FDA DeviceClass IINotable

FDA Recall: Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Mod

Date: 2026-04-01
Brand: Koven Technology, Inc.
Category: Medical Device
FDA Class: Class II

Description

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Hazard

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Remedy

34

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