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

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    JDentalCare Implant System JDIcon

    FDA 510(k)
    FDA Class 2 ·Dental

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515068131·Hibbs Ret, #1 only, 1x 3", 9"

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515026605·Hibbs Ret, #1 only, 1x 3", 9"

    MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOSCOPIC CLIP SYSTEM

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

    DIMENSION XPAND PLUS WITHOUT HM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·October 17, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·June 14, 2013

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·June 22, 2011

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·April 27, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·April 11, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 19, 2022

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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