BEUDAMED
    22 results · 12ms · 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 × Status: Terminated × Clear all

    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

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·March 26, 2014

    Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.

    FDA Enforcement
    Class II ·Terminated·Mar-Med Co·February 10, 2021

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·March 19, 2014

    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·May 14, 2014

    BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.

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

    CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

    FDA Enforcement
    Class I ·Terminated·Del Mar Reynolds Medical, Ltd.·November 27, 2013

    Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.

    FDA Enforcement
    Class I ·Terminated·Del Mar Reynolds Medical, Ltd.·March 27, 2013

    Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·July 31, 2013

    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.

    FDA Enforcement
    Class I ·Terminated·Del Mar Reynolds Medical, Ltd.·April 23, 2014

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012

    Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·March 22, 2017

    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·May 24, 2017