BEUDAMED
    24 results · 32ms · Sources: EU EUDAMED, US FDA

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    GENOSYL DS (Delivery System) console, for use as a vasodilator.

    FDA Enforcement
    Class I ·Completed·Vero Biotech, LLC·October 6, 2021

    SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·March 28, 2018

    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    FDA Enforcement
    Class III ·Terminated·Invivo Corporation·October 28, 2020

    dS Breast 16ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    dS Breast 16ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    microTargeting" Drive System, Product Number MT-DS-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 23, 2021

    Baxter Electrocardiograph, ELI 380 -DCS21

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·February 1, 2023

    VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use

    FDA Enforcement
    Class II ·Ongoing·Vero Biotech, LLC·December 27, 2023

    Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11 (6)S913BX 5-0 NYLON 10 DS12 (7)S931BX 4-0 NYLON 10 DS12

    FDA Enforcement
    Class II ·Ongoing·Covidien, LP·March 8, 2023

    Ultroid Sterile Disposable Probes sold individually

    FDA Enforcement
    Class II ·Terminated·Ultroid Technologies, Inc.·December 28, 2016

    Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.

    FDA Enforcement
    Class II ·Terminated·Ultroid Technologies, Inc.·December 28, 2016

    Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes

    FDA Enforcement
    Class II ·Terminated·Ultroid Technologies, Inc.·December 28, 2016

    Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes

    FDA Enforcement
    Class II ·Terminated·Ultroid Technologies, Inc.·December 28, 2016

    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 24, 2014

    Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·February 20, 2013

    Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·May 4, 2016

    V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·July 23, 2014