10 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471155978·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 230mm
Malibu
FDA UDI
Seaspine Orthopedics Corporation·10889981080464·Malibu Driver Sleeve (Small)
CONTOUR HEALER
FDA 510(k)
FDA Class 2
·Dental
MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
FDA 510(k)
FDA Class 2
·Radiology
FLO-THRU INTRALUMINAL SHUNT
FDA Adverse Event
Malfunction
·SYNOVIS SURGICAL INNOVATIONS·Product code DXC·January 11, 2013
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·December 1, 2010
FENESTRATED BIPOLAR FORCEPS IBSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 3, 2014
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017