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"
49–72 of 135
Search insights Median review: 141d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Neurology
Cleared Aug 24, 2017
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive...
K170750 · MUJ
Brainlab AG
Radiology · 164d
Cleared Apr 13, 2016
DICOM Viewer
K153653 · LLZ
Brainlab AG
Radiology · 114d
Cleared Dec 16, 2014
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
K142108 · MUJ
Brainlab AG
Radiology · 134d
Cleared Jun 20, 2014
QUENTRY DOSE REVIEW
K141199 · LLZ
Brainlab AG
Radiology · 42d
Cleared Feb 28, 2014
ADVANCED VIEWER
K132763 · LLZ
Brainlab AG
Radiology · 177d
Cleared Apr 26, 2013
STERILE RADIOLUCENT SKULL PINS
K122225 · HBL
Brainlab AG
Neurology · 275d
Cleared Nov 15, 2012
NAVIGATION SOFTWARE HIP-UNIVERSAL
K122011 · OLO
Brainlab AG
Orthopedic · 129d
Cleared Sep 28, 2012
EXACTRAC VERO
K122451 · IYE
Brainlab AG
Radiology · 46d
Cleared Aug 14, 2012
EXACTRAC X-RAY X-RAY
K120789 · IYE
Brainlab AG
Radiology · 152d
Cleared Jun 29, 2012
EXACTRAC ROBOTICS NOVALIS ROBOTICS
K120520 · JAI
Brainlab AG
Radiology · 129d
Cleared May 07, 2012
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW,...
K113732 · JAK
Brainlab AG
Radiology · 140d
Cleared Oct 18, 2011
DASH HIP
K110021 · OLO
Brainlab AG
Orthopedic · 288d
Cleared Aug 05, 2011
BRAINLAB TRAUMA
K110204 · OLO
Brainlab AG
Orthopedic · 193d
Cleared Jun 03, 2011
IPLAN
K101627 · HAW
Brainlab AG
Neurology · 359d
Cleared May 17, 2011
DASH KNEE
K102251 · OLO
Brainlab AG
Orthopedic · 281d
Cleared Apr 04, 2011
BRAINLAB KNEE
K102990 · OLO
Brainlab AG
Orthopedic · 178d
Cleared Mar 16, 2011
IPLAN RT
K103246 · MUJ
Brainlab AG
Radiology · 133d
Cleared Jul 14, 2010
DISPOSABLE REFLECTIVE MARKER SPHERES
K100038 · HAW
Brainlab AG
Neurology · 188d
Cleared Jun 11, 2010
BRAINLAB KNEE ARTHROSCOPY
K093118 · OLO
Brainlab AG
Orthopedic · 252d
Cleared May 06, 2010
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL...
K092467 · HAW
Brainlab AG
Neurology · 267d
Cleared Dec 11, 2009
DIGITAL LIGHTBOX
K093117 · LLZ
Brainlab AG
Radiology · 70d
Cleared May 08, 2009
CRANIAL IMAGE GUIDED SURGERY SYSTEM
K082060 · HAW
Brainlab AG
Neurology · 291d
Cleared Apr 08, 2009
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
K083483 · OLO
Brainlab AG
Orthopedic · 135d
Cleared Apr 01, 2009
SPINE & TRAUMA ICT
K083310 · OLO
Brainlab AG
Orthopedic · 142d