BEUDAMED
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    TEARAWAY INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741029028·Catheter Placement Kit

    Keystone Industries

    FDA UDI
    Keystone Industries·H66870003131·D-3 HVE Tips/Wht-KI

    Alpine

    FDA UDI
    Ortho Development Corporation·00822409018857·Alpine Centralizer 13 mm

    ORIO

    FDA UDI
    SPINECRAFT, LLC·00193082155451·PLIF Implant Caddy, 8 deg

    e-vive II NMES System

    FDA UDI
    Motive Health, Inc.·00854691008865·e-vive II NMES System; S/M, Right

    TUFF-TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 15, 2024

    PROVEN KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 2, 2025

    audifon

    FDA UDI
    audifon GmbH & Co. KG·EADF019023700031317201·BTE-TRT

    TUFF-TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 13, 2024

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·July 14, 2024

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 5, 2025

    SINGLE USE ELECTROSURGICAL KNIFE

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code KNS·June 25, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 12, 2013

    LEAD MODEL 302

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·February 18, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 11, 2014

    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014

    BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015