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Baby Doppler

DAGAMMA INC. · Model Ultraline 1000 Blue 2.5MHz · UDI-DI 00628055787266

KNG
1
510(k) clearances
32
Adverse events (2 deaths)
1
Recalls
31
Facilities

Description

The Ultraline 1000 is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart rate.

Recalls

DateFirmReason
2017-10-06CooperSurgical, Inc.The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.