Medical Device Manufacturer · NL , Waddinxveen

Macromedics BV - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2015

Recent clearances: DSPS-Prominent® baseplate, MR (113820), DSPS-Prominent™ Masks, FlexBoardTM, EagleBoardTM, BreastBoard SXTM

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Macromedics BV Radiology ✕

5 devices

1-5 of 5

Cleared Mar 19, 2025

DSPS-Prominent® baseplate, MR (113820)

Radiology · 33d

Cleared Feb 17, 2023

DSPS-Prominent™ Masks

Radiology · 142d

Cleared Jun 24, 2022

FlexBoardTM, EagleBoardTM, BreastBoard SXTM

Radiology · 242d

Cleared May 11, 2022

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System),...

Radiology · 240d

Cleared Mar 27, 2015

Patient Positioning Devices

Radiology · 211d