FDA Device Intelligence
Home › LORTE TECHNOLOGIES, INC › FaceLake

FaceLake

LORTE TECHNOLOGIES, INC · Model FD-200B · UDI-DI 00851908007109

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

Description

The FD-200B 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

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.