BEUDAMED
    31 results · 16ms · Sources: EU EUDAMED, US FDA

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    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

    FDA Recall
    Terminated ·Product code LLZ·November 29, 2013

    Villa Sistemi Rotograph EVO 3D X-ray

    FDA Recall
    Terminated ·Villa Radiology Systems LLC·Product code MUH·August 5, 2015

    Owandy Radiology I -MAX Touch 3D X-ray

    FDA Recall
    Terminated ·Villa Radiology Systems LLC·Product code OAS·August 5, 2015

    Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.

    FDA Recall
    Terminated ·Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK·Product code MNI·October 31, 2008

    ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

    Temporary Titanium Abutments

    FDA Recall
    Open, Classified ·DDS Lab·Product code NHA·December 6, 2024

    Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

    FDA Recall
    Open, Classified ·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code OAS·October 28, 2021

    L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.

    FDA Recall
    Terminated ·Product code RCG·October 27, 2017

    KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

    FDA Recall
    Open, Classified ·Pro-Dex Inc·Product code GET·February 14, 2023

    KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

    FDA Recall
    Open, Classified ·Pro-Dex Inc·Product code MOQ·September 23, 2024

    KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

    FDA Recall
    Open, Classified ·Pro-Dex Inc·Product code GEY·February 15, 2023

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code GEY·September 25, 2018

    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

    Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

    FDA Recall
    Open, Classified ·Philips Healthcare·Product code OWB·September 24, 2021

    Software versions Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10, .2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2. sterEOS software versions: 1.2.3.3788, 1.2.4.4286, 1.3.2.3373, 1.3.3.3671, 1.3.4.3740, 1.3.5.3915, 1.3.6.4272,1.4.1.4813,1.4.2.4850. EOS system is a digital radiography system used in general radiographic examinations. sterEOS workstation is a medical image review station for acceptance, transfer, display, storage, and digital processing of 2D X-ray images.

    FDA Recall
    Terminated ·Eos Imaging 10, Rue Mercoeur Paris France·Product code LLZ·April 13, 2011

    AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.

    FDA Recall
    Open, Classified ·Beckman Coulter Biomedical Division Lismeehan, O'Callaghan's Mills County Clare Ireland·Product code DDD·September 6, 2023

    Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DDC·October 26, 2006

    Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CDX·June 4, 2025

    Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.

    FDA Recall
    Terminated ·Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK·Product code MNI·October 31, 2008