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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 11 of 15

Device	Model / Reference	Registries	Class	Status
Transonic	HQN1.5FSB	FDA UDI	Class II	Unknown
Transonic	HQN8FME	FDA UDI	Class II	Active
Transonic	HQN12FTE	FDA UDI	Class II	Unknown
Transonic	HQD3FSB	FDA UDI	Class II	Unknown
Transonic	HQC8XL	FDA UDI	Class II	Unknown
Transonic	HQN3XLJ	FDA UDI	Class II	Unknown
Transonic	HFW1000	FDA UDI	Class II	Unknown
Transonic	HQF3FME	FDA UDI	Class II	Active
Transonic	HQE3FMV	FDA UDI	Class II	Unknown
Transonic	HQE24AU	FDA UDI	Class II	Unknown
Transonic	HT310	FDA UDI	Class II	Unknown
Transonic	HQE4FMV	FDA UDI	Class II	Active
Transonic	HQD7XL-M10	FDA UDI	Class II	Unknown
Transonic	HQF12AU	FDA UDI	Class II	Active
Transonic	HQC10FMV	FDA UDI	Class II	Unknown
Transonic	HQE1.5FMC	FDA UDI	Class II	Unknown
Transonic	HC2T	FDA UDI	Class II	Active
Transonic	HQD2MR	FDA UDI	Class II	Unknown
Transonic	HQF1.5MR	FDA UDI	Class II	Unknown
Transonic	HQD3FME	FDA UDI	Class II	Unknown
Transonic	HQC3FMV	FDA UDI	Class II	Active
Transonic	HQF4FD	FDA UDI	Class II	Active
Transonic	HQD4MR-S	FDA UDI	Class II	Unknown
Transonic	HQC6XL	FDA UDI	Class II	Unknown
Transonic	HQD14FSB	FDA UDI	Class II	Unknown
Transonic	HQN10FTE	FDA UDI	Class II	Unknown
Transonic	HQD10FMV	FDA UDI	Class II	Unknown
Transonic	HQC12XL	FDA UDI	Class II	Unknown
Transonic	HQD4FTV	FDA UDI	Class II	Unknown
Transonic	HCS6001-5	FDA UDI	Class II	Active
Transonic	HQC10XL	FDA UDI	Class II	Unknown
Transonic	HCS3021-5	FDA UDI	Class II	Active
Transonic	HT364	FDA UDI	Class II	Active
Transonic	HQN6MB-S	FDA UDI	Class II	Active
Transonic	HQE4FTV	FDA UDI	Class II	Unknown
Transonic	HQE10FSB	FDA UDI	Class II	Unknown
Transonic	HQD8FMV	FDA UDI	Class II	Active
Transonic	HCP01	FDA UDI	Class II	Active
Transonic	HQN6FME	FDA UDI	Class II	Active
Transonic	HQD6MR-S	FDA UDI	Class II	Active
Transonic	HQC20XL	FDA UDI	Class II	Unknown
Transonic	H9FX	FDA UDI	Class II	Unknown
Transonic	HQE1.5MU	FDA UDI	Class II	Unknown
Transonic	HQD1.5MR	FDA UDI	Class II	Active
Transonic	ADT1001-10	FDA UDI	Class II	Unknown
Transonic	HT323-FT	FDA UDI	Class II	Unknown
Transonic	HT313-FT	FDA UDI	Class II	Unknown
Transonic	HQF14FMV	FDA UDI	Class II	Unknown
Transonic	HQF2MR	FDA UDI	Class II	Active
Transonic	HQD4FME	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.