BEUDAMED
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    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

    TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

    FDA Enforcement
    Class II ·Completed·Acumed LLC·April 27, 2022

    ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

    FDA Enforcement
    Class I ·Completed·ResMed Ltd.·February 12, 2020

    Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S

    FDA Enforcement
    Class II ·Completed·Covidien Llc·January 6, 2021

    Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L

    FDA Enforcement
    Class II ·Completed·Covidien Llc·January 6, 2021

    TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012

    FDA Enforcement
    Class II ·Completed·Acumed LLC·April 27, 2022

    TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122

    FDA Enforcement
    Class II ·Completed·Philips Ultrasound, LLC·January 7, 2026

    Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00

    FDA Enforcement
    Class II ·Completed·Spectrum Medical Ltd.·October 30, 2024

    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

    FDA Enforcement
    Class II ·Completed·Materialise USA LLC·August 31, 2022

    SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

    FDA Enforcement
    Class II ·Completed·SAFE ORTHOPAEDICS LLC·August 31, 2022

    VariCam

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·January 16, 2019

    Discover VH/Millennium VG Nuclear Medicine Imaging System

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·January 16, 2019

    Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery

    FDA Enforcement
    Class II ·Completed·Stradis Healthcare, LLC.·July 15, 2015

    Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery

    FDA Enforcement
    Class II ·Completed·Stradis Healthcare, LLC.·July 15, 2015

    Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery

    FDA Enforcement
    Class II ·Completed·Stradis Healthcare, LLC.·July 15, 2015