7 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROCLINIC ONE STEP PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DERMACHILLER 4
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY
FDA 510(k)
FDA Class 2
·Hematology
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 14, 2013
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·December 3, 2010
CRUTCH
FDA Adverse Event
UNKNOWN·Product code IPR·July 3, 2014
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