BEUDAMED
    21 results · 25ms · Sources: EU EUDAMED, US FDA

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    CBC PAP TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750002054·VITROS 350 Chemistry System

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668118344·Kalt NH Standard Model, Delicate Jaws

    ULTRASONIC NEBULIZER, MODEL NE-520

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MAJOR.REPAIR

    FDA 510(k)
    FDA Class 2 ·Dental

    SYRINGE S2 2ML 23GA 1-1/4IN BD CHINA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 16, 2021

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 22, 2007

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013

    PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·October 10, 2019

    PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·October 10, 2019

    PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·October 10, 2019

    VITROS 350 Chemistry System, clinical chemistry analyzer

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics·August 14, 2019

    VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·July 10, 2019

    VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 16, 2016

    VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 8, 2019

    VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·February 19, 2014

    VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·December 21, 2015

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022