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9295
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8200
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5402
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1787
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4869
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7533
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6204
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1855
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2394
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15
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4573
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2766
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1729
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1311
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11884
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596
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1459
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7999
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2046
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1171
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1120
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System, Image Processing,...
1091
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Plate, Fixation, Bone
903
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System, Nuclear Magnetic...
813
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System, Imaging, Pulsed Doppler,...
780
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Prosthesis, Knee,...
765
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Laparoscope, General & Plastic...
680
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Hearing Aid, Air-conduction,...
661
NKB
Thoracolumbosacral Pedicle Screw...
650
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Manufacturers
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Search FDA 510(k) devices
510k Database
Manufacturers
DE
Brainlab AG
Medical Device Manufacturer
·
DE , Heimstetten
Brainlab AG - FDA 510(k) Cleared Devices
135 submissions
·
135 cleared
·
Since 1996
Official Website
135
Total
135
Cleared
0
Denied
53
devices
51-53 of 53
Filters
1
2
3
Cleared
Nov 03, 2000
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K002509
·
MUJ
Radiology
·
80d
Cleared
Jul 13, 2000
BRAINSCAN
K994413
·
MUJ
Radiology
·
197d
Cleared
Oct 27, 1997
BRAINSCAN CONFORMAL RT MODULE
K971367
·
IYE
Radiology
·
196d
1
2
3
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135
Neurology
59
Radiology
53
Orthopedic
22
Ear, Nose, Throat
1