Compal Electronics, Inc. is one of 203 FDA 510(k) medical device manufacturers from Taiwan in the dataset, ranked by real submission volume.
Compal Electronics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BreathePal Bilevel (GFM50-MD2201), AblatePal Radiofrequency Ablation System, Apache Ultrasound System (Model C62)
3
Total
3
Cleared
0
Denied
Compal Electronics, Inc. is a leading global manufacturer of advanced electronics and computing devices, with a manufacturing facility in Taipei, Taiwan. The company specializes in notebook PCs, LCD products, smart devices, and healthcare technology solutions, serving Fortune 500 companies and emerging startups worldwide.
Compal has received 3 FDA 510(k) clearances from 3 total submissions since its first clearance in 2020. The company's cleared devices span multiple medical specialties, including anesthesiology, general and plastic surgery, and radiology. The latest clearance in 2026 confirms active regulatory engagement in the medical device sector.
Recent FDA 510(k) cleared products demonstrate Compal's expertise across diverse medical technologies: respiratory support systems, radiofrequency ablation platforms, and advanced ultrasound imaging systems. This portfolio reflects the company's commitment to innovation in surgical, diagnostic, and therapeutic applications.
Explore the complete regulatory record, including device names, product codes, and clearance dates, to learn more about Compal's FDA 510(k) submissions and cleared medical devices.
FDA 510(k) Regulatory Record - Compal Electronics, Inc.
3 devices