BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    D-Fine Double Diamond™ Final High Shine Refill #08

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883003715·Dental burnisher

    D-Fine Double Diamond™ Final High Shine Refill #08

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001946·Dental burnisher

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837000288·

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837000295·

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857561458·Parallel Rasp Size 12x12x11 mm

    YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02

    FDA 510(k)
    FDA Class 2 ·General Hospital

    I-ROOT 100

    FDA 510(k)
    FDA Unclassified ·Unknown

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·May 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 17, 2011

    Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

    FDA Enforcement
    Class II ·Terminated·Neurotherm, Inc.·April 20, 2016

    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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