BEUDAMED
    9 results · 65ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

    FDA Enforcement
    Class II ·Terminated·United Surgical Associates·June 3, 2015

    Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

    FDA Enforcement
    Class II ·Terminated·United Surgical Associates·June 3, 2015

    Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

    FDA Enforcement
    Class II ·Terminated·United Surgical Associates·June 3, 2015

    PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems·May 6, 2015

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    FDA Enforcement
    Class II ·Terminated·CSA Medical·January 14, 2015

    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: 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. 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 doctors 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 (MICU), 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 nad 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, CO2 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of GE Healthcare Page 3 of 6 monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, O2, 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.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 29, 2014

    LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a wide range of clinical settings that includes but is not limited to the following: medical, laboratory/delivery/post-partum, burn unit, surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), pediatrics.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016

    The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 infusion pump allows clinicians to administer or patients to self-administer analgesia safely and effectively within clinician programmed limits. The epidural route can be used to provide anesthesia or analgesia.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016

    The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016