134 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·October 22, 2014
Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 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
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·May 8, 2019
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·May 8, 2019
Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·May 8, 2019
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·May 8, 2019
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
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
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·May 1, 2013
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 Recall
Terminated
·GE Healthcare, LLC·Product code OSP·December 15, 2017
VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·August 22, 2012
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
FDA Recall
Terminated
·Blue Belt Technologies MN·Product code OLO·April 11, 2014
GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various patient monitoring modules with the ventilator.
FDA Recall
Terminated
·GE Healthcare·Product code CBK·April 23, 2008
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
Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package of 10 brushes; Catalog No. 1650, Order No M00516501.
FDA Recall
Terminated
·Boston Scientific Corp·Product code BTG·December 8, 2005