BEUDAMED
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    Rapid Barostat Bag (RBB) Pump and Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017804·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Rotation Shim 3º

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215031671·

    DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136

    FDA 510(k)
    FDA Class 2 ·Microbiology

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·May 14, 2020

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·May 13, 2020

    OSSIX BONE, OSSIX PLUS

    FDA Adverse Event
    Injury ·DATUM DENTAL LTD.·Product code NPM·June 22, 2022

    BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 20, 2024

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2013

    M2A MODULAR HEAD

    FDA Adverse Event
    Injury ·BIOMET INC.·Product code KWY·September 16, 2008

    35" STANDARDBORE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·VYGON·Product code FPA·May 10, 2011

    CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 26, 2022

    PE ADULT-PED DRY/ WET LF 6/CS

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code KDQ·July 29, 2019

    GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 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 healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 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 healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 5, 2014