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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 8 of 15

Device	Model / Reference	Registries	Class	Status
Transonic	HQE10FME	FDA UDI	Class II	Unknown
Transonic	HQF10FMV	FDA UDI	Class II	Unknown
Transonic	HQC14MP	FDA UDI	Class II	Active
Transonic	HQD12FMV	FDA UDI	Class II	Unknown
Transonic	HT322-FT	FDA UDI	Class II	Unknown
Transonic	HQC8FTV	FDA UDI	Class II	Unknown
Transonic	ABLPHS	FDA UDI	Class II	Unknown
Transonic	H12AUL	FDA UDI	Class II	Unknown
Transonic	HQN2FME	FDA UDI	Class II	Unknown
Transonic	HQE4FD	FDA UDI	Class II	Unknown
Transonic	H28AUL-5	FDA UDI	Class II	Unknown
Transonic	HQN2MR	FDA UDI	Class II	Unknown
Transonic	HQD7XL-M10	FDA UDI	Class II	Active
Transonic	HT320	FDA UDI	Class II	Unknown
Transonic	HQC10FME	FDA UDI	Class II	Active
Transonic	HQF1.5FME	FDA UDI	Class II	Active
Transonic	HQD8AU	FDA UDI	Class II	Unknown
Transonic	HQD10FME	FDA UDI	Class II	Unknown
Transonic	HQD3FMV	FDA UDI	Class II	Unknown
Transonic	HQE14AU	FDA UDI	Class II	Unknown
Transonic	HQE6FSB	FDA UDI	Class II	Unknown
Transonic	HQC3FMV	FDA UDI	Class II	Unknown
Transonic	HCS6001-5	FDA UDI	Class II	Unknown
Transonic	HQF8FTE	FDA UDI	Class II	Unknown
Transonic	HQE10AU	FDA UDI	Class II	Unknown
Transonic	HC2T	FDA UDI	Class II	Unknown
Transonic	HCM103	FDA UDI	Class II	Unknown
Transonic	HQG1.5MB	FDA UDI	Class II	Unknown
Transonic	HQD8FMV	FDA UDI	Class II	Unknown
Transonic	HT312-FT	FDA UDI	Class II	Unknown
Transonic	HQE6FMV	FDA UDI	Class II	Unknown
Transonic	HQE1.5FME	FDA UDI	Class II	Unknown
Transonic	HQC14FMV	FDA UDI	Class II	Unknown
Transonic	HQF28AU	FDA UDI	Class II	Active
Transonic	HQC4FMC	FDA UDI	Class II	Unknown
Transonic	HQD1.5FSB	FDA UDI	Class II	Unknown
Transonic	HQF20AU	FDA UDI	Class II	Unknown
Transonic	HQE8FMV	FDA UDI	Class II	Unknown
Transonic	HQD16XL	FDA UDI	Class II	Unknown
Transonic	HQF6FME	FDA UDI	Class II	Unknown
Transonic	HQC3FMC	FDA UDI	Class II	Unknown
Transonic	HQC6FSB	FDA UDI	Class II	Unknown
Transonic	HQF14FMV	FDA UDI	Class II	Active
Transonic	H28AUL-5	FDA UDI	Class II	Active
Transonic	HQF6FMV	FDA UDI	Class II	Active
Transonic	HT322	FDA UDI	Class II	Unknown
Transonic	HT310-FT	FDA UDI	Class II	Unknown
Transonic	HQC2FMC	FDA UDI	Class II	Active
Transonic	HQF16AU	FDA UDI	Class II	Active
Transonic	ADT1002-10	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.