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FDA device clearances in Michigan

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

Decisions14
Applicants9

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

DecidedApplicantDeviceAreaWhereRecord
2026-09-17Stryker InstrumentsNeptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) GEIGeneral, Plastic SurgeryPortage, MichiganK261959
2026-09-10INVIA, LLC4DM QIHRadiologyAnn Arbor, MichiganK260879
2026-09-08Shoulder Innovations, Inc.N22 Offset Humeral Head KWTOrthopedicGrand Rapids, MichiganK262173
2026-07-16Pioneer Surgical Technology, Inc.Cable-Ready® Cable Grip System JDQOrthopedicMarquette, MichiganK261271
2026-06-17Stryker InstrumentsHydro Irrigation System EOBEar, Nose, ThroatPortage, MichiganK261544
2026-06-05Balosmark, Inc.Perfect-O Ostial Positioning Catheter DQYCardiovascularKalamazoo, MichiganK260289
2026-05-24Parallel Robotics, LLCMediBot Needle Driver Uno GCJGastroenterology, UrologyAnn Arbor, MichiganK260183
2026-05-08Stryker InstrumentsHydro Irrigation System GWGNeurologyPortage, MichiganK253679
2026-04-13Shoulder Innovations, Inc.InSet Reverse Total Shoulder System PHXOrthopedicGrand Rapids, MichiganK254128
2026-03-16Stryker InstrumentsSurgiCount+ System PBZGeneral HospitalPortage, MichiganK252282
2026-01-17Auxilium Biotechnologies, Inc.NeuroSpan Bridge JXINeurologyAnn Arbor, MichiganK253363
2026-01-15Thera B Medical ProductsSnugLit(TM) Wearable Phototherapy System (SNGL-01-US) LBIGeneral HospitalEast Lansing, MichiganK251308
2026-01-15Shoulder Innovations, Inc.N22 EZ Glenosphere PHXOrthopedicGrand Rapids, MichiganK252516
2025-12-11Hyperflex MedicalHyperFlex® Bunion Correction System HRSOrthopedicPort Huron, MichiganK252997

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/mi
Last updated 2026-10-18
FDA device clearances in Michigan: 14 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/mi