BEUDAMED
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    SURGEONS CHOICE STAPLE, REMOVE/IMPLANT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750002979·VITROS 3600 Immunodiagnostic System

    FIXION INTERLOCKING NAIL (FIXION IL NAIL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 9, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 1, 2007

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code JDI·October 24, 2012

    Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·January 29, 2025

    VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023

    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024

    VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics·July 8, 2020

    VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics·Product code JJE·May 20, 2020

    VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·May 15, 2019

    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024

    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024

    VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·October 10, 2023

    VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·December 26, 2018

    VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·July 10, 2013

    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 15, 2016