478 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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Ultrasonic Bronchoscope BF-UC160F-OL8
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018
Ultrasonic Bronchoscope BF-UC160F-OL8
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 10, 2018
Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·December 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·December 9, 2020
Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
FDA Recall
Terminated
·LivaNova USA Inc·Product code LYJ·November 16, 2018
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
FDA Recall
Terminated
·LivaNova USA Inc·Product code LYJ·November 16, 2018
Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code ODG·October 16, 2020
Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code ODG·October 16, 2020
OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.
FDA Recall
Terminated
·Celera Corporation·Product code LDT·July 12, 2013
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
FDA Enforcement
Class II
·Terminated·LivaNova USA Inc·February 5, 2020
OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use.
FDA Enforcement
Class III
·Terminated·Celera Corporation·September 4, 2013
The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
FDA Recall
Terminated
·Fresenius Kabi, LLC·Product code LKN·April 19, 2011
OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter) manufactured by Olympus Life and Material Science Europa GmbH, Germany and distributed by Olympus America, Inc., 3131 W. Royal Ln., Irving, TX 75063.
FDA Recall
Terminated
·Olympus America, Inc·Product code JQP·November 18, 2005
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
FDA Enforcement
Class II
·Terminated·LivaNova USA Inc·February 5, 2020
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
FDA Recall
Terminated
·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015
TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.
FDA Recall
Terminated
·Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom·Product code MWI·March 25, 2011
syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LLZ·April 3, 2014
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code LLZ·January 12, 2007
Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
FDA Recall
Terminated
·Vital Images, Inc.·Product code LLZ·October 14, 2010