Data / FDA device clearances / Maryland
FDA device clearances in Maryland: 63 since Nov 2024
The full list. FDA device clearances for applicants in Maryland: 63 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 4 rows a month. The new rows come each week by email, $19 a month.
Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery.
For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/state/maryland, and every list with its row count and price is at https://specstream.ai/data/lists.json.
Updated October 27, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).
FDA made 63 device decisions for applicants in Maryland from November 26, 2024 to October 27, 2026: 36 510(k) clearances and De Novo grants and 27 PMA approvals and supplements, for 32 applicants. The newest, K261379 on October 27, 2026, is BD Veritor System for SARS-CoV-2 from BD Diagnostic Solutions / Becton, Dickinson & Company.
The request: Every new FDA device clearance or approval for a company in Maryland, with its address, the device and the product code. $10 of credit on sign-up, no card.
SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.
- 63Decisions
- 36510(k) and De Novo
- 27PMA
- October 27, 2026Latest decision
Newest decisions
The newest 63 of 63, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.
| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
|---|---|---|---|---|---|---|---|---|
| October 27, 2026 | K261379 | BD Veritor System for SARS-CoV-2 | BD Diagnostic Solutions / Becton, Dickinson & Company | Maryland | Substantially Equivalent | De Novo (dual track) | QVF | accessdata.fda.gov |
| October 16, 2026 | P240033/S002 | LungFX Device | Lung Bioengineering, Inc. | Maryland | Approved | PMA 180-day supplement | PHO | accessdata.fda.gov |
| October 16, 2026 | P240033/S001 | LungFX Device | Lung Bioengineering, Inc. | Maryland | Approved | PMA 180-day supplement | PHO | accessdata.fda.gov |
| October 15, 2026 | K260827 | Oncomine Dx Express Test | Life Technologies Corporation | Maryland | Substantially Equivalent | 510(k) traditional | SBY | accessdata.fda.gov |
| October 14, 2026 | P010033/S053 | QuantiFERON-TB Gold Plus Test | Qiagen | Maryland | 30-day notice accepted | PMA 30-day notice | NCD | accessdata.fda.gov |
| September 14, 2026 | K262163 | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth | Becton Dickinson and Company | Maryland | Substantially Equivalent | 510(k) traditional | JTZ | accessdata.fda.gov |
| September 11, 2026 | K262874 | CraniUS Plate | CraniUS, LLC | Maryland | Substantially Equivalent | 510(k) special | GWO | accessdata.fda.gov |
| September 9, 2026 | P240040/S005 | Oncomine Dx Express Test | Life Technologies Corporation | Maryland | Approved | PMA panel track supplement | PQP | accessdata.fda.gov |
| September 4, 2026 | K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | Maryland | Substantially Equivalent | 510(k) traditional | LLZ | accessdata.fda.gov |
| August 19, 2026 | P160037/S027 | BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR HPV Extraction Trough (SKU 444074) | Becton, Dickinson and Company | Maryland | Approved | PMA 180-day supplement | MAQ | accessdata.fda.gov |
| August 14, 2026 | P160037/S028 | BD Onclarity HPV Assay | Becton, Dickinson and Company | Maryland | Approved | PMA real-time process supplement | MAQ | accessdata.fda.gov |
| August 4, 2026 | P930038/S107 | Angio Seal VIP Vascular Closure Device | Terumo Medical Corporation | Maryland | Approved | PMA 135-day supplement | MGB | accessdata.fda.gov |
| July 31, 2026 | P160036/S008 | Hintermann Series H3 Total Ankle Replacement System | Dt Medtech, LLC | Maryland | Approved | PMA 180-day supplement | NTG | accessdata.fda.gov |
