Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

49 results for "Innovative Health, LLC"
25–48 of 49
Search insights Median review: 141d Cleared: 100% Top manufacturer: Innovative Health, LLC Lead specialty: Cardiovascular
Cleared Feb 22, 2019
Reprocessed Response Diagnostic Electrophysiology Catheter
K182488 · NLH
Innovative Health, LLC
Cardiovascular · 164d
Cleared Jan 18, 2019
Reprocessed Visions PV .035 Digital IVUS Catheter
K181126 · OWQ
Innovative Health, LLC
Cardiovascular · 263d
Cleared Nov 15, 2018
Reprocessed Marinr Diagnostic EP Catheter
K181897 · NLH
Innovative Health, LLC
Cardiovascular · 122d
Cleared Oct 27, 2018
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
K181458 · NLH
Innovative Health, LLC
Cardiovascular · 145d
Cleared Oct 18, 2018
Reprocessed Torqr Diagnostic EP Catheter
K181618 · NLH
Innovative Health, LLC
Cardiovascular · 121d
Cleared Jun 19, 2018
Reprocessed DecaNav Diagnostic Electrophysiology Catheter
K180710 · NLH
Innovative Health, LLC
Cardiovascular · 92d
Cleared Mar 06, 2018
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K173262 · OWQ
Innovative Health, LLC
Cardiovascular · 146d
Cleared Nov 03, 2017
Reprocessed Halo XP Diagnostic Electrophysiology Catheter
K171788 · NLH
Innovative Health, LLC
Cardiovascular · 141d
Cleared Oct 23, 2017
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K171277 · DRF
Innovative Health, LLC
Cardiovascular · 175d
Cleared Oct 05, 2017
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
K171503 · NLH
Innovative Health, LLC
Cardiovascular · 135d
Cleared Jul 12, 2017
Reprocessed AcuNav Diagnostic Ultrasound Catheter
K163560 · OWQ
Innovative Health, LLC
Cardiovascular · 205d
Cleared Jun 22, 2017
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K170922 · NLH
Innovative Health, LLC
Cardiovascular · 85d
Cleared Jun 16, 2017
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
K170474 · OWQ
Innovative Health, LLC
Cardiovascular · 120d
Cleared Jun 02, 2017
Reprocessed Agilis NxT Steerable Introducer
K170311 · PNE
Innovative Health, LLC
Cardiovascular · 121d
Cleared Dec 21, 2016
Reprocessed Viking Diagnostic Electrophysiology Catheters
K162251 · NLH
Innovative Health, LLC
Cardiovascular · 133d
Cleared Dec 08, 2016
Reprocessed Response Diagnostic Electrophysiology Catheters
K161827 · NLH
Innovative Health, LLC
Cardiovascular · 156d
Cleared Dec 06, 2016
Reprocessed Supreme Diagnostic Electrophysiology Catheters
K161769 · DRF
Innovative Health, LLC
Cardiovascular · 161d
Cleared Nov 02, 2016
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed...
K160421 · NLH
Innovative Health, LLC
Cardiovascular · 260d
Cleared Oct 26, 2016
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
K161393 · NLH
Innovative Health, LLC
Cardiovascular · 160d
Cleared Sep 30, 2016
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
K161464 · NLH
Innovative Health, LLC
Cardiovascular · 127d
Cleared Jun 10, 2016
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K160496 · NLH
Innovative Health, LLC
Cardiovascular · 109d
Cleared May 10, 2016
Reprocessed Polaris X Steerable Diagnostic EP Catheter
K160303 · NLH
Innovative Health, LLC
Cardiovascular · 96d
Cleared May 10, 2016
Reprocessed Livewire Steerable Diagnostic EP Catheter
K160242 · NLH
Innovative Health, LLC
Cardiovascular · 99d
Cleared Mar 14, 2016
Reprocessed Electrophysiology Catheter
K153153 · NLH
Innovative Health, LLC
Cardiovascular · 133d