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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 5 of 15

Device	Model / Reference	Registries	Class	Status
Transonic	HQN8FTE	FDA UDI	Class II	Unknown
Transonic	HQF3MR-S	FDA UDI	Class II	Active
Transonic	HT320-FT	FDA UDI	Class II	Unknown
Transonic	HQF10FTE	FDA UDI	Class II	Unknown
Transonic	HQE12AU	FDA UDI	Class II	Unknown
Transonic	HQD2XL-M4	FDA UDI	Class II	Active
Transonic	HQF32AU	FDA UDI	Class II	Unknown
Transonic	HC2TP	FDA UDI	Class II	Unknown
Transonic	HCE101	FDA UDI	Class II	Unknown
Transonic	HQE4AU	FDA UDI	Class II	Unknown
Transonic	HQE2MR	FDA UDI	Class II	Unknown
Transonic	HQE14FMV	FDA UDI	Class II	Active
Transonic	HQF4FME	FDA UDI	Class II	Active
Transonic	HQD4XL-M7	FDA UDI	Class II	Active
Transonic	HQD1.5FMV	FDA UDI	Class II	Unknown
Transonic	HQN6FSB	FDA UDI	Class II	Unknown
Transonic	ADT1004	FDA UDI	Class II	Unknown
Transonic	HQE1.5FSB	FDA UDI	Class II	Unknown
Transonic	HQE3FSB	FDA UDI	Class II	Unknown
Transonic	HQF2MU	FDA UDI	Class II	Active
Transonic	HQC8FSB	FDA UDI	Class II	Unknown
Transonic	HQE2FD	FDA UDI	Class II	Unknown
Transonic	ADT1010-40	FDA UDI	Class II	Unknown
Transonic	HQD4XL-M6	FDA UDI	Class II	Active
Transonic	HT354C	FDA UDI	Class II	Unknown
Transonic	HQD14FMV	FDA UDI	Class II	Active
Transonic	HQD3MR-S	FDA UDI	Class II	Active
Transonic	HQE2FSB	FDA UDI	Class II	Unknown
Transonic	HT110R	FDA UDI	Class II	Unknown
Transonic	HQD8XL-M12	FDA UDI	Class II	Unknown
Transonic	HT364	FDA UDI	Class II	Unknown
Transonic	HQD14XL	FDA UDI	Class II	Active
Transonic	HQC14XL	FDA UDI	Class II	Unknown
Transonic	HQD12XL-M20	FDA UDI	Class II	Unknown
Transonic	HQE10FMV	FDA UDI	Class II	Unknown
Transonic	HQD4FTE	FDA UDI	Class II	Unknown
Transonic	H4AUL-5	FDA UDI	Class II	Unknown
Transonic	HQD4FMC	FDA UDI	Class II	Active
Transonic	HQD3XL	FDA UDI	Class II	Unknown
Transonic	HQC8FME	FDA UDI	Class II	Unknown
Transonic	HQN8FSB	FDA UDI	Class II	Unknown
Transonic	HQE16AU	FDA UDI	Class II	Unknown
Transonic	H24AUL-5	FDA UDI	Class II	Active
Transonic	HQF2FMC	FDA UDI	Class II	Active
Transonic	HVT101	FDA UDI	Class II	Active
Transonic	HQF4FTV	FDA UDI	Class II	Unknown
Transonic	H16AUL-5	FDA UDI	Class II	Unknown
Transonic	HQE8AU	FDA UDI	Class II	Unknown
Transonic	HQN6MB-S	FDA UDI	Class II	Unknown
Transonic	HQD8FME	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.