FDA Device Intelligence
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Device, Cystometric, Hydraulic

FDA product code FEN · Class 2 · Gastroenterology, Urology

527
Registered devices
119
Adverse events
3
Recalls
36
510(k) clearances

Devices with this code

Air-Charged Reusable Cable — Laborie Medical Technologies Canada ULCUniTip Catheter — Unisensor AGMediplus — MEDIPLUS LTDDelphis KT — Laborie Medical Technologies Canada ULCAir-Charged Reusable Cable — Laborie Medical Technologies Canada ULCCatheter, Pura & Pves, Dual Lumen, Coaxial Design, 8Fr — Laborie Medical Technologies Canada ULCAir-Charged Reusable Cable — Laborie Medical Technologies Canada ULCCatheter, Pves & Vinf, Dual Lumen, 10Fr — Laborie Medical Technologies Canada ULCATMOS Air-Charged Pressure Sensor — MEDKONSULT medical technology s.r.o.Air-Charged Single Sensor Catheter, Radiopaque — Laborie Medical Technologies Canada ULCExtension Line, 90 cm — Laborie Medical Technologies Canada ULCAir-Charged Reusable Cable — Laborie Medical Technologies Canada ULCSondeAR - Air Charged Catheter — Laborie Medical Technologies Canada ULC2-lumen Cystometry Pack — Laborie Medical Technologies Canada ULCAir-Charged Reusable Cable — Laborie Medical Technologies Canada ULCUniTip Catheter — Unisensor AGCystometry Pack — Laborie Medical Technologies Canada ULCUniTip Catheter — Unisensor AGWellead Urodynamic Catheter — Well Lead Medical Co.,Ltd1-lumen Catheter — Laborie Medical Technologies Canada ULCWellead Urodynamic Catheter — Well Lead Medical Co.,LtdPorges Coloplast — Coloplast A/SAquarius TT — Laborie Medical Technologies Canada ULCPerfusion Set 3 — Laborie Medical Technologies Canada ULC

Recent recalls

DateFirmReason
2019-07-17LABORIE MEDICAL TECHNOLOGIES, CORPPower supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requir
2018-07-03ConvaTec, IncBubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
2006-10-04Laborie Medical TechnologiesMislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-20

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.