52 results
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9ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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
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
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
Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A. The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw Inserter (a battery operated, disposable device that deploys the screw), the Repose Suture Passer, and the Repose Tongue Retractor.
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code LRK·July 27, 2009
Respire Pink H/S Oral Sleep Apnea Device
FDA Recall
Terminated
·Product code LRK·September 1, 2017
Respire Pink+ Hard Oral Sleep Apnea Device
FDA Recall
Terminated
·Product code LRK·September 1, 2017
Respire Pink H/S Oral Sleep Apnea Device
FDA Recall
Terminated
·Product code LRK·September 1, 2017
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
Respire Pink+ Hard/Soft Oral Sleep Apnea Device
FDA Recall
Terminated
·Product code LRK·September 1, 2017
Respire Pink Series EF+ Oral Sleep Apnea Device.
FDA Recall
Terminated
·Product code LRK·September 1, 2017
Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic Xomed, Inc., Jacksonville, Florida 32216 U.S.A.
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code LRK·July 27, 2009
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
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English SRK.. General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·March 15, 2017
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Dutch SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·March 15, 2017
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Finnish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·March 15, 2017
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Turkish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·March 15, 2017