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FDA device clearances in North Carolina

Every FDA 510(k) decision for applicants based in North Carolina in the last 12 months, with the device, the product area and FDA's own record.

Decisions25
Applicants21

25 premarket notifications (510(k)s) from applicants based in North Carolina were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.

DecidedApplicantDeviceAreaWhereRecord
2026-09-30Qpix Solutions, Inc.EzSensor HD MUHDentalMorrisville, North CarolinaK261663
2026-09-30Spinal Alignment Solutions, Inc.SAS MIS Pelvic Incidence Rods NKBOrthopedicWilmington, North CarolinaK263172
2026-09-11Baebies, Inc.FINDER Flu A&B/SARS-CoV-2 Test QOFMicrobiologyDurham, North CarolinaK261837
2026-08-26Bioventus, LLCStimTrial Neuromodulation System GZFNeurologyDurham, North CarolinaK253877
2026-07-27Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)ARCHIMEDES Biodegradable Stent (Medium) FGEGastroenterology, UrologyCharlotte, North CarolinaK260835
2026-07-09Teleflex Medical, LLCMonodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture NEWGeneral, Plastic SurgeryMorrisville, North CarolinaK261988
2026-07-01Restor3DVeritas Shoulder System PHXOrthopedicDurham, North CarolinaK260556
2026-06-12Konica Minolta Healthcare Americas, Inc.Universal 1417PI MQBRadiologyGarner, North CarolinaK252996
2026-06-11Smart Denture Conversions, LLCOmni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) NHADentalApex, North CarolinaK254145
2026-06-02Wilson-Cook Medical, Inc.Hemospray Endoscopic Hemostat (HEMO-[X]) QAUGeneral, Plastic SurgeryWinston-Salem, North CarolinaK253302
2026-05-21Ulthera, Inc.Ulthera® System OHVGeneral, Plastic SurgeryRaleigh, North CarolinaK260618
2026-05-12Asensus SurgicalSenhance Ultrasonic System NAYGastroenterology, UrologyDurham, North CarolinaK254192
2026-05-07Restor3DVeritas Reverse Total Shoulder System PHXOrthopedicDurham, North CarolinaK253992
2026-05-06Teleflex Medical, LLCPolyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ GATGeneral, Plastic SurgeryMorrisville, North CarolinaK260775
2026-03-30Baebies, Inc.FINDER Flu A&B/SARS-CoV-2 Test QOFMicrobiologyDurham, North CarolinaK252269
2026-03-13Zeto, Inc.New Wave System GWQNeurologyRaleigh, North CarolinaK260455
2026-03-10Reselute, Inc.Reselute Tibial Nail HSBOrthopedicDurham, North CarolinaK253517
2026-02-06Live Medica, LLCLiveMedica Enterprise PACS LLZRadiologyRaleigh, North CarolinaK253927
2026-01-29Medtox Diagnostics, Inc.Labcorp Fentanyl Urine Visual Test DJGClinical ToxicologyBurlington, North CarolinaK252684
2026-01-12Sioxmed, LLCSBC1 Cream FROUnknownWinston Salem, North CarolinaK250890
2025-12-05Restor3D, Inc.Velora Acetabular System LPHOrthopedicDurham, North CarolinaK252067
2025-11-21Staclear, Inc.StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) QLYGeneral HospitalRaleigh, North CarolinaK251849
2025-11-10Qpix Solutions, Inc.EzSensor HD, EzSensor UHD MUHDentalMorrisville, North CarolinaK252570
2025-10-30Arctx MedicalArctx Cool Catheter Set PLACardiovascularRaleigh, North CarolinaK250632
2025-10-23Terarecon,Inc.TeraRecon Cardiovascular.Calcification.CT QIHRadiologyDurham, North CarolinaK250288

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.

All device clearances

Cite this page

Permanent URL: https://mentionfox.com/fda/510k/state/nc
Last updated 2026-10-18
FDA device clearances in North Carolina: 25 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/nc