BEUDAMED
    33 results · 27ms · Sources: EU EUDAMED, US FDA

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    Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.

    FDA Enforcement
    Class II ·Ongoing·Noah Medical Corporation·December 3, 2025

    Galaxy System (GAL-001)

    FDA Enforcement
    Class II ·Ongoing·Noah Medical·December 25, 2024

    Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)

    FDA Enforcement
    Class II ·Ongoing·Noah Medical·December 18, 2024

    Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

    FDA Enforcement
    Class II ·Ongoing·Noah Medical·January 1, 2025

    Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

    intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20

    FDA Enforcement
    Class II ·Ongoing·Biocare Medical, LLC·November 13, 2024

    MiniMed 530G Insulin Pump (MMT-551, MMT-751)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

    Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No

    FDA Enforcement
    Class II ·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·June 18, 2025

    Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

    Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·December 13, 2017

    STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

    FDA Enforcement
    Class II ·Ongoing·Ethicon, Inc.·May 18, 2022

    ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·March 7, 2018

    OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·March 7, 2018

    iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·March 7, 2018

    iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·March 7, 2018