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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 dateNumberDeviceApplicantLocationDecisionTypeProduct codeSource
October 27, 2026K261379BD Veritor System for SARS-CoV-2BD Diagnostic Solutions / Becton, Dickinson & CompanyMarylandSubstantially EquivalentDe Novo (dual track)QVFaccessdata.fda.gov
October 16, 2026P240033/S002LungFX™ DeviceLung Bioengineering, Inc.MarylandApprovedPMA 180-day supplementPHOaccessdata.fda.gov
October 16, 2026P240033/S001LungFX™ DeviceLung Bioengineering, Inc.MarylandApprovedPMA 180-day supplementPHOaccessdata.fda.gov
October 15, 2026K260827Oncomine ™ Dx Express TestLife Technologies CorporationMarylandSubstantially Equivalent510(k) traditionalSBYaccessdata.fda.gov
October 14, 2026P010033/S053QuantiFERON-TB Gold Plus TestQiagenMaryland30-day notice acceptedPMA 30-day noticeNCDaccessdata.fda.gov
September 14, 2026K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton BrothBecton Dickinson and CompanyMarylandSubstantially Equivalent510(k) traditionalJTZaccessdata.fda.gov
September 11, 2026K262874CraniUS PlateCraniUS, LLCMarylandSubstantially Equivalent510(k) specialGWOaccessdata.fda.gov
September 9, 2026P240040/S005Oncomine™ Dx Express TestLife Technologies CorporationMarylandApprovedPMA panel track supplementPQPaccessdata.fda.gov
September 4, 2026K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLCMarylandSubstantially Equivalent510(k) traditionalLLZaccessdata.fda.gov
August 19, 2026P160037/S027BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR™ HPV Extraction Trough (SKU 444074)Becton, Dickinson and CompanyMarylandApprovedPMA 180-day supplementMAQaccessdata.fda.gov
August 14, 2026P160037/S028BD Onclarity™ HPV AssayBecton, Dickinson and CompanyMarylandApprovedPMA real-time process supplementMAQaccessdata.fda.gov
August 4, 2026P930038/S107Angio Seal VIP Vascular Closure DeviceTerumo Medical CorporationMarylandApprovedPMA 135-day supplementMGBaccessdata.fda.gov
July 31, 2026P160036/S008Hintermann Series H3 Total Ankle Replacement SystemDt Medtech, LLCMarylandApprovedPMA 180-day supplementNTGaccessdata.fda.gov
July 30, 2026P250036PGDx elio tissue complete CDxPersonal Genome Diagnostics, Inc.MarylandApprovedPMA original approvalPQPaccessdata.fda.gov
July 29, 2026K261058CraniUS PlateCraniUS, LLCMarylandSubstantially Equivalent510(k) traditionalGWOaccessdata.fda.gov
July 26, 2026K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.MarylandSubstantially Equivalent510(k) traditionalDQKaccessdata.fda.gov
June 25, 2026K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm...Longeviti Neuro SolutionsMarylandSubstantially Equivalent510(k) traditionalGXNaccessdata.fda.gov
June 22, 2026P240033LungFX™ deviceLung Bioengineering, Inc.MarylandApprovedPMA original approvalPHOaccessdata.fda.gov
June 18, 2026K2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)MarylandSubstantially Equivalent510(k) traditionalGXNaccessdata.fda.gov
June 8, 2026P240040/S006Oncomine Dx Express TestLife Technologies CorporationMaryland30-day notice acceptedPMA 30-day noticePQPaccessdata.fda.gov
May 28, 2026K260213BD BACTEC FXI Culture SystemBD Diagnostic SystemsMarylandSubstantially Equivalent510(k) traditionalMDBaccessdata.fda.gov
April 21, 2026K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon MedicalMarylandSubstantially Equivalent510(k) specialMBIaccessdata.fda.gov
April 10, 2026K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc.MarylandSubstantially Equivalent510(k) traditionalDYBaccessdata.fda.gov
April 2, 2026P160037/S025BD Onclarity HPV AssayBecton, Dickinson and CompanyMarylandApprovedPMA 180-day supplementMAQaccessdata.fda.gov
April 2, 2026P160037/S024BD Onclarity HPV AssayBecton, Dickinson and CompanyMarylandApprovedPMA 180-day supplementMAQaccessdata.fda.gov
April 2, 2026K260184Onclarity™ Self-Collection KitBecton, Dickinson and CompanyMarylandSubstantially Equivalent510(k) traditionalSEPaccessdata.fda.gov
March 23, 2026K254275HyperSuture All Green Extension LineThreadstone, LLCMarylandSubstantially Equivalent510(k) traditionalGATaccessdata.fda.gov
March 19, 2026P160048/S031Eversense® Continuous Glucose Monitoring SystemSenseonics, IncorporatedMarylandApprovedPMA 180-day supplementQCDaccessdata.fda.gov
February 12, 2026P160037/S026BD FOX™ PCR Extraction Tubes; BD Onclarity™ HPV AssayBecton, Dickinson and CompanyMaryland30-day notice acceptedPMA 30-day noticeMAQaccessdata.fda.gov
January 23, 2026P010033/S052QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus TestQiagenMaryland30-day notice acceptedPMA 30-day noticeNCDaccessdata.fda.gov
December 4, 2025K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon MedicalMarylandSubstantially Equivalent510(k) traditionalMBIaccessdata.fda.gov
