9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS
FDA 510(k)
FDA Class 2
·Microbiology
3D
FDA UDI
Rmo, Inc.·00885797100061·3D MX BIMETRIC DISTL ARCH ASST
EUSURE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RAEBBITT/EVOLUTION POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
EVOLUT FX VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 9, 2025
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013
NEW LIGASURE 5MM
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 8, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 13, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012