BEUDAMED
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    VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LACTOSORB® SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036054304·

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756670692·Foam Pad, Surgical Positioning

    BD TRUCOUNT¿ TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·November 8, 2022

    VITEK 2 STRPTOCOCCUS AMPICILLIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PROCEDUR-10

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PEN NEEDLE 32GX4MM 14 PACK

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FMI·December 10, 2020

    KYPHON BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    IDENTITY ADX DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 7, 2011

    PROTECTA XT DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·June 7, 2013

    LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. Lacto Sorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the Lacto SorbBulbs Handles or Power Drivers to advance the Tap into the bone.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code HWC·September 15, 2009

    OSTEOCOOL RF ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020

    ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR POWER DRIVER, REF: 915-2185, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. LactoSorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the LactoSorb Bulbs Handles or Power Drivers to advance the Tap into the bone.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code HWC·September 15, 2009

    BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.

    FDA Enforcement
    Class II ·Ongoing·Becton, Dickinson and Company, BD Biosciences·November 9, 2022

    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: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    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