BEUDAMED
    183 results · 17ms · Sources: EU EUDAMED, US FDA

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    Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology Length 7 (2.0 m), XS04620COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), XS04624COV

    FDA Enforcement
    Class II ·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025

    Capnostream20 (INTL) M, CS08654

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 (INTL) M REFURBISHED, CS78654

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 M NICU (CPM), CS08654RN

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 M ADULT ICU (CPM), CS08654RA

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 M W/PRINTER CYVITAL, CS08796

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 (INTL) M W/PRINTER, CS08660

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 (US) M, Part Number CS08653

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 (US)M REFURBISHED, Part Number CS78653

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 (US) M TO MASIMO, Part Number CS08750

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 (US) M W/PRINTER, Part Number CS08659

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

    FDA Enforcement
    Class II ·Ongoing·CORNEAT VISION, LTD.·October 15, 2025

    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026

    Mazor X robotic guidance system REF: TPL0059

    FDA Enforcement
    Class II ·Ongoing·Mazor Robotics Ltd·January 28, 2026

    SMV DSI, System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026

    MAXXUS, System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026

    SMV BodyTrack, System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026