Brainlab AG - FDA 510(k) Cleared Devices
135
Total
135
Cleared
0
Denied
135 devices
Cleared
Dec 16, 2014
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
Radiology
134d
Cleared
Jun 20, 2014
QUENTRY DOSE REVIEW
Radiology
42d
Cleared
Feb 28, 2014
ADVANCED VIEWER
Radiology
177d
Cleared
Apr 26, 2013
STERILE RADIOLUCENT SKULL PINS
Neurology
275d
Cleared
Nov 15, 2012
NAVIGATION SOFTWARE HIP-UNIVERSAL
Orthopedic
129d
Cleared
Sep 28, 2012
EXACTRAC VERO
Radiology
46d
Cleared
Aug 14, 2012
EXACTRAC X-RAY X-RAY
Radiology
152d
Cleared
Jun 29, 2012
EXACTRAC ROBOTICS NOVALIS ROBOTICS
Radiology
129d
Cleared
May 07, 2012
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW,...
Radiology
140d
Cleared
Oct 18, 2011
DASH HIP
Orthopedic
288d
Cleared
Aug 05, 2011
BRAINLAB TRAUMA
Orthopedic
193d
Cleared
Jun 03, 2011
IPLAN
Neurology
359d
Cleared
May 17, 2011
DASH KNEE
Orthopedic
281d
Cleared
Apr 04, 2011
BRAINLAB KNEE
Orthopedic
178d
Cleared
Mar 16, 2011
IPLAN RT
Radiology
133d
Cleared
Jul 14, 2010
DISPOSABLE REFLECTIVE MARKER SPHERES
Neurology
188d
Cleared
Jun 11, 2010
BRAINLAB KNEE ARTHROSCOPY
Orthopedic
252d
Cleared
May 06, 2010
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL...
Neurology
267d
Cleared
Dec 11, 2009
DIGITAL LIGHTBOX
Radiology
70d
Cleared
May 08, 2009
CRANIAL IMAGE GUIDED SURGERY SYSTEM
Neurology
291d
Cleared
Apr 08, 2009
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
Orthopedic
135d
Cleared
Apr 01, 2009
SPINE & TRAUMA ICT
Orthopedic
142d
Cleared
Sep 05, 2008
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
Neurology
254d
Cleared
Jun 24, 2008
IPLAN RT IMAGE
Radiology
85d
Cleared
Jun 11, 2008
MODEIFICATION TO IPLAN RT DOSE
Radiology
72d
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