31 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
FDA 510(k)
FDA Class 2
·Cardiovascular
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 27, 2024
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 29, 2025
EMERGE?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 19, 2026
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 8, 2026
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 30, 2026
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·January 30, 2026
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·October 28, 2025
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 26, 2026
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 21, 2026
EMERGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK113201·DD tempMED are pre-colored dental milling blank...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK112201·DD tempMED are pre-colored dental milling blank...
All-Purpose Arch Set
FDA UDI
Noras MRI products GmbH·04251269205682·
All-Purpose Arch Set
FDA UDI
Noras MRI products GmbH·04251269201066·
VOYAGER PERITONEAL DIALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
FDA 510(k)
FDA Class 2
·Ophthalmic
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2013
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014