BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    Optima XR240amx

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROPELLER HEAD SCREW SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304269712·

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515026964·Brewster Ret,"C" 2" x 1 3/4", 8 3/4" length

    A-DEC 200 DENTAL SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    OEC 9900 ELITE

    FDA 510(k)
    FDA Class 2 ·Radiology

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 106X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023

    EKOSONIC KIT 106CM 12CM TZ

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 14, 2021

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 17, 2014

    UNKNOWN DEPUY FEMORAL HIP STEM

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 21, 2013

    HUT EXT DR FINAL ASSY-STANDARD

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM CO.·Product code KQS·July 12, 2011

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 3, 2022

    GYNECARE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTO·July 27, 2018

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    URETERAL BRUSH BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FDX·November 15, 2023

    URETERAL BRUSH BIOPSY SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FDX·January 7, 2022

    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

    cobas 6000 analyzer series Operators Manual Roche cobas; 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