BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    F383 RECHARGEABLE MINI MASSAGER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BC-1201 CAST ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQY·June 21, 2017

    ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM

    FDA Adverse Event
    Injury ·ARROW INTERNATIONAL LLC·Product code FOZ·February 25, 2026

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DQO·November 13, 2009

    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·June 8, 2016

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·January 14, 2013

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·December 3, 2010

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·July 3, 2014

    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