9 results
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19ms
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Sources: EU EUDAMED, US FDA
MODEL 1858 CAVRO/PRESSURE MODULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Patterson
FDA UDI
PATTERSON DENTAL SUPPLY, INC.·D6620708720771·FILE, PULP CANAL, ENDODONTIC
Cutera enlighten III Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G
FDA 510(k)
FDA Class 2
·Immunology
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 13, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 14, 2010
DUR MAR 20D LINER 28IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDL·December 13, 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