Tennessee FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance and a Tennessee address from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
11 clearances in the last 90 days. The same 90 days a year earlier: 12.
For contract manufacturers and test labs
Tennessee had 11 US 510(k) clearances in the last 90 days and 35 in the last 12 months. The product code with the most clearances in this window is MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). Contract manufacturers and test labs that sell to device companies in Tennessee 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 |
|---|---|---|
MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 |
QIH | Automated Radiological Image Processing Software | 2 |
KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 1 |
KNW | Instrument, Biopsy | 1 |
LHN | System, Radiation Therapy, Charged-Particle, Medical | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 29, 2026 | Medtronic Sofamor Danek USA, Inc. | Symmetrix PX Spinal System | K262572 |
| Oct 21, 2026 | TheraMicro | TeKBrace Knotless Anchor | K263352 |
| Oct 1, 2026 | Microport Orthopedics, Inc. | NEXUS Hip Stem | K262473 |
| Sep 25, 2026 | Siemens Medical Solutions USA, Inc. | syngo.CT Brain Quantification | K260055 |
| Sep 23, 2026 | ProNova Solutions | VIRTUE QA | K260597 |
| Sep 8, 2026 | Smith & Nephew, Inc. | LANDMARK Total Knee System | K261462 |
| Aug 26, 2026 | Heartvue.ai, Inc. | Heartvue.Proton | K260811 |
| Aug 21, 2026 | Microport Orthopedics, Inc. | EVOLUTION AM BIOFOAM Tibial System | K253728 |
| Aug 18, 2026 | Theramicro | TeKBrace Solo Soft Tissue Reinforcement Device | K262729 |
| Aug 18, 2026 | Grace Medical, Inc. | Tympendi (810) | K260266 |
| Aug 4, 2026 | Medimetrix, LLC | Marrow Marxman | K260572 |
- Oct 29, 2026Medtronic Sofamor Danek USA, Inc.
Symmetrix PX Spinal System
- Oct 21, 2026TheraMicro
TeKBrace Knotless Anchor
- Oct 1, 2026Microport Orthopedics, Inc.
NEXUS Hip Stem
- Sep 25, 2026Siemens Medical Solutions USA, Inc.
syngo.CT Brain Quantification
- Sep 23, 2026ProNova Solutions
VIRTUE QA
- Sep 8, 2026Smith & Nephew, Inc.
LANDMARK Total Knee System
- Aug 26, 2026Heartvue.ai, Inc.
Heartvue.Proton
- Aug 21, 2026Microport Orthopedics, Inc.
EVOLUTION AM BIOFOAM Tibial System
- Aug 18, 2026Theramicro
TeKBrace Solo Soft Tissue Reinforcement Device
- Aug 18, 2026Grace Medical, Inc.
Tympendi (810)
- Aug 4, 2026Medimetrix, LLC
Marrow Marxman
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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