BEUDAMED
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    Filters Classification: Class Ii ×

    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·July 9, 2014

    Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 20, 2022

    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 20, 2022

    Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 20, 2022

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 20, 2022

    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 15, 2013

    Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·March 17, 2021

    Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·March 24, 2021

    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics Inc·May 7, 2025

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics Inc·November 13, 2024

    epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023

    ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA¿ Chemistry systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics·September 11, 2013

    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics Inc·August 13, 2025

    The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 5S8keV. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·January 14, 2015

    Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·June 17, 2026

    Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·May 6, 2026

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics Inc·May 6, 2026

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 8, 2026

    Atellica CH Urine Albumin (UAlb). Material Number: 11537225

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·March 11, 2026

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 17, 2025