Medical Device Manufacturer · US , La Jolla , CA

Carlsmed, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2020

Official Website

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Carlsmed, Inc. Radiology ✕

3 devices

1-3 of 3

Cleared Dec 20, 2024

aprevo® Digital Planning

Radiology · 112d

Cleared Nov 03, 2023

aprevo® Digital Segmentation

Radiology · 123d

Cleared Dec 30, 2022

aprevo® Digital Workflow

Radiology · 161d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 25, 2026