8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LORENZ RESORBABLE DISTRACTOR SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTICUL/EZE BALL 32 +17 WH
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 11, 2013
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·March 1, 2011
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 20, 2008
SENSICA UO MONITOR ICU
FDA Adverse Event
Malfunction
·ADAPTEC MEDICAL DEVICES LLC 3014271001·Product code EXS·June 7, 2020
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025