14 premarket notifications (510(k)s) from applicants based in Maryland 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 |
|---|---|---|---|---|---|
| 2026-09-14 | Becton Dickinson and Company | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth JTZ | Microbiology | Sparks, Maryland | K262163 |
| 2026-09-11 | CraniUS, LLC | CraniUS Plate GWO | Neurology | Baltimore, Maryland | K262874 |
| 2026-09-04 | Radiopharmaceutical Imaging & Dosimetry, LLC | 3D-RD-S LLZ | Radiology | Baltimore, Maryland | K262060 |
| 2026-07-29 | CraniUS, LLC | CraniUS Plate GWO | Neurology | Baltimore, Maryland | K261058 |
| 2026-07-26 | Analytics For Life, Inc. | CorVista System® with PCWP Add-On DQK | Cardiovascular | Bethesda, Maryland | K253576 |
| 2026-06-25 | Longeviti Neuro Solutions | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) GXN | Neurology | Baltimore, Maryland | K260709 |
| 2026-06-18 | The Surgeon General, Department of the Army (TSG-DA) | 3D MAC Titanium Cranial Plate (TCP) System GXN | Neurology | Fort Detrick, Maryland | K253116 |
| 2026-05-28 | BD Diagnostic Systems | BD BACTEC FXI Culture System MDB | Microbiology | Sparks, Maryland | K260213 |
| 2026-04-21 | Tigon Medical | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line MBI | Orthopedic | Millersville, Maryland | K260921 |
| 2026-04-10 | Protaryx Medical, Inc. | Protaryx Transseptal Puncture Device (PTX2-001) DYB | Cardiovascular | Baltimore, Maryland | K260839 |
| 2026-04-02 | Becton, Dickinson and Company | Onclarity Self-Collection Kit SEP | Microbiology | Sparks, Maryland | K260184 |
| 2026-03-23 | Threadstone, LLC | HyperSuture All Green Extension Line GAT | General, Plastic Surgery | Millersville, Maryland | K254275 |
| 2025-12-04 | Tigon Medical | Tigon Medical Knotless and Dual Javelin All-Suture Anchors MBI | Orthopedic | Millersville, Maryland | K252596 |
| 2025-10-31 | Becton, Dickinson and Company | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System PCI | Microbiology | Sparks, Maryland | K250358 |
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
https://mentionfox.com/fda/510k/state/md