BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112110·Tap, Cannulated, 4.75 mm

    FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO INTRALASE 600C LASER KERATOME

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

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    CELL-DYN DILUENT/SHEATH

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

    LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·March 11, 2017

    RD SET DCI

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·February 17, 2017

    PROTECTA XT CRT-D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·April 10, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·April 12, 2011

    ACUITY CENTRAL STATION

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code DSI·May 23, 2008

    RAINBOW RC-4

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 11, 2017

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006

    LNCS TC-I SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·August 31, 2015

    INTACS CORNEAL IMPLANTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006

    CELL-DYN RUBY SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·November 10, 2023

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014