Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

135 results for "Brainlab AG"
1–24 of 135
Cleared Oct 16, 2025
Viewer (5.4)
K252476 · LLZ
Brainlab AG
Radiology · 70d
Cleared Sep 12, 2025
Spine & Trauma Navigation Instruments
K252562 · OLO
Brainlab AG
Orthopedic · 29d
Cleared Jul 22, 2025
Vascular Navigation PAD 2.0
K243432 · OWB
Brainlab AG
Radiology · 259d
Cleared Jun 23, 2025
Cranial 4Pi Immobilization
K243142 · IYE
Brainlab AG
Radiology · 266d
Cleared Jun 17, 2025
RT Elements (4.5)
K250440 · MUJ
Brainlab AG
Radiology · 123d
Cleared Jun 13, 2025
Brainlab Elements (7.0)
K243633 · QIH
Brainlab AG
Radiology · 200d
Cleared May 16, 2025
Mixed Reality Spine Navigation
K242569 · SBF
Brainlab AG
Orthopedic · 261d
Cleared Jan 28, 2025
Alignment System Cranial, with Alignment Software Cranial with LITT
K243698 · HAW
Brainlab AG
Neurology · 60d
Cleared Jul 24, 2024
ExacTrac Dynamic (2.0)
K240431 · IYE
Brainlab AG
Radiology · 161d
Cleared May 23, 2024
Drill Guide
K240701 · OLO
Brainlab AG
Orthopedic · 70d
Cleared May 21, 2024
Viewer (5.4)
K232759 · LLZ
Brainlab AG
Radiology · 256d
Cleared Mar 20, 2024
Automatic Registration
K234047 · OLO
Brainlab AG
Orthopedic · 90d
Cleared Sep 09, 2023
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software...
K223864 · HAW
Brainlab AG
Neurology · 260d
Cleared Aug 02, 2023
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
K223553 · OLO
Brainlab AG
Orthopedic · 250d
Cleared Jul 21, 2023
Cranial Navigation, Navigation Software Cranial, Navigation Software...
K223288 · HAW
Brainlab AG
Neurology · 269d
Cleared Jul 14, 2023
Brainlab Elements Image Fusion, Contouring (4.5)
K223106 · QIH
Brainlab AG
Radiology · 287d
Cleared May 11, 2023
ExacTrac Dynamic 1.1.2
K231052 · IYE
Brainlab AG
Radiology · 28d
Cleared Apr 27, 2023
ENT EM
K223734 · PGW
Brainlab AG
Ear, Nose, Throat · 135d
Cleared Apr 19, 2023
Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements...
K223552 · HAW
Brainlab AG
Neurology · 145d
Cleared Mar 14, 2023
RT Elements (4.0)
K223279 · MUJ
Brainlab AG
Radiology · 141d
Cleared Oct 27, 2022
Cirq Arm System (2.0)
K222966 · OLO
Brainlab AG
Orthopedic · 30d
Cleared Sep 08, 2022
Cranial EM System
K213989 · HAW
Brainlab AG
Neurology · 262d
Cleared Aug 30, 2022
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &...
K221618 · OLO
Brainlab AG
Orthopedic · 88d
Cleared Jun 03, 2022
Knee 3
K220652 · OLO
Brainlab AG
Orthopedic · 88d