Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Transonic Systems with 17 510(k) clearances and 13 device recalls. The most recent is a 510(k) clearance dated Oct 27, 2026: FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 27, 2026 | FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and FlowsensorsK261714 · DPW | 510(k) clearances |
| Feb 15, 2018 | Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorpClass II · The sterility of the device cannot be assured. There is a potential for an increased risk of infection. | Device recalls |
| Jul 27, 2015 | Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.Class II · Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users in | Device recalls |
| Jul 27, 2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.Class II · Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users in | Device recalls |
| Jul 27, 2015 | Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.Class II · Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users in | Device recalls |
| Jul 27, 2015 | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.Class II · Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users in | Device recalls |
| Jul 27, 2015 | Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.Class II · Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users in | Device recalls |
| Jul 27, 2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.Class II · Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users in | Device recalls |
| Jul 27, 2015 | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.Class II · Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users in | Device recalls |
| Jul 23, 2015 | TRANSONIC TISSUE PERFUSION MONITORK140740 · DPW | 510(k) clearances |
| Jan 29, 2015 | TRANSONIC ELSA SYSTEMK134051 · DXG | 510(k) clearances |
| Sep 17, 2014 | TRANSONIC HCM 103 SYSTEMK134035 · DXG | 510(k) clearances |
| Sep 16, 2014 | TRANSONIC HCM 102 SYSTEMK140017 · DXG | 510(k) clearances |
| Sep 7, 2012 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMK113821 · DXG | 510(k) clearances |
| Dec 21, 2011 | AUREFLO MONITORING SYSTEMK112657 · DPW | 510(k) clearances |
| Sep 8, 2008 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMK080116 · DXG | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
