Data / Medical devices / Netherlands / Macromedics BV
Macromedics BV: FDA-registered device maker in Moordrecht Zuid-Holland, Netherlands, 5 510(k) clearances
Macromedics BV is registered with the FDA (registration 3010701021) in Moordrecht Zuid-Holland, Netherlands. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010701021
- Address
- Oostbaan 670, Moordrecht Zuid-Holland, Netherlands, 2841ML
- Owner or operator
- MacroMedics BV (10046168)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- September 13, 2016
- Registered through
- 2026
- Brand names listed
- BreastBoard SX, CouchStripCS53FGF-PRO, CouchStrips, DSPS PRO Mask Shim Set HNS, DSPS PRO Mask Shim Set HO, DSPS-Prominent® Cradle-I, DSPS-Prominent® Cradle-II, DSPS-Prominent® Cradle-III and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 19, 2025 | 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 | Substantially Equivalent | Macromedics BV | accessdata.fda.gov |
| February 17, 2023 | K222977 | DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip | IYE | Substantially Equivalent | Macromedics BV | accessdata.fda.gov |
| June 24, 2022 | K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTM | IYE | Substantially Equivalent | Macromedics BV | accessdata.fda.gov |
| May 11, 2022 | K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips | IYE | Substantially Equivalent | Macromedics BV | accessdata.fda.gov |
| March 27, 2015 | K142420 | Patient Positioning Devices | IYE | Substantially Equivalent | Macromedics BV | accessdata.fda.gov |
Compare with other makers
Updated March 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.