BEUDAMED
    10,000 results · 14ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 10, 2023

    Atellica IM 1600 Analyzer, SMN 11066000

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc·October 27, 2021

    Atellica IM 1300 Analyzer, SMN 11066001

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc·October 27, 2021

    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 14, 2021

    Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 14, 2021

    Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·March 1, 2023

    Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·March 1, 2023

    TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·TriMed Inc.·May 22, 2024

    TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·TriMed Inc.·May 22, 2024

    Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·June 4, 2025

    Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·October 9, 2024

    Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 14, 2021

    Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc·September 15, 2021

    Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc·September 15, 2021

    Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc·September 15, 2021

    Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·March 1, 2023

    Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 18, 2024

    Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 11206239

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 18, 2024

    Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN:10995489

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 18, 2024

    Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·December 27, 2023