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

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    DERMABOND NX ADHESIVE MODEL: DNX6, DNX12

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

    Bur PM2-70 50K Steel Ø3.1 St

    FDA UDI
    Bien-Air Surgery SA·17630055503791·

    BLOXR

    FDA UDI
    BLOXR Solutions, LLC·10811042030453·XPF® Frontal Apron with elastic back, LARGE

    Digital Analogue EV/4.2

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059074529·

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 26, 2021

    NA

    FDA UDI
    STERILMED, INC.·10888551036962·BUR CARBIDE ROUND 8 FLUTES

    Bicon Impression Component

    FDA UDI
    BICON, LLC·00813110023681·2.0mm Two-Part Titanium Impression Post and Pla...

    Stryker

    FDA UDI
    Provision·B504OM22961004230·

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    S52D DIGITAL VIDEO LAPAROSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 8, 2013

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·May 13, 2011

    ANGIOJET ULTRA XMI

    FDA Adverse Event
    Other ·POSSIS MEDICAL, INC.·Product code DXE·August 6, 2008

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 11, 2012

    INFANT LOW FLOW BREATHING CIRCUIT KIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 15, 2011

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 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

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024