9 results
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14ms
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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 Recall
Open, Classified
·Koven Technology, Inc.·Product code DPW·March 4, 2026
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
FDA Recall
Open, Classified
·Securitas Healthcare LLC·Product code IQA·December 8, 2025
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
FDA Recall
Open, Classified
·Securitas Healthcare LLC·Product code IQA·December 8, 2025
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 Recall
Open, Classified
·Baxter Healthcare Corporation·Product code DPS·December 8, 2023
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code MHZ·August 31, 2018
EasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
FDA Recall
Open, Classified
·MHC Medical Products LLC·Product code FMI·April 6, 2018
EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
FDA Recall
Open, Classified
·MHC Medical Products LLC·Product code FMI·April 6, 2018
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.
FDA Recall
Open, Classified
·Iantrek Inc.·Product code HMZ·September 6, 2025
STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code EHZ·November 2, 2022