510k
Database
Specialties
Anesthesiology
135
Cardiovascular
570
Chemistry
165
Dental
318
Ear, Nose, Throat
68
Gastroenterology & Urology
290
General & Plastic Surgery
526
General Hospital
377
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
62
Ophthalmic
51
Orthopedic
1296
Pathology
18
Physical Medicine
87
Radiology
874
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
151
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Biotex, Inc.
Medical Device Manufacturer
·
US , Houston , TX
Biotex, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2006
10
Total
10
Cleared
0
Denied
FDA 510(k) cleared devices by Biotex, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 10, 2008
VISUALASE THERMAL THERAPY SYSTEM
K081656
·
LLZ
Radiology
·
90d
Cleared
Aug 31, 2007
VISUALASE THERMAL THERAPY SYSTEM
K071328
·
GEX
Radiology
·
112d
Cleared
Dec 12, 2006
VISUALASE ENVISION SOFTWARE SYSTEM
K063505
·
LLZ
Radiology
·
22d
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10
General & Plastic Surgery
5
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3
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1
Dental
1