BEUDAMED
    4,843 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)

    FDA Enforcement
    Class II ·Ongoing·CUE HEALTH INC·October 23, 2024

    3mensio Workstation (Vascular Fenestrated) software

    FDA Enforcement
    Class II ·Ongoing·PIE Medical Imaging B.V.·August 20, 2025

    Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15

    FDA Enforcement
    Class II ·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019

    Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·September 8, 2021

    Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 8, 2015

    Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.

    FDA Enforcement
    Class II ·Ongoing·ETAC A/S·February 11, 2026

    Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.

    FDA Enforcement
    Class II ·Ongoing·ETAC A/S·February 11, 2026

    Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017