6 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Switzerland
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FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·November 23, 2016
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·May 20, 2020
Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur.
FDA Enforcement
Class II
·Terminated·Zimmer Gmbh·March 4, 2015
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·November 7, 2018
Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·June 10, 2020
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·November 18, 2020