Machine learning and artificial intelligence (AI/ML) models in healthcare may exacerbate health biases. Regulatory oversight is critical in evaluating the safety and effectiveness of AI/ML devices in clinical settings. We conducted a scoping review on 692 FDA-approved AI/ML-enabled medical devices to examine transparency, safety reporting, and sociodemographic representation. This dataset contains extracted information from 692 Summary of Safety and Effectiveness Documents (SSEDs) of FDA-approved medical devices between 1995 and 2023.