Leltek, Inc. is one of 203 FDA 510(k) medical device manufacturers from Taiwan in the dataset, ranked by real submission volume.
Leltek, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Ultrasound Imaging System (LU700 Series), Ultrasound Imaging System (LK128L), Leltek Ultrasound Imaging System (Model: LU700 Series)
5
Total
5
Cleared
0
Denied
Leltek, Inc. has 5 FDA 510(k) cleared medical devices. Based in New Taipei City, TW.
Latest FDA clearance: May 2025. Active since 2020. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Leltek, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Leltek, Inc.
5 devices
Cleared
May 08, 2025
Ultrasound Imaging System (LU700 Series)
Radiology
212d
Cleared
Sep 11, 2024
Ultrasound Imaging System (LK128L)
Radiology
138d
Cleared
Oct 25, 2022
Leltek Ultrasound Imaging System (Model: LU700 Series)
Radiology
82d
Cleared
Nov 03, 2021
LELTEK Ultrasound Imaging System (Model: LU700 Series)
Radiology
264d
Cleared
Feb 12, 2020
Leltek Ultrasound Imaging System
Radiology
280d