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Data / Medical devices / System, Imaging, Pulsed Doppler, Ultrasonic / United States

FDA-registered makers of System, Imaging, Pulsed Doppler, Ultrasonic in the United States: 49 establishments

49 establishments in the United States are registered with the FDA to make System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN). 36 have a 510(k) clearance or PMA approval on file and 13 have a recall event. FDA data exported November 2, 2026.

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Device
System, Imaging, Pulsed Doppler, Ultrasonic
Product code
IYN
Country
United States

Makers of System, Imaging, Pulsed Doppler, Ultrasonic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ge Parallel Design, Inc.Phoenix, AZ, United StatesManufacturer103October 2, 2026000api.fda.gov
Philips Ultrasound LLCBothell, WA, United StatesComplaint file establishment, Manufacturer, Specification developer64September 25, 20260221api.fda.gov
Philips Ultrasound LLCReedsville, PA, United StatesContract manufacturer, Manufacturer, Specification developer50September 25, 2026010api.fda.gov
GE Medical Systems Ultrasound & Primary Care Diagnostics LLCNoblesville, IN, United StatesManufacturer, Remanufacturer42January 8, 2026000api.fda.gov
Philips Ultrasound LLCCambridge, MA, United StatesManufacturer, Specification developer42December 22, 2025000api.fda.gov
Siemens Medical Solutions Usa, Inc.Issaquah, WA, United StatesComplaint file establishment, Manufacturer, Specification developer40June 16, 2026080api.fda.gov
Fujifilm Sonosite,inc.Bothell, WA, United StatesComplaint file establishment, Manufacturer, Remanufacturer30March 10, 2026050api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer27May 30, 2025010api.fda.gov
Sound Technology Inc.State College, PA, United StatesManufacturer27September 2, 2026000api.fda.gov
Vomark Technologies IncWheeling, IL, United StatesRemanufacturer, Repackager or relabeler13June 9, 2023000api.fda.gov
GE Medical Systems Ultrasound and Primary Care Diagnostics LLCWauwatosa, WI, United StatesManufacturer, Specification developer11November 7, 2023010api.fda.gov
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLCWaukesha, WI, United StatesSpecification developer9August 7, 2026000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler9August 17, 2018000api.fda.gov
Butterfly Network, Inc.Burlington, MA, United StatesManufacturer, Specification developer4March 27, 2026020api.fda.gov
Echonous, Inc.Redmond, WA, United StatesComplaint file establishment, Manufacturer, Remanufacturer4April 25, 2025010api.fda.gov
Siemens Medical Solutions USA, Inc.Plymouth Meeting, PA, United StatesManufacturer, Specification developer4October 15, 2020020api.fda.gov
Teratech Corp.Burlington, MA, United StatesManufacturer4July 2, 2020000api.fda.gov
FUJIFILM Healthcare Americas CorporationLexington, MA, United StatesManufacturer3August 9, 2019010api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer2August 31, 2017000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer2October 17, 2013010api.fda.gov
FUJIFILM Healthcare Americas CorporationTwinsburg, OH, United StatesSpecification developer2May 30, 2017060api.fda.gov
IMACOR, IncJericho, NY, United StatesComplaint file establishment, Manufacturer, Specification developer2April 8, 2022000api.fda.gov
Interson Corp.Pleasanton, CA, United StatesContract manufacturer, Manufacturer2December 22, 2023000api.fda.gov
NeuraSignal, Inc.Los Angeles, CA, United StatesManufacturer2March 2, 2022020api.fda.gov
Seno Medical Instruments, Inc.San Antonio, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2October 25, 2019000api.fda.gov
Accutome, Inc.Malvern, PA, United StatesManufacturer1March 14, 2011000api.fda.gov
BioticsAI, Inc.San Francisco, CA, United StatesManufacturer1December 22, 2025000api.fda.gov
Devicor Medical Products, Inc.Cincinnati, OH, United StatesSpecification developer1December 29, 1994000api.fda.gov
Edge Life Technologies, LLCDoral, FL, United StatesManufacturer1September 18, 2024000api.fda.gov
Exo Imaging, Inc.Santa Clara, CA, United StatesManufacturer, Specification developer1November 9, 2022000api.fda.gov
Neo Medical Usa, Inc.San Jose, CA, United StatesRepackager or relabeler, Specification developer1October 24, 2023000api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesManufacturer, Specification developer1January 28, 2024000api.fda.gov
Trice MedicalMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1April 13, 2017000api.fda.gov
Ultravision CorporationNorth Palm Beach, FL, United StatesManufacturer1November 7, 2017000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer1December 23, 2009000api.fda.gov
Vave Health IncSan Jose, CA, United StatesManufacturer, Specification developer1August 30, 2024000api.fda.gov
Advanced Tactile Imaging, Inc.Trenton, NJ, United StatesManufacturer0000api.fda.gov
Dymax, Corp.Zelienople, PA, United StatesContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Endosound IncPortland, OR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Intravent Medical Partners LPBlue Bell, PA, United StatesSpecification developer0000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Phillips-Medisize Costa Mesa LLCCosta Mesa, CA, United StatesContract manufacturer0000api.fda.gov
Sonavex, Inc.Baltimore, MD, United StatesManufacturer0000api.fda.gov
Steripack Usa (limited) LLCLakeland, FL, United StatesContract manufacturer0000api.fda.gov
TransducerworksCentre Hall, PA, United StatesContract manufacturer0000api.fda.gov
Vivemos, LLCKennewick, WA, United StatesContract manufacturer0000api.fda.gov
Yorlabs, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.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.