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

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

    Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;

    FDA Enforcement
    Class II ·Ongoing·LeMaitre Vascular, Inc.·October 8, 2025

    Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

    FDA Enforcement
    Class II ·Ongoing·Medartis AG·June 17, 2026

    Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

    FDA Enforcement
    Class II ·Ongoing·Medartis AG·March 18, 2026

    Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

    FDA Enforcement
    Class II ·Ongoing·Medartis AG·March 18, 2026

    AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

    FDA Enforcement
    Class II ·Ongoing·Aesculap AG·October 8, 2025

    AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

    FDA Enforcement
    Class II ·Ongoing·Aesculap AG·October 8, 2025

    Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006

    FDA Enforcement
    Class II ·Ongoing·Schiller, Ag·October 8, 2025

    CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570

    FDA Enforcement
    Class II ·Ongoing·Schiller, Ag·September 4, 2024

    Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat patients with walking disabilities caused by neurological, muscular or bone-related disorders. isokinetic testing and evaluation system

    FDA Enforcement
    Class II ·Ongoing·Hocoma AG·July 1, 2020

    Cirq Arm System 2.0

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·April 5, 2023

    VADER pedicle system, torque wrench, Catalog Number 42-702

    FDA Enforcement
    Class II ·Ongoing·Icotec Ag·January 17, 2024

    SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·February 24, 2021

    ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·March 16, 2022

    Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·March 22, 2023

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·September 27, 2023

    VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

    FDA Enforcement
    Class II ·Ongoing·Icotec Ag·December 28, 2022

    VADER pedicle system, torque wrench, Catalog Number 42-703

    FDA Enforcement
    Class II ·Ongoing·Icotec Ag·January 17, 2024

    V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·June 28, 2023

    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

    FDA Enforcement
    Class II ·Ongoing·Brainlab AG·March 26, 2025

    Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical AG·June 24, 2026