510k
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Anesthesiology
451
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1370
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334
Dental
1061
Ear, Nose, Throat
195
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812
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1790
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1222
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121
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84
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7
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420
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767
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337
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214
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2429
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44
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411
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1983
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143
Categories
GEX
Powered Laser Surgical Instrument
293
LLZ
System, Image Processing,...
284
GEI
Electrosurgical, Cutting &...
254
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Automated Radiological Image...
251
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
207
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
168
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Brainlab Med. Computersysteme GmbH
Medical Device Manufacturer
·
US , Troy , NY
Brainlab Med. Computersysteme GmbH - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1994
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Brainlab Med. Computersysteme GmbH
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Feb 02, 1996
BRAINLAB STEROTATIC HEADRING
K952390
·
HAW
Neurology
·
256d
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5
Radiology
4
Neurology
1