Home › Device types › FEN
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
NGM EMG Cable, Non-shielded, Long — Laborie Medical Technologies Corp.2-lumen Catheter for Abdominal Pressure — Laborie Medical Technologies Canada ULCUniTip Catheter — Unisensor AGMediplus — MEDIPLUS LTDMediplus — MEDIPLUS LTDGoby EMG Cable Extension, Non-shielded — Laborie Medical Technologies Corp.Mediplus — MEDIPLUS LTD2-lumen Catheter for Abdominal Pressure — Laborie Medical Technologies Canada ULCABVISER — CONVATEC, PURCHASING DEPARTMENTAir-Charged Reusable Cable — Laborie Medical Technologies Canada ULCABVISER — CONVATEC, PURCHASING DEPARTMENTUniTip Catheter — Unisensor AGATMOS Air-Charged Pressure Sensor — MEDKONSULT medical technology s.r.o.ABVISER — CONVATEC, PURCHASING DEPARTMENTBubble Detector — Laborie Medical Technologies Canada ULCInfusion Pump Tube Set — Laborie Medical Technologies Canada ULCSolar Silver L4, Trolley system — Medical Measurement Systems B.V.NXT EMG cable, Long, 1-channel — Laborie Medical Technologies Corp.TDOC Air-Charged 7Fr Dual Lumen, Single Sensor Bladder Catheter — Laborie Medical Technologies Canada ULCNXT — Laborie Medical Technologies Corp.2-lumen Catheter — Laborie Medical Technologies Canada ULCATMOS Air-Charged Pressure Sensor — MEDKONSULT medical technology s.r.o.Coude Dual Lumen Catheter 7F — Laborie Medical Technologies Canada ULCAtmos — Gemini Medical Technologies LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-07-17 | LABORIE MEDICAL TECHNOLOGIES, CORP | Power 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 |
| 2018-07-03 | ConvaTec, Inc | Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier. |
| 2006-10-04 | Laborie Medical Technologies | Mislabeling: 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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