Macromedics B V

FDA Filings

This page includes the latest FDA filings for Macromedics B V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010701021
FEI Number3010701021
NameAnthony Palin
Owner & OperatorMacroMedics BV
Contact AddressKouwe Hoek 18
Waddinxveen NL-ZH Zuid-Holland 2741PX NL
Official Correspondent
  • J. Drenth
  • 031-182-389777-x
US Agent
Importing Logistics Registration
ImporterMacroMedics USA
Address3545 Ellicott Mills Drive Suite 206
Ellicott City, MD 21043 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3545 Ellicott Mills Drive Suite 206
Ellicott City, MD 21043 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
MACROMEDICS B.V.
 MLDRM tool 1137102023-05-01
MACROMEDICS B.V.
 Profile BreastBoardSX™ right 172420R2023-05-01
MACROMEDICS B.V.
 OmniBoard™ bottomstop sliding 1742302023-05-01
MACROMEDICS B.V.
 OmniBoard™ 3.0 base,RE 1742102023-05-01
MACROMEDICS B.V.
 Mask DSPS®-PROSL 113980M2023-05-01
MACROMEDICS B.V.
 Mask DSPS®-PROSVRL 113950M2023-05-01
MACROMEDICS B.V.
 Mask DSPS®-PROSL, set/5 1139802023-05-01
MACROMEDICS B.V.
 Mask DSPS®-PROSVRL, set/5 1139502023-05-01
MACROMEDICS B.V.
 Mask DSPS®-PROSVR 113970M2023-05-01
MACROMEDICS B.V.
 Mask DSPS®-PROSVR, set/5 1139702023-05-01
MACROMEDICS B.V.
 Mask DSPS®-PRO 113990M2023-05-01
MACROMEDICS B.V.
 Mask DSPS®-PROS 113960M2023-05-01
MACROMEDICS B.V.
 Mask DSPS®-PROS, set/5 1139602023-05-01
MACROMEDICS B.V.
 CouchStrip CS53FGF-PRO 1474102023-05-01
MACROMEDICS B.V.
 DSPS-Prominent® baseplate, MR 1138202023-05-01
MACROMEDICS B.V.
 VacuumCushion EB-2 1556102023-05-01
MACROMEDICS B.V.
 Cranial AS for BBLX/TS, left 122330L2023-05-01
MACROMEDICS B.V.
 Cranial AS for BBLX/TS, right 122330R2023-05-01
MACROMEDICS B.V.
 Upper AS TS/MBLX, left 122300L2023-05-01
MACROMEDICS B.V.
 Upper AS TS/MBLX, right 122300R2023-05-01
MACROMEDICS B.V.
 Shoulder retr. for LEPS™ 130350U2023-05-01
MACROMEDICS B.V.
 FlexBoard™ BTM-LX module 1736602023-05-01
MACROMEDICS B.V.
 Adjust. UAS right 125320R2023-05-01
MACROMEDICS B.V.
 Adjust. UAS left 125320L2023-05-01
MACROMEDICS B.V.
 Profile BreastBoardSX™ left 172420L2023-05-01
MACROMEDICS B.V.
 EagleBoard™-2 M-Grip, MR 1229702023-05-01
MACROMEDICS B.V.
 EagleBoard™-2 Base, MR 1229502023-05-01
MACROMEDICS B.V.
 FlexBoard™ BTM-SX 1746302023-05-01
MACROMEDICS B.V.
 EagleBoard™-2 Adaptor HS RE 1229602023-05-01
MACROMEDICS B.V.
 EagleBoard™-2 M-Grip 1229402023-05-01
MACROMEDICS B.V.
 EagleBoard™-2 Base 1229302023-05-01
MACROMEDICS B.V.
 FlexBoard™ BTM-EX 1721202023-05-01
MACROMEDICS B.V.
 FlexBoard™ base 1721102023-05-01
MACROMEDICS B.V.
 FeetSupport™, fixed 2.0 1304502023-05-01
MACROMEDICS B.V.
 VacuumCushion Pos.Strip MR 1559502023-05-01
MACROMEDICS B.V.
 CouchStrip CS53FGF-S 1471502023-05-01
MACROMEDICS B.V.
 CouchStrip CS50FCF-S 1471402023-05-01
MACROMEDICS B.V.
 CouchStrip CS53FCF-IB 1471102023-05-01
MACROMEDICS B.V.
 FeetSupport™, rotatable 2.0 1304602023-05-01
MACROMEDICS B.V.
 CouchStrip CS53FCF-S 1471302023-05-01
MACROMEDICS B.V.
 CouchStrip CS53FGF-EX 1479302023-05-01
MACROMEDICS B.V.
 CouchStrip CS53FCF-EX 1479602023-05-01
MACROMEDICS B.V.
 LEPS™ baseplate short 1304202023-05-01
