BEUDAMED
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    LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators

    FDA 510(k)
    FDA Class 2 ·Immunology

    Equator

    FDA UDI
    Preat Corporation·00842092176658·Equator Abutment for Astra EV 3.0 x 5mm

    ONE DAY FLAT PACK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·November 16, 2018

    TRANSITION 6.5MM HA POLYAXIAL PEDICLE SCREW,

    FDA Adverse Event
    Injury ·GLOBUS MEDICAL, INC.·Product code NQP·May 22, 2013

    ENTRAK 2500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·September 12, 2014

    NI

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWP·June 22, 2011

    WILSON-COOK ACHALASIA BALLOON

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code PID·June 17, 2021

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·November 8, 2018

    WILSON-COOK ACHALASIA BALLOON

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code PID·October 6, 2020

    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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022