Uvision360, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Uvision360, Inc. - FDA 510(k) Cleared Devices
Recent clearances: LUMINELLE DTx System, Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic), Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
4
Total
4
Cleared
0
Denied
Uvision360, Inc. has 4 FDA 510(k) cleared medical devices. Based in Raleigh, US.
Last cleared in 2021. Active since 2018. Primary specialty: Obstetrics & Gynecology.
Browse the FDA 510(k) cleared devices submitted by Uvision360, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by MethodSense, Inc. and Third Party Review Group, LLC.
FDA 510(k) Regulatory Record - Uvision360, Inc.
4 devices
Cleared
Jun 30, 2021
LUMINELLE DTx System
Obstetrics & Gynecology
127d
Cleared
Nov 01, 2019
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable...
Obstetrics & Gynecology
71d
Cleared
Jun 06, 2019
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable...
Obstetrics & Gynecology
66d
Cleared
Aug 16, 2018
Luminelle DTx Hysteroscopy System
Obstetrics & Gynecology
30d