7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AGA TRACH TIES
FDA 510(k)
FDA Class 1
·Anesthesiology
MEBO Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
EMIT-AMD AMIKACIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OMNISPAN MENISCAL FASTENER W/27 DEGREE NEEDLE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MBI·November 12, 2010
QUICK COUPLING FOR K-WIRES
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·July 9, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 27, 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