7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
FDA 510(k)
FDA Class 2
·Cardiovascular
BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304254640·
HUMID-VENT HEPA
FDA 510(k)
FDA Class 2
·Anesthesiology
PHILIPS AVALON FETAL MONITOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CONCERTO II CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 15, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013