Colorado FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance and a Colorado address from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
12 clearances in the last 90 days. The same 90 days a year earlier: 9.
For contract manufacturers and test labs
Colorado had 12 US 510(k) clearances in the last 90 days and 43 in the last 12 months. The product code with the most clearances in this window is DWJ (System, Thermal Regulating). Contract manufacturers and test labs that sell to device companies in Colorado 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 |
|---|---|---|
DWJ | System, Thermal Regulating | 1 |
EIH | Powder, Porcelain | 1 |
GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 1 |
HTY | Pin, Fixation, Smooth | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 30, 2026 | Medivance, Inc. | Arctic Sun Neonatal ArcticGel Pad | K263587 |
| Oct 30, 2026 | Zirconia Collective, Inc. | Zirconia Collective 4Y Dental Zirconia Blank | K262685 |
| Oct 29, 2026 | Cleerly, Inc. | Cleerly ISCHEMIA | K262839 |
| Oct 27, 2026 | Sienco, Inc. | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation & Platelet Function Analzyer System with Sonoclot Viewer (SCP2); Sonoclot Coagulation Analyzer System with Sonoclot Viewer (SC1) | K260909 |
| Oct 9, 2026 | Ischemaview, Inc. | Rapid ICH (v4.0) | K262301 |
| Oct 7, 2026 | Paragon 28, Inc. | APEX 3D S Diamond Tibia | K261120 |
| Sep 21, 2026 | Ischemaview, Inc. | Rapid Platform (R6.7) | K261368 |
| Sep 21, 2026 | Trisalus Life Sciences | TriSalus TriNav Advance Infusion System | K253509 |
| Sep 15, 2026 | Covidien, LLC | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | K261070 |
| Aug 28, 2026 | Paragon 28, Inc. | Primal K-Wire (P99-193-1410) | K262722 |
| Aug 6, 2026 | Paragon 28, Inc. | Megalodon Dynamic Compression System | K261121 |
| Aug 3, 2026 | Paragon 28, Inc. | Grappler Suture Anchor System | K262047 |
- Oct 30, 2026Medivance, Inc.
Arctic Sun Neonatal ArcticGel Pad
- Oct 30, 2026Zirconia Collective, Inc.
Zirconia Collective 4Y Dental Zirconia Blank
- Oct 29, 2026Cleerly, Inc.
Cleerly ISCHEMIA
- Oct 27, 2026Sienco, Inc.
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation & Platelet Function Analzyer System with Sonoclot Viewer (SCP2); Sonoclot Coagulation Analyzer System with Sonoclot Viewer (SC1)
- Oct 9, 2026Ischemaview, Inc.
Rapid ICH (v4.0)
- Oct 7, 2026Paragon 28, Inc.
APEX 3D S Diamond Tibia
- Sep 21, 2026Ischemaview, Inc.
Rapid Platform (R6.7)
- Sep 21, 2026Trisalus Life Sciences
TriSalus TriNav Advance Infusion System
- Sep 15, 2026Covidien, LLC
LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
- Aug 28, 2026Paragon 28, Inc.
Primal K-Wire (P99-193-1410)
- Aug 6, 2026Paragon 28, Inc.
Megalodon Dynamic Compression System
- Aug 3, 2026Paragon 28, Inc.
Grappler Suture Anchor 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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