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"
1–24 of 49
Search insights Median review: 141d Cleared: 100% Top manufacturer: Innovative Health, LLC Lead specialty: Cardiovascular
Cleared Oct 19, 2026
Reprocessed BRK Transseptal Needle
K262917 · NMK
Innovative Health, LLC
Cardiovascular · 60d
Cleared Jul 01, 2024
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
K231015 · NLI
Innovative Health, LLC
Cardiovascular · 448d
Cleared Apr 04, 2024
Reprocessed VersaCross Steerable Sheath
K232037 · PNE
Innovative Health, LLC
Cardiovascular · 269d
Cleared Aug 07, 2023
Reprocessed Agilis NxT Steerable Introducer
K230376 · PNE
Innovative Health, LLC
Cardiovascular · 175d
Cleared Apr 04, 2023
Reprocessed NRG Transseptal Needle
K213584 · QLZ
Innovative Health, LLC
Cardiovascular · 508d
Cleared Aug 06, 2022
Reprocesses Umbilical Cable
K221854 · NLH
Innovative Health, LLC
Cardiovascular · 40d
Cleared May 25, 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · OWQ
Innovative Health, LLC
Cardiovascular · 447d
Cleared Mar 10, 2022
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
K212165 · PNE
Innovative Health, LLC
Cardiovascular · 241d
Cleared Dec 20, 2021
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K212776 · NLG
Innovative Health, LLC
Cardiovascular · 110d
Cleared Nov 18, 2021
Reprocessed IntellaMap Orion High Resolution Mapping Catheter
K211662 · NLG
Innovative Health, LLC
Cardiovascular · 170d
Cleared Sep 15, 2021
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
K211276 · NLH
Innovative Health, LLC
Cardiovascular · 141d
Cleared May 04, 2021
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K203655 · NLH
Innovative Health, LLC
Cardiovascular · 140d
Cleared Mar 05, 2021
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K203261 · DRF
Innovative Health, LLC
Cardiovascular · 120d
Cleared Nov 20, 2020
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K202042 · OWQ
Innovative Health, LLC
Cardiovascular · 120d
Cleared Sep 03, 2020
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K200212 · MTD
Innovative Health, LLC
Cardiovascular · 219d
Cleared Jul 30, 2020
Reprocessed NRG Transseptal Needle
K200060 · QLZ
Innovative Health, LLC
Cardiovascular · 199d
Cleared Jul 22, 2020
Reprocessed BRK Transseptal Needle
K192998 · NMK
Innovative Health, LLC
Cardiovascular · 268d
Cleared Jan 24, 2020
Reprocessed Achieve Catheter Connecting Cable
K193263 · NLH
Innovative Health, LLC
Cardiovascular · 59d
Cleared Dec 11, 2019
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
K191880 · DRF
Innovative Health, LLC
Cardiovascular · 149d
Cleared Oct 30, 2019
Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology...
K191170 · NLH
Innovative Health, LLC
Cardiovascular · 182d
Cleared Aug 23, 2019
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
K190127 · NLH
Innovative Health, LLC
Cardiovascular · 207d
Cleared Jul 01, 2019
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K190980 · DRF
Innovative Health, LLC
Cardiovascular · 77d
Cleared Jun 25, 2019
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
K190785 · NLG
Innovative Health, LLC
Cardiovascular · 90d
Cleared Apr 23, 2019
Reprocessed Supreme Diagnostic Electrophysiology Catheter
K182386 · DRF
Innovative Health, LLC
Cardiovascular · 231d