12 results
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25ms
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Sources: EU EUDAMED, US FDA
PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480
FDA 510(k)
FDA Class 2
·Ophthalmic
PROFYLE
FDA UDI
Stryker GmbH·04546540363879·Sterilizing Container
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540244407·BONE SCREWS, CROSS-FIT, SELF-TAPPING
Malibu
FDA UDI
Seaspine Orthopedics Corporation·10889981080594·Modular Poly Driver Sleeve
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
RANDOX DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PROTECTOR P21J
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·October 1, 2020
VASOVIEW HEMOPRO 2 WITH VASOSHIELD
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 13, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2015
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·January 11, 2013
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