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

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

    Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 19, 2025

    Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 19, 2025

    TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·August 14, 2024

    TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z

    FDA Enforcement
    Class II ·Ongoing·Acclarent, Inc.·December 29, 2021

    Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·July 10, 2024

    DR 800. Digital Radiography X-ray System.

    FDA Enforcement
    Class II ·Ongoing·Agfa N.V.·September 4, 2024

    Barco MDSC-8527 NXF, Part Number K9352421

    FDA Enforcement
    Class II ·Ongoing·Barco N.V.·February 14, 2024

    Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400

    FDA Enforcement
    Class II ·Ongoing·Agfa N.V.·April 10, 2024

    Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system

    FDA Enforcement
    Class II ·Ongoing·Barco N.V.·July 2, 2025

    V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

    FDA Enforcement
    Class II ·Ongoing·Vital Scientific N.V.·December 4, 2019

    V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    FDA Enforcement
    Class II ·Ongoing·Vital Scientific N.V.·October 2, 2019

    X-Guide Handpiece Adaptor Sleeve 3, Model P010727

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·April 10, 2024

    X-Guide Handpiece Adaptor Sleeve 1, Model P010701

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·April 10, 2024

    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·November 16, 2022

    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.

    FDA Enforcement
    Class II ·Ongoing·Alphatec Spine, Inc.·February 18, 2026

    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.

    FDA Enforcement
    Class II ·Ongoing·Alphatec Spine, Inc.·February 18, 2026

    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

    FDA Enforcement
    Class II ·Ongoing·Biocartis Nv·January 22, 2025

    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

    FDA Enforcement
    Class II ·Ongoing·BARCO NV·October 5, 2022

    Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)

    FDA Enforcement
    Class II ·Ongoing·Agfa Healthcare NV·October 16, 2024

    Agfa HealthCare Enterprise Imaging XERO Viewer

    FDA Enforcement
    Class II ·Ongoing·Agfa Healthcare NV·February 1, 2023