| Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (K252476) | Brainlab AG | 2025-10-16 |
| Spine & Trauma Navigation Instruments (K252562) | Brainlab AG | 2025-09-12 |
| Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (K243432) | Brainlab AG | 2025-07-22 |
| Cranial 4Pi Immobilization (K243142) | Brainlab AG | 2025-06-23 |
| RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT (K250440) | Brainlab AG | 2025-06-17 |
| Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) (K243633) | Brainlab AG | 2025-06-13 |
| Mixed Reality Spine Navigation (K242569) | Brainlab AG | 2025-05-16 |
| Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (K243698) | Brainlab AG | 2025-01-28 |
| ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface (K240431) | Brainlab AG | 2024-07-24 |
| Drill Guide; Drill Bit; Spine & Trauma Navigation (K240701) | Brainlab AG | 2024-05-23 |
| Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (K232759) | Brainlab AG | 2024-05-21 |
| Automatic Registration (K234047) | Brainlab AG | 2024-03-20 |
| Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial (K223864) | Brainlab AG | 2023-09-09 |
| Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine (K223553) | Brainlab AG | 2023-08-02 |
| Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI (K223288) | Brainlab AG | 2023-07-21 |
| Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) (K223106) | Brainlab AG | 2023-07-14 |
| ExacTrac Dynamic 1.1.2 (K231052) | Brainlab AG | 2023-05-11 |
| ENT EM (K223734) | Brainlab AG | 2023-04-27 |
| Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial (K223552) | Brainlab AG | 2023-04-19 |
| RT Elements (4.0) (K223279) | Brainlab AG | 2023-03-14 |
| Cirq Arm System (2.0);Alignment System Spine (K222966) | Brainlab AG | 2022-10-27 |
| Cranial EM System (K213989) | Brainlab AG | 2022-09-08 |
| Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System (K221618) | Brainlab AG | 2022-08-30 |
| Knee 3 (K220652) | Brainlab AG | 2022-06-03 |
| ExacTrac Dynamic (K220338) | Brainlab AG | 2022-04-29 |
| Brainlab Elements Guide XT, Guide 3.0 (K213930) | Brainlab AG | 2022-04-19 |
| Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning (K212245) | Brainlab AG | 2022-04-13 |
| Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio (K212420) | Brainlab AG | 2021-12-16 |
| Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System (K210989) | Brainlab AG | 2021-11-12 |
| Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization (K211544) | Brainlab AG | 2021-11-03 |
| ExacTrac Dynamic (K211939) | Brainlab AG | 2021-07-22 |
| RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review (K203681) | Brainlab AG | 2021-04-09 |
| Automatic Registration (K203679) | Brainlab AG | 2021-03-18 |
| Disposable Pre-calibrated Suction (K201752) | Brainlab AG | 2021-01-29 |
| CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System (K202320) | Brainlab AG | 2020-12-23 |
| ExacTrac Dynamic (K203173) | Brainlab AG | 2020-11-12 |
| Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update (K192703) | Brainlab AG | 2020-10-08 |
| Cranial 4Pi Immobilization (K202050) | Brainlab AG | 2020-08-19 |
| ExacTrac Dynamic (K201276) | Brainlab AG | 2020-07-13 |
| HIP7 (K193307) | Brainlab AG | 2020-06-02 |
| Elements Viewer (K191014) | Brainlab AG | 2020-01-23 |
| Microscope Navigation (K190250) | Brainlab AG | 2019-09-06 |
| Spine & Trauma Navigation (K183605) | Brainlab AG | 2019-08-29 |
| Spine & Trauma Navigation (K191285) | Brainlab AG | 2019-06-11 |
| Brainlab Elements Image Fusion Angio (K190042) | Brainlab AG | 2019-04-25 |
| RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review (K190664) | Brainlab AG | 2019-04-12 |
