BEUDAMED
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    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code GZB·July 29, 2014

    Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code GZB·July 29, 2014

    St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Recall
    Terminated ·Abbott·Product code MXC·November 19, 2018

    Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·September 18, 2025

    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code BRY·January 15, 2016

    Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code PMP·May 16, 2024

    Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·January 8, 2025

    Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·February 1, 2024

    Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code LWS·June 20, 2019