7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GYRUS HYSTEROSCOPIC RESECTOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CN GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
GC AADVA IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·July 8, 2014
ITREL
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·January 13, 2011
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021