10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEDIBYTE, MODEL MP8
FDA 510(k)
FDA Class 2
·Anesthesiology
HOTLINE 2 FLUID WARMER
FDA 510(k)
FDA Class 2
·General Hospital
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
FDA 510(k)
FDA Class 2
·Anesthesiology
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 16, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 18, 2011
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·June 13, 2008
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