45 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product is labeled on the outer case with a stick-on label that reads in part, ''**medex Dublin, OH 43016 USA**STERILE***MX441B CVP Manometer**Lot#***Latex Free''
FDA Recall
Terminated
·Medex Inc·Product code KRK·November 18, 2005
Manometer, 550 ml three-Way Stopcock; STERILE;
FDA Recall
Terminated
·Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845·Product code KRK·February 23, 2017
AUTO REF/KERATOMETER ARK-1s
FDA Recall
Terminated
·Nidek Inc.·Product code HKO·December 20, 2017
AUTO REF/KERATOMETER ARK-1s
FDA Enforcement
Class II
·Terminated·Nidek Inc.·April 18, 2018
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
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
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 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 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
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 Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·May 21, 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 Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·May 21, 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
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 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 Addendum 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
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 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
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