7 results
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17ms
·
Sources: EU EUDAMED, US FDA
BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER
FDA 510(k)
FDA Class 2
·Cardiovascular
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVANTAGE EP
FDA 510(k)
FDA Class 2
·Neurology
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 14, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 23, 2010
MICROFRANCE® INSTRUMENT
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GEI·July 3, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015