510k
Database
Specialties
Anesthesiology
202
Cardiovascular
731
Chemistry
187
Dental
459
Ear, Nose, Throat
88
Gastroenterology & Urology
389
General & Plastic Surgery
762
General Hospital
468
Hematology
77
Immunology
62
Medical Genetics
1
Microbiology
274
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294
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113
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76
Orthopedic
1471
Pathology
26
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151
Radiology
1079
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
165
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
LLZ
System, Image Processing,...
123
GEX
Powered Laser Surgical Instrument
123
QIH
Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Akros Medical
Medical Device Manufacturer
·
US , Durham , NC
Akros Medical - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Akros Medical
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 06, 2020
Akros Scruture Anchor LisFranc Repair Kit
K200361
·
HTN
Orthopedic
·
52d
Cleared
Dec 14, 2017
Akros FibuLink™ Syndesmosis Repair Kit
K173550
·
HTN
Orthopedic
·
28d
Cleared
Jan 10, 2017
Akros Fibulink Syndesmosis Repair Kit
K162805
·
HTN
Orthopedic
·
97d
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Orthopedic
3