November 21, 2025P010033/S051QuantiFERON-TB Gold Plus TestQiagenMarylandApprovedPMA real-time process supplementNCDaccessdata.fda.gov
October 31, 2025K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric...Becton, Dickinson and CompanyMarylandSubstantially Equivalent510(k) traditionalPCIaccessdata.fda.gov
October 22, 2025P240040/S003Oncomine Dx Express TestLife Technologies CorporationMaryland30-day notice acceptedPMA 30-day noticePQPaccessdata.fda.gov
October 17, 2025K252075Program insite® Powder-Free, Disposable Nitrile Exam GlovesProgram Insite, LLCMarylandSubstantially Equivalent510(k) abbreviatedLZAaccessdata.fda.gov
October 15, 2025P240040/S002Oncomine Dx Express TestLife Technologies CorporationMarylandApprovedPMA 180-day supplementPQPaccessdata.fda.gov
September 26, 2025K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.MarylandSubstantially Equivalent510(k) traditionalBZQaccessdata.fda.gov
August 25, 2025P160037/S022BD ONCLARITY HPV ASSAYBecton, Dickinson and CompanyMarylandApprovedPMA 180-day supplementMAQaccessdata.fda.gov
August 8, 2025K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and CompanyMarylandSubstantially Equivalent510(k) traditionalLONaccessdata.fda.gov
August 7, 2025P930038/S106Angio-Seal Vascular Closure DeviceTerumo Medical CorporationMaryland30-day notice acceptedPMA 30-day noticeMGBaccessdata.fda.gov
August 7, 2025P240040/S001Oncomine™ Dx Express TestLife Technologies CorporationMaryland30-day notice acceptedPMA 30-day noticePQPaccessdata.fda.gov
August 1, 2025K243496MycoMEIA Aspergillus AssayPearl Diagnostics, Inc.MarylandSubstantially Equivalent510(k) traditionalNOMaccessdata.fda.gov
July 2, 2025P240040Oncomine Dx Express TestLife Technologies CorporationMarylandApprovedPMA original approvalPQPaccessdata.fda.gov
July 2, 2025P160037/S023BD Onclarity HPV AssayBecton, Dickinson and CompanyMarylandApprovedPMA real-time process supplementMAQaccessdata.fda.gov
June 16, 2025K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and CompanyMarylandSubstantially EquivalentDe Novo (dual track)QVFaccessdata.fda.gov
June 13, 2025K2432372008T 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, LLCMarylandSubstantially Equivalent510(k) traditionalKDIaccessdata.fda.gov
May 19, 2025K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and CompanyMarylandSubstantially Equivalent510(k) traditionalLONaccessdata.fda.gov
April 29, 2025K242211PUMA-G Pediatric SystemCoaptech, Inc.MarylandSubstantially Equivalent510(k) traditionalKGCaccessdata.fda.gov
April 23, 2025K243479EchoGuide (Version 1)Sonavex, Inc.MarylandSubstantially Equivalent510(k) traditionalIYOaccessdata.fda.gov
April 22, 2025K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,MarylandSubstantially Equivalent510(k) traditionalQEPaccessdata.fda.gov
April 18, 2025K240355FROG (Filter Removal of Glass)Carrtech CorpMarylandSubstantially Equivalent510(k) traditionalFMIaccessdata.fda.gov
April 11, 2025K242748OncospaceOncospace, Inc.MarylandSubstantially Equivalent510(k) traditionalMUJaccessdata.fda.gov
March 27, 2025P160048/S029EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEMSenseonics, IncorporatedMarylandApprovedPMA 180-day supplementQHJaccessdata.fda.gov
March 27, 2025K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max...Access Vascular, Inc.MarylandSubstantially Equivalent510(k) specialFOZaccessdata.fda.gov
March 27, 2025K242201HyperSuture White/Green Extension LineThreadstone, LLCMarylandSubstantially Equivalent510(k) traditionalGATaccessdata.fda.gov
March 12, 2025P160037/S021Onclarity HPV AssayBecton, Dickinson and CompanyMarylandApprovedPMA 180-day supplementMAQaccessdata.fda.gov
March 7, 2025K243515EpiWatch Monitoring SystemEpiwatch, Inc.MarylandSubstantially Equivalent510(k) traditionalPOSaccessdata.fda.gov
March 6, 2025K250344BD Phoenix™ Automated Microbiology SystemBecton, Dickinson and CompanyMarylandSubstantially Equivalent510(k) specialLONaccessdata.fda.gov
February 19, 2025K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLCMarylandSubstantially Equivalent510(k) traditionalOWNaccessdata.fda.gov
December 20, 2024K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)Congruence Medical Solutions, LLCMarylandSubstantially Equivalent510(k) traditionalQLYaccessdata.fda.gov
December 20, 2024K242529Tigon Medical All-Suture Anchors (ASA)Tigon MedicalMarylandSubstantially Equivalent510(k) traditionalMBIaccessdata.fda.gov
December 19, 2024K243725BD Vaginal PanelBecton, Dickinson and CompanyMarylandSubstantially Equivalent510(k) specialPQAaccessdata.fda.gov
November 26, 2024P930038/S105ANGIO-SEAL VIP Vascular Closure DeviceTerumo Medical CorporationMaryland30-day notice acceptedPMA 30-day noticeMGBaccessdata.fda.gov

