12 results
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No
FDA Enforcement
Class II
·Ongoing·Staar Surgical AG·June 24, 2026
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·October 12, 2022
IBA Proton Therapy System - PROTEUS 235
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·March 18, 2026
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·September 18, 2024
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·June 12, 2024
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·June 8, 2022
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·November 22, 2023
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·May 1, 2024
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·March 16, 2022
Proteus 235-Proton Therapy System
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·August 4, 2021
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·September 15, 2021
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·August 28, 2024