510k
Database
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Anesthesiology
544
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1689
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370
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1347
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250
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979
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2204
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2052
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126
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100
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8
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472
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975
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437
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280
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2977
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52
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515
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2463
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
396
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Zevex, Inc.
Medical Device Manufacturer
·
US , Salt Lake City , UT
Zevex, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2001
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Zevex, Inc.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 08, 2015
EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding...
K142539
·
PIF
Gastroenterology & Urology
·
121d
Cleared
Nov 02, 2001
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K012147
·
KNT
Gastroenterology & Urology
·
115d
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5
General Hospital
3
Gastroenterology & Urology
2