BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    REFLECTIVE BLANKET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Pro-Link® Stand-Alone Cervical Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERIFY 3-10 MIN FLASH INTEGRATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·November 21, 2012

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·September 17, 2010

    Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012