BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.

    FDA Enforcement
    Class II ·Ongoing·Covidien LLC·June 10, 2026

    Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·December 30, 2020

    ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·December 30, 2020

    Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023

    DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

    FDA Enforcement
    Class II ·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024

    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 5, 2014

    Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023

    Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023

    Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023