BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    SPA SHELL

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SwishPlant® Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307105862·4.1mmD x 6mmL, 4.8mmD Platform

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150737·K-WIRE - SINGLE TROCAR 1.0mm DIA x 150mm

    CLOSED DISCONNECT SYSTEM

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

    ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IV SET AN115 23G 1IN BP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·August 2, 2019

    TENACULUM FORCEPS

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·January 9, 2013

    DUAL LEAD EXTENSION

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024