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FaceLake

LORTE TECHNOLOGIES, INC · Model FL-100B · UDI-DI 00851908007093

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

Description

JPD-100B Ultrasonic Doppler Fetal Heartbeat Detector is an equipment to detect the fetal heartbeat in the body of the pregnant woman.

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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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.