BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LCP

    FDA UDI
    Synthes GmbH·10886982166890·LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES...

    Broach 37.5 size 1

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215055387·

    SONICISION CORDLESS ULTRASONIC DISSECTOR

    FDA 510(k)
    FDA Unclassified ·Unknown

    BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN

    FDA 510(k)
    FDA Class 1 ·Dental

    CERTAIN GOLD-TITE HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·May 7, 2021

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSD·November 14, 2023

    NEUROMONITOR BASIC KIT

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC·Product code GWM·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 22, 2013

    REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018