BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    KNIFE, OPHTHALMIC

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DIGITAL PULSE OXIMETER, MODEL 7500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARIX Diaphysis System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 2012

    PINNACLE SECTOR II CUP 52MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.-1818910·Product code KWA·June 13, 2014

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 26, 2015

    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