510k
Database
Specialties
Anesthesiology
198
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720
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185
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449
Ear, Nose, Throat
86
Gastroenterology & Urology
382
General & Plastic Surgery
750
General Hospital
460
Hematology
74
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61
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1
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271
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286
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111
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75
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1464
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26
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145
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1066
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
161
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
LLZ
System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
106
NHA
Abutment, Implant, Dental,...
103
GEI
Electrosurgical, Cutting &...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Blue Spark Technologies, Inc.
Medical Device Manufacturer
·
US , Westlake , OH
Blue Spark Technologies, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2015
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Blue Spark Technologies, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 03, 2020
TempTraq
K201977
·
FLL
General Hospital
·
140d
Cleared
Sep 02, 2015
TempTraq TT-100
K143267
·
FLL
General Hospital
·
293d
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2
General Hospital
2