3 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089
FDA Enforcement
Class III
·Ongoing·S & MOHR AMERICA, S.A. DE C.V.·March 1, 2023
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience Inc·August 22, 2018
Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
FDA Enforcement
Class III
·Ongoing·AMS Diagnostics, LLC·July 19, 2017