BEUDAMED
    12 results · 6ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Ongoing × Clear all

    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

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

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

    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

    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

    ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208

    FDA Enforcement
    Class II ·Ongoing·Erbe Medical, LLC·May 13, 2026

    ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

    FDA Enforcement
    Class II ·Ongoing·Erbe Medical, LLC·May 13, 2026

    ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

    FDA Enforcement
    Class II ·Ongoing·Erbe Medical, LLC·May 13, 2026