9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
CENTRIA T4 RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VASC-GUARD PERIPHERAL VASCULAR PATCH
FDA Adverse Event
Other
·SYNOVIS SURGICAL INNOVATIONS·Product code DXZ·July 15, 2008
VASC-GUARD PERIPHERAL VASCULAR PATCH
FDA Adverse Event
Other
·SYNOVIS SURGICAL INNOVATIONS·Product code FTL·July 15, 2008
CIRCUIT, PRINTED, SERVO-MECHANISM
FDA 510(k)
FDA Class 2
·Cardiovascular
Supreme and Response Electrophysiology Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
ZOOM
FDA Adverse Event
Malfunction
·EXTERNAL MANUFACTURER·Product code KRG·April 21, 2014
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·September 26, 2012
INFUSOR SINGLEDAY 2ML/HR 12PK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 19, 2010
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025