Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

135 results for "Brainlab AG"
1–24 of 135
Search insights Median review: 141d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Neurology
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