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

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    TINA-QUANT COMPLEMENT C3C TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056523·Zirlux Multi Anterior B2,98.5X18

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673136·LEVAMED STABILI-TRI ANK SUP BLU L I

    MiRus Bifurcated Illuminator

    FDA UDI
    Lumitex, Inc.·00810025485344·

    G-aenial™

    FDA UDI
    Gc America Inc.·D0470123611·G-aenial Univ. Injectable Unitip AE

    FALLS CREEK

    FDA UDI
    FGX INTERNATIONAL INC.·00193033383872·

    FALLS CREEK

    FDA UDI
    FGX INTERNATIONAL INC.·00719283536617·

    K012364

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 3, 2015

    MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONSULT HCG TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 22, 2020

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 20, 2013

    6000034-2010-00576

    FDA Adverse Event
    Injury ·COCHLEAR LTD·March 9, 2011

    SAF-T-INTIMA SHIELDED IV CATHETER

    FDA Adverse Event
    BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·March 10, 2008

    CONSULT HCG URINE CASSETTE 5001 25T

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019

    VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001

    FDA Enforcement
    Class II ·Ongoing·Visionsense, Ltd.·November 30, 2022

    Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 14, 2013

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019