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

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    SCHIFF REAGENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    DIGITAL FLUROGRAPHIC IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    IPL Hair Removal Device

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

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 23, 2026

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 5, 2025

    Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.

    FDA Enforcement
    Class II ·Terminated·Medrobotics Corporation·April 24, 2019

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 7, 2014

    ZUI UTERINE INJECTOR 2.0MM

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL·Product code LKF·October 20, 2010

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Injury ·HEARTWARE, INC·Product code DSQ·December 21, 2012

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 21, 2025

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 5, 2025

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 24, 2025

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 30, 2026

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 12, 2025

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·September 15, 2025

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 20, 2026

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 13, 2026