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

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    Rapid Aid Instant Disposable Infant Heel Warmer

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171028086·PESSARY, DISH #6, W/SUPPORT, 80mm

    SET SCREW, TI GAMMA3 8X17.5MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 27, 2012

    LIFESTENT TURBO BILIARY STENT SYSTEMS

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

    NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·June 6, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 22, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·October 16, 2017

    SMALL HEXAGONAL SCREWDRIVER SHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·August 22, 2023

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018