Texas FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance and a Texas address from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
16 clearances in the last 90 days. The same 90 days a year earlier: 19.
For contract manufacturers and test labs
Texas had 16 US 510(k) clearances in the last 90 days and 73 in the last 12 months. The product code with the most clearances in this window is DPS (Electrocardiograph). Contract manufacturers and test labs that sell to device companies in Texas can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
DPS | Electrocardiograph | 2 |
DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
HRS | Plate, Fixation, Bone | 1 |
HWC | Screw, Fixation, Bone | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 23, 2026 | Monebo Technologies, Inc. | Kinetic Software Library | K260640 |
| Oct 21, 2026 | Nuclein, LLC | DASH Flu A/B Test | K261347 |
| Oct 14, 2026 | Nvision Biomedical Technologies | Ntegrate Threaded Nail System | K261961 |
| Oct 5, 2026 | HeartSciences, Inc. | MyoVista wavECG (DG-200-B15-003) | K260005 |
| Oct 2, 2026 | Encore Medical L.P. | AltiVate Reverse Glenosphere with RAVN Technology | K263086 |
| Sep 25, 2026 | Solventum US, LLC | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | K261992 |
| Sep 18, 2026 | Nvision Biomedical Technologies | EnHAnce PEEK Bunion System | K262098 |
| Sep 16, 2026 | Stabilix, LLC | AerFrame Alignment Laser Box (LBV2) | K261865 |
| Sep 11, 2026 | Bone Solutions, Inc. | Mg OSTEOREVIVE;Mg OSTEOCRETE | K262230 |
| Sep 9, 2026 | Maxter Healthcare, Inc. | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | K261793 |
| Sep 4, 2026 | NuSmile, Ltd. | NeoPEX Pre-Mixed Obturation Paste | K253909 |
| Sep 3, 2026 | Happy Health, Inc. | Happy Health Blood Pressure Monitor | K254000 |
| Sep 2, 2026 | Ellian Corp | Ellian Enigma RF Device | K262364 |
| Aug 26, 2026 | Wenzel Spine, Inc. | VariLift-C Cervical Interbody Fusion System | K262595 |
| Aug 21, 2026 | Osseus Fusions Systems, LLC | Pisces-SC Standalone Cervical Interbody System | K261882 |
| Aug 12, 2026 | Manamed, LLC | ManaCold Compression System | K260944 |
- Oct 23, 2026Monebo Technologies, Inc.
Kinetic Software Library
- Oct 21, 2026Nuclein, LLC
DASH Flu A/B Test
- Oct 14, 2026Nvision Biomedical Technologies
Ntegrate Threaded Nail System
- Oct 5, 2026HeartSciences, Inc.
MyoVista wavECG (DG-200-B15-003)
- Oct 2, 2026Encore Medical L.P.
AltiVate Reverse Glenosphere with RAVN Technology
- Sep 25, 2026Solventum US, LLC
3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
- Sep 18, 2026Nvision Biomedical Technologies
EnHAnce PEEK Bunion System
- Sep 16, 2026Stabilix, LLC
AerFrame Alignment Laser Box (LBV2)
- Sep 11, 2026Bone Solutions, Inc.
Mg OSTEOREVIVE;Mg OSTEOCRETE
- Sep 9, 2026Maxter Healthcare, Inc.
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
- Sep 4, 2026NuSmile, Ltd.
NeoPEX Pre-Mixed Obturation Paste
- Sep 3, 2026Happy Health, Inc.
Happy Health Blood Pressure Monitor
- Sep 2, 2026Ellian Corp
Ellian Enigma RF Device
- Aug 26, 2026Wenzel Spine, Inc.
VariLift-C Cervical Interbody Fusion System
- Aug 21, 2026Osseus Fusions Systems, LLC
Pisces-SC Standalone Cervical Interbody System
- Aug 12, 2026Manamed, LLC
ManaCold Compression System
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
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