10 results
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18ms
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Sources: EU EUDAMED, US FDA
E-Z PREP
FDA 510(k)
FDA Class 1
·Hematology
PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6
FDA 510(k)
FDA Class 2
·Cardiovascular
SMB Luer lock disposable syringe
FDA 510(k)
FDA Class 2
·General Hospital
MICROTARGETING ELECTRODE
FDA Adverse Event
Injury
·FHC INC.·Product code GZL·November 5, 2012
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2015
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·September 10, 2010
TORQUE WRENCH
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code HXC·December 10, 2025
TORQUE WRENCH
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code HXC·November 16, 2016
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