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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180¿ and counterclockwise = 180¿. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems.
FDA Enforcement
Class II
·Ongoing·Biosense Webster, Inc.·March 20, 2024
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·October 12, 2022
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
FDA Enforcement
Class II
·Ongoing·NOA Medical Industries Inc·January 22, 2025
Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No
FDA Enforcement
Not Yet Classified
·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024