Brainlab AG
Brainlab AG holds FDA 510(k) medical device clearances, first cleared 1996, most recent 2025, with 39 FDA device recalls on record.
Top product codes for Brainlab AG
FDA recalls by Brainlab AG
10 most recent of 39- Z-1392-2025 — Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
- Z-1292-2023 — Cirq Arm System 2.0
- Z-1259-2023 — Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
- Z-0733-2022 — ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
- Z-1846-2021 — ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Z-1185-2021 — ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
- Z-0056-2021 — Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
- Z-2925-2020 — Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
- Z-2793-2020 — BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
- Z-2792-2020 — BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Brainlab AG
1–100 of 135- K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- K252562 — Spine & Trauma Navigation Instruments
- K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
- K243142 — Cranial 4Pi Immobilization
- K250440 — RT Elements (4.5) +11 more
- K243633 — Brainlab Elements (7.0) +5 more
- K242569 — Mixed Reality Spine Navigation
- K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT +4 more
- K240431 — ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
- K240701 — Drill Guide; Drill Bit; Spine & Trauma Navigation
- K232759 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- K234047 — Automatic Registration
- K223864 — Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
- K223553 — Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
- K223288 — Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
- K223106 — Brainlab Elements Image Fusion, Contouring (4.5) +4 more
- K231052 — ExacTrac Dynamic 1.1.2
- K223734 — ENT EM
- K223552 — Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
- K223279 — RT Elements (4.0)
- K222966 — Cirq Arm System (2.0); Alignment System Spine
- K213989 — Cranial EM System
- K221618 — Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
- K220652 — Knee 3
- K220338 — ExacTrac Dynamic
- K213930 — Brainlab Elements Guide XT, Guide 3.0
- K212245 — 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
- K212420 — Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
- K210989 — 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
- K211544 — Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
- K211939 — ExacTrac Dynamic
- K203681 — RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
- K203679 — Automatic Registration
- K201752 — Disposable Pre-calibrated Suction
- K202320 — CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System
- K203173 — ExacTrac Dynamic
- K192703 — 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
- K202050 — Cranial 4Pi Immobilization
- K201276 — ExacTrac Dynamic
- K193307 — HIP7
- K191014 — Elements Viewer
- K190250 — Microscope Navigation
- K183605 — Spine & Trauma Navigation
- K191285 — Spine & Trauma Navigation
- K190042 — Brainlab Elements Image Fusion Angio
- K190664 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
- K172820 — Microscope Navigation Software
- K170816 — Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
- K170750 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
- K153653 — DICOM Viewer
- K142108 — RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
- K141199 — QUENTRY DOSE REVIEW
- K132763 — ADVANCED VIEWER
- K122225 — STERILE RADIOLUCENT SKULL PINS
- K122011 — NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
- K122451 — EXACTRAC VERO
- K120789 — EXACTRAC X-RAY X-RAY
- K120520 — EXACTRAC ROBOTICS NOVALIS ROBOTICS
- K113732 — IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
- K110021 — DASH HIP
- K110204 — BRAINLAB TRAUMA
- K101627 — IPLAN
- K102251 — DASH KNEE
- K102990 — BRAINLAB KNEE
- K103246 — IPLAN RT
- K100038 — DISPOSABLE REFLECTIVE MARKER SPHERES
- K093118 — BRAINLAB KNEE ARTHROSCOPY
- K092467 — VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
- K093117 — DIGITAL LIGHTBOX
- K082060 — CRANIAL IMAGE GUIDED SURGERY SYSTEM
- K083483 — BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
- K083310 — SPINE & TRAUMA ICT
- K073615 — BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
- K080886 — IPLAN RT IMAGE
- K080888 — MODEIFICATION TO IPLAN RT DOSE
- K080678 — UNI-KNEE 2.0
- K080608 — DIGITAL LIGHTBOX
- K073018 — STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT
- K072506 — EXACTRAC 5.5
- K072046 — EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM
- K072716 — VECTOR VISION HIP
- K072573 — VECTORVISION HIP AND HIP SR
- K070556 — BRAINSUITE NET
- K070106 — VV FLUORO 3D
- K062358 — MODIFICATION TO VECTORVISION TRAUMA
- K063028 — VECTORVISION HIP SR
- K062086 — NAVIVISION
- K060727 — VECTORVISION HIP
- K053584 — IPLAN RT DOSE
- K053159 — VECTORVISION SPINE
- K053164 — IPLAN FLOW
- K060468 — VECTORVISION HIP
- K052966 — CI KNEE, CI MI TKR
- K053127 — IPLAN
- K053500 — FRAMELESS RADIOSURGERY COMPONENTS
- K052213 — NAVIGATION SW HIP 3.1 ON CI
- K052220 — IPLAN RT FIBERTRACKING
- K042543 — IPLAN! DIGITAL TEMPLATING
- K042721 — KOLIBRI SPINE
- K042513 — VECTORVISION OSTEOTOMY
Data sourced from openFDA. This site is unofficial and independent of the FDA.