BEUDAMED
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    Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. Novii Pod - The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Novii Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Novii Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.

    FDA Enforcement
    Class II ·Terminated·MONICA HEALTHCARE LTD·June 21, 2017

    Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 11, 2018

    Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 11, 2018

    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew Orthopaedics Ltd. (Aurora)·August 18, 2021

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

    BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    microTargeting" Drive System, Product Number MT-DS-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number FC1006

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018