21 results
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15ms
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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
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
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·March 9, 2022
MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
FDA Enforcement
Class II
·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·August 14, 2019
Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·July 24, 2019
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 31, 2021
MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 14, 2015
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 8, 2016