11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACRA-CUT
FDA 510(k)
FDA Class 2
·Neurology
RUMI II KOH-EFFICIENT
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·October 20, 2022
RHEUMAGEN ASO T-CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
CHIROFLEX II LENS MICROSERT(TM)
FDA 510(k)
FDA Class 3
·Ophthalmic
KOH-EFFICIENT,RUMI
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·November 4, 2022
KOH-EFFICIENT,RUMI
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·November 3, 2022
THUNDERBEAT 5 MM 35 CM FRONT-ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·May 8, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·January 10, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·December 6, 2010
TM-ECOCHGTRODE
FDA Adverse Event
Other
·NATUS MEDICAL INC·Product code GXY·January 9, 2009
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