Decisions38
Applicants15
38 premarket notifications (510(k)s) from applicants based in Indiana were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.
| Decided | Applicant | Device | Area | Where | Record |
|---|---|---|---|---|---|
| 2026-10-02 | Roche Diagnostics | Elecsys EBV EBNA IgG LSE | Microbiology | Indianapolis, Indiana | K260221 |
| 2026-10-02 | Roche Diagnostics | Elecsys EBV VCA IgG LSE | Microbiology | Indianapolis, Indiana | K260232 |
| 2026-10-02 | Roche Diagnostics | Elecsys EBV IgM LJN | Microbiology | Indianapolis, Indiana | K260233 |
| 2026-09-30 | Duet Spine Holdings, LLC | Duet Spinal Fixation System NKB | Orthopedic | Winona Lake, Indiana | K262712 |
| 2026-09-24 | OrthoPediatrics Corp. | Pediatric Nailing Platform Femur HSB | Orthopedic | Warsaw, Indiana | K261345 |
| 2026-09-24 | Zimmer, Inc. | OsseoFit Stemless Shoulder System PKC | Orthopedic | Warsaw, Indiana | K262955 |
| 2026-09-23 | Zimmer Biomet | G7® Acetabular System LPH | Orthopedic | Warsaw, Indiana | K261453 |
| 2026-09-04 | Depuy Orthopaedics, Inc. | ATTUNE Revision Knee System JWH | Orthopedic | Warsaw, Indiana | K262130 |
| 2026-08-24 | Biomet Orthopedics, Inc. | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments JDI | Orthopedic | Warsaw, Indiana | K253515 |
| 2026-08-19 | Roche Diagnostics | Elecsys Phospho-Tau (217P) Plasma SET | Immunology | Indianapolis, Indiana | K261686 |
| 2026-08-13 | Hill-Rom, Inc. | Dashboard (P007000) MSX | Cardiovascular | Batesville, Indiana | K260211 |
| 2026-07-01 | Biomet, Inc. | OSSTM Orthopedic Salvage System JDI | Orthopedic | Warsaw, Indiana | K253434 |
| 2026-06-18 | Avalign Technologies, Inc. | CONDUIT ZERO-P VA Secured Spacer System OVE | Orthopedic | Fort Wayne, Indiana | K252982 |
| 2026-06-16 | Zimmer, Inc. | Z1 Hip System LZO | Orthopedic | Warsaw, Indiana | K260831 |
| 2026-06-16 | Zimmer, Inc. | Augment Off-Axis Instrument System PHX | Orthopedic | Warsaw, Indiana | K261683 |
| 2026-06-12 | Roche Diagnostics | cobas pulse blood glucose monitoring system PZI | Clinical Chemistry | Indianapolis, Indiana | K252323 |
| 2026-05-28 | Zimmer, Inc. | Zimmer® Persona® Personalized Knee System MBH | Orthopedic | Warsaw, Indiana | K251840 |
| 2026-05-22 | DePuy Orthopaedics, Inc. | DePuy ATTUNE Knee System OIY | Orthopedic | Warsaw, Indiana | K252887 |
| 2026-05-21 | Cork Medical | Nisus NPWT Canister 500-mL (CPC-500) OMP | General, Plastic Surgery | Indianapolis, Indiana | K261291 |
| 2026-05-19 | Biomet, Inc. | Taperloc® Complete Hip Stem LPH | Orthopedic | Warsaw, Indiana | K251270 |
| 2026-04-30 | OrthoPediatrics Corp. | OrthoPediatrics® Locking Cannulated Blade Plate System HRS | Orthopedic | Warsaw, Indiana | K260323 |
| 2026-04-27 | Zimmer, Inc. | Avenir® Müller Stem; Avenir Complete Hip System LZO | Orthopedic | Warsaw, Indiana | K260182 |
| 2026-04-15 | Biomet Orthopedics | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates PHX | Orthopedic | Warsaw, Indiana | K252404 |
| 2026-04-13 | Roche Diagnostics | Elecsys Anti-SARS-CoV-2 S QVP | Microbiology | Indianapolis, Indiana | K252280 |
| 2026-04-13 | Zimmer, Inc. | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) MBF | Orthopedic | Warsaw, Indiana | K253592 |
| 2026-04-07 | Roche Diagnostics | Elecsys Anti-HBc II SEI | Microbiology | Indianapolis, Indiana | K260046 |
| 2026-04-07 | Roche Diagnostics | Elecsys Anti-HBc IgM SEI | Microbiology | Indianapolis, Indiana | K260049 |
| 2026-04-02 | Roche Diagnostics | Tina-quant Cardiac high sensitivity CRP III NQD | Immunology | Indianapolis, Indiana | K260026 |
| 2026-03-17 | Serim Research | GUARDIAN Quick Dip Residual Chlorine (5212) FKJ | Gastroenterology, Urology | Elkhart, Indiana | K253863 |
| 2026-03-12 | Zimmer, Inc. | Affixus Retrograde Femoral Nailing System HSB | Orthopedic | Warsaw, Indiana | K253566 |
| 2026-03-11 | Kulzer, LLC | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One EBF | Dental | South Bend, Indiana | K260783 |
| 2026-03-09 | Zimmer, Inc. | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) MBH | Orthopedic | Warsaw, Indiana | K253189 |
| 2026-02-12 | Roche Diagnostics | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions CFR | Clinical Chemistry | Indianapolis, Indiana | K253490 |
| 2026-02-12 | Roche Diagnostics | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions CEM | Clinical Chemistry | Indianapolis, Indiana | K253491 |
| 2026-02-04 | Zimmer, Inc. | G7® Revision Acetabular System LPH | Orthopedic | Warsaw, Indiana | K252623 |
| 2025-12-19 | Kulzer, LLC | iCEM Universal Plus EMA | Dental | South Bend, Indiana | K254063 |
| 2025-12-17 | Roche Diagnostics | Elecsys Anti-SARS-CoV-2 QVP | Microbiology | Indianapolis, Indiana | K253839 |
| 2025-10-24 | Roche Diagnostics | CoaguChek XS Plus System GJS | Hematology | Indianapolis, Indiana | K253188 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
Cite this page
Permanent URL:
https://mentionfox.com/fda/510k/state/inLast updated 2026-10-18
FDA device clearances in Indiana: 38 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/in