3 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
FDA Enforcement
Class II
·Ongoing·Elekta Instrument AB·May 29, 2019
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front.
FDA Enforcement
Class II
·Ongoing·Elekta Instrument AB·April 5, 2023
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
FDA Enforcement
Class II
·Terminated·Elekta Instrument AB·July 8, 2020