BEUDAMED
    844 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 [323], MD BD Pyxis SupplyStation V9 [317], Security Module [139698-01], BD Knowledge Portal for Medication Technologies [136607-01], STOCKSTN V10.X WRD/WL SCANNERS [132-53-02], PRS STOCKSTN V10.X WRD/WL SCANNERS [132-53-01], STOCKSTN V10.X WIRED SCANNER [132-52-02], PRS STOCKSTN V10.X WIRED SCANNER [132-52-01], BD Pyxis CII Safe ES Desktop PC [1156-00], BD Pyxis SupplyStation Panel PC V11 [1132-00], BD Pyxis SupplyRoller V11 [1127-00], Dell 640 Server [1128-00], BD Pyxis SupplyStation System V11 [1123-00], BD Pyxis CII Safe ES 10885403512605 [1116-00], BD Pyxis Enterprise Server 10885403518348, 10885403520341 [1115-00], BD Pyxis SupplyRoller V10 [1101-00], BD Pyxis CIISafe V9.X SGL IM BIO 10885403512520 [111-221], BD Pyxis CIISafe V7.X DBL INTG MAIN BIO, SOLID DO [111-194], BD Pyxis CIISafe V8.X Desktop PC, Bio [107-245-01], BD Pyxis SupplyStation V10 [347], BD Pyxis CII Safe V9.X DESKTOP PC [107-252-01], BD Pyxis CII Safe V7.X DBL INTG MAIN BIO CLEAR DO [111-191], BD Pyxis CII Safe V7.XSGL INTG MAIN BIO SOLID DO [111-198], BD Pyxis CII SafeV8.XDBL INTG MAIN BIO SOLID DO [111-202-01], BD Pyxis CII SafeV8.XSGL INTG MAIN BIO SOLID DO [111-206-01], BD Pyxis CII Safe V9.X DBL IM BIO SLD DOORS [111-215], BD Pyxis CII Safe V9.X SGL IM BIO CLR DOORS [111-216], BD Pyxis CII Safe V9.X DBL IM BIO CLR DOORS [111-219], Supply itParActive RF V11 (Supply Kanban) [138566-01]

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·July 2, 2025

    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·April 19, 2023

    Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.

    FDA Enforcement
    Class II ·Terminated·Thermo Fisher Scientific (Monterrey)·June 3, 2020

    Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126

    FDA Enforcement
    Class II ·Terminated·Geistlich Pharma North America, Inc.·December 2, 2020

    Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115

    FDA Enforcement
    Class II ·Terminated·Geistlich Pharma North America, Inc.·December 2, 2020

    Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116

    FDA Enforcement
    Class II ·Terminated·Geistlich Pharma North America, Inc.·December 2, 2020

    BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·April 19, 2023

    D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis.

    FDA Enforcement
    Class II ·Terminated·Bio-Rad Laboratories, Inc.·April 2, 2014

    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.

    FDA Enforcement
    Class II ·Terminated·Bio-Rad Laboratories·September 26, 2012

    Extra corporeal circuit with bio-active surface.

    FDA Enforcement
    Class II ·Terminated·Medtronic Perfusion Systems·July 15, 2020

    Bio-CORE Cannula (Needle) Set

    FDA Enforcement
    Class II ·Terminated·Biologic Therapies, Inc·April 8, 2015

    Bio-PLASTY Cannula (Needle)

    FDA Enforcement
    Class II ·Terminated·Biologic Therapies, Inc·April 8, 2015

    Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·May 17, 2017

    Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018

    Bio-MAC Cannula (Needle) Set

    FDA Enforcement
    Class II ·Terminated·Biologic Therapies, Inc·April 8, 2015

    Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018

    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018

    Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

    FDA Enforcement
    Class II ·Ongoing·SCIENCE & BIO MATERIALS·May 14, 2025

    SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·August 12, 2015

    Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 20, 2018