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·November 3, 2014
TAXUS (R) LIBERTÉ (R)
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025