FDA Device Intelligence
HomeDevice types › JAF

Monitor, Ultrasonic, Nonfetal

FDA product code JAF · Class 2 · Radiology

122
Registered devices
80
Adverse events
8
Recalls
38
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-02-10Unetixs Vascular, Inc.The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10Unetixs Vascular, Inc.The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10Unetixs Vascular, Inc.The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10Unetixs Vascular, Inc.The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2017-06-09Natus Neurology IncSome of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear hear
2017-06-09Natus Neurology IncSome of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear hear
2017-06-09Natus Neurology IncSome of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear hear
2017-06-09Natus Neurology IncSome of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear hear

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