Brainlab AG - FDA 510(k) Cleared Devices
135
Total
135
Cleared
0
Denied
22 devices
Cleared
Sep 12, 2025
Spine & Trauma Navigation Instruments
Orthopedic
29d
Cleared
May 16, 2025
Mixed Reality Spine Navigation
Orthopedic
261d
Cleared
May 23, 2024
Drill Guide
Orthopedic
70d
Cleared
Mar 20, 2024
Automatic Registration
Orthopedic
90d
Cleared
Aug 02, 2023
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Orthopedic
250d
Cleared
Oct 27, 2022
Cirq Arm System (2.0)
Orthopedic
30d
Cleared
Aug 30, 2022
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &...
Orthopedic
88d
Cleared
Jun 03, 2022
Knee 3
Orthopedic
88d
Cleared
Apr 13, 2022
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument...
Orthopedic
268d
Cleared
Mar 18, 2021
Automatic Registration
Orthopedic
91d
Cleared
Dec 23, 2020
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal,...
Orthopedic
128d
Cleared
Jun 02, 2020
HIP7
Orthopedic
186d
Cleared
Aug 29, 2019
Spine & Trauma Navigation
Orthopedic
246d
Cleared
Jun 11, 2019
Spine & Trauma Navigation
Orthopedic
29d
Cleared
Nov 15, 2012
NAVIGATION SOFTWARE HIP-UNIVERSAL
Orthopedic
129d
Cleared
Oct 18, 2011
DASH HIP
Orthopedic
288d
Cleared
Aug 05, 2011
BRAINLAB TRAUMA
Orthopedic
193d
Cleared
May 17, 2011
DASH KNEE
Orthopedic
281d
Cleared
Apr 04, 2011
BRAINLAB KNEE
Orthopedic
178d
Cleared
Jun 11, 2010
BRAINLAB KNEE ARTHROSCOPY
Orthopedic
252d
Cleared
Apr 08, 2009
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
Orthopedic
135d
Cleared
Apr 01, 2009
SPINE & TRAUMA ICT
Orthopedic
142d