510k
Database
Specialties
Anesthesiology
198
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721
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185
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450
Ear, Nose, Throat
86
Gastroenterology & Urology
383
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751
General Hospital
460
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74
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61
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1
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271
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288
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111
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75
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1464
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26
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146
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1068
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93
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IYN
System, Imaging, Pulsed Doppler,...
162
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
128
LLZ
System, Image Processing,...
122
GEX
Powered Laser Surgical Instrument
122
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Automated Radiological Image...
106
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
103
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Mesa Biotech, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Mesa Biotech, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Mesa Biotech, Inc.
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 09, 2020
Accula Strep A Test
K201269
·
PGX
Microbiology
·
181d
Cleared
Nov 23, 2018
Accula RSV Test
K181443
·
OCC
Microbiology
·
176d
Cleared
Feb 06, 2018
Accula Flu A/Flu B Test
K171641
·
OZE
Microbiology
·
249d
Filters
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3
Microbiology
3