BEUDAMED
    145 results · 7ms · Sources: EU EUDAMED, US FDA

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

    CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·February 5, 2025

    Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

    FDA Enforcement
    Class II ·Completed·Fukuda Denshi Co., Ltd.·December 13, 2017

    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

    FDA Enforcement
    Class II ·Completed·Fresenius Medical Care Holdings, Inc.·November 18, 2020

    LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

    FDA Enforcement
    Class II ·Completed·Fresenius Kabi USA, LLC·March 20, 2024

    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

    FDA Enforcement
    Class II ·Completed·Fresenius Kabi USA, LLC·March 20, 2024

    YelloPort Elite Universal Seal. For use in laparoscopic procedures.

    FDA Enforcement
    Class II ·Completed·Surgical Innovations Ltd·July 27, 2022

    SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

    FDA Enforcement
    Class II ·Completed·Cardinal Health 200, LLC·June 18, 2025

    Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

    FDA Enforcement
    Class II ·Completed·ASPEN SURGICAL·July 3, 2024

    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·May 26, 2021

    Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

    FDA Enforcement
    Class II ·Completed·Cardinal Health 200, LLC·June 18, 2025

    Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

    FDA Enforcement
    Class II ·Completed·Cardinal Health 200, LLC·June 18, 2025

    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

    FDA Enforcement
    Class II ·Completed·Beckman Coulter Mishima K.K.·June 11, 2025

    Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers

    FDA Enforcement
    Class II ·Completed·Sysmex America, Inc.·November 1, 2017

    AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

    FDA Enforcement
    Class II ·Completed·Accriva Diagnostics, Inc.·November 6, 2024

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·May 26, 2021

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

    FDA Enforcement
    Class II ·Completed·Bioseal Corporation·May 26, 2021

    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

    FDA Enforcement
    Class II ·Completed·International Science & Technology, LP, DBA Diamatrix Ltd.·June 1, 2022

    Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire

    FDA Enforcement
    Class II ·Completed·EYE COMFORT CARE LLC·August 21, 2024

    Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000

    FDA Enforcement
    Class II ·Completed·Landauer·January 3, 2024

    Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

    FDA Enforcement
    Class II ·Completed·Cook Incorporated·July 20, 2022