BEUDAMED
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    N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    Gladstone ALIF Trial Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215045104·

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

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

    PROTRACT PRESS FIT HIP STEM-HA COATED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·August 30, 2010

    RADICAL

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·April 16, 2015

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·March 18, 2013

    ONE TOUCH BASIC ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·May 7, 2008

    IL NUTRIFLO Y TYPE SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SHERBROOKE·Product code FPA·April 5, 2011

    ALLOCL SLL REVISION STEM 9 14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·August 19, 2019

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·August 5, 2011

    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019