BEUDAMED
    136 results · 42ms · Sources: EU EUDAMED, US FDA

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    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

    FDA Recall
    Completed ·Withings Sas 2 rue Maurice Hartmann Issy les Moulineaux France·Product code DXN·June 11, 2018

    MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 20, 2016

    MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 20, 2016

    Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.

    FDA Recall
    Terminated ·Tornier, Inc·Product code KWS·May 28, 2021

    PET Infusion Pump

    FDA Recall
    Terminated ·Bayer Healthcare·Product code FRN·September 30, 2016

    Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.

    FDA Recall
    Terminated ·Bayer Healthcare·Product code FRN·November 30, 2015

    Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·April 16, 2008

    Physio-Control LIFEPAK 20 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·April 16, 2008

    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone Industrielle des Fourneaux Sees France·Product code JIX·April 18, 2017

    HIGH V+ Spinal Cement System REF T040321K

    FDA Recall
    Open, Classified ·TEKNIMED SAS Zone Industrielle Montredone 11 Rue D Apollo L'Union France·Product code NDN·December 15, 2022

    Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·April 16, 2008

    Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA Stryker Mantis Rod Inserter Inner Shaft Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA IS2097MAN Mantis Rod Inserter Shaft Used to facilitate insertion and delivery of a Mantis rod.

    FDA Recall
    Terminated ·Stryker Spine·Product code HSB·June 24, 2011

    Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

    Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

    Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

    Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E - ARD568803951

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FTD·November 8, 2023

    Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD567501960A, AXL 5501 - ARD567501960C, AXL 5501S - ARD567505960C, AXL+5001 DF - ARD567502961C, AXL+5001 SF - ARD567502861C, AXL+5301 DF - ARD567502971C, AXL+5501 DF - ARD567502960C, AXL+5501 SF - ARD567502860C, AXL+5531 DF - ARD567502930C, AXL50 RLC - ARDRLC309000C, AXL50 RLC - ARDRLC309006C, AXL5003 - ARD567505968C, AXL5003 US - ARD567505969C

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

    Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.

    FDA Recall
    Open, Classified ·Bayer Medical Care, Inc.·Product code FRN·November 30, 2022

    Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015A, ROL PWDII70SF - ARDPWT309016A, ROL VCS40SF - ARDROL309031A, ROL VCS60SF - ARDROL309032A, ROL VST40SF - ARDROL309033A, ROL VST40SF - ARDROL309034A, ROL VST40SF B - ARDROL309037A, ROL VST60SF - ARDROL309035A, ROL VST60SF - ARDROL309036A, ROL VST60SF B - ARDROL309038A, ROL VCSII40SF - ARDROL309039A, ROL VCSII40SF - ARDROL309040A, ROL VCSII60SF - ARDROL309041A, ROL VCSII60SF - ARDROL309042A, ROL PWDII50SF - ARDROL309043A, ROL PWDII50SF - ARDROL309044A, ROL PWDII70SF - ARDROL309045A, ROL PWDII70SF - ARDROL309046A, ROL PWDII50SF - ARDROL309047A, ROL PWDII50SF - ARDROL309048A, ROL PWDII70SF - ARDROL309049A, ROL PWDII70SF - ARDROL309050A, ROL VSTII40SF - ARDROL309051A, ROL VSTII60SF - ARDROL309052A, ROL VSTII40SF - ARDROL309053A, ROL VSTII60SF - ARDROL309054A

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FTD·November 8, 2023

    Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD569035111C, BLUE 30 - ARD569035131C, BLUE 30 - ARD569045111C, BLUE 30 - ARD569045131C, BLUE 30 - ARD569055111C, BLUE 30 - ARD569055131C, BLUE 30 - ARD569065112C, BLUE 30 - ARD569065132C, BLUE 30 C - ARDBLU209000C, BLUE 3030 - ARD569015411C, BLUE 3030 - ARD569015431C, BLUE 80 - ARD569014111A, BLUE 80 - ARD569014111C, BLUE 80 - ARD569014131C, BLUE 80 - ARD569064112C, BLUE 80 - ARD569064132C, BLUE 8030 - ARD569014411C, BLUE 8030 - ARD569014431C, BLUE 8080 - ARD569014211C, BLUE 8080 - ARD569014231C, BLUE 30 - ARD569065113C, BLUE 30 - ARD569065123C, BLUE 30 - ARD569075113A, BLUE 30 - ARD569075113C, BLUE 30 - ARD569075123C, BLUE 80 - ARD569064113C, BLUE 80 - ARD569064123C, BLUE 80 - ARD569074113A, BLUE 80 - ARD569074113C, BLUE 80 - ARD569074123C, HLX BLUE 3 - ARD569132113A

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023