48 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666
FDA Enforcement
Class II
·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 1, 2026
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 1, 2026
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
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 11, 2026
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 11, 2026
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·February 14, 2024
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 1, 2026