BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    TGS Guidewire and updated Scopis Software

    FDA 510(k)
    FDA Class 2 ·Neurology

    ECHO BI-METRIC MICROPLASTY HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304698000·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198116·AK3 PS Insert Trial Size 1, 18mm

    BRAINLAB KNEE ARTHROSCOPY

    FDA 510(k)
    FDA Class 2 ·Neurology

    REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR

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

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·October 6, 2008

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2011

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·June 27, 2013

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

    Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026