Transonic Systems, Inc.
Medical device manufacturer in Ithaca, NY.
16510(k) clearances
0PMA approvals
13recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K140740 | Transonic Tissue Perfusion MonitorDPW · Traditional | 07/23/2015SE |
| K134051 | Transonic Elsa SystemDXG · Traditional | 01/29/2015SE |
| K134035 | Transonic HCM 103 SystemDXG · Traditional | 09/17/2014SE |
| K140017 | Transonic HCM 102 SystemDXG · Traditional | 09/16/2014SE |
| K113821 | Transonic Costatus Cardiac Output SystemDXG · Traditional | 09/07/2012SE |
| K112657 | Aureflo Monitoring SystemDPW · Traditional | 12/21/2011SE |
| K080116 | Transonic Costatus Cardiac Output SystemDXG · Traditional | 09/08/2008SE |
| K033424 | Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models…DPW · Special | 12/11/2003SE |
| K022963 | Transonic Syringe Warmer, Model SYR-1000MQS · Traditional | 12/04/2002SE |
| K021571 | Transonic Flow-Qc Set Model ADT1010MQS · Traditional | 08/12/2002SE |
| K010253 | Angio Flow Thermodilution Catheter, Model AF-CATH-01; Angioflow Meter, Models HQ100 and…DYG · Traditional | 03/19/2002SE |
| K002816 | Transonic Hemodialysis Flow Reverser, Model B FlowrevKOC · Traditional | 11/22/2000SE |
| K980906 | Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-COMQS · Traditional | 10/06/1998SE |
| K960817 | HD01-SERIES Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2)MQS · Traditional | 02/11/1997SE |
| K903633 | Advance Laser Flowmeter, Alf 21DPW · Traditional | 10/09/1990SE |
| K872048 | Transonic FlowmeterDPW · Traditional | 06/21/1988SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1776-2018 Class II | Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The…The sterility of the device cannot be assured. There is a potential for an increased risk of infection. | 02/15/2018Terminated |
| Z-2729-2015 Class II | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2728-2015 Class II | Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2727-2015 Class II | Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2726-2015 Class II | Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2725-2015 Class II | Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2724-2015 Class II | Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2723-2015 Class II | Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2722-2015 Class II | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2721-2015 Class II | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-2720-2015 Class II | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow…Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints… | 07/27/2015Terminated |
| Z-1295-2015 Class II | Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is…Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during… | 02/17/2015Terminated |
| Z-1147-2013 Class II | HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit…Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. | 03/28/2013Terminated |