BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    da Vinci Surgical System, IS5000

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

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776170998·SCOTT-MC ELEVATOR W -L

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813058046·STERILE CARBIDE BUR FG1157 DARBY

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306824784·Scott Mc Elevator, 13mm

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250442050·ceraMotion® PZr Ingot C3, 5 x 2 g / dental cera...

    MILLENNIUM MULTI-LEAF COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Volcano Visions PV .018 Digital IVUS Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 7, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·July 26, 2013

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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