510k
Database
Specialties
Anesthesiology
134
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569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
288
General & Plastic Surgery
516
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
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167
Obstetrics & Gynecology
61
Ophthalmic
49
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1293
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18
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86
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870
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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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) cleared devices by Zevex, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 03, 2024
Curlin 8000 Ambulatory Infusion System
K242660
·
FRN
General Hospital
·
29d
Cleared
May 17, 2024
Curlin 8000 Ambulatory Infusion System
K232793
·
FRN
General Hospital
·
249d
Cleared
Feb 12, 2014
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET
K131154
·
LZH
General Hospital
·
294d
Filters
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5
General Hospital
3
Gastroenterology & Urology
2