BEUDAMED
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    MODIFICATION TO: VIPER SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496071860·STRIPE GAME NEBULA, SIZE S, BLU CINA, GRADUATED...

    Mallet

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108604·MALLET LEAD FILLED STAINLESS

    PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    KEYST0NE MEDICAL PICC CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 12, 2019

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·April 22, 2013

    SMITH AND NEPHEW JOURNEY KNEE REPLACEMENT

    FDA Adverse Event
    Injury ·SMITH AND NEPHEW·Product code JWH·April 22, 2011

    RIA TUBE ASSEMBLY MIN 520MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·July 8, 2008

    SPECTRA WAVEWRITER?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 27, 2026

    BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 9, 2019

    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