BEUDAMED
    11 results · 33ms · Sources: EU EUDAMED, US FDA

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    Kinos Axiom Total Ankle System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AccuQuest

    FDA UDI
    Bernafon AG·05711584089828·AQ CO1 MNR, 2.4G NFM PB MSIL ACCUQ

    CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION

    FDA 510(k)
    FDA Class 2 ·Hematology

    SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING

    FDA 510(k)
    FDA Class 2 ·Radiology

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAN·October 8, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 27, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011

    METRX® SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 11, 2025

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 20, 2025

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014