BEUDAMED
    53 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Completed × Clear all

    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

    FDA Enforcement
    Class II ·Completed·Philips Healthcare Informatics, Inc.·June 17, 2020

    Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

    FDA Enforcement
    Class II ·Completed·Abbott Diabetes Care, Inc.·January 24, 2024

    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

    FDA Enforcement
    Class II ·Completed·Fresenius Medical Care Holdings, Inc.·November 18, 2020

    Discovery NM/CT 670 Pro, model 5376204-70-54

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    Discovery NM/CT 670 ES, model 5376204-70-57

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

    FDA Enforcement
    Class II ·Completed·Murata Vios, Inc.·January 22, 2025

    ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Completed·ICU Medical, Inc.·October 10, 2018

    VariCam

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·January 16, 2019

    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

    FDA Enforcement
    Class II ·Completed·Withings Sas·August 22, 2018

    SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

    FDA Enforcement
    Class II ·Completed·SynCardia Systems LLC·November 1, 2023

    SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.

    FDA Enforcement
    Class II ·Completed·C.R. Bard, Inc.·April 26, 2017

    RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.

    FDA Enforcement
    Class II ·Completed·Appliedvr·July 5, 2023

    Revolution CT

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·July 14, 2021

    Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.

    FDA Enforcement
    Class II ·Completed·Smiths Medical ASD, Inc.·January 7, 2015

    Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.

    FDA Enforcement
    Class II ·Completed·Smiths Medical ASD, Inc.·January 7, 2015

    Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.

    FDA Enforcement
    Class II ·Completed·Smiths Medical ASD, Inc.·January 7, 2015

    Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

    FDA Enforcement
    Class II ·Completed·Hologic, Inc·December 18, 2024

    iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System

    FDA Enforcement
    Class II ·Completed·Boston Scientific Corporation·May 6, 2020

    6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    FDA Enforcement
    Class II ·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020