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

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    P-Cure Proton Therapy System (PPTS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    I.T.S. Hand Locking Plates System - HLS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    GENTEEL HOMECARE PRODUCTS·Product code ITJ·November 11, 2014

    ATLAS II VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2011

    ARTICUL/EZE BALL 32 +5 BR

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·July 23, 2013

    TMC SPEEDMTP

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 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