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FDA 510(k) Applications Submitted by SYNAPTIVE MEDICAL INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K232981
09/21/2023
Synq Software Version 1.3
Synaptive Medical Inc.
K140337
02/10/2014
BRIGHTMATTER PLANNING SOFTWARE
SYNAPTIVE MEDICAL INC.
K160523
02/25/2016
BrightMatter Guide with BrightMatter Pointer
SYNAPTIVE MEDICAL INC.
K142024
07/25/2014
BRIGHTMATTER NAVIGATION SYSTEM
SYNAPTIVE MEDICAL INC.
K153281
11/12/2015
BrightMatter Guide with Surface Trace Registration
SYNAPTIVE MEDICAL INC.
K153284
11/12/2015
Synaptive ImageDrive Pro
SYNAPTIVE MEDICAL INC.
K200327
02/10/2020
Evry
Synaptive Medical Inc.
K180394
02/13/2018
BrightMatter Plan 1.6.0
Synaptive Medical Inc.
K183325
11/30/2018
Modus Nav
Synaptive Medical Inc.
K231986
07/05/2023
Modus IR
Synaptive Medical Inc.
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