This article provides an updated overview of FDA-approved artificial intelligence (AI) and machine learning (ML)-enabled medical devices in the United States as of October 19, 2023. It analyzes 691 FDA-approved devices, focusing on clearance pathways, approval timelines, regulation types, medical specialties, decision types, and recall history. The study reveals a significant increase in approvals since 2018, with radiology being the most dominant specialty due to the availability of large clinical datasets. The majority of devices (96.7%) were cleared via the 510(k) pathway, which relies on substantial equivalence rather than new clinical trials. However, there is a lack of pediatric-focused devices and trials, indicating a need for expansion in this demographic. Clinical trials are primarily conducted within the United States, highlighting the need for more globally inclusive studies. The analysis also highlights trends, potential gaps, and areas for future research, emphasizing the importance of addressing disparities in clinical trials and regulatory approaches. The study underscores the current state of FDA-approved AI/ML-enabled medical devices and the need for balanced approaches to leverage AI's benefits while addressing its challenges in healthcare.This article provides an updated overview of FDA-approved artificial intelligence (AI) and machine learning (ML)-enabled medical devices in the United States as of October 19, 2023. It analyzes 691 FDA-approved devices, focusing on clearance pathways, approval timelines, regulation types, medical specialties, decision types, and recall history. The study reveals a significant increase in approvals since 2018, with radiology being the most dominant specialty due to the availability of large clinical datasets. The majority of devices (96.7%) were cleared via the 510(k) pathway, which relies on substantial equivalence rather than new clinical trials. However, there is a lack of pediatric-focused devices and trials, indicating a need for expansion in this demographic. Clinical trials are primarily conducted within the United States, highlighting the need for more globally inclusive studies. The analysis also highlights trends, potential gaps, and areas for future research, emphasizing the importance of addressing disparities in clinical trials and regulatory approaches. The study underscores the current state of FDA-approved AI/ML-enabled medical devices and the need for balanced approaches to leverage AI's benefits while addressing its challenges in healthcare.