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Data / Medical devices / Interventional Fluoroscopic X-Ray System / United States

FDA-registered makers of Interventional Fluoroscopic X-Ray System in the United States: 38 establishments

38 establishments in the United States are registered with the FDA to make Interventional Fluoroscopic X-Ray System (product code OWB). 21 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
Interventional Fluoroscopic X-Ray System
Product code
OWB
Country
United States

Makers of Interventional Fluoroscopic X-Ray System in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ge Oec Medical Systems, IncSalt Lake City, UT, United StatesManufacturer12August 10, 2017070api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer5November 16, 2017000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer5November 16, 2017000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesManufacturer3June 21, 2024000api.fda.gov
MEDTRONIC NAVIGATION, INC. (Boxborough)Boxborough, MA, United StatesRemanufacturer, Specification developer3June 21, 20240100api.fda.gov
Omega Medical Imaging, LLCSanford, FL, United StatesManufacturer, Specification developer3November 17, 2021000api.fda.gov
Volcano CorporationRancho Cordova, CA, United StatesManufacturer3April 12, 2019010api.fda.gov
Volcano CorporationSan Diego, CA, United StatesComplaint file establishment, Specification developer3April 12, 2019000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer2November 16, 2017000api.fda.gov
Nview MedicalSalt Lake City, UT, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2December 28, 2022000api.fda.gov
Oxos Medical, IncAtlanta, GA, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler2December 22, 2025010api.fda.gov
TRACKX TECHNOLOGY Inc.Hillsborough, NC, United StatesManufacturer2March 5, 2020020api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer1May 22, 2024000api.fda.gov
Aspen Imaging Healthcare, IncPlano, TX, United StatesManufacturer, Remanufacturer, Repackager or relabeler1April 3, 2020000api.fda.gov
Accogent PauschEatontown, NJ, United StatesManufacturer1December 5, 2008000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer1May 22, 2024000api.fda.gov
Circinus Medical Technology, LLCConcord, MA, United StatesSpecification developer1December 1, 2022000api.fda.gov
Globus Medical, Inc.Methuen, MA, United StatesManufacturer1August 12, 2021000api.fda.gov
Kimball Solutions Jasper, Inc.Jasper, IN, United StatesContract manufacturer, Repackager or relabeler1April 12, 2019000api.fda.gov
Pulmera Inc.Charlotte, NC, United StatesSpecification developer1May 22, 2026000api.fda.gov
Xoran Technologies, LLCAnn Arbor, MI, United StatesComplaint file establishment, Manufacturer, Remanufacturer1July 28, 2022000api.fda.gov
Angiowave Imaging, Inc.Concord, MA, United StatesManufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
Anholt Technologies Inc.Avondale, PA, United StatesManufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Imaging Engineering, LLCGainesville, FL, United StatesManufacturer0000api.fda.gov
Kapstone ManufacturingCharlotte, NC, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Spectrum Assembly Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Sage Product Development, Inc.Foxborough, MA, United StatesContract manufacturer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Wheelhouse MedicalMonroe, NC, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.