10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RENASYS-G Gauze Dressing Kits with Soft Port
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776020262·Slotted U Bracket
P.0004 IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013
UNKNOWN DEEP BRAIN STIMULATOR
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·July 8, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC·Product code LZG·July 16, 2014
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·December 2, 2015
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·November 25, 2024
Philips Zenition 70, Model Number: 718133
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024