Fmi Medisch B V

FDA Filings

This page includes the latest FDA filings for Fmi Medisch 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 Number: 3010370500
• FEI Number: 3010370500
• Name: Michael van der Woude
• Owner & Operator: FMI Medisch BV
• Contact Address: De Brauwweg 17 ; Schiedam NL-NOTA 3125 AE NL
• Official Correspondent:
  • Gerard Freriks
  • 31-010-4626899-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation
  • 512 3279997
  • 512 3279998
  • usagent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road Bldg 1, Suite 300; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K190870 | OVE Michael van der Woude [FMI Medisch BV]	Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device	2019-11-15
PMN K180437 | MAX Michael van der Woude [FMI Medisch BV]	Hexanium? TLIF	2019-04-12
PMN K133575 | MNI Michael van der Woude [FMI Medisch BV]	U.L.I.S.? UNIVERSAL SCREWDRIVER	2014-08-27
PMN K133575 | MNI Michael van der Woude [FMI Medisch BV]	LUMIS UNIVERSAL SCREWDRIVER	2014-08-27
PMN K133575 | MNH Michael van der Woude [FMI Medisch BV]	U.L.I.S.? UNIVERSAL SCREWDRIVER	2014-08-27
PMN K133575 | MNH Michael van der Woude [FMI Medisch BV]	LUMIS UNIVERSAL SCREWDRIVER	2014-08-27
PMN K133575 | KWQ Michael van der Woude [FMI Medisch BV]	U.L.I.S.? UNIVERSAL SCREWDRIVER	2014-08-27
PMN K133575 | KWQ Michael van der Woude [FMI Medisch BV]	LUMIS UNIVERSAL SCREWDRIVER	2014-08-27
PMN K133575 | KWP Michael van der Woude [FMI Medisch BV]	U.L.I.S.? UNIVERSAL SCREWDRIVER	2014-08-27
PMN K133575 | KWP Michael van der Woude [FMI Medisch BV]	LUMIS UNIVERSAL SCREWDRIVER	2014-08-27
PMN K112607 | NKB Michael van der Woude [FMI Medisch BV]	Screw extender	2013-03-19
PMN K112607 | NKB Michael van der Woude [FMI Medisch BV]	ENLARGED SCREW EXTENDER	2013-03-19
PMN K112607 | MNI Michael van der Woude [FMI Medisch BV]	Screw extender	2013-03-19
PMN K112607 | MNI Michael van der Woude [FMI Medisch BV]	ENLARGED SCREW EXTENDER	2013-03-19
PMN K112607 | MNH Michael van der Woude [FMI Medisch BV]	Screw extender	2013-03-19
PMN K112607 | MNH Michael van der Woude [FMI Medisch BV]	ENLARGED SCREW EXTENDER	2013-03-19
PMN K112607 | KWQ Michael van der Woude [FMI Medisch BV]	Screw extender	2013-03-19
PMN K112607 | KWQ Michael van der Woude [FMI Medisch BV]	ENLARGED SCREW EXTENDER	2013-03-19
PMN K112607 | KWP Michael van der Woude [FMI Medisch BV]	Screw extender	2013-03-19
PMN K112607 | KWP Michael van der Woude [FMI Medisch BV]	ENLARGED SCREW EXTENDER	2013-03-19
PMN K013312 | MNI Michael van der Woude [FMI Medisch BV]	ST MULTI AXIAL TRANSVERSE CONNECTOR	2013-03-19
PMN K013312 | MNI Michael van der Woude [FMI Medisch BV]	ST ILIAC ROD RIGHT SIDE	2013-03-19
PMN K013312 | MNI Michael van der Woude [FMI Medisch BV]	ST ILIAC ROD LEFT SIDE	2013-03-19
PMN K013312 | MNH Michael van der Woude [FMI Medisch BV]	ST MULTI AXIAL TRANSVERSE CONNECTOR	2013-03-19
PMN K013312 | MNH Michael van der Woude [FMI Medisch BV]	ST ILIAC ROD RIGHT SIDE	2013-03-19
PMN K013312 | MNH Michael van der Woude [FMI Medisch BV]	ST ILIAC ROD LEFT SIDE	2013-03-19
