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

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    Vantage Orian 1.5T, MRT-1550, V4.5

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517638922·CoRoent Ant TLIF PEEK, 8x12x28mm 12°

    HEALIX TI ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·February 12, 2026

    COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·October 21, 2024

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 21, 2013

    SENSATION 7 FR 40 CM

    FDA Adverse Event
    Injury ·MAQUET, DATASCOPE CORP.·Product code DSP·July 22, 2011

    COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·March 29, 2024

    COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·March 28, 2024

    COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·December 28, 2023

    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 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012