BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018

    DXS DIGITAL X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO ITI DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 26, 2024

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 22, 2019

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 14, 2018

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 5, 2018

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·April 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 13, 2011

    PROXIMATE PPH PROCEDURE SET

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC·Product code GDW·July 29, 2008

    Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014