Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.
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Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/03/2025
Short Title (70 char) Wedgewood Connect, LLC. San Jose, CA. 483 issued 07/03/2025
FEI Number 3003434972
Firm Name Wedgewood Connect, LLC
Record Type 483
State CA
Establishment Type Outsourcing FacilitFDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children
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The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.” This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology.
