Innovative Health, LLC - FDA 510(k) Cleared Devices
48
Total
48
Cleared
0
Denied
48 devices
Cleared
Nov 15, 2018
Reprocessed Marinr Diagnostic EP Catheter
Cardiovascular
122d
Cleared
Oct 27, 2018
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
Cardiovascular
145d
Cleared
Oct 18, 2018
Reprocessed Torqr Diagnostic EP Catheter
Cardiovascular
121d
Cleared
Jun 19, 2018
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
Cardiovascular
92d
Cleared
Mar 06, 2018
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
Cardiovascular
146d
Cleared
Nov 03, 2017
Reprocessed Halo XP Diagnostic Electrophysiology Catheter
Cardiovascular
141d
Cleared
Oct 23, 2017
Reprocessed Inquiry Steerable Diagnostic EP Catheter
Cardiovascular
175d
Cleared
Oct 05, 2017
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
Cardiovascular
135d
Cleared
Jul 12, 2017
Reprocessed AcuNav Diagnostic Ultrasound Catheter
Cardiovascular
205d
Cleared
Jun 22, 2017
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
Cardiovascular
85d
Cleared
Jun 16, 2017
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
Cardiovascular
120d
Cleared
Jun 02, 2017
Reprocessed Agilis NxT Steerable Introducer
Cardiovascular
121d
Cleared
Dec 21, 2016
Reprocessed Viking Diagnostic Electrophysiology Catheters
Cardiovascular
133d
Cleared
Dec 08, 2016
Reprocessed Response Diagnostic Electrophysiology Catheters
Cardiovascular
156d
Cleared
Dec 06, 2016
Reprocessed Supreme Diagnostic Electrophysiology Catheters
Cardiovascular
161d
Cleared
Nov 02, 2016
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed...
Cardiovascular
260d
Cleared
Oct 26, 2016
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
Cardiovascular
160d
Cleared
Sep 30, 2016
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
Cardiovascular
127d
Cleared
Jun 10, 2016
Reprocessed Inquiry Steerable Diagnostic EP Catheter
Cardiovascular
109d
Cleared
May 10, 2016
Reprocessed Livewire Steerable Diagnostic EP Catheter
Cardiovascular
99d
Cleared
May 10, 2016
Reprocessed Polaris X Steerable Diagnostic EP Catheter
Cardiovascular
96d
Cleared
Mar 14, 2016
Reprocessed Electrophysiology Catheter
Cardiovascular
133d
Cleared
Mar 10, 2016
Reprocessed Diagnostic Ultrasound Catheter
Cardiovascular
136d