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Sign in to claim this brandTransonic 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
- —
- [email protected]
- Phone
- 607-257-5300
- PRRC Contact
- Cornelis Drost
- EUDAMED SRN
- US-MF-000008784
- FDA FEI Number
- —
- DUNS Number
- 101317451
Catalogue (713)
Page 4 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Transonic | HQE4FD | FDA UDI | Class II | Active |
| Transonic | HQE3FME | FDA UDI | Class II | Unknown |
| Transonic | HQD10FSB | FDA UDI | Class II | Unknown |
| Transonic | HT350 | FDA UDI | Class II | Active |
| Transonic | HT314 | FDA UDI | Class II | Unknown |
| Transonic | HQD4XL-M7 | FDA UDI | Class II | Unknown |
| Transonic | HCS3011-5 | FDA UDI | Class II | Unknown |
| Transonic | HQE2MU | FDA UDI | Class II | Unknown |
| Transonic | HQD4P | FDA UDI | Class II | Unknown |
| Transonic | HQC4FTE | FDA UDI | Class II | Unknown |
| Transonic | HQC12AU | FDA UDI | Class II | Unknown |
| Transonic | HQF6FSB | FDA UDI | Class II | Unknown |
| Transonic | HQD3FME | FDA UDI | Class II | Active |
| Transonic | HQE8FMV | FDA UDI | Class II | Active |
| Transonic | HQF1.5MU | FDA UDI | Class II | Active |
| Transonic | H20AUL-5 | FDA UDI | Class II | Unknown |
| Transonic | HQE2P | FDA UDI | Class II | Active |
| Transonic | HQN6FME | FDA UDI | Class II | Unknown |
| Transonic | HQN2MR | FDA UDI | Class II | Active |
| Transonic | HQF3P | FDA UDI | Class II | Unknown |
| Transonic | HQC4FSB | FDA UDI | Class II | Unknown |
| Transonic | H24AUL | FDA UDI | Class II | Unknown |
| Transonic | HCS3002-5 | FDA UDI | Class II | Unknown |
| Transonic | HQE6MR-S | FDA UDI | Class II | Unknown |
| Transonic | HQE12FTE | FDA UDI | Class II | Unknown |
| Transonic | HQD24AU | FDA UDI | Class II | Active |
| Transonic | HQD10FMV | FDA UDI | Class II | Active |
| Transonic | HQN4MB-S | FDA UDI | Class II | Unknown |
| Transonic | ADT1018-40 | FDA UDI | Class II | Unknown |
| Transonic | HQN2FME | FDA UDI | Class II | Active |
| Transonic | HQE6MR-S | FDA UDI | Class II | Active |
| Transonic | HQE4P | FDA UDI | Class II | Unknown |
| Transonic | HQF4FTE | FDA UDI | Class II | Unknown |
| Transonic | HQD8AU | FDA UDI | Class II | Active |
| Transonic | HT354 | FDA UDI | Class II | Unknown |
| Transonic | HCM102 | FDA UDI | Class II | Unknown |
| Transonic | HQF12FSB | FDA UDI | Class II | Unknown |
| Transonic | HQE3FMC | FDA UDI | Class II | Unknown |
| Transonic | HCS3012 | FDA UDI | Class II | Unknown |
| Transonic | HCS3012-5 | FDA UDI | Class II | Active |
| Transonic | HQD1.5FMC | FDA UDI | Class II | Unknown |
| Transonic | HQC16XL | FDA UDI | Class II | Unknown |
| Transonic | HQF4P | FDA UDI | Class II | Unknown |
| Transonic | HQD4FMV | FDA UDI | Class II | Unknown |
| Transonic | HQF28AU | FDA UDI | Class II | Unknown |
| Transonic | HQC2MP | FDA UDI | Class II | Unknown |
| Transonic | HQD6FSB | FDA UDI | Class II | Unknown |
| Transonic | HQD12XL-M20 | FDA UDI | Class II | Active |
| Transonic | HQN6MR-S | FDA UDI | Class II | Active |
| Transonic | BLF22 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
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. |