15 results
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6ms
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Sources: EU EUDAMED, US FDA
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
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
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016