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Stylet For Catheter, Gastro-Urology

FDA product code EZB · Class 1 · Gastroenterology, Urology

162
Registered devices
2,447
Adverse events
13
Recalls
3
510(k) clearances

Devices with this code

Lubriglide — BOSTON SCIENTIFIC CORPORATIONIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONZebra — BOSTON SCIENTIFIC CORPORATIONCatheter Stylet — C. R. Bard, Inc.Amplatz Super Stiff — BOSTON SCIENTIFIC CORPORATIONHydra Jagwire — BOSTON SCIENTIFIC CORPORATIONBard® Guidewires — C. R. Bard, Inc.Greenwald Surgical Company, Inc. — GRACE MANUFACTURING, INC.Zebra — BOSTON SCIENTIFIC CORPORATIONSOLO PLUS Stiff Hybrid Guidewires — HERAEUS MEDICAL COMPONENTS LLCSOLO FLEX Hybrid Guidewires — HERAEUS MEDICAL COMPONENTS LLCAmplatz Super Stiff — BOSTON SCIENTIFIC CORPORATIONSOLO FLEX Hybrid Guidewires — HERAEUS MEDICAL COMPONENTS LLCPTFE Coated Urological Guidewire — LAKE REGION MEDICAL LIMITEDLubriglide — BOSTON SCIENTIFIC CORPORATIONBard® Hydro-Glide™ Guidewire — C. R. Bard, Inc.PTFE Coated Urological Guidewire — LAKE REGION MEDICAL LIMITEDDreamwire — BOSTON SCIENTIFIC CORPORATIONCatheter Stylet — C. R. Bard, Inc.PTFE Coated Urological Guidewire — LAKE REGION MEDICAL LIMITEDMillennium — Avalign Technologies, Inc.Sensor — BOSTON SCIENTIFIC CORPORATIONPTFE Coated Urological Guidewire — LAKE REGION MEDICAL LIMITEDMotion Hybrid Wire Guide — HERAEUS MEDICAL COMPONENTS LLC

Recent recalls

DateFirmReason
2020-03-09Boston ScientificAn increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the
2020-03-09Boston ScientificAn increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the
2020-03-09Boston ScientificAn increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the
2020-03-09Boston ScientificAn increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the
2020-03-09Boston ScientificAn increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the
2020-03-09Boston ScientificAn increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the
2020-03-09Boston ScientificAn increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the
2020-03-09Boston ScientificAn increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the
2020-03-09Boston ScientificAn increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the
2020-03-09Boston ScientificAn increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.