Macromedics BV

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-March 19, 2025
K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripFebruary 17, 2023
K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTMJune 24, 2022
K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsMay 11, 2022
K142420Patient Positioning DevicesMarch 27, 2015