510k
Database
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Anesthesiology
5951
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14082
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11040
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9286
Ear, Nose, Throat
2723
Gastroenterology & Urology
7393
General & Plastic Surgery
13072
General Hospital
11227
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2578
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3096
Medical Genetics
20
Microbiology
5902
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4549
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3080
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2807
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16101
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850
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2793
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11863
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2586
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GEX
Powered Laser Surgical Instrument
2219
LLZ
System, Image Processing,...
1780
GEI
Electrosurgical, Cutting &...
1761
HRS
Plate, Fixation, Bone
1223
DZE
Implant, Endosseous, Root-form
1196
IYN
System, Imaging, Pulsed Doppler,...
1087
GCJ
Laparoscope, General & Plastic...
1068
LZA
Polymer Patient Examination Glove
1017
LNH
System, Nuclear Magnetic...
962
ESD
Hearing Aid, Air-conduction,...
953
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Manufacturers
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Search FDA 510(k) devices
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
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