12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MALLORY/HEAD TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209117284·KIT, CUSTOM CCRK; This kit contains item(s) la...
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746165788·WIRE SS GOLD COATED FORM I UPPER 018X018 10/PK
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971116·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971208·
DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE
FDA 510(k)
FDA Class 1
·General Hospital
VasoStat Hemostasis Device
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 5, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTH CORPORATION·Product code FRN·January 23, 2014
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·March 18, 2009
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