Ondine Research Laboratories Ondine Biomedical Inc Us

FDA Filings

This page includes the latest FDA filings for Ondine Research Laboratories Ondine Biomedical Inc Us. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006845489
FEI Number3006845489
NameONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US)
Owner & OperatorOndine Biomedical Inc.
Contact Address19017 120Th Ave NE Ste. 102
Bothell WA 98011 US
Official Correspondent
  • Roger C Andersen
  • x-425-4891100-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address19017 120TH AVE NE STE 102
Bothell, WA 98011 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US) [Ondine Biomedical Inc.]
Periowave Light Diffusing Tip2018-05-07
ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US) [Ondine Biomedical Inc.]
Periowave 1.0ml photosensitizer2018-05-07
ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US) [Ondine Biomedical Inc.]
SurgENT Sinus Irrigation Catheter2017-09-13
ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US) [Ondine Biomedical Inc.]
Champion Debrider Sinus Irrigation Catheter2017-09-13
ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US) [Ondine Biomedical Inc.]
MRSAid Nasal Light Illuminator Assembly (NLIA)2015-07-07

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