BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    VECTRA PLUS LASER SYSTEM AND ACCESSORIES

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

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16740822300·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674082230060·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L082230120·8mm H x 22mm W x 30mm L XLIF Trial 12 degree Lo...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X082230120·8mm H x 22mm W x 30mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X08223080·8mm H x 22mm W x 30mm L x 8 degrees XLIF

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 11, 2025

    CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHEM-ALERT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NEURON DELIVERY CATHETER 053

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·March 16, 2010

    NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

    FDA Adverse Event
    Death ·ATRICURE, INC.·Product code OCL·November 13, 2018

    2.0MM PARALLEL DRILL GUIDE AND DRILL SLEEVE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code FZX·April 29, 2013

    ECHELON*FLEX45 LONG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2011

    INTREL 3

    FDA Adverse Event
    Death ·MEDTRONIC NEUROMODULATION·Product code LNQ·July 25, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    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