510k
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Anesthesiology
3449
Cardiovascular
9789
Chemistry
8514
Dental
5905
Ear, Nose, Throat
1951
Gastroenterology & Urology
5142
General & Plastic Surgery
8056
General Hospital
6597
Hematology
1965
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2510
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16
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4753
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2853
Obstetrics & Gynecology
1844
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1440
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12302
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635
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1560
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8197
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2130
Categories
GEX
Powered Laser Surgical Instrument
1289
GEI
Electrosurgical, Cutting &...
1165
LLZ
System, Image Processing,...
1128
HRS
Plate, Fixation, Bone
923
LNH
System, Nuclear Magnetic...
818
IYN
System, Imaging, Pulsed Doppler,...
793
JWH
Prosthesis, Knee,...
787
ESD
Hearing Aid, Air-conduction,...
740
GCJ
Laparoscope, General & Plastic...
702
DZE
Implant, Endosseous, Root-form
673
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Search FDA 510(k) devices
510k Database
Manufacturers
US
Axonics, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Axonics, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1983
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Axonics, Inc.
Immunology
✕
1
devices
1-1 of 1
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Cleared
Jan 14, 1983
TOTAL IGE-FAST TEST
K823494
·
DGC
Immunology
·
52d
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5
Neurology
2
Ear, Nose, Throat
1
Immunology
1
Chemistry
1