BEUDAMED
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    The C100 Contactless Breathing Monitor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034006666·ISOLA SPINE SYSTEM OPEN PEDICLE HOOK 4.75 x 11.0mm

    Intraoral Scan Body 3.8

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059075250·

    CASTANARES FACE LIFT SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896047198·CASTANARES FACE LIFT SCISSORS STRAIGHT BLADE PO...

    Drill Tack

    FDA UDI
    Treace Medical Concepts, Inc.·00810111225076·2.9MM Tack

    MEDTRONIC MODEL 7499 EXTENSION

    FDA 510(k)
    FDA Class 2 ·Neurology

    THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG

    FDA 510(k)
    FDA Class 2 ·Neurology

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code OZO·September 28, 2023

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·September 12, 2017

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    ROTABLATOR GUIDE WIRE

    FDA Adverse Event
    BOSTON SCIENTIFIC·Product code MCX·September 9, 2008

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA·Product code ITJ·July 1, 2013

    STEM: QUADRA-H 01.12.033 CEMENTLESS, HA COATED LAT STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 27, 2023

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 25, 2013

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021