Femselect L T D

FDA Filings

This page includes the latest FDA filings for Femselect L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010892271
• FEI Number: 3010892271
• Name: FEMSelect Ltd
• Owner & Operator: FEMSelect Ltd
• Contact Address: HaMa'ayan 2 First Floor; Modi'in IL-NOTA 7177871 IL
• Official Correspondent:
  • Debbie Garner
  • 972-54-9456260-x
• US Agent:
  • Matt Dryden
  • ProMedic, LLC
  • 239 3076063
  • 239 3076070
  • matt.dryden@promedic.cc
• Importing Logistics Registration:
  • Importer: Cleveland Clinic Florida
  • Address: 2950 Cleveland Clinic Blvd. ; Weston, FL 33331 UNITED STATES
  • Email Address: killinc@ccf.org
  • Phone: 1 954 6596247
• Importing Logistics Registration:
  • Importer: INOVA Womens Hospital
  • Address: 500 N. Washington Street Suite 300 ; Falls Church, VA 22046 UNITED STATES
  • Email Address: Rashmi.Mishra@inova.org
• Importing Logistics Registration:
  • Importer: MedStar Health Research Institute
  • Address: 110 Irving St., NW East Building 5108 ; Washington, DC 20010 UNITED STATES
  • Email Address: Patricia.Tanjutco@medstar.net
  • Phone: 1 202 5706499
• Importing Logistics Registration:
  • Importer: National Center for Advanced Pelvic Surgery
  • Address: 106 Irving St., NW Suite 405 S. POB ; Washington, DC 20010 UNITED STATES
  • Email Address: Andrew.I.Sokol@medstar.net
  • Phone: 1 202 8776526
  • Importer Type: POST MARKET STUDY
• Importing Logistics Registration:
  • Importer: South Nassau Communities Hospital
  • Address: 1 South Central Avenue ; New York City, NY 10128 UNITED STATES
  • Phone: 1 516 6323966
  • Importer Type: POST MARKET STUDY
• Importing Logistics Registration:
  • Importer: South Nassau Community Hospital Cancer Center
  • Address: 1 South Central Avenue ; Valley Stream, NY 11580 UNITED STATES
• Importing Logistics Registration:
  • Importer: The Female Pelvic Health Center
  • Address: 760 Newtown-Yardley Road Suite 115 ; Newtown, PA 18940 UNITED STATES
• Importing Logistics Registration:
  • Importer: The Institute for Female Pelvic Medicine and Recon
  • Address: 3050 Hamilton Blvd. Suite 200 ; Allentown, PA 18103 UNITED STATES
  • Email Address: vlucente@fpminstittute.com
• Importing Logistics Registration:
  • Importer: Walnut Hill OB/GYN Associates
  • Address: 8305 Walnut Hill Lane Suite 100 ; Dallas, TX 75231 UNITED STATES
  • Phone: 1 214 3637801
  • Importer Type: IRB STUDY
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: HaMa'ayan 2 First Floor; Modi'in, 7177871 IL
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 17290017082025 FEMSELECT LTD	EnPlace FG-00001-02	2022-06-27
PMN K160569 | PBQ FEMSelect Ltd	EnPlace	2016-12-27