8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
Alinity m CMV
FDA 510(k)
FDA Class 2
·Microbiology
iGuide 2.1
FDA 510(k)
FDA Class 2
·Radiology
IMPELLA RP
FDA Adverse Event
Death
·ABIOMED EUROPE, GMBH (GERMANY)·Product code DWA·July 27, 2015
SELOX ST 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·January 9, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 18, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 14, 2015
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