8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
PerforMax
FDA UDI
Respironics, Inc.·00606959007703·Performax Mask, with Standard Elbow, Single Use...
DARDIK CAROTID SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
KOALA CLAMP, KOALA CLAMP AND CUTTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 28, 2013
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MQR·June 17, 2008
ADAPTA SR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·April 18, 2011
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