14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIZION + DR
FDA 510(k)
FDA Class 2
·Radiology
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564033024·Basin Linen Minor, Rex
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PILOT TUBE REPAIR KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·July 31, 2017
SIG MOD TIB TRAY CEM COCR 3
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code JWH·May 22, 2013
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 14, 2011
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·September 15, 2015
SENTRANT INTRODUCER SHEATH
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code DYB·November 11, 2025
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·May 12, 2017
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·May 12, 2017
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 2022