BEUDAMED
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    MR INSPIRE WITH EXTENDED KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    DOYEN INTESTINAL FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896046344·DOYEN INTESTINAL FORCEPS CURVED DIAGONAL SERRAT...

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120366·Guidewire 1.6x100mm Sgl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120359·Guidewire 1.6x100mm Dbl Trocar

    COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ICG MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINER: MPACT FLAT PE HC Ø40/F

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 22, 2021

    OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

    FDA Enforcement
    Class II ·Terminated·Bacterin International, Inc.·April 24, 2013

    DUODERM

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code NAD·April 19, 2023

    DUODERM PASTE AND GELS

    FDA Adverse Event
    Malfunction ·CONVATEC LTD·Product code NAE·March 29, 2023

    MOTOR EM210 LEGEND STYLUS TOUCH

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·May 8, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 12, 2011

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code MMI·July 30, 2008

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020