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633
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537
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524
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499
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490
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465
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448
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510k Database
Manufacturers
DE
Sivantos GmbH
Medical Device Manufacturer
·
DE , Erlangen
Sivantos GmbH - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2026
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sivantos GmbH
Ear, Nose, Throat
✕
1
devices
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Cleared
Jun 10, 2026
Tinnitus Therapy
K260614
·
KLW
Ear, Nose, Throat
·
105d
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Ear, Nose, Throat
1