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

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    Straumann BLX Gold Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180108684·5 MM DIA., 33 CM BIPOLAR DUAL NEEDLE MYOMA COAG...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694016285·2.0mm/2.4mm Plate Organizer

    Olympus

    FDA UDI
    Gyrus ACMI, LLC·00821925047150·ES-IP DUAL IN-ROOM System - EXPANDED 48U

    16PW - Cal OSHA

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588025971·16PW - Cal OSHA

    VITA RESPONSE

    FDA 510(k)
    FDA Class 2 ·Dental

    SERRALGUT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    CAMERA, POLARIS VEGA

    FDA Adverse Event
    Malfunction ·BLUE BELT TECHNOLOGIES·Product code OLO·December 8, 2020

    CAMERA, POLARIS VEGA

    FDA Adverse Event
    Malfunction ·BLUE BELT TECHNOLOGIES·Product code OLO·November 26, 2020

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code FRC·July 1, 2013

    CAMERA, POLARIS VEGA

    FDA Adverse Event
    Injury ·BLUE BELT TECHNOLOGIES·Product code OLO·June 28, 2023

    CAMERA, POLARIS VEGA

    FDA Adverse Event
    Malfunction ·BLUE BELT TECHNOLOGIES·Product code OLO·July 3, 2024

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014