BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    LIFESYS PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ceramco® II Silver™

    FDA UDI
    Dentsply International Inc.·D0011613410·

    POWDERED VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PALMLIGHT 10, MODEL 001-00030

    FDA 510(k)
    FDA Class 2 ·Dental

    BENCHMARK GX, STAINER MODULE

    FDA Adverse Event
    Injury ·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 18, 2024

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 13, 2011

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·October 10, 2014

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020