BEUDAMED
    53 results · 20ms · Sources: EU EUDAMED, US FDA

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    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN (R) PACING SYSTEM

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL K (UNIPOLAR) & M (BIPOLAR) ENDOCARDIAL LEADS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL Q (UNIPOLAR) & R (BIPOLAR) ENDOCARDIAL LEADS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS.

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700541·GC Initial™ MC Dentin DA3.5, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556700836·GC Initial™ MC Dentin DA3.5, 20g

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867316270·Driver Shaft, T8, Self Retaining, AO

    DRILL BIT, 1.7MM

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HTW·August 12, 2024

    DRIVER SHAFT, T8, SELF RETAINING, AO

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·August 2, 2024

    Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

    FDA Pre-Market Approval
    FDA Class 3 ·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900

    DRIVER SHAFT, T8, SELF RETAINING, AO

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·December 8, 2025

    DRIVER SHAFT, T8, SELF RETAINING, AO

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·June 4, 2024

    DRIVER SHAFT, T8, SELF RETAINING, AO

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·February 5, 2025