BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Neurology

    VERSE POLY DRIVER SHAFT NAV

    FDA Adverse Event
    Malfunction ·DEPUY SPINE INC·Product code OLO·April 29, 2022

    Mini Unicycle™

    FDA UDI
    Ortho Organizers, Inc.·00190707056759·Mini Unicycle™ .120” Ligature Ties - Light Green

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319704103·Bishop-Harmon Micro Tissue Forceps 3-3/8" (8.6c...

    IROOT FS

    FDA 510(k)
    FDA Class 2 ·Dental

    BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 21, 2024

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·October 16, 2020

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 20, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 11, 2011

    CARPENTIER-EDWARDS BIOPROSTHETIC VALVE CONDUIT

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·August 15, 2008

    MEGA 7.5FR. 40CC

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 10, 2020

    Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·October 25, 2017