BEUDAMED
    61 results · 19ms · Sources: EU EUDAMED, US FDA

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    Llyods pharmacy hypertonic nasal spray ENG/IT 100 ml

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Laboratoire d'Odonto-Stomatologie Thermal·1 device

    Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.

    FDA Enforcement
    Class II ·Ongoing·Clariance-SAS·April 22, 2026

    Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·January 21, 2026

    The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

    FDA Enforcement
    Class II ·Ongoing·Sophysa·January 14, 2026

    Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·January 21, 2026

    Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A

    FDA Enforcement
    Class II ·Ongoing·B.Braun Medical S.A.S.·September 17, 2025

    Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).

    FDA Enforcement
    Class II ·Ongoing·INSTITUT GEORGES LOPEZ·August 6, 2025

    EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.

    FDA Enforcement
    Class II ·Ongoing·QUANTUM SURGICAL SAS·June 18, 2025

    Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.

    FDA Enforcement
    Class II ·Ongoing·WANDERCRAFT SAS·May 14, 2025

    stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

    Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

    FDA Enforcement
    Class II ·Ongoing·SCIENCE & BIO MATERIALS·May 14, 2025

    stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

    stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

    stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

    stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

    stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

    stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

    Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·May 14, 2025

    stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025

    stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·April 16, 2025