162 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers; Made in USA for: Medline Industries; BEMIS label has Manufactured by Bemis Mtg. Co., Sheboygan Falls, WI.
FDA Recall
Terminated
·Bemis Health Care, Inc·Product code MMK·August 23, 2006
Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total PSA levels are between 4 and 10 ng/mL.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MTG·October 11, 2011
Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code MTG·January 8, 2008
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
AMT G-Jet Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.
FDA Recall
Terminated
·Applied Medical Technology Inc·Product code KNT·January 26, 2016
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
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 ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
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
AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.
FDA Enforcement
Class II
·Terminated·Applied Medical Technology Inc·April 20, 2016
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
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
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