BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    GC85A

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120540·Guidewire 1.6x150mm Dbl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120557·Guidewire 1.6x150mm Sgl Trocar

    TiLock

    FDA UDI
    Genesys Orthopedics Systems LLC·M719G1501650·Pre-Bent Rod

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117537·Distal Reamer (Hudson)

    Tap for Ø6.5mm Screw

    FDA UDI
    XENCO MEDICAL LLC·B064XM21501651·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192602·Distal Reamer (Hudson)

    MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100

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

    FREERIDER MODEL LUGGIE MODEL 168-4IT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EQUINOXE CAGE GLENOID S, POST AUG, RIGHT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·November 14, 2022

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    LEGEND FOOTED ATTACHMENT

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·June 6, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    SYNCHROMED II

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 3, 2008

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015