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

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    F&P ICON SERIES CPAP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ICON PREMO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 20, 2024

    ICON PREMO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·June 26, 2025

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0140400·Driver Shaft, T30 Final Cap Driver

    REDTECH GIPC 2000

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

    FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS

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

    ARCOM 28MM RNGLOC LNR HWALL 24

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·July 21, 2022

    CORAIL AMT COLLAR SIZE 12

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS 3003895575·Product code KWA·May 6, 2013

    PROMUS PREMIER?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 16, 2014

    4 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 20, 2011

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015