510k
Database
Specialties
Anesthesiology
201
Cardiovascular
729
Chemistry
187
Dental
458
Ear, Nose, Throat
86
Gastroenterology & Urology
387
General & Plastic Surgery
757
General Hospital
466
Hematology
77
Immunology
62
Medical Genetics
1
Microbiology
273
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292
Obstetrics & Gynecology
113
Ophthalmic
76
Orthopedic
1467
Pathology
26
Physical Medicine
150
Radiology
1078
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
164
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
LLZ
System, Image Processing,...
123
GEX
Powered Laser Surgical Instrument
122
QIH
Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Tear Film Innovations, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Tear Film Innovations, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Tear Film Innovations, Inc.
Ophthalmic
✕
2
devices
1-2 of 2
Filters
Cleared
May 21, 2020
Systane iLux2
K200400
·
ORZ
Ophthalmic
·
93d
Cleared
Dec 26, 2017
iLux Instrument, iLux Disposable
K172645
·
ORZ
Ophthalmic
·
116d
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2
Ophthalmic
2