Skip to the page
Get started – free

Data / Medical devices / Transducer, Ultrasonic, Diagnostic / United States

FDA-registered makers of Transducer, Ultrasonic, Diagnostic in the United States: 105 establishments

105 establishments in the United States are registered with the FDA to make Transducer, Ultrasonic, Diagnostic (product code ITX). 28 have a 510(k) clearance or PMA approval on file and 10 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.

Get makers of this device in the United StatesWatch these makers
Device
Transducer, Ultrasonic, Diagnostic
Product code
ITX
Country
United States

Makers of Transducer, Ultrasonic, Diagnostic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CIVCO Medical Instruments Co., Inc.Coralville, IA, United StatesManufacturer, Specification developer15December 22, 2023080api.fda.gov
Sheathing Technologies, Inc.Morgan Hill, CA, United StatesManufacturer, Repackager or relabeler6March 4, 2016010api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer4April 17, 2020000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Specification developer3April 17, 2020000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer3May 22, 2017010api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer, Specification developer3July 17, 2018000api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesManufacturer, Repackager or relabeler, Specification developer2August 2, 2023010api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer2May 20, 2003000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer2September 6, 2002000api.fda.gov
Esi, Inc.Minneapolis, MN, United StatesManufacturer2December 5, 2008000api.fda.gov
Fujifilm Sonosite,inc.Bothell, WA, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Specification developer2August 12, 2010010api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer2November 3, 2010000api.fda.gov
Philips Ultrasound LLCReedsville, PA, United StatesContract manufacturer, Manufacturer, Specification developer2July 17, 2009030api.fda.gov
Philips Ultrasound LLCCambridge, MA, United StatesManufacturer, Specification developer2July 17, 2009000api.fda.gov
Philips Ultrasound LLCBothell, WA, United StatesComplaint file establishment, Manufacturer, Specification developer2July 17, 2009020api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer1January 22, 1998000api.fda.gov
Best NomosPittsburgh, PA, United StatesComplaint file establishment, Manufacturer1February 19, 2010000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer1April 17, 2020000api.fda.gov
Dymax, Corp.Zelienople, PA, United StatesContract manufacturer, Remanufacturer, Repackager or relabeler1October 19, 2004000api.fda.gov
Ivu Imaging CorporationSouthlake, TX, United StatesManufacturer1June 3, 2008000api.fda.gov
Mayer LaboratoriesBerkeley, CA, United StatesRepackager or relabeler, Specification developer1January 6, 1994000api.fda.gov
Mendaera, Inc.San Mateo, CA, United StatesManufacturer, Specification developer1July 2, 2025000api.fda.gov
Newman MedicalArvada, CO, United StatesManufacturer1April 8, 2009000api.fda.gov
Sonomed, Inc.Westbury, NY, United StatesManufacturer1September 24, 2009000api.fda.gov
Sound Technology Inc.State College, PA, United StatesManufacturer1May 15, 2014000api.fda.gov
Volcano CorporationRancho Cordova, CA, United StatesManufacturer1September 16, 1996000api.fda.gov
Vomark Technologies IncWheeling, IL, United StatesRemanufacturer, Repackager or relabeler1May 15, 2014000api.fda.gov
Volcano CorporationSan Diego, CA, United StatesComplaint file establishment, Specification developer1September 16, 1996000api.fda.gov
Accutome, Inc.Malvern, PA, United StatesManufacturer0000api.fda.gov
Acertara Acoustic Laboratories, LLCLongmont, CO, United StatesContract manufacturer0000api.fda.gov
Adroit Medical Systems, Inc.Loudon, TN, United StatesContract manufacturer0000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Advantech CorporationMilpitas, CA, United StatesContract manufacturer0000api.fda.gov
Amphenol DC ElectronicsSan Jose, CA, United StatesManufacturer0000api.fda.gov
Apex Medical Technologies, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Apical InstrumentsRedwood City, CA, United StatesContract manufacturer0000api.fda.gov
Arcscan, Inc.Golden, CO, United StatesManufacturer0000api.fda.gov
Bard Shannon LimitedHumacao, PR, United StatesContract manufacturer0000api.fda.gov
Butterfly Network, Inc.Burlington, MA, United StatesManufacturer, Specification developer0000api.fda.gov
Carl Zeiss Meditec IncDublin, CA, United StatesManufacturer0000api.fda.gov
