BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    AMERICAN BANTEX, MODEL MS 3

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    COMBINED PHYSIOLOGICAL MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AISYS

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016

    AISYS

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 9, 2013

    DURA DURATION A/P TIB LG 9

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code JWH·March 30, 2011

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    ARROW CVC SET: 2-LUMEN 4 FR X 5 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code DQY·September 10, 2024

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code FOZ·August 8, 2023

    PKG, 5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 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

    Depuy brand ACE trochanteric nail; sterile, short 130 deg x 9 mm; Product 903209130.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018