BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    QUANTIEN Measurement System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.

    FDA Enforcement
    Class III ·Ongoing·Cardiac Assist, Inc·December 8, 2021

    REALIZED GASTRIC BAND

    FDA Adverse Event
    Injury ·ALLERGAN INC·Product code LTI·June 9, 2014

    M1 AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FPO·October 12, 2010

    HOLDING SLEEVE-LONG FOR MATRIX

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·December 13, 2012

    Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature 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 IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·May 21, 2014