Fortimedix Surgical B V

FDA Filings

This page includes the latest FDA filings for Fortimedix Surgical 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: 3013186644
• FEI Number: 3013186644
• Name: FORTIMEDIX SURGICAL B.V.
• Owner & Operator: Fortimedix Surgical B.V.
• Contact Address: Urmonderbaan 22 ; Geleen NL-LI Limburg 6167 RD NL
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • usagent@ul.com
• Importing Logistics Registration:
  • Importer: Buffalo General Medical Center
  • Address: 100 High Street ; Buffalo, NY 14203 UNITED STATES
  • Importer Type: Hospital
• Importing Logistics Registration:
  • Importer: Houston Methodist The Woodlands Hospital
  • Address: 17201 N Interstate 45, ; Conroe, TX 77385 UNITED STATES
• Importing Logistics Registration:
  • Importer: Houston Methodist Willowbrook Hospital
  • Address: 18220 Texas 249 ; Houston, TX 77070 UNITED STATES
• Importing Logistics Registration:
  • Importer: Jacobs Medical Center
  • Address: 9300 Campus Point Drive #7701 ; La Jolla, CA 92037 UNITED STATES
• Importing Logistics Registration:
  • Importer: Keck Hospital of USC
  • Address: 1500 San Pablo Street ; Los Angeles, CA 90003 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Loma Linda University Medical Center
  • Address: 11234 Anderson Street ; Loma Linda, CA 92354 UNITED STATES
  • Phone: 1 909 5580245 88158
  • Importer Type: HOSPITAL
• Importing Logistics Registration:
  • Importer: MEDICAL CITY DALLAS
  • Address: 7777 Forest Lane ; Dallas, TX 75230 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Memorial Hermann Hospital
  • Address: Surgical Innovation & Robotics Institute (SIRI) 2001 Hermann Dr., Suite 1-C ; Houston, TX 77004 UNITED STATES
  • Importer Type: HOSPITAL
• Importing Logistics Registration:
  • Importer: Memorial Hermann Surgery Center
  • Address: 6400 Fannin, Suite 1500 ; Houston, TX 77030 UNITED STATES
  • Importer Type: Hospital
• Importing Logistics Registration:
  • Importer: Montefiore Medical Center
  • Address: 111 East 210th St. ; Allerton, NY 10467 UNITED STATES
  • Importer Type: Hospital
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Urmonderbaan 22 ; Geleen Limburg, 6167 RD NL
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 08719324463355 Fortimedix Surgical B.V.	symphonX™ 314-011	2019-11-15
GUDID 08719324463348 Fortimedix Surgical B.V.	symphonX™ 314-010	2019-11-15
GUDID 08719324463331 Fortimedix Surgical B.V.	symphonX™ 314-009	2019-11-15
GUDID 08719324463324 Fortimedix Surgical B.V.	symphonX™ 314-008	2019-11-15
GUDID 08719324463317 Fortimedix Surgical B.V.	symphonX™ 314-007	2019-11-15
GUDID 08719324463201 Fortimedix Surgical B.V.	symphonX™ 314-104	2019-11-15
GUDID 08719324463195 Fortimedix Surgical B.V.	symphonX™ 314-103	2019-11-15
GUDID 08719324463188 Fortimedix Surgical B.V.	symphonX™ 314-102	2019-11-15
GUDID 08719324463119 Fortimedix Surgical B.V.	symphonX™ 314-001	2019-11-15
GUDID 08719324463102 Fortimedix Surgical B.V.	symphonX™ 314-303	2019-11-15
GUDID 08719324463096 Fortimedix Surgical B.V.	symphonX™ 314-302	2019-11-15
GUDID 08719324463089 Fortimedix Surgical B.V.	symphonX™ 314-301	2019-11-15
GUDID 08719324463072 Fortimedix Surgical B.V.	symphonX™ 314-201	2019-11-15
GUDID 08719324463065 Fortimedix Surgical B.V.	symphonX™ 314-006	2019-11-15
GUDID 08719324463058 Fortimedix Surgical B.V.	symphonX™ 314-005	2019-11-15
GUDID 08719324463041 Fortimedix Surgical B.V.	symphonX™ 314-004	2019-11-15
GUDID 08719324463034 Fortimedix Surgical B.V.	symphonX™ 314-003	2019-11-15
GUDID 08719324463027 Fortimedix Surgical B.V.	symphonX™ 314-002	2019-11-15
GUDID 08719324463003 Fortimedix Surgical B.V.	symphonX™ 314-101	2019-11-15
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonx Introducer	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX? Suction/Irrigation	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX? Scissors	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX? Maryland	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX? Hook-knife	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX? Handle with ratchet	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX? Handle with on/off ratchet	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX? Grasper	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX? Clip Applier	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX scissors short	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX Maryland short	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX Introducer Clamp Type B	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX Introducer Clamp Type A	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX Hub Cap & Sealing Unit	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX Hook-knife short	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX Handle	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX Grasper short	2016-10-05
PMN K160797 | OTJ FORTIMEDIX SURGICAL B.V.	symphonX Clip Applier short	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonx Introducer	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX? Suction/Irrigation	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX? Scissors	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX? Maryland	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX? Hook-knife	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX? Handle with ratchet	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX? Handle with on/off ratchet	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX? Grasper	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX? Clip Applier	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX scissors short	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX Maryland short	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX Introducer Clamp Type B	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX Introducer Clamp Type A	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX Hub Cap & Sealing Unit	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX Hook-knife short	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX Handle	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX Grasper short	2016-10-05
PMN K160797 | GCJ FORTIMEDIX SURGICAL B.V.	symphonX Clip Applier short	2016-10-05
PMN K160797 Fortimedix Surgical B.V.	FMX314 Surgical Platform	2016-08-26