BEUDAMED
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    WavelinQ Plus EndoAVF System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COMPREHENSIVE LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019

    ROSA SURGICAL DEVICE, MODEL ROSA 1.1

    FDA 510(k)
    FDA Class 2 ·Neurology

    CARESCAPE MONITOR B650

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TPRLOC COCR CMTD STM T1 12.5MM

    FDA Adverse Event
    Death ·BIOMET UK LTD.·Product code JDI·March 23, 2026

    CMK MOD 12/14 SZ202 L130

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LZO·November 24, 2025

    REENCY SC+

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·August 4, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code KWQ·September 27, 2016

    REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWY·July 20, 2023

    CMK MOD 12/14 SZ202 L130

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·January 8, 2026

    Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 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(NMT) 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. K092027 CARESCAPE Monitor B850 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. K131414 CARESCAPE MONITOR B850 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, Thermodilution and pulse contour), Temperature, Mixed Venous Oxygen Saturation, and Central Venous Oxygen Saturation). Respiratory [Impedance Respiration, Airway Gases (C02, 02, N20 and Anesthetic Agents), Spirometry, Gas Exchange] and N

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·February 28, 2014

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 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(NMT) 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. K092027 CARESCAPE Monitor B850 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. K131414 CARESCAPE MONITOR B850 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, Thermodilution and pulse contour), Temperature, Mixed Venous Oxygen Saturation, and Central Venous Oxygen Saturation). Respiratory [Impedance Respiration, Airway Gases (C02, 02, N20 and Anesthetic Agents), Spirometry, Gas Exchange] and N

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·March 19, 2014