Terumobct, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Spectra Optia Apheresis System, Spectra Optia Apheresis System, Spectra Optia Apheresis System
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Terumobct, Inc. Gastroenterology & Urology ✕
7 devices
Cleared
Feb 05, 2019
Spectra Optia Apheresis System
Gastroenterology & Urology
91d
Cleared
Nov 01, 2018
Spectra Optia Apheresis System
Gastroenterology & Urology
195d
Cleared
Mar 02, 2018
Spectra Optia Apheresis System
Gastroenterology & Urology
185d
Cleared
Jan 14, 2016
Spectra Optia Apheresis System
Gastroenterology & Urology
29d
Cleared
Mar 23, 2015
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD...
Gastroenterology & Urology
249d
Cleared
Dec 06, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA...
Gastroenterology & Urology
123d
Cleared
Aug 08, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR,...
Gastroenterology & Urology
56d