8 results
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25ms
·
Sources: EU EUDAMED, US FDA
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VESSEL RETRACTOR, #600732
FDA 510(k)
FDA Class 2
·Cardiovascular
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 10, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 8, 2010
ON-Q C-BLOC: 600ML, 2-14ML/HR SELECT-A-FLOW
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code MEB·November 29, 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