Od Os G M B H

FDA Filings

This page includes the latest FDA filings for Od Os G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008252121
• FEI Number: 3008252121
• Name: OD-OS GMBH
• Owner & Operator: OD-OS GmbH
• Contact Address: Warthestr. 21 ; Teltow DE-BB Brandenburg 14513 DE
• US Agent:
  • Debe Deck
  • ClinReg Consulting Services, Inc.
  • 949 3754387
  • debe@clinregconsulting.com
• Importing Logistics Registration:
  • Importer: OD-OS, Inc.
  • Address: 31 Journey, Suite 120 ; Aliso Viejo, CA 92656 UNITED STATES
  • Importer Type: Initial Importer
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Warthestr. 21 ; Teltow Brandenburg, 14513 DE
• Establishment Type: Manufacture Medical Device

• Registration Number: 3009316629
• FEI Number: 3009316629
• Name: OD-OS, Inc.
• Owner & Operator: OD-OS GmbH
• Contact Address: Warthestr. 21 ; Teltow DE-BB Brandenburg 14513 DE
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 6201 Oak Canyon Drive Suite 200; Irvine, CA 92618 US

FDA Filings

Device Company	Device	Date
GUDID 04260284390013 OD-OS GmbH	Navilas® Laser System 577s 156000	2023-11-29
PMN K162191 | NFG OD-OS GMBH	Navilas Laser System 577s	2017-11-21
PMN K162191 | NFF OD-OS GMBH	Navilas Laser System 577s	2017-11-21
PMN K162191 | HKI OD-OS GMBH	Navilas Laser System 577s	2017-11-21
PMN K162191 | GEX OD-OS GMBH	Navilas Laser System 577s	2017-11-21
PMN K162191 OD-OS GMBH	NAVILAS Laser System	2016-11-22
PMN K141851 | GEX OD-OS GMBH	Navilas Laser System	2015-05-11
PMN K141851 OD -OS GMBH	NAVILAS LASER SYSTEM	2015-01-02
PMN K091064 OD -OS GMBH	NAVILAS LASER SYSTEM	2009-10-27