Matthew Stepanek

FDA Filings

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

FDA Registration(s)

• Registration Number: 9611896
• FEI Number: 3002957361
• Name: Matthew Stepanek
• Owner & Operator: MEDICAL MEASUREMENT SYSTEMS B.V.
• Contact Address: 5420 Feltl Road ; Minnetonka MN 55343 US
• Official Correspondent:
  • Matthew - Stepanek
  • 1-952-4266146-x
• US Agent:
  • Matthew Stepanek
  • 951 4266146
  • mstepanek@laborie.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5420 Felt Road ; Minnetonka, MN 55343 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K033906 | IYO Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Portascan+	2015-12-08
PMN K033906 | ITX Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Portascan+	2015-12-08
PMN K121014 | FFX Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	MPP Plus	2012-11-01
PMN K071094 | FFX Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Solar perfusion pump	2007-12-20
PMN K060166 | FFX Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Orion II	2007-12-13
PMN K060166 | FFX Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Ohmega	2007-12-13
PMN K052338 | FFX Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Solar GI including CIM-AUX	2007-12-13
PMN K050993 | LLZ Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	network and Dicom	2007-12-13
PMN K050993 | LLZ Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	MMS Video option	2007-12-13
PMN K031930 | JXE Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Solar Neuro Module	2007-12-13
PMN K031930 | GWF Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Solar Neuro Module	2007-12-13
PMN K031930 | FEN Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Solar Neuro Module	2007-12-13
PMN K031084 | FFX Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Solar GI	2007-12-13
FEN Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Urodynamic catheters & accessories	2003-12-18
FEN Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Solar Uro	2003-12-18
FEN Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Solar Blue	2003-12-18
FEN Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Nexam	2003-12-18
FEN Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Luna	2003-12-18
EXY Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Urodyn+	1999-11-03
EXQ Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Flowtaker	1999-11-03
EXQ Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Flowstar	1999-11-03
EXQ Matthew Stepanek [MEDICAL MEASUREMENT SYSTEMS B.V.]	Flowmaster	1999-11-03