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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 13 of 15

Device	Model / Reference	Registries	Class	Status
Transonic	H12AUL-5	FDA UDI	Class II	Unknown
Transonic	HQF2FME	FDA UDI	Class II	Active
Transonic	HVT100	FDA UDI	Class II	Unknown
Transonic	HQC28AU	FDA UDI	Class II	Unknown
Transonic	HT313	FDA UDI	Class II	Unknown
Transonic	HQD12FMV	FDA UDI	Class II	Active
Transonic	HQE4FMC	FDA UDI	Class II	Unknown
Transonic	HVT101	FDA UDI	Class II	Unknown
Transonic	HQE2FMV	FDA UDI	Class II	Active
Transonic	HQD14AU	FDA UDI	Class II	Active
Transonic	HQF10AU	FDA UDI	Class II	Unknown
Transonic	HQF36AU	FDA UDI	Class II	Active
Transonic	HCS3002-5	FDA UDI	Class II	Active
Transonic	HQD10XL-M16	FDA UDI	Class II	Active
Transonic	HQC4XL	FDA UDI	Class II	Unknown
Transonic	HQF2MU	FDA UDI	Class II	Unknown
Transonic	HQD10FTE	FDA UDI	Class II	Unknown
Transonic	HQF8FME	FDA UDI	Class II	Unknown
Transonic	HQD32AU	FDA UDI	Class II	Active
Transonic	HT353C	FDA UDI	Class II	Active
Transonic	HQC1.5FME	FDA UDI	Class II	Active
Transonic	HQD4FME	FDA UDI	Class II	Unknown
Transonic	HQN10FSB	FDA UDI	Class II	Unknown
Transonic	HQE1.5MR	FDA UDI	Class II	Unknown
Transonic	H32AUL-5	FDA UDI	Class II	Active
Transonic	HQE4FSB	FDA UDI	Class II	Unknown
Transonic	HQD4FSB	FDA UDI	Class II	Unknown
Transonic	HQC16AU	FDA UDI	Class II	Unknown
Transonic	HQF4FMC	FDA UDI	Class II	Active
Transonic	HQC14AU	FDA UDI	Class II	Unknown
Transonic	ADT1001	FDA UDI	Class II	Unknown
Transonic	HQD10AU	FDA UDI	Class II	Active
Transonic	HQD10XL	FDA UDI	Class II	Unknown
Transonic	HQE36AU	FDA UDI	Class II	Unknown
Transonic	H7FX	FDA UDI	Class II	Unknown
Transonic	HQF6FMV	FDA UDI	Class II	Unknown
Transonic	HQN4FTE	FDA UDI	Class II	Unknown
Transonic	HQC12FTE	FDA UDI	Class II	Unknown
Transonic	HQC4FMV	FDA UDI	Class II	Unknown
Transonic	HQD20AU	FDA UDI	Class II	Unknown
Transonic	HQD20AU	FDA UDI	Class II	Active
Transonic	HQE3FMV	FDA UDI	Class II	Active
Transonic	HQF2FSB	FDA UDI	Class II	Unknown
Transonic	HQD16AU	FDA UDI	Class II	Unknown
Transonic	H36AUL-5	FDA UDI	Class II	Active
Transonic	HT363	FDA UDI	Class II	Unknown
Transonic	HQF3MU	FDA UDI	Class II	Active
Transonic	HT353C	FDA UDI	Class II	Unknown
Transonic	HQE4FMV	FDA UDI	Class II	Unknown
Transonic	HQC1.5FMV	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.