Emblation Limited - FDA 510(k) Cleared Devices

Emblation Limited, is a leader in energy-based medical technology with a manufacturing facility in Stirling, GB. The company specializes in microwave technology for clinical and research applications across multiple medical specialties.

Emblation has received 2 FDA 510(k) clearances from 2 total submissions since 2024. The company's cleared devices focus on General & Plastic Surgery applications. The latest clearance was in 2025, demonstrating continued regulatory activity and product innovation.

The company's product portfolio includes the swiftPro System, a portable microwave device for targeted clinical treatments, alongside high-power microwave generators for oncology, cardiology, and other therapeutic applications. Emblation also develops OEM microwave systems for industrial, scientific, and research use.

Explore the company's cleared device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by Blackwell Device Consulting as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.