BEUDAMED
    84 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories·April 3, 2024

    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

    FDA Enforcement
    Class II ·Ongoing·Cepheid·December 24, 2025

    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

    FDA Enforcement
    Class II ·Ongoing·Cepheid·December 24, 2025

    20" Lead Wires, Replacement Part Number: 1067724-2

    FDA Enforcement
    Class II ·Ongoing·EBI, LLC·May 1, 2024

    48" Lead Wires, Replacement Part Number: 1067724-4

    FDA Enforcement
    Class II ·Ongoing·EBI, LLC·May 1, 2024

    Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718

    FDA Enforcement
    Class II ·Ongoing·EBI, LLC·May 1, 2024

    Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716

    FDA Enforcement
    Class II ·Ongoing·EBI, LLC·May 1, 2024

    Omnipod 5 Automated Insulin Delivery System

    FDA Enforcement
    Class II ·Ongoing·Insulet Corporation·September 27, 2023

    Philips IntelliSpace Cardiovascular software, Model 830089.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Nederland B.V.·March 12, 2025

    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 20, 2024

    Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

    FDA Enforcement
    Class II ·Ongoing·Stryker GmbH·July 3, 2024

    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880

    FDA Enforcement
    Class II ·Ongoing·Davol, Inc.·July 6, 2022

    stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·October 25, 2023

    GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B-L, ONE-CUF, ADULT LONG, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 5. ONEA2-2A, ONE-CUF, ADULT, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 6. ONE-A2-2A-L, ONE-CUF, ADULT LONG, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 7. ONE-A3-1B, ONE-CUF, LARGE ADULT, 1 TB BAYONET, 31 - 40 CM, 20/BOX; 8. ONE-A3-2A, ONE-CUF, LARGE ADULT, DINACLICK 80369-5, 31 - 40 CM, 20/BOX; 9. ONE-P1-1B, ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM, 20/BOX; 10. ONE-P1-2A, ONE-CUF, INFANT, DINACLICK 80369-5, 08 - 13 CM, , 20/BOX; 11. ONE-P2-1B, ONE-CUF, CHILD, 1 TB BAYONET, 12 - 19 CM, 20/BOX; and 12. ONE-P2-2A, ONE-CUF, CHILD, DINACLICK 80369-5, 12 - 19 CM, 20/BOX.

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 12, 2024

    Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·January 31, 2024

    Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·January 21, 2026

    Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

    FDA Enforcement
    Class II ·Ongoing·Paragon 28, Inc.·December 10, 2025

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·April 12, 2023

    Medtronic Reveal LINQ LNQ11 / PA96000

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·July 28, 2021

    MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 16, 2023