510k
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Anesthesiology
204
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739
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187
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466
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91
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394
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774
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476
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77
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64
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277
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117
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152
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1092
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94
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IYN
System, Imaging, Pulsed Doppler,...
167
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
131
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Powered Laser Surgical Instrument
126
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System, Image Processing,...
124
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Automated Radiological Image...
111
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Electrosurgical, Cutting &...
105
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Abutment, Implant, Dental,...
105
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Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Focal Therapeutics
Medical Device Manufacturer
·
US , Portola Valley , CA
Focal Therapeutics - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2012
5
Total
5
Cleared
0
Denied
FDA 510(k) cleared devices by Focal Therapeutics
General & Plastic Surgery
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 26, 2019
BioZorb SP Marker
K192371
·
NEU
General & Plastic Surgery
·
27d
Cleared
Aug 26, 2015
BioZorb LP Marker
K152070
·
NEU
General & Plastic Surgery
·
30d
Cleared
Jun 29, 2015
BioZorb Marker
K143484
·
NEU
General & Plastic Surgery
·
203d
Cleared
Feb 28, 2012
TISSUE MARKER
K113202
·
NEU
General & Plastic Surgery
·
120d
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5
General & Plastic Surgery
4
Radiology
1