BEUDAMED
    158 results · 29ms · Sources: EU EUDAMED, US FDA

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    CARDIOMPO TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    MedGyn Pessary Ring w/support #4

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050029·Pessary ring is used to treat uterine prolapse.

    LATERALIZED AND AUGMENTED BASEPLATE

    FDA UDI
    FX SOLUTIONS·03701037316801·TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW Ti/H...

    Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989025408·PREF.LING.ARCH NI-TI LO16 SZ2 PK/10

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690129806·Modular Tibia Fluted Keel Stem, Size 14mm x 100mm

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·HELIOS II ABLATION CATHETER

    Matira

    FDA UDI
    Kalitec Direct LLC·B073DRK010029·Drill Guide, Variable, Attached Handle

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K0100290·Caddie Lid, MIS Rods and Caps

    HOME HEALTH MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    UNK

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF, INC·Product code HCG·June 22, 2017

    UNK

    FDA Adverse Event
    Death ·CODMAN AND SHURTLEFF, INC·Product code HCG·June 22, 2017

    UNK

    FDA Adverse Event
    Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·June 22, 2017

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 10, 2013

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 8, 2008

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 1, 2011

    BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code DRC·July 27, 2023

    PANEL PHOENIX PMIC-110

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026

    PANEL PHOENIX PMIC-110

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

    PANEL PHOENIX PMIC-110

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026