| July 30, 2026 | P250036 | PGDx elio tissue complete CDx | Personal Genome Diagnostics, Inc. | Maryland | Approved | PMA original approval | PQP | accessdata.fda.gov |
| July 29, 2026 | K261058 | CraniUS Plate | CraniUS, LLC | Maryland | Substantially Equivalent | 510(k) traditional | GWO | accessdata.fda.gov |
| July 26, 2026 | K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | Maryland | Substantially Equivalent | 510(k) traditional | DQK | accessdata.fda.gov |
| June 25, 2026 | K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm... | Longeviti Neuro Solutions | Maryland | Substantially Equivalent | 510(k) traditional | GXN | accessdata.fda.gov |
| June 22, 2026 | P240033 | LungFX device | Lung Bioengineering, Inc. | Maryland | Approved | PMA original approval | PHO | accessdata.fda.gov |
| June 18, 2026 | K253116 | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | Maryland | Substantially Equivalent | 510(k) traditional | GXN | accessdata.fda.gov |
| June 8, 2026 | P240040/S006 | Oncomine Dx Express Test | Life Technologies Corporation | Maryland | 30-day notice accepted | PMA 30-day notice | PQP | accessdata.fda.gov |
| May 28, 2026 | K260213 | BD BACTEC FXI Culture System | BD Diagnostic Systems | Maryland | Substantially Equivalent | 510(k) traditional | MDB | accessdata.fda.gov |
| April 21, 2026 | K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | Maryland | Substantially Equivalent | 510(k) special | MBI | accessdata.fda.gov |
| April 10, 2026 | K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | Maryland | Substantially Equivalent | 510(k) traditional | DYB | accessdata.fda.gov |
| April 2, 2026 | P160037/S025 | BD Onclarity HPV Assay | Becton, Dickinson and Company | Maryland | Approved | PMA 180-day supplement | MAQ | accessdata.fda.gov |
| April 2, 2026 | P160037/S024 | BD Onclarity HPV Assay | Becton, Dickinson and Company | Maryland | Approved | PMA 180-day supplement | MAQ | accessdata.fda.gov |
| April 2, 2026 | K260184 | Onclarity Self-Collection Kit | Becton, Dickinson and Company | Maryland | Substantially Equivalent | 510(k) traditional | SEP | accessdata.fda.gov |
| March 23, 2026 | K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | Maryland | Substantially Equivalent | 510(k) traditional | GAT | accessdata.fda.gov |
| March 19, 2026 | P160048/S031 | Eversense® Continuous Glucose Monitoring System | Senseonics, Incorporated | Maryland | Approved | PMA 180-day supplement | QCD | accessdata.fda.gov |
| February 12, 2026 | P160037/S026 | BD FOX PCR Extraction Tubes; BD Onclarity HPV Assay | Becton, Dickinson and Company | Maryland | 30-day notice accepted | PMA 30-day notice | MAQ | accessdata.fda.gov |
| January 23, 2026 | P010033/S052 | QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus Test | Qiagen | Maryland | 30-day notice accepted | PMA 30-day notice | NCD | accessdata.fda.gov |
| December 4, 2025 | K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | Maryland | Substantially Equivalent | 510(k) traditional | MBI | accessdata.fda.gov |
| November 21, 2025 | P010033/S051 | QuantiFERON-TB Gold Plus Test | Qiagen | Maryland | Approved | PMA real-time process supplement | NCD | accessdata.fda.gov |
| October 31, 2025 | K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric... | Becton, Dickinson and Company | Maryland | Substantially Equivalent | 510(k) traditional | PCI | accessdata.fda.gov |
| October 22, 2025 | P240040/S003 | Oncomine Dx Express Test | Life Technologies Corporation | Maryland | 30-day notice accepted | PMA 30-day notice | PQP | accessdata.fda.gov |
