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FDA device clearances in Arizona

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

Decisions19
Applicants16

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

DecidedApplicantDeviceAreaWhereRecord
2026-09-23Costa Surgical, Inc.ProRib Fixation System HRSOrthopedicChandler, ArizonaK261892
2026-09-01Sequitur Health Corp.AMI™ Plasma Cartridge, AMI™ JIDClinical ChemistryPhoenix, ArizonaK260613
2026-08-19Nipro Technical Solutions, IncoporatedNipro Dry Acid Concentrate Mixer KPOGastroenterology, UrologyMesa, ArizonaK260799
2026-08-14Bard Peripheral Vascular, Inc.EnCor EnCompass™ Breast Biopsy and Tissue Removal System KNWGastroenterology, UrologyTempe, ArizonaK262571
2026-07-31Foundation Surgical GroupInterwedge® Standalone Lateral OVDOrthopedicScottsdale, ArizonaK261809
2026-07-31Foundation Surgical GroupVertiwedge® Intraosseous System MQPOrthopedicScottsdale, ArizonaK261810
2026-07-27Accurate Access, LLCND Needle Guidance System ITXRadiologyParadise Valley, ArizonaK262474
2026-06-18Stryker Sustainability SolutionsRemanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating GEIGeneral, Plastic SurgeryTempe, ArizonaK260636
2026-05-06Intervention Tech, Inc. ; dba CorventionKardiaPSI Balloon Catheter OZTCardiovascularFlagstaff, ArizonaK253855
2026-04-16Foundation Surgical Group, Inc.Foundation Surgical Navigated Lateral Disc Prep Instruments OLONeurologyScottsdale, ArizonaK260011
2026-03-18Fusion Orthopedics USA, LLCFusion FibFix Nail HSBOrthopedicMesa, ArizonaK252961
2026-03-04Satori Orthopaedics, Inc.Active Intramedullary (AIM) Tibial Nail System HSBOrthopedicPhoenix, ArizonaK252025
2026-02-111World Vista MedicalSteriHub™ Disinfecting Device and Protective Cover QBPGeneral HospitalRio Verde, ArizonaK251592
2026-02-04Bard Peripheral Vascular, Inc.UltraScore™ Focused Force PTA Balloon PNOCardiovascularTempe, ArizonaK260012
2026-01-14Ziehm-Orthoscan, Inc.Orthoscan TAU MVP Mini C-Arm System OXORadiologyScottsdale, ArizonaK252579
2026-01-07Innovative HealthReprocessed Agilis NxT Steerable Introducer PNECardiovascularScottsdale, ArizonaK250305
2025-12-12Bard Peripheral Vascular, Inc.EnCor EnCompass™ Breast Biopsy and Tissue Removal System KNWGastroenterology, UrologyTempe, ArizonaK252681
2025-11-06Motive Health, Inc.Motive™ Muscle Stimulator for Lower Back (OT01-1003) NGXPhysical MedicineTempe, ArizonaK253478
2025-10-27Patriot Laser, LLCPatriot Duo GEXGeneral, Plastic SurgeryPhoenix, ArizonaK251824

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/az
Last updated 2026-10-18
FDA device clearances in Arizona: 19 510(k) decisions in the last 12 months. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k/state/az