BEUDAMED
    1,724 results · 9ms · 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

    ORAcollect RNA: ORE-100

    FDA Enforcement
    Class II ·Ongoing·DNA Genotek Inc.·April 27, 2022

    Cardiosave Rescue. Model Number: 0998-00-0800-83.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·March 15, 2023

    6IN PRESSURE TUBING, List Number MX20617

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    Medex LOGICAL CATH LAB KIT, List Number M20754

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical Asd Inc·January 24, 2024

    PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·February 14, 2024

    Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

    FDA Enforcement
    Class II ·Ongoing·Philips Healthcare·December 1, 2021

    Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, D998-UC-0800-55.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·March 15, 2023

    Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235; Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235;

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·April 5, 2023

    VACUETTE SAFELINK, REF: 450210

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One GmbH·January 15, 2025

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Enforcement
    Class II ·Ongoing·DRE Medical Group Inc·July 5, 2023

    GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;

    FDA Enforcement
    Class II ·Ongoing·W.L. Gore & Associates, Inc.·August 14, 2024

    GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes

    FDA Enforcement
    Class II ·Ongoing·W.L. Gore & Associates, Inc.·February 28, 2024

    GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·October 8, 2025