BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    Mako Total Knee Application

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772412488·PROTECT.LUMBOSTYLE BACK SUPPORT BLACK II

    EarQ

    FDA UDI
    Sbo Hearing A/S·05714464121939·EARQ E40 MINIRITE T C063 DEMO

    COMPRESSION SCREW SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304249943·

    LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP

    FDA 510(k)
    FDA Class 2 ·Neurology

    OIC Cervical PEEK Spacer

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLIDEWELL HT IMPLANT Ø4.3 X 11.5 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 13, 2025

    TALENT AAA STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·November 18, 2014

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KOG·September 22, 2011

    XIA 3 TITANIUM TORQUE WRENCH SHORT

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code LXH·August 1, 2013

    COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 15, 2026

    Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).

    FDA Enforcement
    Class I ·Ongoing·Cook Incorporated·June 25, 2025

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021