G B S R L

FDA Filings

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

FDA Registration(s)

• Registration Number: 1000494477
• FEI Number: 1000494477
• Name: Swea Nightingale
• Owner & Operator: G.B. SRL
• Contact Address: LOCALITA' CIMA GOGNA 56 --; AURONZO DI CADORE BL IT-NOTA 32041 IT
• Official Correspondent:
  • STEFANO - LARCHER
  • 39-0435-9878-x
• US Agent:
  • Swea Nightingale
  • THE VISION COUCIL
  • 703 5484560
  • 703 5484580
  • snightingale@thevisioncouncil.org
• Importing Logistics Registration:
  • Importer: Ioptix Mr. Klein
  • Address: 1703 Clifton Avenue ; Lakewood, NJ 08701 UNITED STATES
  • Phone: 1 732 3640110
  • Importer Type: RETAILER
• Importing Logistics Registration:
  • Importer: Selective Eyewear Elements
  • Address: 19800 West Eight Mile Road ; Southfield, MI 48075 UNITED STATES
  • Phone: 1 248 3547100
  • Importer Type: RETAILER
• Importing Logistics Registration:
  • Importer: Tryiton Eyewear, LLC
  • Address: 147 Post Road East ; Saugatuck, CT 06880 UNITED STATES
  • Phone: 1 203 5440770
  • Importer Type: RETAILER
• Importing Logistics Registration:
  • Importer: Yosam, LLC
  • Address: 1875 N.E. 168th Street ; Miami, FL 33162 UNITED STATES
  • Phone: 1 954 2884026
  • Importer Type: RETAILER
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 225 REINEKERS LANE SUITE 700; Alexandria, VA 22314 US
• Establishment Type: Manufacture Medical Device

