8 results
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17ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE O.R. TOWEL, STERILE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SLT MICROPLATE WASHER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RESORBABLE BONE PLUG
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·PRODUCTOS PARA EL CUIDADO DE LA SALUD·Product code EZL·June 12, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 6, 2010
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 15, 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