7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Clinical Toxicology
InFill® Interbody Fusion Device
FDA 510(k)
FDA Class 2
·Orthopedic
HAND SPLINTS & COMPONENTS
FDA 510(k)
FDA Class 1
·Physical Medicine
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 13, 2014
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·October 8, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 13, 2012
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·May 21, 2014