9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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da Vinci Firefly Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024039162·
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
TEMA ELBOW SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code JDB·September 26, 2024
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·November 3, 2008
AMBULIFT
FDA Adverse Event
ARJO MED AB LTD·Product code FSA·August 1, 2011
COULTER® LH 750 HEMATOLOGY ANALYXZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 12, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025