8 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Advantis Platform
FDA 510(k)
FDA Class 2
·Radiology
GKS PRIME FLEX CR TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ETCHING 15
FDA 510(k)
FDA Class 2
·Dental
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·September 24, 2019
HUT EXT DR FINAL ASSY-STANDARD
FDA Adverse Event
Malfunction
·LIEBEL FLARSHEIM·Product code IXR·November 4, 2014
ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 10, 2011
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018