BEUDAMED
    46 results · 12ms · Sources: EU EUDAMED, US FDA

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    ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JIT·September 22, 2020

    ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JIT·April 24, 2025

    Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JIT·September 22, 2020

    ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JIT·April 24, 2025

    Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIT·January 31, 2024

    VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics·Product code JIT·May 8, 2023

    Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIT·December 3, 2018

    QMS Tacrolimus Calibrators, Product code 10015573

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JIT·November 21, 2023

    ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JIT·April 24, 2025

    ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JIT·July 25, 2023

    ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JIT·April 24, 2025

    MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KRR·December 22, 2022

    Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code KWT·August 21, 2018

    1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S

    FDA Recall
    Open, Classified ·Synthes (USA) Products LLC·Product code HSZ·January 24, 2024

    Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·January 10, 2025

    2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S

    FDA Recall
    Open, Classified ·Synthes (USA) Products LLC·Product code HSZ·January 24, 2024

    Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·April 17, 2024

    SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216

    FDA Recall
    Open, Classified ·C.R. Bard Inc·Product code MJC·July 17, 2025

    Ref No: INSHITHND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

    Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024