BEUDAMED
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    Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814213·GENUMEDI PT SILVER L IV

    1.5 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036054922·

    BD PROBE TEC URINE PRESERVATIVE TRANSPORT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PIXI PEDIATRIC MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code OJX·June 7, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 23, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·April 25, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·January 4, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·February 18, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·July 26, 2019

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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