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3824
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9922
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18359
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3293
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7089
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5119
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2317
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2294
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LYY
1954
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DZE
1549
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1432
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1366
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1333
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1224
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1188
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510k Database
Manufacturers
DE
Brainlab AG
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Medical Device Manufacturer
·
DE , Heimstetten
Brainlab AG - FDA 510(k) Cleared Devices
135 submissions
·
135 cleared
·
Since 1996
View 135 510(k) Devices ↓
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