BEUDAMED
    71 results · 12ms · Sources: EU EUDAMED, US FDA

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    nordicBrainEX, software versions 2.21 through 2.3.10

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·August 3, 2022

    Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 3, 2021

    Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 3, 2021

    Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 3, 2021

    Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international) The Orthoralix 8500 DDE Panoramic Dental X-Ray System is used as an extraoral source of x-rays for imaging of the dento-maxillofacial area.

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code EHD·December 21, 2010

    Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code EHD·February 4, 2011

    Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123

    FDA Recall
    Terminated ·Product code GAM·June 6, 2007

    nordicBrainEX, software versions 2.21 through 2.3.10

    FDA Recall
    Terminated ·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·June 16, 2022

    Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code EHD·February 4, 2011

    Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·November 15, 2020

    Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·November 15, 2020

    Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NIK·November 15, 2020

    Microwave Ovens, Model Number DG-2

    FDA Recall
    Terminated ·Duke Manufacturing Co.·Product code RCS·May 12, 2010

    3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010

    3M Micropore Paper Tape, Cat. No. 1530-15Y, 1 in x 5YDS., 441 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010

    3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010

    3M Micropore Paper Tape, Cat. No. 1530-136, 1 in x 36 in., 800 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010

    3M Micropore Paper Tape, Cat. No. 1530-118, 1 in x 18 in., 800 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010

    3M Micropore Paper Tape, Cat. No. 1530-12Y, 1 in x 2YDS., 630 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010

    3M Micropore Paper Tape, Cat. No. 1530-254, 2 in x 54 in., 400 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010