Applicants with the most decisions

ApplicantDecisionsLatest
Becton, Dickinson and Company15August 19, 2026
Life Technologies Corporation7October 15, 2026
Lung Bioengineering, Inc.3October 16, 2026
Qiagen3October 14, 2026
Terumo Medical Corporation3August 4, 2026
Tigon Medical3April 21, 2026
CraniUS, LLC2September 11, 2026
Threadstone, LLC2March 23, 2026
Senseonics, Incorporated2March 19, 2026
BD Diagnostic Solutions / Becton, Dickinson & Company1October 27, 2026
Becton Dickinson and Company1September 14, 2026
Radiopharmaceutical Imaging & Dosimetry, LLC1September 4, 2026
Dt Medtech, LLC1July 31, 2026
Personal Genome Diagnostics, Inc.1July 30, 2026
Analytics For Life, Inc.1July 26, 2026
Longeviti Neuro Solutions1June 25, 2026
The Surgeon General, Department of the Army (TSG-DA)1June 18, 2026
BD Diagnostic Systems1May 28, 2026
Protaryx Medical, Inc.1April 10, 2026
Program Insite, LLC1October 17, 2025

By panel

PanelDecisionsLatest
Microbiology23October 27, 2026
Pathology7October 15, 2026
Gastroenterology, Urology6October 16, 2026
Neurology5September 11, 2026
Cardiovascular5August 4, 2026
Orthopedic4July 31, 2026
General Hospital4October 17, 2025
Radiology3September 4, 2026
General, Plastic Surgery2March 23, 2026
Clinical Chemistry2March 19, 2026
Medical Genetics1July 30, 2026
Anesthesiology1September 26, 2025

By decision type

Decision typeDecisionsLatest
510(k) traditional28October 15, 2026
PMA 180-day supplement11October 16, 2026
PMA 30-day notice8October 14, 2026
510(k) special5September 11, 2026
PMA real-time process supplement3August 14, 2026
PMA original approval3July 30, 2026
De Novo (dual track)2October 27, 2026
PMA panel track supplement1September 9, 2026
PMA 135-day supplement1August 4, 2026
510(k) abbreviated1October 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.