BEUDAMED
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    ASCENSION NUGRIP CMC IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InnoSpire Deluxe

    FDA UDI
    VEGA TECHNOLOGIES INC.·06946159502016·1112278

    CASPIAN Spinal System

    FDA UDI
    VB Spine LLC·10888857235564·Connector Driver, Hex Connect

    QUADRA BLOC TENS PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    THEKEN SMALL CEMENT RESTRICTOR

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

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024

    ARCHITECT TOTAL T3

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code CDP·September 23, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 3, 2011

    BED BAR

    FDA Adverse Event
    Injury ·BROWN ENGINEERING·Product code FNJ·August 28, 2006

    BD¿ 5ML SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 2, 2017

    BD¿ 5ML SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 3, 2017

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 6, 2023

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·February 10, 2023

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    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