FDA Owner/Operator Registration

Similar & Related FDA Registered Companies

• GBM Authorised Representative Ltd.
• Global Quality Solutions International, LLC (GQSI)
• GLOBUS SPORT AND HEALTH TECHNOLOGIES LLC.
• GLOBAL RESOURCES INTERNATIONAL, INC.
• global pro-tech industries, llc
• Global Focus Marketing & Distributioin Ltd
• Goodyear Rubber Company of Southern California
• Gibson Area Hospital
• Global Industrial Distribution Inc
• GLOBAL SECURITY INTERNATIONAL LLC
• Global USA Distribution, LLC
• G. ALBERT STORZ INH, DIPL-ING ULRICH BINDER
• G. R. Bioure Surgical System Private Limited
• Gaomi Hansheng Labor Insurance Co., Ltd.
• GARWARE BESTRETCH, LTD.
• Gebr. Held Hydraulik Technischer Grosshandel GmbH
• GIBSON LABORATORIES, LLC
• GLOBAL BLOOD RESOURCES, LLC
• Global Health Services, LLC
• GLOBAL INSTRUMENTATION, LLC
• Global Medical Supply Group, LLC
• Global Product Sources, LLC
• Global Resources (Vietnam) Group Limited Company
• Global Resources International Dominicana, SRL
• Global Respiratory Solutions, Inc. (dba) Respiralogics
• GLOBAL SURGICAL CORP.
• GLOBUS SPORT AND HEALTH TECHNOLOGIES
• Gruppo Bioimpianti S.r.l.
• GUANGDONG BAOSHENG COLOR PRINTING CO., LTD.
• GUANGDONG BEIUN HOUSEHOLD PAPER INDUSTRY CO., LTD
• Guangdong Benruson Medical Products Co., Ltd
• GUANGDONG BESTEK E-COMMERCE CO LTD
• Guangdong Obee Personal Care Products Co., Ltd.
• Guangdong Xunyue Labor Insurance Products Co., Ltd.
• Guanghzou Qingding Business Operation Management Co., Ltd
• GUANGXI BONLALA SMART TECHNOLOGY CO., LTD
• Guangxi Pubei Xinsheng Garments Co., Ltd
• Guangzhou Baiyun District Longgui Shengshi Shoes Factory
• Guangzhou BLS Leather Co., Ltd
• Guangzhou Blue Sky Electronic Technology Co., Ltd.
• Guangzhou Bofeite Safety Protective Supplies Co., Ltd.
• GUANGZHOU BOSLUN INDUSTRIAL CO.,LTD
• Guangzhou Hezhong Labor Insurance Supplies Co., Ltd.
• GuangZhou Kwong Fai Rubber Plastic & Metal Products Ltd
• Guangzhou Wanzhong Yixin Labao Insurance Supplies Co Ltd
• Guizhou Zunyi Busbar Sci-Tech Development Co.Ltd
• Gnali Bocia S.R.L.
• GLOBAL TREASURE INDUSTRIES LTD.
• GLOBAL TREASURE LTD.
• GABRIS SURGICAL CORP.
• GILBERT SURGICAL INSTRUMENTS, INC.
• GOOD BOND INDUSTRIAL CORP.
• GABEL MEDICAL INSTRUMENTS, LTD.
• GROMAX RUBBER INDUSTRY CO., LTD.
• GOLDEN BONANZA INDUSTRIAL CORP.
• GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS227 Date Received12/12/2022 Decision Date12/20/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS226 Date Received12/07/2022 Decision Date12/14/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS225 Date Received10/26/2022 Decision Date12/12/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Greatbatch Medical2300 Berkshire Lane Northminneapolis, MN 55441 PMA NumberP130012 Supplement NumberS010 Date Received08/08/2022 Decision Date12/12/2022 Product Code DTB  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS224 Date Received10/05/2022 Decision Date10/28/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Greatbatch Medical2300 Berkshire Lane Northminneapolis, MN 55441 PMA NumberP130012 Supplement NumberS009 Date Received08/05/2022 Decision Date10/05/2022 Product Code DTB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS221 Date Received09/20/2022 Decision Date09/27/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• GLAUKOS, CORPORATION26051 Merit Circle, Suite 103laguna Hills, CA 92653 PMA NumberP080030 Supplement NumberS024 Date Received05/31/2022 Decision Date08/29/2022 Product Code OGO  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Glaukos Corporation229 Avenida Fabricantesan Clemente, CA 92672 PMA NumberP170043 Supplement NumberS014 Date Received05/31/2022 Decision Date08/29/2022 Product Code OGO  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Guardant Health, Inc.505 Penobscot Driveredwood City, CA 94063 PMA NumberP200010 Supplement NumberS011 Date Received07/01/2022 Decision Date07/29/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS219 Date Received07/21/2022 Decision Date07/27/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• GUIDANT CORP.4100 Hamline Avenue Northst. Paul, MN 55112-5798 PMA NumberP030005 Supplement NumberS218 Date Received06/29/2022 Decision Date07/13/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Gyrus ACMI, Inc.6675 185th Avenue Neredmond, WA 98052 PMA NumberP180007 Supplement NumberS009 Date Received04/12/2022 Decision Date05/12/2022 Product Code NJK  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Guardant Health, Inc.505 Penobscot Driveredwood City, CA 94063 PMA NumberP200010 Supplement NumberS005 Date Received12/17/2021 Decision Date03/16/2022 Product Code PQP  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Guardant Health, Inc.505 Penobscot Driveredwood City, CA 94063 PMA NumberP200010 Supplement NumberS007 Date Received02/02/2022 Decision Date02/28/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• GEN-PROBE INCORPORATED10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP120007 Supplement NumberS029 Date Received12/14/2021 Decision Date02/25/2022 Product Code OYB  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Ganzhou Hongda Biochemical and Industrial Chemical Co., Ltd
• Germbusters Sanitize and Supply, LLC
• GLOBAL COMMODITY SUPPLIER LLC
• Global Genesis Partners Llc
• Global Guard Services LLC
• Global Isotopes, LLC d/b/a Zevacor Molecular
• Global Medical and Health Services, LLC
• Global Pharm Distribution LLC
• Global Products Group, LLC
• Global Treat srl
• Global Universal SRL LLC dba Minhas Micro Distillery
• Grabeel Construction LLC
• GUANGDONG JUNBAO INDUSTRY CO., LTD
• Guangdong Youbaijia Cosmetic Industry Co., Ltd
• Guangzhou Biosphere Cosmetics Co., Ltd.
• Guangzhou Baishili Trading Co., Ltd
• Guangzhou Baiyunshan Guanghua Pharmacy Co.,Ltd.
• GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL CO., LTD
• GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY
• GUANGZHOU BAIYUNSHAN PHARMACEUTICAL CO., LTD. BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY
• Guangzhou Bomei Cross border Supply Chain Management Co., Ltd
• Guangzhou Danting Bath&Body Care Industry Co. Ltd.
• Guangzhou Oubeijia Superfine Chemical Industry Co., Ltd.
• Guangzhou Yibai Technology Sarl
• Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
• GE Holdings Luxembourg & Co SARL
• GLOBAL DENTAL TRANSFER LTD

Related Finance Registrations

NCAGE Code	A9302	G.B. SRL
CAGE Code	A9302	G.B. SRL