BEUDAMED
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    EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776404949·Spread-Out Lamina Forceps, Wide, Angled, 12mm T...

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1671333120·

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613025090·Reynolds (Jamison) Scissors, Super Cut, Curved,...

    Zavation

    FDA UDI
    Zavation LLC·00197157006150·Sizer with One Stop/0deg/11&12mm

    UPD-Y0003

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EBI TOP LOADING MAS SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523144778·L UHMWPE PS Tibial Insert Sz B 12mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523143733·L CIMA HXL PS Tibial Insert Sz B 12mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523147182·PS Tibia Insert Trial Size B, 12mm - Left

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523172696·PS Tibia Insert Trial with Posterior Pin Relief...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523142873·L E-CIMA Vitamin E PS Tibial Insert Sz B 12mm

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 28, 2019

    MENTOR MEMORYGEL BOOST BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 16, 2026

    CARELINK PERSONAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·October 1, 2014

    ATTAIN ABILITY STRAIGHT

    FDA Adverse Event
    Death ·MPRI·Product code OJX·May 29, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 20, 2011

    G7 FREEDOM CONST E1 LNR 36MM G

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·May 1, 2023

    Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.

    FDA Enforcement
    Class III ·Terminated·ELITech Group B.V.·October 9, 2019

    TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions. This device is also intended for injection of radiopaque contrast media for the purpose of angiography.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017