| October 17, 2025 | K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | Maryland | Substantially Equivalent | 510(k) abbreviated | LZA | accessdata.fda.gov |
| October 15, 2025 | P240040/S002 | Oncomine Dx Express Test | Life Technologies Corporation | Maryland | Approved | PMA 180-day supplement | PQP | accessdata.fda.gov |
| September 26, 2025 | K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | Maryland | Substantially Equivalent | 510(k) traditional | BZQ | accessdata.fda.gov |
| August 25, 2025 | P160037/S022 | BD ONCLARITY HPV ASSAY | Becton, Dickinson and Company | Maryland | Approved | PMA 180-day supplement | MAQ | accessdata.fda.gov |
| August 8, 2025 | K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Becton, Dickinson and Company | Maryland | Substantially Equivalent | 510(k) traditional | LON | accessdata.fda.gov |
| August 7, 2025 | P930038/S106 | Angio-Seal Vascular Closure Device | Terumo Medical Corporation | Maryland | 30-day notice accepted | PMA 30-day notice | MGB | accessdata.fda.gov |
| August 7, 2025 | P240040/S001 | Oncomine Dx Express Test | Life Technologies Corporation | Maryland | 30-day notice accepted | PMA 30-day notice | PQP | accessdata.fda.gov |
| August 1, 2025 | K243496 | MycoMEIA Aspergillus Assay | Pearl Diagnostics, Inc. | Maryland | Substantially Equivalent | 510(k) traditional | NOM | accessdata.fda.gov |
| July 2, 2025 | P240040 | Oncomine Dx Express Test | Life Technologies Corporation | Maryland | Approved | PMA original approval | PQP | accessdata.fda.gov |
| July 2, 2025 | P160037/S023 | BD Onclarity HPV Assay | Becton, Dickinson and Company | Maryland | Approved | PMA real-time process supplement | MAQ | accessdata.fda.gov |
| June 16, 2025 | K243872 | BD Veritor System for SARS-CoV-2 | Becton, Dickinson and Company | Maryland | Substantially Equivalent | De Novo (dual track) | QVF | accessdata.fda.gov |
| June 13, 2025 | K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX... | Fresenius Medical Care Renal Therapies Group, LLC | Maryland | Substantially Equivalent | 510(k) traditional | KDI | accessdata.fda.gov |
| May 19, 2025 | K250447 | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton, Dickinson and Company | Maryland | Substantially Equivalent | 510(k) traditional | LON | accessdata.fda.gov |
| April 29, 2025 | K242211 | PUMA-G Pediatric System | Coaptech, Inc. | Maryland | Substantially Equivalent | 510(k) traditional | KGC | accessdata.fda.gov |
| April 23, 2025 | K243479 | EchoGuide (Version 1) | Sonavex, Inc. | Maryland | Substantially Equivalent | 510(k) traditional | IYO | accessdata.fda.gov |
| April 22, 2025 | K243343 | BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, | Maryland | Substantially Equivalent | 510(k) traditional | QEP | accessdata.fda.gov |
| April 18, 2025 | K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | Maryland | Substantially Equivalent | 510(k) traditional | FMI | accessdata.fda.gov |
| April 11, 2025 | K242748 | Oncospace | Oncospace, Inc. | Maryland | Substantially Equivalent | 510(k) traditional | MUJ | accessdata.fda.gov |
| March 27, 2025 | P160048/S029 | EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM | Senseonics, Incorporated | Maryland | Approved | PMA 180-day supplement | QHJ | accessdata.fda.gov |
| March 27, 2025 | K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max... | Access Vascular, Inc. | Maryland | Substantially Equivalent | 510(k) special | FOZ | accessdata.fda.gov |
| March 27, 2025 | K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | Maryland | Substantially Equivalent | 510(k) traditional | GAT | accessdata.fda.gov |
| March 12, 2025 | P160037/S021 | Onclarity HPV Assay | Becton, Dickinson and Company | Maryland | Approved | PMA 180-day supplement | MAQ | accessdata.fda.gov |
