BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    Linkt Compression Staple System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COE®

    FDA UDI
    Gc America Inc.·10386040001915·MASTER PAK #7D SPACER TRAY PERF

    COE®

    FDA UDI
    Gc America Inc.·40386040001916·MASTER PAK #7D SPACER TRAY PERF

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016340·

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613327029857·Tibial Bearing Insert - PS

    4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    LTM-Perforated Surgical Mesh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    THERMOPHORE ARTHRITIS PAD

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·December 1, 2008

    UNKNOWN SPINAL CORD STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·September 12, 2011

    PELVICOL 4 X 12 CM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 19, 2013

    TELEGRAPH®

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489507120·

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013