9 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXILLARY BLOCK NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
Disposable guides KDNG00
FDA 510(k)
FDA Class 2
·Radiology
USHIFU STEPPER
FDA 510(k)
FDA Class 2
·Radiology
CUSA NXT CONSOLE (115-230V)
FDA Adverse Event
Malfunction
·INTEGRA RADIONICS, INC.·Product code LFL·October 5, 2010
FORTIFY ASSURA DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·December 14, 2012
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 1, 2018
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020