Medical Device Manufacturer · NL , Roden, Drenthe

Imds Operations B.V. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2012

Recent clearances: FlowGuide (FG60F), ShapeIT (SI014135), Micro Rx

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Imds Operations B.V. Cardiovascular ✕

8 devices

1-8 of 8

Cleared Apr 17, 2025

FlowGuide (FG60F)

Cardiovascular · 253d

Cleared Sep 03, 2024

ShapeIT (SI014135)

Cardiovascular · 90d

Cleared Jul 13, 2023

Cardiovascular · 212d

Cleared Jul 15, 2021

Cardiovascular · 153d

Cleared Mar 31, 2021

Cardiovascular · 71d

Cleared Aug 06, 2020

Cardiovascular · 178d

Cleared Jan 21, 2020

Cardiovascular · 258d

Cleared Dec 21, 2012

Cardiovascular · 256d