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

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    ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)

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

    Polishers

    FDA UDI
    DFS - DIAMON GmbH·04057176161451·2metal polisher small point CA 6p

    MGB Alert HSV 1&2 Typer Primer Mix ASR - 48 rxn

    FDA UDI
    Elitechgroup Mdx LLC·03661540951503·MGB Alert® HSV 1 & 2 Primer Mix contains chemic...

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209101030·KIT, NAR-5 SAR AID

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756016070·ARM SLING

    TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001

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

    Boston One Step Liquid Enzymatic Cleaner

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    UNSPECIFIED BY THE COMPLAINANT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code OTN·April 3, 2014

    ARCHITECT STAT TROPONIN-I

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MMI·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007

    regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025