9 results
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18ms
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Sources: EU EUDAMED, US FDA
ADJUST. WEIGHTS-BK5171-05,10,20 BEOK
FDA 510(k)
FDA Class 1
·Physical Medicine
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STARCAST DENTAL ALLOYS
FDA 510(k)
FDA Class 2
·Dental
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWC·May 25, 2014
PROSIMA PELVIC FLOOR REPAIR KIT
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 14, 2012
OT VITA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 10, 2010
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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