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

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    Triathlon Total Knee System-Additional Components

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768468·GENUMEDI PSS GREEN II

    Oticon

    FDA UDI
    Oticon A/S·05707131338761·SIYA 1, BTE 13 2.4G 85 C092

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065661·INTRAORAL ELASTICS 2,5 oz 5/16" blue

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402573·Starter Reamer, Cone

    SITE-RITE VISION ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIODESIGN NIPPLE RECONSTRUCTION CYLINDER

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

    MONOJECT

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD·Product code PNR·April 14, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    CARDINAL

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 21, 2014

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 26, 2013

    RESTORATION MODULAR

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code JDI·July 28, 2011

    MAMBA? FLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    BACT/ALERT MP - 419744

    FDA Adverse Event
    Malfunction ·BIOMERIEUX INC.·Product code MDB·December 5, 2019

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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