Biotex, Inc. is one of 16310 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biotex, Inc. - FDA 510(k) Cleared Devices
Recent clearances: troCarWash™ System, troCarWash™ System, The Slide
10
Total
10
Cleared
0
Denied
Biotex, Inc. has 10 FDA 510(k) cleared medical devices. Based in Houston, US.
Latest FDA clearance: May 2024. Active since 2006. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Biotex, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Phasor Health, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Biotex, Inc.
10 devices
Cleared
May 21, 2024
troCarWash™ System
General & Plastic Surgery
216d
Cleared
Feb 17, 2023
troCarWash™ System
General & Plastic Surgery
164d
Cleared
Jul 20, 2021
The Slide
Dental
211d
Cleared
Dec 01, 2016
Phasor Drill
Neurology
164d
Cleared
Oct 06, 2009
PHOTEX30 DIODE LASER SERIES: 980, 810, 940
General & Plastic Surgery
77d
Cleared
Sep 10, 2008
VISUALASE THERMAL THERAPY SYSTEM
Radiology
90d
Cleared
Aug 31, 2007
VISUALASE THERMAL THERAPY SYSTEM
Radiology
112d
Cleared
Dec 12, 2006
VISUALASE ENVISION SOFTWARE SYSTEM
Radiology
22d
Cleared
Mar 21, 2006
PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940
General & Plastic Surgery
43d
Cleared
Mar 01, 2006
VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING...
General & Plastic Surgery
119d