510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1709
Chemistry
380
Dental
1355
Ear, Nose, Throat
252
Gastroenterology & Urology
982
General & Plastic Surgery
2215
General Hospital
2079
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
441
Ophthalmic
282
Orthopedic
3023
Pathology
52
Physical Medicine
515
Radiology
2486
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
399
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
290
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
231
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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) Regulatory Record - 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
Dental
1
Neurology
1