7 results
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19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BACTIDROP NINHYDRIN
FDA 510(k)
FDA Class 1
·Microbiology
ATLAS PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DCM 2.0
FDA 510(k)
FDA Class 2
·Radiology
15.5F X 32CM DURA-FLOW
FDA Adverse Event
Malfunction
·MEDCOMP·Product code MSD·November 11, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 28, 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