10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169600140·TRIAL 2173560 O25 IB 20MM 18 DEG 16X60
SHASER IPL HAIR REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CELOX GAUZE PRO
FDA 510(k)
FDA Unclassified
·Unknown
BD INSYTE¿ AUTOGUARD¿ 24G X 0.75IN (0.7 X 19 MM)
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 8, 2017
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017
PERFUSOR SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·June 5, 2013
ENDO GIA ARTICULATING RELOAD WITH TRI-STAPLE TECHNOLOGY
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GDW·September 19, 2014
TWINFIX FT HA RC 4.5
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE·Product code MAI·July 23, 2011
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018