Clear Guide MedicalBaltimore, MD, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Cook IncorporatedEllettsville, IN, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Dbmedx, Inc.Littleton, CO, United StatesManufacturer0000api.fda.gov
DGH Technology, Inc.Exton, PA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Echonous, Inc.Redmond, WA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edge Life Technologies, LLCDoral, FL, United StatesManufacturer0000api.fda.gov
Endosound IncPortland, OR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Exo Imaging, Inc.Santa Clara, CA, United StatesSpecification developer0000api.fda.gov
FUJIFILM Healthcare Americas CorporationLexington, MA, United StatesManufacturer0000api.fda.gov
FUJIFILM Healthcare Americas CorporationTwinsburg, OH, United StatesSpecification developer0040api.fda.gov
GE Medical Systems Ultrasound & Primary Care Diagnostics LLCNoblesville, IN, United StatesManufacturer, Remanufacturer0000api.fda.gov
GE Medical Systems Ultrasound and Primary Care Diagnostics LLCWauwatosa, WI, United StatesManufacturer, Specification developer0000api.fda.gov
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLCWaukesha, WI, United StatesSpecification developer0000api.fda.gov
Ge Parallel Design, Inc.Phoenix, AZ, United StatesManufacturer0000api.fda.gov
Gynesonics, Inc.Redwood City, CA, United StatesManufacturer0000api.fda.gov
Halo Medical TechnologiesBethlehem, PA, United StatesManufacturer0000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesManufacturer0000api.fda.gov
I-Tek Medical, Inc.White Bear Lake, MN, United StatesContract manufacturer0000api.fda.gov
IMACOR, IncJericho, NY, United StatesComplaint file establishment, Manufacturer, Specification developer0020api.fda.gov
Interson Corp.Pleasanton, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Isono Health Inc.Sunnyvale, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Innovatus Imaging CorporationEnglewood, CO, United StatesContract manufacturer0000api.fda.gov
Janco, Inc.Rollinsford, NH, United StatesContract manufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
Micro Medical Devices, Inc.Calabasas, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Micro Tool Engineering, Inc.West Palm Beach, FL, United StatesContract manufacturer0000api.fda.gov
Neo Medical Usa, Inc.San Jose, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Nidek IncorporatedThe Colony, TX, United StatesManufacturer0000api.fda.gov
NeuraSignal, Inc.Los Angeles, CA, United StatesManufacturer0000api.fda.gov
PROCEPT BioRobotics CorporationSan Jose, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Provisio Medical Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Phillips-Medisize Costa Mesa LLCCosta Mesa, CA, United StatesContract manufacturer0000api.fda.gov
QT Imaging, Inc.Novato, CA, United StatesManufacturer0000api.fda.gov
Qualitel CorporationEverett, WA, United StatesContract manufacturer0000api.fda.gov
Ray Vision Inc.Lake Forest, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Rivanna Medical, IncCharlottesville, VA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Seno Medical Instruments, Inc.San Antonio, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Siemens Medical Solutions Usa, Inc.Issaquah, WA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Sonavex, Inc.Baltimore, MD, United StatesManufacturer0000api.fda.gov
Steripack Usa (limited) LLCLakeland, FL, United StatesContract manufacturer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesManufacturer, Specification developer0000api.fda.gov
Siemens Medical Solutions USA, Inc.Plymouth Meeting, PA, United StatesManufacturer, Specification developer0000api.fda.gov
Sonivate Medical, Inc.Portland, OR, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Teratech Corp.Burlington, MA, United StatesManufacturer0000api.fda.gov
The Prometheus GroupDover, NH, United StatesManufacturer0000api.fda.gov
TransducerworksCentre Hall, PA, United StatesContract manufacturer0000api.fda.gov
Trice MedicalMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Ultravision CorporationNorth Palm Beach, FL, United StatesManufacturer0000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer0000api.fda.gov
Vave Health IncSan Jose, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Verdure Imaging IncStockton, CA, United StatesManufacturer0000api.fda.gov
Visura Technologies, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Verathon Inc.Bothell, WA, United StatesManufacturer0020api.fda.gov
Viant AS&O Holdings, LLCLaconia, NH, United StatesContract manufacturer0000api.fda.gov
X9 Inc.Wallingford, CT, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Yorlabs, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, 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.