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Optovue, Inc.

5 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for recall (Z-1441-2013)Optovue, Inc.2013-05-31
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue Sys recall (Z-0024-2013)Optovue Inc.2012-10-09
RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software) recall (Z-1340-2012)Optovue Inc.2012-03-30
Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging sy recall (Z-1004-2011)Optovue Inc.2011-02-01
Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x recall (Z-1131-2010)Optovue Inc.2010-03-15

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Every clearance here is in the API, with alerts when new ones post.