BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    ANKLE TRAUMA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R

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

    LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 27, 2024

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 25, 2012

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 3, 2024

    RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125°

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·July 23, 2018

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·May 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    BIVONA UNCUFFED PEDIATRIC FLEX TEND PLUS TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 9, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·April 14, 2022

    INTERGRATED APD SET

    FDA Adverse Event
    Malfunction ·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025