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

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    CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN

    FDA 510(k)
    FDA Class 1 ·Radiology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198291·AK3 PS Insert Trial Size 5, 10mm

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978075136·INSTRUMENT 893-510 THNDL TREPHINE 8MM

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867131910·LO-PRO SCRW,TI,3.5MMX 10MM

    Terason uSmart3200T Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    LUMENVU CATHETER GUIDANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 2, 2013

    ADVANCE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 14, 2014

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 8, 2010

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020