10 results
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18ms
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Sources: EU EUDAMED, US FDA
CENTERCOM CONTROL
FDA 510(k)
FDA Class 2
·General Hospital
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209117666·
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746165818·WIRE SS GOLD COATED FORM I LOWER 019X025 10/PK
TruGuard Custom Tongue and Jaw Positioner
FDA 510(k)
FDA Class 2
·Radiology
IVENT 201
FDA 510(k)
FDA Class 2
·Anesthesiology
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 5, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 23, 2014
*
FDA Adverse Event
Malfunction
·HOSPIRA·Product code FRN·November 21, 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