12 results
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7ms
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Sources: EU EUDAMED, US FDA
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·February 12, 2014
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·June 10, 2015
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·November 2, 2016
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·January 29, 2014
C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.
FDA Enforcement
Class II
·Terminated·Hansen Medical Inc·January 7, 2015
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 1, 2015
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 1, 2015
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024