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Monitor, Fetal Doppler Ultrasound

FDA product code MAA · Class 2 · Obstetrics/Gynecology

14
Registered devices
0
Adverse events
3
Recalls
9
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2003-12-05Danatech Medical Systems IncThis prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet.
2003-03-31Siemens Medical Solutions USA, Inc.The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
2003-03-31Siemens Medical Solutions USA, Inc.The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.

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