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Macromedics BV FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
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 set510(k)Mar 19, 2025Radiology
DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip510(k)Feb 17, 2023Radiology
FlexBoardTM, EagleBoardTM, BreastBoard SXTM510(k)Jun 24, 2022Radiology
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips510(k)May 11, 2022Radiology

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