7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
VACUUM-ASSISTED BLOOD COLLECTION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
FDA 510(k)
FDA Class 2
·Hematology
PUMP MMT-522LNAS PRDGM INS SK EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·November 30, 2010
UNKNOWN DEPUY SIGMA SZ 4 CR FEMUR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 15, 2013
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 7, 2014
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. 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 the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·October 25, 2017