Macromedics BV is one of 68 FDA 510(k) medical device manufacturers from Netherlands in the dataset, ranked by real submission volume.
Macromedics BV - FDA 510(k) Cleared Devices
Recent clearances: DSPS-Prominent® baseplate, MR (113820), DSPS-Prominent™ Masks, FlexBoardTM, EagleBoardTM, BreastBoard SXTM
5
Total
5
Cleared
0
Denied
Macromedics BV has 5 FDA 510(k) cleared medical devices. Based in Waddinxveen, NL.
Latest FDA clearance: Mar 2025. Active since 2015. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Macromedics BV Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Macromedics BV
5 devices
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