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FDA device clearances in Oregon

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

Decisions10
Applicants7

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

DecidedApplicantDeviceAreaWhereRecord
2026-09-29Riverpoint Medical, LLCFast Absorbing PGLA GAMGeneral, Plastic SurgeryPortland, OregonK263073
2026-08-27Riverpoint MedicalIconix Knotless T MBIOrthopedicPortland, OregonK262677
2026-05-22Tz Medical, Inc.Arc Adjustable Radial Cuff Compression Device DXCCardiovascularTualatin, OregonK252772
2026-05-01Biotronik, Inc.BIOMONITOR IV (471155) MXDCardiovascularLake Oswego, OregonK261074
2026-03-25Letus CorporationMiraChlor Antimicrobial Wound Solution FROUnknownHappy Valley, OregonK252023
2026-03-11Riverpoint Medical, LLCStrut Suture; No-Tie Button MBIOrthopedicPortland, OregonK253693
2026-02-27Riverpoint Medical, LLCLigaMend MBIOrthopedicPortland, OregonK253695
2025-12-19Surgical Instrument Service and Savings, Inc.Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer PNECardiovascularRedmond, OregonK250314
2025-11-26Surgical Instrument Service and Savings, Inc.Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter NLHCardiovascularRedmond, OregonK252405
2025-11-12Revmedx, Inc.XSTAT P15 PGZGeneral, Plastic SurgeryWilsonville, OregonK253290

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