9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FMF·December 28, 2018
NARKOMED MRI , NM-MRI
FDA 510(k)
FDA Class 2
·Anesthesiology
SPIRABRUSH CX BIOPSY INSTRUMENT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 16, 2013
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·March 16, 2011
CONCERTO
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FPO·June 16, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015