3 results
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6ms
·
Sources: EU EUDAMED, US FDA
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
FDA Enforcement
Class II
·Terminated·Smith & Nephew Inc.·March 5, 2014
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
FDA Enforcement
Class II
·Terminated·Accelerate Diagnostics Inc·May 2, 2018
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
FDA Enforcement
Class II
·Terminated·Integra Burlington MA, Inc.·April 10, 2013