48 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.
FDA Recall
Terminated
·Qrs Diagnostic·Product code LOS·February 16, 2012
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·May 21, 2014
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·May 21, 2014
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·May 21, 2014
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·May 21, 2014
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·May 21, 2014
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·July 9, 2014
Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.
FDA Enforcement
Class III
·Terminated·HemoCue AB·January 9, 2013
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·January 16, 2019