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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.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 05, 1985
AUDIT TM V
K843712
·
GWF
Neurology
·
196d
Cleared
Dec 01, 1983
AUDIT V AX 135
K833298
·
GWK
Neurology
·
69d
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5
Neurology
2
Immunology
1
Chemistry
1
Ear, Nose, Throat
1