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Sources: EU EUDAMED, US FDA
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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
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 Recall
Terminated
·MONICA HEALTHCARE LTD Interchange 25 Business Park Bostocks Lane Nottingham United Kingdom·Product code OSP·April 28, 2017
Corometrics MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002. Intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SP02.
FDA Recall
Terminated
·Datex Ohmeda, Inc. dba GE Healthcare·Product code HGM·May 5, 2008
Philips Avalon Fetal Monitor FM 50 Catalog Number: M2705A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·November 23, 2009
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 Recall
Terminated
·GE Healthcare, LLC·Product code OSP·December 15, 2017
Philips Avalon Fetal Monitor FM 30 Catalog Number: M2703A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·November 23, 2009
Philips Avalon Fetal Monitor FM 20 Catalog Number: M2702A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·November 23, 2009
Philips Avalon Fetal Monitor FM 40 Catalog Number: M2704A.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code HGM·November 23, 2009
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 Recall
Terminated
·GE Healthcare, LLC·Product code OSP·December 15, 2017
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 BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
FDA Recall
Terminated
·Smith & Nephew Orthopaedics Ltd. (Aurora) Aurora, Spa Park Harrison Way Leamington Spa United Kingdom·Product code NXT·July 14, 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
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 58 mm cup Ref.: 74120158
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref.: 74120150
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007