MACROMEDICS B.V.
 Rigid UAS left 125300L2023-05-01
MACROMEDICS B.V.
 Rigid UAS right 125300R2023-05-01
MACROMEDICS B.V.
 BreastBoard SX™ 1724102023-05-01
MACROMEDICS B.V.
 KneeSupport™, plastic 1301402023-05-01
MACROMEDICS B.V.
 KneeSupport™ low,plastic 1301302023-05-01
MACROMEDICS B.V.
 CouchStrip CS50FCF-EX 1479502023-05-01
MACROMEDICS B.V.
 Adjust. UAS set/2 1253202023-05-01
MACROMEDICS B.V.
 EagleBoard™ MR 1228502023-05-01
MACROMEDICS B.V.
 Cranial AS for BBLX/TS, set/2 1223302023-05-01
MACROMEDICS B.V.
 Upper AS TS/MBLX, set/2 1223002023-05-01
MACROMEDICS B.V.
 MaxSupport™ Extender 1211802023-05-01
MACROMEDICS B.V.
 HighBridgeSupport RE 1735302023-05-01
MACROMEDICS B.V.
 Shoulder retr. for LEPS™,set/2 1303502023-05-01
MACROMEDICS B.V.
 Profiles BreastBoardSX™ set/2 1724202023-05-01
MACROMEDICS B.V.
 U-Grip for EagleBoard™ MR 1228702023-05-01
MACROMEDICS B.V.
 T-Grip for EagleBoard™ MR 1228602023-05-01
MACROMEDICS B.V.
 FeetSupport™, fixed 1302502023-04-24
MACROMEDICS B.V.
 KneeSupport™ LiftBlock™ 1301202023-04-24
MACROMEDICS B.V.
 MaxSupport™ 1 1171102023-04-24
MACROMEDICS B.V.
 Low Bridge Support, RE 1735102023-04-21
MACROMEDICS B.V.
 VacuumCushion 120x120 T 1555202023-04-21
MACROMEDICS B.V.
 Rigid UAS set/2 1253002023-04-21
MACROMEDICS B.V.
 VacuumCushion 200x100 1555102023-04-21
MACROMEDICS B.V.
 VacuumCushion 100x150 1554502023-04-21
MACROMEDICS B.V.
 VacuumCushion 120x80 1554302023-04-21
MACROMEDICS B.V.
 VacuumCushion 100x80 1554102023-04-21
MACROMEDICS B.V.
 VacuumCushion 100x70 1554002023-04-21
MACROMEDICS B.V.
 VacuumCushion 65x65 1553002023-04-21
MACROMEDICS B.V.
 VacuumCushion 50x70 1552102023-04-21
MACROMEDICS B.V.
 VacuumCushion 50x70 T 1551502023-04-21
MACROMEDICS B.V.
 VacuumCushion 25x50 1551402023-04-21
MACROMEDICS B.V.
 VacuumCushion 30x40 1551102023-04-21
MACROMEDICS B.V.
 VacuumCushion, abdom. XL 1234702023-04-21
MACROMEDICS B.V.
 VacuumCushion, abdom. S 1234502023-04-21
MACROMEDICS B.V.
 LEPS™ baseplate 1302002023-04-21
MACROMEDICS B.V.
 FeetSupport™, rotatable 1302602023-04-21
MACROMEDICS B.V.
 KneeSupport™ 1301002023-04-21
MACROMEDICS B.V.
 BottomStop Adaption 1225902023-04-21
MACROMEDICS B.V.
 Wedge 15 CF ExaFix™ 1105602023-04-21
MACROMEDICS B.V.
 Wedge 10 CF ExaFix™ 1105502023-04-21
MACROMEDICS B.V.
 Wedge 5 CF ExaFix™ 1105302023-04-21
MACROMEDICS B.V.
 Wedge 7 CF ExaFix™ 1105402023-04-21
MacroMedics BV
FlexBoardTM, EagleBoardTM, BreastBoard SXTM2022-06-24
MacroMedics BV
LEPS, LEPS FeetSupport (including Variations Of FeetSupport, KneeSupport, KneeSupport LiftBlock, Shoulder Retr. For LEPS, LEPS Baseplate, LEPS Baseplate Short), FeetSupport (various Models) ,CouchStrip, VacuumCushion Pos. Strip, MRIdian Rail (various2022-05-11
Anthony Palin [MacroMedics BV]
Patient Positioning Devices2016-09-13
Anthony Palin [MacroMedics BV]
Patient Positioning Devices2016-09-13
MACROMEDICS BV
Patient Positioning Devices2015-03-27

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018021354526Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseySLAC MEDICAL EQUIPMENT HS CODE:90189080 LOADED ON 7 PALLETS B80008927 PKG
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