510k
Database
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Anesthesiology
410
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1240
Chemistry
309
Dental
938
Ear, Nose, Throat
180
Gastroenterology & Urology
728
General & Plastic Surgery
1591
General Hospital
985
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113
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80
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6
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400
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692
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298
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184
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2245
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43
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371
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1812
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
261
LLZ
System, Image Processing,...
255
QIH
Automated Radiological Image...
236
IYN
System, Imaging, Pulsed Doppler,...
224
GEI
Electrosurgical, Cutting &...
222
HRS
Plate, Fixation, Bone
220
OLO
Orthopedic Stereotaxic Instrument
184
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
149
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Mazor Surgical Technologies , Ltd.
Medical Device Manufacturer
·
IL , Kfar Saba
Mazor Surgical Technologies , Ltd. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2004
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mazor Surgical Technologies , Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 26, 2010
TENZING SYSTEM
K102130
·
HAW
Radiology
·
28d
Cleared
Aug 15, 2008
C-INSIGHT
K081672
·
LLZ
Radiology
·
63d
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7
Neurology
4
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2
Orthopedic
1