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FaceLake

LORTE TECHNOLOGIES, INC · Model FD-300P · UDI-DI 00851908007130

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

Description

The FD-300P is a 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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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.