9 results
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19ms
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Sources: EU EUDAMED, US FDA
FIBRINOSTIKA TDP MICROELISA SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100653·KATENA DOUBLE-X SPECULUM SOLID
CORDIS OPTA 5
FDA 510(k)
FDA Class 2
·Cardiovascular
AFFINITY FREE T4 TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 15, 2013
HEALIX 5.5 MM ANCHOR W/ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code HWC·December 1, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 7, 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