BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    Trilogy Tissue Marker

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

    BEE Cages

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CRANE ACRYLIC HERBST APPLIANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code GFD·July 18, 2013

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·April 23, 2025

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020