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Macromedics BV

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

Total Devices4
Categories1
Latest Approval2025-03-19
TypeNumberDevice NameCodeDate
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 set IYE 2025-03-19 View
510(k) K222977 DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip IYE 2023-02-17 View
510(k) K213439 FlexBoardTM, EagleBoardTM, BreastBoard SXTM IYE 2022-06-24 View
510(k) K212909 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips IYE 2022-05-11 View
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