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Stylet For Catheter, Gastro-Urology

FDA product code EZB · Class 1 · Gastroenterology, Urology

163
Registered devices
2,454
Adverse events
13
Recalls
3
510(k) clearances

Devices with this code

Hydra Jagwire — BOSTON SCIENTIFIC CORPORATIONSOLO PLUS Stiff Hybrid Guidewires — HERAEUS MEDICAL COMPONENTS LLCSOLO PLUS Stiff Hybrid Guidewires — HERAEUS MEDICAL COMPONENTS LLCMillennium — Avalign Technologies, Inc.Lubriglide — BOSTON SCIENTIFIC CORPORATIONHydra Jagwire — BOSTON SCIENTIFIC CORPORATIONPTFE Coated Urological Guidewire — LAKE REGION MEDICAL LIMITEDACUCISE® PROCEDURAL PACK STARTER PACK — APPLIED MEDICAL RESOURCES CORPORATIONBard® Guidewires — C. R. Bard, Inc.SOLO FLEX Hybrid Guidewires — HERAEUS MEDICAL COMPONENTS LLCAmplatz Super Stiff — BOSTON SCIENTIFIC CORPORATIONAmplatz Super Stiff — BOSTON SCIENTIFIC CORPORATIONSOLO FLEX Hybrid Guidewires — HERAEUS MEDICAL COMPONENTS LLCDreamwire — BOSTON SCIENTIFIC CORPORATIONSOLO FLEX Hybrid Guidewires — HERAEUS MEDICAL COMPONENTS LLCSilhouette® Pediatric Ureteral Stent with Urowire® Guidewire — APPLIED MEDICAL RESOURCES CORPORATIONSensor — BOSTON SCIENTIFIC CORPORATIONSensor — BOSTON SCIENTIFIC CORPORATIONBard® Hydro-Glide™ Guidewire — C. R. Bard, Inc.Greenwald Surgical Company, Inc. — GRACE MANUFACTURING, INC.Integra® Miltex® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONBard Solo Hydro Urology Wire — HERAEUS MEDICAL COMPONENTS LLCGreenwald Surgical Company, Inc. — GRACE MANUFACTURING, INC.Amplatz Super Stiff — BOSTON SCIENTIFIC CORPORATION

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.