510k
Database
Specialties
Anesthesiology
325
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1044
Chemistry
264
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783
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147
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609
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1286
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733
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97
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72
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1
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363
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552
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240
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148
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1984
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38
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307
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1546
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128
Categories
GEX
Powered Laser Surgical Instrument
226
IYN
System, Imaging, Pulsed Doppler,...
205
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Plate, Fixation, Bone
204
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Automated Radiological Image...
202
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System, Image Processing,...
191
GEI
Electrosurgical, Cutting &...
181
OLO
Orthopedic Stereotaxic Instrument
166
NHA
Abutment, Implant, Dental,...
151
MAX
Intervertebral Fusion Device...
136
NKB
Thoracolumbosacral Pedicle Screw...
130
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Glooko, Inc.
Medical Device Manufacturer
·
US , Palo Alto , CA
Glooko, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2012
Official Website
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Glooko, Inc.
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
May 01, 2026
EndoTool IV Cloud 1.0
K260910
·
NDC
Chemistry
·
43d
Cleared
Oct 17, 2013
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
K132272
·
NBW
Chemistry
·
87d
Cleared
Apr 25, 2013
GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
K130886
·
NBW
Chemistry
·
27d
Cleared
Dec 21, 2012
GLOOKO LOGBOOK CHARTS
K122142
·
NBW
Chemistry
·
155d
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5
Chemistry
4
General Hospital
1