510k
Database
Specialties
Anesthesiology
1012
Cardiovascular
4313
Chemistry
3201
Dental
2736
Ear, Nose, Throat
464
Gastroenterology & Urology
2287
General & Plastic Surgery
3890
General Hospital
3553
Hematology
778
Immunology
774
Medical Genetics
15
Microbiology
1404
Neurology
1730
Obstetrics & Gynecology
851
Ophthalmic
492
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7454
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163
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958
Radiology
4597
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1235
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
688
GEI
Electrosurgical, Cutting &...
549
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
450
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
389
Browse all 339 categories →
Manufacturers
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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