Transonic Systems Inc

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
16
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1776-2018Class IITransonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is iFebruary 15, 2018
Z-2727-2015Class IITransonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatJuly 27, 2015
Z-2724-2015Class IITransonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operaJuly 27, 2015
Z-2723-2015Class IITransonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatJuly 27, 2015
Z-2720-2015Class IITransonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatiJuly 27, 2015
Z-2725-2015Class IITransonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatiJuly 27, 2015
Z-2728-2015Class IITransonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operativJuly 27, 2015
Z-2721-2015Class IITransonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operaJuly 27, 2015
Z-2729-2015Class IITransonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operJuly 27, 2015
Z-2722-2015Class IITransonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operJuly 27, 2015
Z-2726-2015Class IITransonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatJuly 27, 2015
Z-1295-2015Class IITransonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is inteFebruary 17, 2015
Z-1147-2013Class IIHCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with March 28, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K140740TRANSONIC TISSUE PERFUSION MONITORJuly 23, 2015
K134051TRANSONIC ELSA SYSTEMJanuary 29, 2015
K134035TRANSONIC HCM 103 SYSTEMSeptember 17, 2014
K140017TRANSONIC HCM 102 SYSTEMSeptember 16, 2014
K113821TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMSeptember 7, 2012
K112657AUREFLO MONITORING SYSTEMDecember 21, 2011
K080116TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMSeptember 8, 2008
K033424ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001December 11, 2003
K022963TRANSONIC SYRINGE WARMER, MODEL SYR-1000December 4, 2002
K021571TRANSONIC FLOW-QC SET MODEL ADT1010August 12, 2002
K010253ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101March 19, 2002
K002816TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREVNovember 22, 2000
K980906TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-COOctober 6, 1998
K960817HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)February 11, 1997
K903633ADVANCE LASER FLOWMETER, ALF 21October 9, 1990
K872048TRANSONIC FLOWMETERJune 21, 1988