BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.

    FDA Enforcement
    Class II ·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018

    CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 1, 2020

    The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    FDA Enforcement
    Class II ·Terminated·EKOS Corporation·July 29, 2015

    GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·May 20, 2015

    ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 1, 2020

    GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 20, 2013

    CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 1, 2020

    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 26, 2014

    GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICUI, pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, C02 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, 02, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000i patient monitoring system also provides physiological data over the UNITY NETWORK TM.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·March 12, 2014

    Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)

    FDA Enforcement
    Class II ·Terminated·Abiomed, Inc.·February 28, 2024

    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·June 11, 2014

    Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

    FDA Enforcement
    Class II ·Terminated·Abiomed, Inc.·December 13, 2023

    Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

    FDA Enforcement
    Class II ·Terminated·Abiomed, Inc.·December 13, 2023

    Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc.·July 8, 2020

    The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·December 10, 2014

    Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·July 16, 2014

    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).

    FDA Enforcement
    Class II ·Terminated·B Braun Medical Inc·April 20, 2022

    Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. Activa PC Deep Brain Stimulator is indicated for Obsessive-Compulsive Disorder. Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs)

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·November 6, 2013