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

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    ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM

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

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033053·Baltic Denture System BDLoad ↓ Mw7 PLSEum2DFm D...

    SlimLine®

    FDA UDI
    ZIMMER SPINE, INC.·00889024403673·

    NEEDLE 27GA 1-1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·February 20, 2025

    MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING

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

    DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 7, 2025

    ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM

    FDA Adverse Event
    Other ·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013

    MEDIVATORS

    FDA Adverse Event
    Malfunction ·MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH·Product code FEB·March 30, 2011

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·April 23, 2008

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. 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