| March 7, 2025 | K243515 | EpiWatch Monitoring System | Epiwatch, Inc. | Maryland | Substantially Equivalent | 510(k) traditional | POS | accessdata.fda.gov |
| March 6, 2025 | K250344 | BD Phoenix Automated Microbiology System | Becton, Dickinson and Company | Maryland | Substantially Equivalent | 510(k) special | LON | accessdata.fda.gov |
| February 19, 2025 | K243591 | OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC | Maryland | Substantially Equivalent | 510(k) traditional | OWN | accessdata.fda.gov |
| December 20, 2024 | K243149 | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | Congruence Medical Solutions, LLC | Maryland | Substantially Equivalent | 510(k) traditional | QLY | accessdata.fda.gov |
| December 20, 2024 | K242529 | Tigon Medical All-Suture Anchors (ASA) | Tigon Medical | Maryland | Substantially Equivalent | 510(k) traditional | MBI | accessdata.fda.gov |
| December 19, 2024 | K243725 | BD Vaginal Panel | Becton, Dickinson and Company | Maryland | Substantially Equivalent | 510(k) special | PQA | accessdata.fda.gov |
| November 26, 2024 | P930038/S105 | ANGIO-SEAL VIP Vascular Closure Device | Terumo Medical Corporation | Maryland | 30-day notice accepted | PMA 30-day notice | MGB | accessdata.fda.gov |
Applicants with the most decisions
| Applicant | Decisions | Latest |
|---|---|---|
| Becton, Dickinson and Company | 15 | August 19, 2026 |
| Life Technologies Corporation | 7 | October 15, 2026 |
| Lung Bioengineering, Inc. | 3 | October 16, 2026 |
| Qiagen | 3 | October 14, 2026 |
| Terumo Medical Corporation | 3 | August 4, 2026 |
| Tigon Medical | 3 | April 21, 2026 |
| CraniUS, LLC | 2 | September 11, 2026 |
| Threadstone, LLC | 2 | March 23, 2026 |
| Senseonics, Incorporated | 2 | March 19, 2026 |
| BD Diagnostic Solutions / Becton, Dickinson & Company | 1 | October 27, 2026 |
| Becton Dickinson and Company | 1 | September 14, 2026 |
| Radiopharmaceutical Imaging & Dosimetry, LLC | 1 | September 4, 2026 |
| Dt Medtech, LLC | 1 | July 31, 2026 |
| Personal Genome Diagnostics, Inc. | 1 | July 30, 2026 |
| Analytics For Life, Inc. | 1 | July 26, 2026 |
| Longeviti Neuro Solutions | 1 | June 25, 2026 |
| The Surgeon General, Department of the Army (TSG-DA) | 1 | June 18, 2026 |
| BD Diagnostic Systems | 1 | May 28, 2026 |
| Protaryx Medical, Inc. | 1 | April 10, 2026 |
| Program Insite, LLC | 1 | October 17, 2025 |
By panel
| Panel | Decisions | Latest |
|---|---|---|
| Microbiology | 23 | October 27, 2026 |
| Pathology | 7 | October 15, 2026 |
| Gastroenterology, Urology | 6 | October 16, 2026 |
| Neurology | 5 | September 11, 2026 |
| Cardiovascular | 5 | August 4, 2026 |
| Orthopedic | 4 | July 31, 2026 |
| General Hospital | 4 | October 17, 2025 |
| Radiology | 3 | September 4, 2026 |
| General, Plastic Surgery | 2 | March 23, 2026 |
| Clinical Chemistry | 2 | March 19, 2026 |
| Medical Genetics | 1 | July 30, 2026 |
| Anesthesiology | 1 | September 26, 2025 |
By decision type
| Decision type | Decisions | Latest |
|---|---|---|
| 510(k) traditional | 28 | October 15, 2026 |
| PMA 180-day supplement | 11 | October 16, 2026 |
| PMA 30-day notice | 8 | October 14, 2026 |
| 510(k) special | 5 | September 11, 2026 |
| PMA real-time process supplement | 3 | August 14, 2026 |
| PMA original approval | 3 | July 30, 2026 |
| De Novo (dual track) | 2 | October 27, 2026 |
| PMA panel track supplement | 1 | September 9, 2026 |
| PMA 135-day supplement | 1 | August 4, 2026 |
| 510(k) abbreviated | 1 | October 17, 2025 |
Where FDA publishes these decisions
CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.