BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    Entuit Start Initial Placement Gastrostomy Set

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

    NAVIGATOR HD URETERAL ACCESS SHEATH SETS

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

    TEMPORARY LIMB SALVAGE SHUNT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code QFG·June 15, 2023

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·February 27, 2018

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 20, 2011

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 12, 2008

    PROGREAT

    FDA Adverse Event
    Injury ·Product code DQO·April 30, 2021

    PROGREAT

    FDA Adverse Event
    Malfunction ·Product code DQO·May 28, 2021

    TERUMO PROGREAT CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 25, 2022

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024