FDA Device Intelligence
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Urinometer, Electrical

FDA product code EXS · Class 2 · Gastroenterology, Urology

17
Registered devices
464
Adverse events
6
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-11-15C.R. Bard IncBD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed duri
2022-05-19C.R. Bard IncComplaints relating to urine output measurement accuracy.
2017-11-10C.R. Bard, Inc.Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
2017-11-10C.R. Bard, Inc.BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperat
2017-09-29C.R. Bard, Inc.The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine ou
2010-11-17C.R. Bard, Inc., Urological DivisionError can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid contain

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