MentionFox
Home › FDA device clearances › Delaware
FDA · 510(k) decisions

FDA device clearances in Delaware

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

Decisions15
Applicants10

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

DecidedApplicantDeviceAreaWhereRecord
2026-09-24Karl Storz SE & CO. KGKARL STORZ SUPRALOOP KNFObstetrics/GynecologyTuttlingen, DelawareK254303
2026-09-04MRI2CT, Inc.NextMR Spine QIHRadiologyClaymont, DelawareK260525
2026-09-02Hologic, Inc.I-View® MUERadiologyNewark, DelawareK254090
2026-08-31Evolym, LLCAerloom JOWCardiovascularWilmington, DelawareK254217
2026-08-14ADVAHEALTH SOLUTIONS, LLCAdvaView LLZRadiologyDover, DelawareK262449
2026-07-30VertigoDx, Inc.SMARTVERTIGO™ Vestibular Assessment System GWNNeurologyWilmington, DelawareK260566
2026-07-17Assure Tech., LLCAssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup NFTClinical ToxicologyWilmington, DelawareK261984
2026-06-05Assure Tech., LLCFastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test QYTMicrobiologyWilmington, DelawareK260754
2026-05-21Boston Aesthetics, Inc.Boston 2910 (Boston 2910) GEXGeneral, Plastic SurgeryWilmington, DelawareK253245
2026-05-11Karl Storz SE & CO. KGKARL STORZ Trocars with Valve Seals GCJGastroenterology, UrologyTuttlingen, DelawareK254228
2026-05-09Avanti Orthopaedics, LLCAvanti Distal Elbow ORIF System HRSOrthopedicWilmington, DelawareK261145
2026-02-27Siemens Healthcare Diagnostics, Inc.Atellica CH Diazo Total Bilirubin (D_TBil) CIGClinical ChemistryNewark, DelawareK251998
2026-01-30Boston Aesthetics, Inc.Boston PICO (Boston PICO) GEXGeneral, Plastic SurgeryWilmington, DelawareK251981
2026-01-21Boston Aesthetics, Inc.Boston Pico755 GEXGeneral, Plastic SurgeryWilmington, DelawareK252369
2026-01-12Boston Aesthetics, Inc.Boston iFace (Boston iFace) GEIGeneral, Plastic SurgeryWilmington, DelawareK251988

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/de
Last updated 2026-10-18
FDA device clearances in Delaware: 15 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/de