Ondal Medical Systems Inc

FDA Filings

This page includes the latest FDA filings for Ondal Medical Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Ondal Medical Systems Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• ONDAL MEDICAL SYSTEMS GMBH

FDA Registration(s)

• Registration Number: 3009028104
• FEI Number: 3009028104
• Name: ONDAL MEDICAL SYSTEMS OF AMERICA, INC.
• Owner & Operator: Ondal Medical Systems of America, Inc.
• Contact Address: 540 Eastpark Court, Suite A ; Sandston VA 23150 US
• Official Correspondent:
  • Terry T Ward
  • x-804-6293565-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 540 Eastpark Ct Ste A ; Sandston, VA 23150 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
FQO ONDAL MEDICAL SYSTEMS OF AMERICA, INC.	Monitor Carrier System CEMOR, CEMOR Smart, VarioView, VarioView 32	2015-04-01
FQO ONDAL MEDICAL SYSTEMS OF AMERICA, INC.	Medium Duty Suspension VaLia S	2015-04-01
FQO ONDAL MEDICAL SYSTEMS OF AMERICA, INC.	Medium Duty Suspension Hybrid Central Axis	2015-04-01
FQO ONDAL MEDICAL SYSTEMS OF AMERICA, INC.	Medium Duty Suspension Central Axis	2015-04-01
FQO ONDAL MEDICAL SYSTEMS OF AMERICA, INC.	Medium Duty Suspension ACROBAT 3000, ONDASPACE, SPACEPORT	2015-04-01
FQO ONDAL MEDICAL SYSTEMS OF AMERICA, INC.	Light Duty Suspension VaLia L21, MD21, MD21+, LCH17	2015-04-01
FQO ONDAL MEDICAL SYSTEMS OF AMERICA, INC.	Light Duty Suspension ACROBAT 2000, ACROBAT SWING	2015-04-01
FQO ONDAL MEDICAL SYSTEMS OF AMERICA, INC.	Heavy Duty Suspension MediLift	2015-04-01
FQO ONDAL MEDICAL SYSTEMS OF AMERICA, INC.	Heavy Duty Suspension MediBoom	2015-04-01
FQO ONDAL MEDICAL SYSTEMS OF AMERICA, INC.	Ceiling Mounted Supply Unit Service Head M6	2015-04-01