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

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    uMR Omega

    FDA 510(k)
    FDA Class 2 ·Radiology

    Andwin Scientific

    FDA UDI
    Andwin Scientific·00187207000160·PAPKIT, (1) Single Frost Slide & Fixative Pouch

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573020348·INTRG WHISP-Z ROTH CUS HK -11T +5A 022 LL

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK

    HYDRASOLVE LIPOPLASTY SYSTEM

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

    Disposable Face Mask

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 24, 2014

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

    Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 23, 2025

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014