BEUDAMED
    23 results · 26ms · Sources: EU EUDAMED, US FDA

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    TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LANDANGER

    FDA UDI
    LANDANGER·03661219442479·

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521110070D0·10 x 70 mm Anodized SI Implant Fully Threaded

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1100000·Tray Lid, Universal Blank, Arcamed

    NA

    FDA UDI
    STRYKER CORPORATION·04546540466884·1.2mm x 6.0mm Straight Router

    NA

    FDA UDI
    STRYKER CORPORATION·04546540077264·1.5mm x 11.1mm Straight Router

    NA

    FDA UDI
    STRYKER CORPORATION·04546540077257·1.3mm x 7.7mm Straight Router

    ULTRAPAK NEHA

    FDA 510(k)
    FDA Unclassified ·Unknown

    UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Widex

    FDA UDI
    Widex A/S·05706069575491·Widex UNIQUE U-FM (Copper brown ) 110, RC coil

    Widex

    FDA UDI
    Widex A/S·05706069553512·Widex UNIQUE U-FA (Copper brown ) 110, Telecoil...

    Widex

    FDA UDI
    Widex A/S·05706069563986·Widex UNIQUE U-FP (Copper brown ) 110, Telecoil...

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    GENTEEL HOMECARE PRODUCTS·Product code ITJ·May 13, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

    GOLVO

    FDA Adverse Event
    Injury ·LIKO AB·Product code FSA·May 20, 2011

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 26, 2018

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 10, 2023

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024