BEUDAMED
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    GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DQX·March 27, 2025

    Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

    FDA Recall
    Open, Classified ·Human Care Hc Sweden Ab Arstaangsvagen 21 B Stockholm Sweden·Product code FSA·February 23, 2024

    VADER pedicle system, torque wrench, Catalog Number 42-703

    FDA Recall
    Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023

    VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

    FDA Recall
    Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code NKB·November 3, 2022

    VADER pedicle system, torque wrench, Catalog Number 42-702

    FDA Recall
    Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023

    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·December 3, 2022

    Model A710 Intellis Clinician Programmer Application, version 2.0.97

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·December 19, 2023

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

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

    Vanta Implantable Neurostimulator (INS), Model 977006

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·August 21, 2024

    A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·June 21, 2023

    Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·July 18, 2023

    Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·July 18, 2023

    Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·July 18, 2023

    Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·July 18, 2023

    Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·October 19, 2023

    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

    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·December 3, 2022

    Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·October 6, 2025

    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·December 3, 2022