7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRATO MEDICAL LIFEPORT LPS 7515
FDA 510(k)
FDA Class 2
·General Hospital
EAZY PRIMER
FDA 510(k)
FDA Class 2
·Dental
FRC POSTEC PLUS
FDA 510(k)
FDA Class 1
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 5, 2013
INTEGRIS H3000
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code IZI·December 21, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 17, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015