ClearanceBrief
Panels › Cardiovascular › Product code NLH · Class 2

Catheter, Recording, Electrode, Reprocessed

Regulation 870.1220

1510(k)s in 12 months (70 all time)
32recalls in 12 months (49 all time)
47recalls that name a 510(k)
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Top companies in NLH

Company510(k)sRecalls
Stryker Sustainability Solutions438
Innovative Health240
Sterilmed, Inc.101
Alliance Medical Corp.100
Vanguard Medical Concepts, Inc.90
Medline Industries, LP08
Surgical Instrument Service and Savings, Inc.70
Ascent Healthcare Solutions40
MEDLINE INDUSTRIES, LP - Northfield02
Surgical Instrument Service and Savings Inc.(Dba Medline Ren20
Decided510(k)Device and applicantCode
Nov 26, 2025K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter
Surgical Instrument Service and Savings, Inc.
NLH
Jul 11, 2025K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
Surgical Instrument Service and Savings, Inc.
NLH
Nov 29, 2024K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
Surgical Instrument Service and Savings, Inc.
NLH
Nov 15, 2024K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocesse
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
NLH
Oct 11, 2024K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
Sterilmed, Inc.
NLH
Sep 14, 2024K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (40
Surgical Instrument Service and Savings, Inc.
NLH
Jun 7, 2024K240972Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
Surgical Instrument Service and Savings, Inc.
NLH
Jun 7, 2024K233825Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
Innovative Health
NLH
May 31, 2023K221067Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
Surgical Instrument Service and Savings, Inc.
NLH
Aug 6, 2022K221854Reprocesses Umbilical Cable
Innovative Health, LLC
NLH
Sep 15, 2021K211276Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
Innovative Health, LLC
NLH
May 4, 2021K203655Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Cathet
Innovative Health, LLC
NLH
May 13, 2020K200205Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
Stryker Sustainability Solutions
NLH
Jan 24, 2020K193263Reprocessed Achieve Catheter Connecting Cable
Innovative Health, LLC
NLH
Oct 30, 2019K191170Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter
Innovative Health, LLC
NLH
Aug 23, 2019K190127Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
Innovative Health, LLC
NLH
Feb 22, 2019K182488Reprocessed Response Diagnostic Electrophysiology Catheter
Innovative Health, LLC
NLH
Jan 24, 2019K181056Reprocessed CS Diagnostic Electrophysiology Catheter
Stryker Sustainability Solutions
NLH
Nov 15, 2018K181897Reprocessed Marinr Diagnostic EP Catheter
Innovative Health, LLC
NLH
Oct 27, 2018K181458Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
Innovative Health, LLC
NLH
Oct 18, 2018K181618Reprocessed Torqr Diagnostic EP Catheter
Innovative Health, LLC
NLH
Jun 19, 2018K180710Reprocessed DecaNav Diagnostic Electrophysiology Catheter
Innovative Health, LLC
NLH
Nov 3, 2017K171788Reprocessed Halo XP Diagnostic Electrophysiology Catheter
Innovative Health, LLC
NLH
Oct 5, 2017K171503Reprocessed CristaCath Diagnostic Electrophysiology Catheter
Innovative Health, LLC
NLH
Jun 22, 2017K170922Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Cathet
Innovative Health, LLC
NLH
May 18, 2017K161272Supreme and Response Electrophysiology Catheters
Surgical Instrument Service and Savings, Inc.
NLH
Dec 21, 2016K162251Reprocessed Viking Diagnostic Electrophysiology Catheters
Innovative Health, LLC
NLH
Dec 8, 2016K161827Reprocessed Response Diagnostic Electrophysiology Catheters
Innovative Health, LLC
NLH
Nov 2, 2016K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Cat
Innovative Health, LLC
NLH
Oct 26, 2016K161393Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
Innovative Health, LLC
NLH
Sep 30, 2016K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
Innovative Health, LLC
NLH
Jun 23, 2016K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
Sterilmed, Inc.
NLH
Jun 10, 2016K160496Reprocessed Inquiry Steerable Diagnostic EP Catheter
Innovative Health, LLC
NLH
May 10, 2016K160303Reprocessed Polaris X Steerable Diagnostic EP Catheter
Innovative Health, LLC
NLH
May 10, 2016K160242Reprocessed Livewire Steerable Diagnostic EP Catheter
Innovative Health, LLC
NLH
Mar 14, 2016K153153Reprocessed Electrophysiology Catheter
Innovative Health, LLC
NLH
Jan 22, 2016K151617Livewire Electrophysiology Catheter
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
NLH
Aug 27, 2015K150357Reprocessed Electrophysiology Diagnostic Catheters
Sterilmed, Inc.
NLH
Aug 6, 2012K121158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
Sterilmed, Inc.
NLH
Oct 21, 2011K112292REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
NLH
Sep 26, 2011K112232REPROCESSED ELECTROPHYSIOLOGY CATHETERS
Stryker Sustainability Solutions
NLH
Aug 19, 2010K101789REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
Sterilmed, Inc.
NLH
May 28, 2010K100254REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
Ascent Healthcare Solutions
NLH
Jan 14, 2010K092158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
Sterilmed, Inc.
NLH
Apr 1, 2009K090323REPROCESSED ELECTROPHYSIOLOGY CATHETERS
Ascent Healthcare Solutions
NLH
Sep 16, 2008K082023REPROCESSED ELECTROPHYSIOLOGY CATHETERS
Ascent Healthcare Solutions
NLH
Jul 9, 2008K081329REPROCESSED ELECTROPHYSIOLOGY CATHETERS
Ascent Healthcare Solutions
NLH
Aug 31, 2006K061045REPROCESSED ELECTROPHYSIOLOGY CATHETERS
Alliance Medical Corp.
NLH
Nov 16, 2005K052603REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
Alliance Medical Corp.
NLH
Nov 16, 2005K052414REPROCESSED ELECTROPHYSIOLOGY CATHETER
Alliance Medical Corp.
NLH

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