BEUDAMED
    18 results · 8ms · Sources: EU EUDAMED, US FDA

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

    Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·November 27, 2024

    Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·November 27, 2024

    TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18

    FDA Enforcement
    Class II ·Ongoing·Tomtec Imaging Systems Gmbh·July 15, 2020

    ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023

    ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023

    ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023

    (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.

    FDA Enforcement
    Class II ·Ongoing·LUMENIS, LTD.·March 12, 2025

    BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·February 4, 2026

    Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025

    Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025

    LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021

    FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021

    Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021

    LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021

    Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·February 23, 2022

    Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·February 23, 2022

    OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021

    Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025