PMN K013312 | KWP Michael van der Woude [FMI Medisch BV]	ST MULTI AXIAL TRANSVERSE CONNECTOR	2013-03-19
PMN K013312 | KWP Michael van der Woude [FMI Medisch BV]	ST ILIAC ROD RIGHT SIDE	2013-03-19
PMN K013312 | KWP Michael van der Woude [FMI Medisch BV]	ST ILIAC ROD LEFT SIDE	2013-03-19
HXX Michael van der Woude [FMI Medisch BV]	UNIVERSAL PEDICLE SCREWDRIVER	2013-03-19
HXX Michael van der Woude [FMI Medisch BV]	T20 RATCHET SCREWDRIVER	2013-03-19
HXX Michael van der Woude [FMI Medisch BV]	MULTI-AXIAL SCREWDRIVER	2013-03-19
HXX Michael van der Woude [FMI Medisch BV]	CANNULATED SCREWDRIVER	2013-03-19
HXB Michael van der Woude [FMI Medisch BV]	PEDICLE PROBE WITH BALL TIP	2013-03-19
HTC Michael van der Woude [FMI Medisch BV]	Setscrew guide + Counter torque	2013-03-19
HTC Michael van der Woude [FMI Medisch BV]	SCREW FOR ROD PERSUADER	2013-03-19
HTC Michael van der Woude [FMI Medisch BV]	ROD PERSUADER	2013-03-19
HTC Michael van der Woude [FMI Medisch BV]	LONG SCREW FOR ROD PERSUADER	2013-03-19
HTC Michael van der Woude [FMI Medisch BV]	COUNTER TORQUE	2013-03-19
PMN K010840 | LZN Michael van der Woude [FMI Medisch BV]	Synplug	2013-02-12
LXH Michael van der Woude [FMI Medisch BV]	Vanguard PFR	2013-02-12
LXH Michael van der Woude [FMI Medisch BV]	T30 SHAFT	2013-02-12
LXH Michael van der Woude [FMI Medisch BV]	Snap-on handle for drills	2013-02-12
LXH Michael van der Woude [FMI Medisch BV]	Setscrew holder	2013-02-12
LXH Michael van der Woude [FMI Medisch BV]	Screw aligner	2013-02-12
LXH Michael van der Woude [FMI Medisch BV]	ROD GRIPPER	2013-02-12
LXH Michael van der Woude [FMI Medisch BV]	Pins for distractor/compressor	2013-02-12
LXH Michael van der Woude [FMI Medisch BV]	INDEX RING FOR SETSCREW HOLDER	2013-02-12
LXH Michael van der Woude [FMI Medisch BV]	Distractor / compressor	2013-02-12
LXH Michael van der Woude [FMI Medisch BV]	CLIP INTRODUCER	2013-02-12
KTZ Michael van der Woude [FMI Medisch BV]	Vanguard PFR	2013-02-12
HXY Michael van der Woude [FMI Medisch BV]	Vanguard PFR	2013-02-12
HXD Michael van der Woude [FMI Medisch BV]	Vanguard PFR	2013-02-12
HWX Michael van der Woude [FMI Medisch BV]	?7mm CANNULATED TAP	2013-02-12
HWX Michael van der Woude [FMI Medisch BV]	?6mm CANNULATED TAP	2013-02-12
HWX Michael van der Woude [FMI Medisch BV]	?5mm CANNULATED TAP	2013-02-12
HWX Michael van der Woude [FMI Medisch BV]	7mm TAP	2013-02-12
HWX Michael van der Woude [FMI Medisch BV]	6mm TAP	2013-02-12
HWX Michael van der Woude [FMI Medisch BV]	5mm TAP	2013-02-12
HWX Michael van der Woude [FMI Medisch BV]	12mm stop tap	2013-02-12
HWB Michael van der Woude [FMI Medisch BV]	Vanguard PFR	2013-02-12
GAC Michael van der Woude [FMI Medisch BV]	Vanguard PFR	2013-02-12
FZX Michael van der Woude [FMI Medisch BV]	Vanguard PFR	2013-02-12
FZX Michael van der Woude [FMI Medisch BV]	New Fixed Angle Drill Guide	2013-02-12
FZX Michael van der Woude [FMI Medisch BV]	AXIAL ROD INTRODUCER / CLIP GUIDE - U1 - A337N1	2013-02-12
FZX Michael van der Woude [FMI Medisch BV]	AXIAL ROD INTRODUCER / CLIP GUIDE - U1 - A337	2013-02-12