FDA 510(k) Applications for Medical Device Product Code "OVB"

FDA 510(k) Number Applicant Device Name Decision Date
DEN140030 AUGMENIX , INC. SpaceOAR System 04/01/2015
K182971 Augmenix, Inc SpaceOAR Vue Hydrogel 07/19/2019
K181465 Augmenix, Inc. SpaceOAR System 06/25/2018
K222972 BioProtect, Ltd. BioProtect Balloon ImplantÖ System 08/25/2023
K202224 Boston Scientific Corporation SpaceOAR System 08/28/2020
K220641 Palette Life Sciences Barrigel Injectable Gel 05/26/2022


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact