8 results
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26ms
·
Sources: EU EUDAMED, US FDA
MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
FDA 510(k)
FDA Class 1
·General Hospital
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·October 8, 2010
VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW LE S
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·December 7, 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