510k
Database
Specialties
Anesthesiology
132
Cardiovascular
568
Chemistry
162
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
370
Hematology
67
Immunology
56
Medical Genetics
0
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232
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163
Obstetrics & Gynecology
61
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49
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1288
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Ortho8, Inc.
Medical Device Manufacturer
·
US , Rocklin , CA
Ortho8, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Ortho8, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 03, 2022
CIRCUL8 Connect DVT Prevention Device
K220761
·
JOW
Cardiovascular
·
80d
Cleared
Nov 15, 2021
Circul8 Pro
K212731
·
JOW
Cardiovascular
·
77d
Cleared
Sep 08, 2021
CIRCUL8 Luxe DVT Prevention Device
K211235
·
JOW
Cardiovascular
·
135d
Filters
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3
Cardiovascular
3