BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    KENDRO HERACELL CO2 INCUBATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AUTOMARQER

    FDA 510(k)
    FDA Class 2 ·Hematology

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·April 4, 2013

    DISP 30X4, 1BLA, 1PRT QUICK

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS PUERTO RICO·Product code KCY·March 30, 2011

    CONTAK RENEWAL 3 RF

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    PKG, 3MM INSERT, FUNDUS GRASPER, 29CM, P/N 0250282050 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1- PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60'' 2- TUBING FITTINGS 1- 22x22mm ADAPTER

    FDA Recall
    Terminated ·Bio-Med Devices, Inc.·Product code CBK·December 6, 2004

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018