| Microscope Navigation Software (K172820) | Brainlab AG | 2018-03-01 |
| Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM (K170816) | Brainlab AG | 2017-09-26 |
| RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review (K170750) | Brainlab AG | 2017-08-24 |
| DICOM Viewer (K153653) | Brainlab AG | 2016-04-13 |
| RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS (K142108) | Brainlab AG | 2014-12-16 |
| QUENTRY DOSE REVIEW (K141199) | Brainlab AG | 2014-06-20 |
| ADVANCED VIEWER (K132763) | Brainlab AG | 2014-02-28 |
| STERILE RADIOLUCENT SKULL PINS (K122225) | Brainlab AG | 2013-04-26 |
| NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP (K122011) | Brainlab AG | 2012-11-15 |
| EXACTRAC VERO (K122451) | Brainlab AG | 2012-09-28 |
| EXACTRAC X-RAY X-RAY (K120789) | Brainlab AG | 2012-08-14 |
| EXACTRAC ROBOTICS NOVALIS ROBOTICS (K120520) | Brainlab AG | 2012-06-29 |
| IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) (K113732) | Brainlab AG | 2012-05-07 |
| DASH HIP (K110021) | Brainlab AG | 2011-10-18 |
| BRAINLAB TRAUMA (K110204) | Brainlab AG | 2011-08-05 |
| IPLAN (K101627) | Brainlab AG | 2011-06-03 |
| DASH KNEE (K102251) | Brainlab AG | 2011-05-17 |
| BRAINLAB KNEE (K102990) | Brainlab AG | 2011-04-04 |
| IPLAN RT (K103246) | Brainlab AG | 2011-03-16 |
| DISPOSABLE REFLECTIVE MARKER SPHERES (K100038) | Brainlab AG | 2010-07-14 |
| BRAINLAB KNEE ARTHROSCOPY (K093118) | Brainlab AG | 2010-06-11 |
| VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED (K092467) | Brainlab AG | 2010-05-06 |
| DIGITAL LIGHTBOX (K093117) | Brainlab AG | 2009-12-11 |
| CRANIAL IMAGE GUIDED SURGERY SYSTEM (K082060) | Brainlab AG | 2009-05-08 |
| BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED (K083483) | Brainlab AG | 2009-04-08 |
| SPINE & TRAUMA ICT (K083310) | Brainlab AG | 2009-04-01 |
| BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED (K073615) | Brainlab AG | 2008-09-05 |
| IPLAN RT IMAGE (K080886) | Brainlab AG | 2008-06-24 |
| MODEIFICATION TO IPLAN RT DOSE (K080888) | Brainlab AG | 2008-06-11 |
| UNI-KNEE 2.0 (K080678) | Brainlab AG | 2008-06-06 |
| DIGITAL LIGHTBOX (K080608) | Brainlab AG | 2008-04-17 |
| STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT (K073018) | Brainlab AG | 2008-01-23 |
| EXACTRAC 5.5 (K072506) | Brainlab AG | 2007-10-26 |
| EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM (K072046) | Brainlab AG | 2007-10-17 |
| VECTOR VISION HIP (K072716) | Brainlab AG | 2007-10-12 |
| VECTORVISION HIP AND HIP SR (K072573) | Brainlab AG | 2007-10-11 |
| BRAINSUITE NET (K070556) | Brainlab AG | 2007-09-25 |
| VV FLUORO 3D (K070106) | Brainlab AG | 2007-04-23 |
| MODIFICATION TO VECTORVISION TRAUMA (K062358) | Brainlab AG | 2007-01-17 |
| VECTORVISION HIP SR (K063028) | Brainlab AG | 2006-12-12 |
| NAVIVISION (K062086) | Brainlab AG | 2006-09-20 |
| VECTORVISION HIP (K060727) | Brainlab AG | 2006-08-21 |
| IPLAN RT DOSE (K053584) | Brainlab AG | 2006-07-12 |
| VECTORVISION SPINE (K053159) | Brainlab AG | 2006-06-06 |
| IPLAN FLOW (K053164) | Brainlab AG | 2006-03-23 |
| VECTORVISION HIP (K060468) | Brainlab AG | 2006-03-20 |
| CI KNEE, CI MI TKR (K052966) | Brainlab AG | 2006-02-13 |
| IPLAN (K053127) | Brainlab AG | 2006-02-09 |
| FRAMELESS RADIOSURGERY COMPONENTS (K053500) | Brainlab AG | 2006-02-03 |
| NAVIGATION SW HIP 3.1 ON CI (K052213) | Brainlab AG | 2005-11-02 |
| IPLAN RT FIBERTRACKING (K052220) | Brainlab AG | 2005-09-30 |
| IPLAN! DIGITAL TEMPLATING (K042543) | Brainlab AG | 2005-05-17 |
| KOLIBRI SPINE (K042721) | Brainlab AG | 2005-04-19 |
| VECTORVISION OSTEOTOMY (K042513) | Brainlab AG | 2005-02-10 |