510k
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Anesthesiology
3771
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10065
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8803
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6178
Ear, Nose, Throat
2016
Gastroenterology & Urology
5358
General & Plastic Surgery
8496
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6901
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2048
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2624
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16
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4947
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2971
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1899
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1481
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12532
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639
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1633
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8417
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2194
Categories
GEX
Powered Laser Surgical Instrument
1449
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Electrosurgical, Cutting &...
1193
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System, Image Processing,...
1152
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Plate, Fixation, Bone
947
LNH
System, Nuclear Magnetic...
818
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System, Imaging, Pulsed Doppler,...
795
JWH
Prosthesis, Knee,...
788
ESD
Hearing Aid, Air-conduction,...
740
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Laparoscope, General & Plastic...
724
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Implant, Endosseous, Root-form
699
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Manufacturers
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510k Database
Manufacturers
US
Spiration, Inc.
Medical Device Manufacturer
·
US , Redmond , WA
Spiration, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2015
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spiration, Inc.
Ear, Nose, Throat
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 20, 2017
B7 2C Occlusion Balloon
K171492
·
EOQ
Ear, Nose, Throat
·
182d
Cleared
Feb 09, 2017
PeriFLEX
K162611
·
EOQ
Ear, Nose, Throat
·
143d
Cleared
Feb 19, 2016
ViziShot FLEX
K152922
·
KTI
Ear, Nose, Throat
·
140d
Cleared
Apr 24, 2015
Flexible 19G EBUS Needle
K142909
·
EOQ
Ear, Nose, Throat
·
200d
Filters
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5
Ear, Nose, Throat
4
General & Plastic Surgery
1