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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 2 of 15

Device	Model / Reference	Registries	Class	Status
Transonic	HD02	FDA UDI	Class II	Unknown
Transonic	HQD1.5FME	FDA UDI	Class II	Active
Transonic	HQC12MP	FDA UDI	Class II	Active
Transonic	HQF1.5FMV	FDA UDI	Class II	Active
Transonic	HQD5XL	FDA UDI	Class II	Unknown
Transonic	HQE4MR-S	FDA UDI	Class II	Active
Transonic	HQD7XL	FDA UDI	Class II	Unknown
Transonic	HQF3FMV	FDA UDI	Class II	Active
Transonic	HQC3XL	FDA UDI	Class II	Unknown
Transonic	HQC4FMC	FDA UDI	Class II	Active
Transonic	HQF2FD	FDA UDI	Class II	Active
Transonic	HQC10FTE	FDA UDI	Class II	Unknown
Transonic	HQN3MB-S	FDA UDI	Class II	Unknown
Transonic	H14AUL-5	FDA UDI	Class II	Unknown
Transonic	HQE12FTV	FDA UDI	Class II	Unknown
Transonic	HQC10FSB	FDA UDI	Class II	Unknown
Transonic	ABLPHE	FDA UDI	Class II	Active
Transonic	HQF12FTE	FDA UDI	Class II	Unknown
Transonic	HQE32AU	FDA UDI	Class II	Unknown
Transonic	HQG1.5MB	FDA UDI	Class II	Active
Transonic	HQG4MB-S	FDA UDI	Class II	Unknown
Transonic	HQF12AU	FDA UDI	Class II	Unknown
Transonic	HQF14AU	FDA UDI	Class II	Active
Transonic	HQD6FTV	FDA UDI	Class II	Unknown
Transonic	HQD3XL-M5	FDA UDI	Class II	Active
Transonic	ABLPHI	FDA UDI	Class II	Unknown
Transonic	ADT1018	FDA UDI	Class II	Unknown
Transonic	HQN6MR-S	FDA UDI	Class II	Unknown
Transonic	HQE2FMV	FDA UDI	Class II	Unknown
Transonic	HQC8FMV	FDA UDI	Class II	Active
Transonic	HQC12FTV	FDA UDI	Class II	Unknown
Transonic	HQD8XL-M12	FDA UDI	Class II	Active
Transonic	HQC24AU	FDA UDI	Class II	Unknown
Transonic	HQC2FME	FDA UDI	Class II	Active
Transonic	HQF12FTV	FDA UDI	Class II	Unknown
Transonic	HQC4MP	FDA UDI	Class II	Active
Transonic	BLF21	FDA UDI	Class II	Active
Transonic	HQF8FMV	FDA UDI	Class II	Unknown
Transonic	HQC8FTE	FDA UDI	Class II	Unknown
Transonic	HQC6FMV	FDA UDI	Class II	Active
Transonic	H16XL	FDA UDI	Class II	Unknown
Transonic	HQD2FMC	FDA UDI	Class II	Unknown
Transonic	HQF2MR	FDA UDI	Class II	Unknown
Transonic	HQC2FME	FDA UDI	Class II	Unknown
Transonic	ABLPHS	FDA UDI	Class II	Active
Transonic	HQE8FTV	FDA UDI	Class II	Unknown
Transonic	HQE2P	FDA UDI	Class II	Unknown
Transonic	HQF4MR-S	FDA UDI	Class II	Active
Transonic	HQE1.5FMV	FDA UDI	Class II	Active
Transonic	HQC9XL	FDA UDI	Class II	Unknown

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.