Transonic Systems, Inc.
Transonic Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2015, with 13 FDA device recalls on record.
Top product codes for Transonic Systems, Inc.
FDA recalls by Transonic Systems, Inc.
10 most recent of 13- Z-1776-2018 — Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.
- Z-2727-2015 — Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
- Z-2724-2015 — Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
- Z-2723-2015 — Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
- Z-2720-2015 — Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
- Z-2725-2015 — Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
- Z-2729-2015 — Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
- Z-2722-2015 — Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
- Z-2726-2015 — Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
- Z-2728-2015 — Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Transonic Systems, Inc.
- K140740 — TRANSONIC TISSUE PERFUSION MONITOR
- K134051 — TRANSONIC ELSA SYSTEM
- K134035 — TRANSONIC HCM 103 SYSTEM
- K140017 — TRANSONIC HCM 102 SYSTEM
- K113821 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
- K112657 — AUREFLO MONITORING SYSTEM
- K080116 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
- K033424 — ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
- K022963 — TRANSONIC SYRINGE WARMER, MODEL SYR-1000
- K021571 — TRANSONIC FLOW-QC SET MODEL ADT1010
- K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101
- K002816 — TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
- K980906 — TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
- K960817 — HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
- K903633 — ADVANCE LASER FLOWMETER, ALF 21
- K872048 — TRANSONIC FLOWMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.