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Question: 1 / 655

Class II medical devices include which of the following?

Heart valves

Hand-held surgical instruments

Sterilization equipment

Class II medical devices are those that require the regulatory oversight of the FDA to ensure they meet specific requirements for safety and effectiveness, but they are typically less invasive than Class III devices. Sterilization equipment fits into this category because it is crucial for maintaining a sterile environment and preventing infections in medical settings. This equipment must adhere to certain performance standards and undergo regulatory reviews, which aligns with the Class II designation.

On the other hand, heart valves and defibrillators are examples of Class III devices, which are generally more complex and pose a higher risk to patients, thus requiring more stringent regulatory controls. Hand-held surgical instruments are often considered Class I devices, as they usually have a low risk and may not require extensive regulatory oversight.

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