2 results
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6ms
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Sources: EU EUDAMED, US FDA
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
FDA Enforcement
Class III
·Terminated·Iris Diagnostics·August 8, 2012