BEUDAMED
    11 results · 17ms · Sources: EU EUDAMED, US FDA

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    PROXIMATE DISPOSABLE SKIN STAPLERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743700·ACHIMED ACHILLES SUPP SAND I

    LEKSELL GAMMA KNIFE PERFEXION

    FDA 510(k)
    FDA Class 2 ·Radiology

    MONOJECT ROOT CANAL FILLING MAT. NEEDLE

    FDA 510(k)
    FDA Class 1 ·Dental

    Vaginal Verification Panel Ref 8208 Lot 8208-11

    FDA Enforcement
    Class II ·Terminated·Microbiologics Inc·February 12, 2020

    BCS POLY

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·November 6, 2012

    HS HAND CONTROLLED CURVED SHEA

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GEI·August 16, 2007

    UNIVERSAL II

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 8, 2014

    Vaginal Verification Panel Ref 8208 Lot 8208-11

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·January 3, 2020

    MENTOR SMOOTH ROUND HIGH PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·May 15, 2018

    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