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Brainlab AG

28 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 recall (Z-1392-2025)Brainlab AG2025-03-18
Cirq Arm System 2.0 recall (Z-1292-2023)Brainlab AG2023-03-28
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, mod recall (Z-1259-2023)Brainlab AG2023-03-16
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma recall (Z-1082-2019)Brainlab AG2019-04-15
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiolo recall (Z-0598-2016)Brainlab AG2016-01-19
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cr recall (Z-0282-2016)Brainlab AG2015-11-17
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place recall (Z-2440-2015)Brainlab AG2015-08-21
ExacTrac 6.x. is software used to place patients at an accurately defined point within the recall (Z-1582-2015)Brainlab AG2015-05-06
ExacTrac versions 6.x patient positioning systems are used to position patients during rad recall (Z-1316-2015)Brainlab AG2015-03-25
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraopera recall (Z-1215-2015)Brainlab AG2015-02-26
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for u recall (Z-0956-2015)Brainlab AG2015-01-15
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic recall (Z-0957-2015)Brainlab AG2015-01-15
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-gu recall (Z-2213-2014)Brainlab AG2014-08-13
ExacTrac is intended to be used to place patients at an accurately defined point within th recall (Z-2146-2014)Brainlab AG2014-08-04
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brai recall (Z-2134-2014)Brainlab AG2014-07-30
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therap recall (Z-1707-2014)Brainlab AG2014-06-03
ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 2083 recall (Z-1513-2014)Brainlab AG2014-04-25
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided local recall (Z-1469-2014)Brainlab AG2014-04-17
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided locali recall (Z-0967-2014)Brainlab AG2014-02-10
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotation recall (Z-2083-2013)Brainlab AG2013-08-26
BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 recall (Z-2251-2009)Brainlab AG2009-09-20
BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622 F recall (Z-1544-2009)Brainlab AG2009-07-02
BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; BrainL recall (Z-1545-2009)Brainlab AG2009-07-02
BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC, mod recall (Z-1546-2009)Brainlab AG2009-07-02
BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-0 recall (Z-1547-2009)Brainlab AG2009-07-02
VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a recall (Z-2209-2008)Brainlab AG2008-09-17
BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, recall (Z-1010-2007)Brainlab AG2007-07-03
ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as cata recall (Z-1255-06)Brainlab AG2006-07-27

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