Is this your brand? Sign in to claim ownership.

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 6 of 15

Device	Model / Reference	Registries	Class	Status
Transonic	H14AUL-5	FDA UDI	Class II	Active
Transonic	HQD6FTE	FDA UDI	Class II	Unknown
Transonic	HQC1.5FME	FDA UDI	Class II	Unknown
Transonic	HQC6MP	FDA UDI	Class II	Unknown
Transonic	HQE12FSB	FDA UDI	Class II	Unknown
Transonic	HQD10XL-M16	FDA UDI	Class II	Unknown
Transonic	HQD14AU	FDA UDI	Class II	Unknown
Transonic	HQF2FME	FDA UDI	Class II	Unknown
Transonic	HQD28AU	FDA UDI	Class II	Active
Transonic	HT360	FDA UDI	Class II	Unknown
Transonic	HQE10FMV	FDA UDI	Class II	Active
Transonic	HQF1.5MU	FDA UDI	Class II	Unknown
Transonic	HQN2XLP	FDA UDI	Class II	Unknown
Transonic	HQD16AU	FDA UDI	Class II	Active
Transonic	AOS1005	FDA UDI	Class II	Active
Transonic	HQF4FMC	FDA UDI	Class II	Unknown
Transonic	HQE6AU	FDA UDI	Class II	Unknown
Transonic	H32AUL	FDA UDI	Class II	Unknown
Transonic	HQC14FSB	FDA UDI	Class II	Unknown
Transonic	BLF22A	FDA UDI	Class II	Unknown
Transonic	HQF3FSB	FDA UDI	Class II	Unknown
Transonic	HQN3MB-S	FDA UDI	Class II	Active
Transonic	HQF1.5MR	FDA UDI	Class II	Active
Transonic	HQN3FME	FDA UDI	Class II	Unknown
Transonic	HQD8FME	FDA UDI	Class II	Unknown
Transonic	HQG3MB-S	FDA UDI	Class II	Unknown
Transonic	HQC12FSB	FDA UDI	Class II	Unknown
Transonic	HQN1.5FME	FDA UDI	Class II	Active
Transonic	HQD9XL-M14	FDA UDI	Class II	Active
Transonic	HQD4FMV	FDA UDI	Class II	Active
Transonic	HT353	FDA UDI	Class II	Active
Transonic	HQE6FTE	FDA UDI	Class II	Unknown
Transonic	HQD3XL-M5	FDA UDI	Class II	Unknown
Transonic	H10AUL-5	FDA UDI	Class II	Active
Transonic	HQF24AU	FDA UDI	Class II	Unknown
Transonic	BLF22	FDA UDI	Class II	Unknown
Transonic	HCP01	FDA UDI	Class II	Unknown
Transonic	H32AUL-5	FDA UDI	Class II	Unknown
Transonic	HQF4P	FDA UDI	Class II	Active
Transonic	HQC2FMV	FDA UDI	Class II	Unknown
Transonic	HQF8FMV	FDA UDI	Class II	Active
Transonic	HQE2FMC	FDA UDI	Class II	Unknown
Transonic	HQC4MP	FDA UDI	Class II	Unknown
Transonic	HQC4FME	FDA UDI	Class II	Active
Transonic	HQF12FMV	FDA UDI	Class II	Active
Transonic	HQD3XLJ	FDA UDI	Class II	Unknown
Transonic	HQC8MP	FDA UDI	Class II	Unknown
Transonic	HQF4FMV	FDA UDI	Class II	Active
Transonic	HQC20AU	FDA UDI	Class II	Unknown
Transonic	H4E	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.