6 results
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14ms
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Sources: EU EUDAMED, US FDA
Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.
FDA Enforcement
Class II
·Terminated·Allergan Inc·July 29, 2015
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
FDA Enforcement
Class II
·Terminated·AGFA Healthcare Corp.·July 5, 2017
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
FDA Enforcement
Class II
·Terminated·Allergan Inc·July 29, 2015
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Enforcement
Class II
·Terminated·MTI Precision Products LLC.·July 23, 2014
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·October 3, 2012
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10 . Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·September 26, 2012