6 results
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15ms
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Sources: EU EUDAMED, US FDA
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
FDA Enforcement
Class II
·Ongoing·Koven Technology, Inc.·April 1, 2026
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
FDA Enforcement
Class II
·Ongoing·LimFlow, Inc.·February 4, 2026
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·January 14, 2026
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·January 14, 2026
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 17, 2024
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
FDA Enforcement
Class II
·Ongoing·IN MY BATHROOM LLC·October 12, 2022