BEUDAMED
    28 results · 16ms · Sources: EU EUDAMED, US FDA

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    Karl Storz, Model # 11161C2, Flexible Neuroscope

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·April 1, 2020

    Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·April 1, 2020

    Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·April 1, 2020

    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·December 26, 2012

    BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461

    FDA Enforcement
    Class II ·Terminated·Datascope Corporation·May 16, 2018

    Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·September 9, 2015

    namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·May 22, 2024

    Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Getinge Usa Sales Inc·February 19, 2025

    Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00

    FDA Enforcement
    Class II ·Ongoing·Mindray DS USA, Inc. dba Mindray North America·September 11, 2024

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Enforcement
    Class II ·Terminated·Water Pik, Inc.·August 15, 2018

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·February 5, 2014