8 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CIBA CORNING MODEL 664/FAST 4 SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011871028000·Standard Band, Tooth 47-46/36-37, Size 28
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
FDA 510(k)
FDA Class 2
·Anesthesiology
VIEWMATE SYSTEM
FDA 510(k)
FDA Class 1
·Physical Medicine
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014
EON MINI 16-CHANNEL IPG
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 8, 2010
COULTER® ACT DIFF 12¿ ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·December 12, 2012
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