12 results
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20ms
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Sources: EU EUDAMED, US FDA
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAC
FDA UDI
Ge Medical Systems Information Technologies, Inc.·00195278276087·MAC 5 Lite
RYDERS
FDA UDI
FGX INTERNATIONAL INC.·00772956426592·
Arx MIS
FDA UDI
Life Spine, Inc.·00190837144944·
Arx
FDA UDI
Life Spine, Inc.·00190837124083·
CUDDLE CARRIER - INFANT BED
FDA 510(k)
FDA Class 2
·General Hospital
COXSACKIE B SERIES CF ANTIGENS
FDA 510(k)
FDA Class 1
·Microbiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 9, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 5, 2010
PLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTW·December 3, 2012
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