BEUDAMED
    19 results · 31ms · Sources: EU EUDAMED, US FDA

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    RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014609904·MIDMARK 3" SOFTCARE

    Clear Readers

    FDA UDI
    Diversified Products, Inc.·00842894127636·

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0861500·Pituitary, Up Biting, 3mm

    DRIDAU OPIATE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE

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

    CADD MEDICATION CASSETTE

    FDA Adverse Event
    Malfunction ·NULL·Product code FPA·February 4, 2022

    PAXGENE® BLOOD RNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code NTW·May 1, 2026

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.1818910·Product code KWA·April 26, 2013

    CIC PRO CLINICAL INFORMATION CENTER

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code DSI·April 14, 2011

    CHARLOTTE MULTI-USE COMPRESSION SCREW

    FDA Adverse Event
    Malfunction ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·July 15, 2008

    SMARTSET MV 40G - EO

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LOD·October 18, 2019

    UNSPECIFIED BD PAXGENE® BLOOD TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code PJE·June 13, 2025

    PAXGENE® BLOOD RNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 23, 2026

    PAXGENE® BLOOD RNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 31, 2026

    PAXGENE® BLOOD RNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·February 9, 2026

    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

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020