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

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    AIR POWERED DENTAL HANDPIECE

    FDA 510(k)
    FDA Class 1 ·Dental

    Hysteroscope System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    UNKNOWN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·April 30, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 22, 2007

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 10, 2012

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020

    UNFOLDER PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021

    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024