Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Macromedics BV

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories1
Latest FDA decision2025-03-19
TypeNumberDevice NameCodeDateActions
510(k) K250429 DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH setIYE2025-03-19 View
510(k) K222977 DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripIYE2023-02-17 View
510(k) K213439 FlexBoardTM, EagleBoardTM, BreastBoard SXTMIYE2022-06-24 View
510(k) K212909 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsIYE2022-05-11 View
↑