BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    ProPerformance Recovery System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DMP PIT & FISSURE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code OWN·March 5, 2025

    COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·October 21, 2024

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code LWP·January 13, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·March 29, 2024

    COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·March 28, 2024

    COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·December 28, 2023

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024