9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFLATABLE INVALID RING
FDA 510(k)
FDA Class 1
·Physical Medicine
TwinFix
FDA UDI
Stryker GmbH·04546540362162·CANNULATED COMPRESSION SCREW
SUMITOMO PROTON THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
OMNILUX RED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·May 11, 2018
SINGLE USE INJECTOR
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KOG·May 13, 2014
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·November 13, 2012
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015