BEUDAMED
    39 results · 15ms · Sources: EU EUDAMED, US FDA

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    GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code KPS·May 19, 2017

    Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS vl CMV lgG.asy ZEUS vl CMV lgM.asy ZEUS vl EBV-VCA lgG.asy ZEUS vl EBV-VCA lgM.asy ZEUS vl H. pylori lgG.asy ZEUS vl M. pneumoniae lgG.asy ZEUS vl M. pneumoniae lgM.asy ZEUS vl Measles lgG.asy ZEUS vl Mumps lgG .asy ZEUS vl T. gondii lgG .asy ZEUS vl T. gondii lgM.asy ZEUS vl VZV lgG.asy ZEUS vl Rubella lgG .asy ZEUS vl Rubella lgM.asy ZEUS vl MPO [CF].asy ZEUS vl MPO [CV].asy ZEUS vl EBNA-1 lgG.asy ZEUS vl.1 HSV-1 and 2 lgM.asy Product Usage: The DYNEX DSX Automated ELISA System is an open automated open system to perform ELISA immunoassay

    FDA Recall
    Terminated ·Zeus Scientific, Inc.·Product code N/A·July 22, 2019

    Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system.

    FDA Recall
    Terminated ·Dynex Technologies, Inc.·Product code JQW·June 11, 2004

    Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).

    FDA Recall
    Terminated ·FSC Laboratories, Inc·Product code NVP·May 16, 2016

    Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.

    FDA Recall
    Terminated ·Berchtold Corp.·Product code LWG·April 19, 2016

    Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·June 26, 2008

    Lysus Transport Stand (infusion stand), part number 4896-003

    FDA Recall
    Terminated ·Ekos Corp·Product code FDX·October 12, 2006

    Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.

    FDA Recall
    Terminated ·Hobbs Medical, Inc.·Product code FDX·May 1, 2018

    PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FCX·September 16, 2013

    Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

    FDA Recall
    Terminated ·Northgate Technologies, Inc.·Product code FCX·January 15, 2021

    Artis zee biplane, Model Number 10094141

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    Artis zee floor MN, Model Number 10094142

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    Artis zee ceiling, Model Number 10094137

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    AXIOM Artis dFC, Model Number 7412807

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    AXIOM Artis dTC, Model Number 7413078

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    AXIOM Artis BC, Model Number 5904649

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    AXIOM Artis TC, Model Number 7728350

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    AXIOM Artis dFC, Model Number 7727717

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    AXIOM Artis BA, Model Number 5904656

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

    AXIOM Artis FA, Model Number 5904441

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019