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Transonic Systems Inc.

United States·US-MF-000008784

Last updated September 18, 2026

About

The unprecedented resolution of Transonic measurements has made Transonic synonymous with gold standard diagnostic and research measurement tools.

From the manufacturer's own website. Source

What Transonic Systems Inc. makes

Transonic Systems Inc. manufactures invasive and noninvasive vascular ultrasound systems for real-time blood flow assessment, including line-powered portable models. The company also produces thermal-dilution cardiac output units for precise hemodynamic monitoring and laser Doppler blood flowmeters for microcirculatory analysis. Additionally, it supplies clinical chemistry analysers for metabolic profiling and surgical anti-adhesion materials designed to prevent tissue adhesion during procedures.

The company’s devices are authorised under FDA 510(k) and UDI regulations in the US and listed in the EU’s eudamed registry, with classifications spanning Class I, Class II, and Class IIa. Its portfolio is regulated according to regional medical device standards, ensuring compliance with invasive, diagnostic, and implantable product requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 34, Dutch Mill Rd., Ithaca, United States
Website: www.transonic.com
LinkedIn: linkedin.com/company/transonic-systems-inc-
Facebook: —
Email: [email protected]
Phone: 607-257-5300
PRRC Contact: Cornelis Drost
EUDAMED SRN: US-MF-000008784
FDA FEI Number: —
DUNS Number: 101317451

Catalogue (713)

Page 3 of 15

Device	Model / Reference	Registries	Class	Status
Transonic	HQE4AU	FDA UDI	Class II	Active
Transonic	HQE3FD	FDA UDI	Class II	Active
Transonic	H16AUL-5	FDA UDI	Class II	Active
Transonic	HQF24AU	FDA UDI	Class II	Active
Transonic	HQE2FD	FDA UDI	Class II	Active
Transonic	HQE3MR-S	FDA UDI	Class II	Unknown
Transonic	ABLPHI	FDA UDI	Class II	Active
Transonic	HT313	FDA UDI	Class II	Unknown
Transonic	HQC10MP	FDA UDI	Class II	Active
Transonic	HQF1.5FD	FDA UDI	Class II	Unknown
Transonic	HQN14FSB	FDA UDI	Class II	Unknown
Transonic	HQF10FTV	FDA UDI	Class II	Unknown
Transonic	HQD9XL-M14	FDA UDI	Class II	Unknown
Transonic	HQC12MP	FDA UDI	Class II	Unknown
Transonic	HQC6FMV	FDA UDI	Class II	Unknown
Transonic	HQE6AU	FDA UDI	Class II	Active
Transonic	HQD3FMC	FDA UDI	Class II	Active
Transonic	HQF4FME	FDA UDI	Class II	Unknown
Transonic	HQF10FMV	FDA UDI	Class II	Active
Transonic	HQC8FME	FDA UDI	Class II	Active
Transonic	HQD6XL	FDA UDI	Class II	Unknown
Transonic	HQE1.5FMV	FDA UDI	Class II	Unknown
Transonic	HD03	FDA UDI	Class II	Unknown
Transonic	HQD1.5FME	FDA UDI	Class II	Unknown
Transonic	HT354C	FDA UDI	Class II	Active
Transonic	HQD1.5FMV	FDA UDI	Class II	Active
Transonic	HQF4FD	FDA UDI	Class II	Unknown
Transonic	HQF3FME	FDA UDI	Class II	Unknown
Transonic	HCS3011-5	FDA UDI	Class II	Active
Transonic	HQE3P	FDA UDI	Class II	Active
Transonic	ABLPHR	FDA UDI	Class II	Unknown
Transonic	ADT1001-10	FDA UDI	Class II	Active
Transonic	HQE3MR	FDA UDI	Class II	Unknown
Transonic	HQF3MR-S	FDA UDI	Class II	Unknown
Transonic	HCM101	FDA UDI	Class II	Unknown
Transonic	HT353	FDA UDI	Class II	Unknown
Transonic	HQE6FTV	FDA UDI	Class II	Unknown
Transonic	HQN2FSB	FDA UDI	Class II	Unknown
Transonic	HQN1.5FME	FDA UDI	Class II	Unknown
Transonic	HQE6FMV	FDA UDI	Class II	Active
Transonic	HT350	FDA UDI	Class II	Unknown
Transonic	HQD36AU	FDA UDI	Class II	Unknown
Transonic	HQD1.5FMC	FDA UDI	Class II	Active
Transonic	HQN3MB	FDA UDI	Class II	Active
Transonic	H6FX	FDA UDI	Class II	Unknown
Transonic	HQN6FTE	FDA UDI	Class II	Unknown
Transonic	HQD6FME	FDA UDI	Class II	Active
Transonic	ADT1010	FDA UDI	Class II	Unknown
Transonic	HQC6FME	FDA UDI	Class II	Active
Transonic	HQN2MR	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Transonic Europe BV NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (11)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Transonic Systems Inc. has 11 FDA recall records, all initiated between July 27, 2015, and February 15, 2018, with all records marked as terminated. The reasons cited include concerns about the sterility of a device, stating there is a potential for an increased risk of infection, and software defects in blood flow probes, specifically programming errors causing incorrect readings when connected to flow meters.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 15, 2018	Z-1776-2018	—	terminated	The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Jul 27, 2015	Z-2725-2015	—	terminated	Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Jul 27, 2015	Z-2720-2015	—	terminated	Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Jul 27, 2015	Z-2728-2015	—	terminated	Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Jul 27, 2015	Z-2721-2015	—	terminated	Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Jul 27, 2015	Z-2723-2015	—	terminated	Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Jul 27, 2015	Z-2722-2015	—	terminated	Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Jul 27, 2015	Z-2727-2015	—	terminated	Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Jul 27, 2015	Z-2726-2015	—	terminated	Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Jul 27, 2015	Z-2729-2015	—	terminated	Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Jul 27, 2015	Z-2724-2015	—	terminated	Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.