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Manufacturers
US
Stryker Ent
Medical Device Manufacturer
·
US , Plymouth , MN
Stryker Ent - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stryker Ent
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 15, 2020
SINUSPRIME Dilation System
K201398
·
LRC
Ear, Nose, Throat
·
140d
Cleared
Feb 21, 2020
TGS Guidewire and updated Scopis Software
K193118
·
PGW
Ear, Nose, Throat
·
101d
Cleared
Feb 14, 2020
TGS Universal Headrest with Mounting Arm
K193502
·
PGW
Ear, Nose, Throat
·
58d
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3
Ear, Nose, Throat
3