9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXACTECH BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
STUART TITANIUM SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
FDA 510(k)
FDA Class 2
·Ophthalmic
PYRAMESH® IMPLANT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code EZX·July 17, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2014
IDENTITY ADX SR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
DUROM HIP
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·December 27, 2012
PYRAMESH IMPLANT SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·December 9, 2016
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020