Medical Device Manufacturer · DE , Heimstetten

Brainlab AG - FDA 510(k) Cleared Devices

135 submissions · 135 cleared · Since 1996

Recent clearances: Viewer (5.4), Spine & Trauma Navigation Instruments, Vascular Navigation PAD 2.0

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135

Total

135

Cleared

0

Denied

FDA 510(k) Regulatory Record - Brainlab AG Radiology ✕

53 devices

1-12 of 53

Cleared Oct 16, 2025

Radiology · 70d

Cleared Jul 22, 2025

Vascular Navigation PAD 2.0

Radiology · 259d

Cleared Jun 23, 2025

Cranial 4Pi Immobilization

Radiology · 266d

Cleared Jun 17, 2025

RT Elements (4.5)

Radiology · 123d

Cleared Jun 13, 2025

Brainlab Elements (7.0)

Radiology · 200d

Cleared Jul 24, 2024

ExacTrac Dynamic (2.0)

Radiology · 161d

Cleared May 21, 2024

Radiology · 256d

Cleared Jul 14, 2023

Brainlab Elements Image Fusion, Contouring (4.5)

Radiology · 287d

Cleared May 11, 2023

ExacTrac Dynamic 1.1.2

Radiology · 28d

Cleared Mar 14, 2023

RT Elements (4.0)

Radiology · 141d

Cleared Apr 29, 2022

ExacTrac Dynamic

Radiology · 81d

Cleared Dec 16, 2021

Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements...

Radiology · 134d

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