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Elekta Instrument AB

3 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter recall (Z-0227-2025)Elekta Instrument AB2024-11-06
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Dia recall (Z-1397-2024)Elekta Instrument AB2024-04-16
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgic recall (Z-1309-2023)Elekta Instrument AB2023-03-30

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Every clearance here is in the API, with alerts when new ones post.