8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VENOUS CANNULA W/BENT, TIP WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
INRATIO2 PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 25, 2015
SMK, CX, CXE, RCN
FDA 510(k)
FDA Class 2
·Neurology
OR3O Dual Mobility System
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 1, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 9, 2012
HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·August 31, 2010
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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