Indiana FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance and a Indiana 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: 7.
For contract manufacturers and test labs
Indiana had 11 US 510(k) clearances in the last 90 days and 37 in the last 12 months. The product code with the most clearances in this window is LSE (Epstein-Barr Virus, Other). Contract manufacturers and test labs that sell to device companies in Indiana 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 |
|---|---|---|
LSE | Epstein-Barr Virus, Other | 2 |
HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 |
LJN | Antibody Igm, If, Epstein-Barr Virus | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 2, 2026 | Roche Diagnostics | Elecsys EBV IgM | K260233 |
| Oct 2, 2026 | Roche Diagnostics | Elecsys EBV VCA IgG | K260232 |
| Oct 2, 2026 | Roche Diagnostics | Elecsys EBV EBNA IgG | K260221 |
| Sep 30, 2026 | Duet Spine Holdings, LLC | Duet Spinal Fixation System | K262712 |
| Sep 24, 2026 | Zimmer, Inc. | OsseoFit Stemless Shoulder System | K262955 |
| Sep 24, 2026 | OrthoPediatrics Corp. | Pediatric Nailing Platform Femur | K261345 |
| Sep 23, 2026 | Zimmer Biomet | G7 Acetabular System | K261453 |
| Sep 4, 2026 | Depuy Orthopaedics, Inc. | ATTUNE Revision Knee System | K262130 |
| Aug 24, 2026 | Biomet Orthopedics, Inc. | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi Sleeves and Augments | K253515 |
| Aug 19, 2026 | Roche Diagnostics | Elecsys Phospho-Tau (217P) Plasma | K261686 |
| Aug 13, 2026 | Hill-Rom, Inc. | Dashboard (P007000) | K260211 |
- Oct 2, 2026Roche Diagnostics
Elecsys EBV IgM
- Oct 2, 2026Roche Diagnostics
Elecsys EBV VCA IgG
- Oct 2, 2026Roche Diagnostics
Elecsys EBV EBNA IgG
- Sep 30, 2026Duet Spine Holdings, LLC
Duet Spinal Fixation System
- Sep 24, 2026Zimmer, Inc.
OsseoFit Stemless Shoulder System
- Sep 24, 2026OrthoPediatrics Corp.
Pediatric Nailing Platform Femur
- Sep 23, 2026Zimmer Biomet
G7 Acetabular System
- Sep 4, 2026Depuy Orthopaedics, Inc.
ATTUNE Revision Knee System
- Aug 24, 2026Biomet Orthopedics, Inc.
Zimmer Biomet OSS Orthopedic Salvage System OsseoTi Sleeves and Augments
- Aug 19, 2026Roche Diagnostics
Elecsys Phospho-Tau (217P) Plasma
- Aug 13, 2026Hill-Rom, Inc.
Dashboard (P007000)
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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