510k
Database
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Anesthesiology
653
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1990
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433
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1608
Ear, Nose, Throat
287
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1140
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2497
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2295
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142
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112
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536
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1126
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512
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333
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3478
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57
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556
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2835
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165
Categories
LLZ
System, Image Processing,...
462
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Polymer Patient Examination Glove
435
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Powered Laser Surgical Instrument
406
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384
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Electrosurgical, Cutting &...
359
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System, Imaging, Pulsed Doppler,...
348
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Plate, Fixation, Bone
324
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Automated Radiological Image...
284
MAX
Intervertebral Fusion Device...
268
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Orthopedic Stereotaxic Instrument
263
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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
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5
Ear, Nose, Throat
4
General & Plastic Surgery
1