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Navigating Sterility: FDA's Comprehensive Guidelines on 510(k) Submissions for Sterile Devices

FDA's latest guidance on 510(k) submissions for sterile devices outlines priorities and updates for traditional and novel sterilization methods, ensuring a comprehensive approach to information inclusion. ....

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FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization
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FDA warns clinicians of recalled saline

FDA alerts healthcare providers to not use some saline and sterile water products made by Nurse Assist due to lack of sterility assurance. ....

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Cardinal Health recalls 3.9M syringes

Millions of syringes are being recalled in the U.S., including nearly 4 million from Cardinal Health because of compatibility issues. ....

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B. Braun recalls more than 1M syringes

B. Braun Medical is voluntarily recalling 1.1 million syringes due to a possible sterility issue. ....

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