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

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    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 3D

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code OTE·January 8, 2025

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·SELENIA DIMENSIONS 3D SYSTEM

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Selenia Dimensions 3D System High Resolution Tomosynthesis

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Selenia Dimensions 3D System.

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Envision Mammography Platform

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·3Dimensions

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Selenia Dimensions/3Dimensions 3D System

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Selenia Dimensions/3Dimensions

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Selenia Dimensions / 3Dimensions

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Envision Mammography Platform

    3DIMENSIONS

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code OTE·April 24, 2024

    3DIMENSIONS

    FDA Adverse Event
    Malfunction ·HOLOGIC, INC·Product code OTE·June 24, 2024

    Saw Blade

    FDA UDI
    Gebr. Brasseler GmbH & Co. KG·14053613215104·STRYKER® RECIPROCATOR BLADE REPLACEMENT

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114502·LOCATOR F-Tx Abutment for 3.3mm CAMLOG Connecti...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110870·LOCATOR R-Tx Abutment for 3.3mm Camlog Connecti...

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094282610·Cuff, Ambulo ABPM, Large Adult Long 31-40 cm ra...

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094258752·Cuff, Ambulo ABPM, Large Adult 31-40 cm range

    BINAXNOW G6PD TEST

    FDA 510(k)
    FDA Class 2 ·Hematology