Approvals

LuMend, Inc. (Coronary and peripheral catheters)

Device: Mod to Outback Catheter
510(k): K043534 (link to summary)
Decision Date: 01/21/2005

Device: Mod to Outback Catheter
510(k): K040771 (link to summary)
Decision Date: 04/23/2004

Device: Frontrunner CTO Cath and Accessories
510(k): K033535 (link to summary)
Decision Date: 01/07/2004

Device: Mod to Outback Catheter
510(k): K032298 (link to summary)
Decision Date: 08/26/2003

Device: Details Frontrunner Gw
510(k): K031005 (link to summary)
Decision Date: 06/18/2003

Device: Details Frontrunner Cto
510(k): K023114 (link to summary)
Decision Date: 01/23/2003

Device: Mod to Frontrunner Cto
510(k): K023223 (link to summary)
Decision Date: 10/24/2002

Device: Frontrunner Cto Coronary Cath
510(k): K013284 (link to summary)
Decision Date: 02/11/2002

Device: Percutaneous Catheter
510(k): K011562 (link to summary)
Decision Date: 01/16/2002

Mauna Kea Technologies (Confocal Laser Imaging Systems)

Device: Confocal Optical Imaging
510(k): K122042 (link to summary)
Decision Date: 09/04/2012

Device: System, Image Processing, Radiological
510(k): K120208
Decision Date: 04/20/2012

Device: Confocal Optical Imaging
510(k): K123676 (link to summary)
Decision Date: 04/18/2013

Device: Confocal Optical Imaging
510(k): K133466 (link to summary)
Decision Date: 07/25/2014

Device: Confocal Optical Imaging
510(k): K141358 (link to summary)
Decision Date: 09/25/2014

Device: Confocal Optical Imaging
510(k): K151593 (link to summary)
Decision Date: 10/23/2015

Device: Confocal Optical Imaging
510(k): K150831 (link to summary)
Decision Date: 12/22/2015

Device: Confocal Optical Imaging
510(k): K160416 (link to summary)
Decision Date: 05/20/2016

Device: Confocal Optical Imaging
510(k): K171345
Decision Date: 08/04/2017

Device: Confocal Optical Imaging
510(k): K172844 (link to summary)
Decision Date: 12/15/2017

Device: Confocal Optical Imaging
510(k): K180270 (link to summary)
Decision Date: 5/22/2018

Device: Confocal Optical Imaging
510(k): K183640 (link to summary)
Decision Date: 2/22/2019

Device: Confocal Optical Imaging
510(k): K191144 (link to summary)
Decision Date: 1/24/2020

NeoGuide Systems, Inc. (Partially automated colonoscopy devices & NOTES)

Device: Colonoscope
510(k): K052930 (link to summary)
Decision Date: 01/31/2006

NiTiLoop, Inc. (Catheters)

Device: Catheter, Percutaneous
510(k): K160389 (link to summary)
Decision Date: 03/11/2016

Device: Catheter, Percutaneous
510(k): K143608 (link to summary)
Decision Date: 05/04/2015

Device: NovaCross Microcatheter
510(k): K172297 (link to summary)
Decision Date: 10/18/2017

SinuSys ("Sinus dilation systems / ENT devices")

Device: Instrument, Ent Manual Surgical
510(k):K133016 (link to summary)
Decision Date: 12/09/2013

Device: Vent-Os Sinus Dilation Family
510(k):K160770 (link to summary)
Decision Date: 06/29/2016

Smith Kline Diagnostics (SKD), Inc. (Immunochemical IVDs)

Device: Campylobactor Pylori
510(k): K934863 (link to summary)
Decision Date: 05/18/1994

Vascular Pathways (Vascular access devices)

Device: Catheter, Intravascular
510(k): K112347 (link to summary)
Decision Date: 09/22/2011

ZipLine (wound and incision closure devices) [513(g) approvals]

Device:
http://www.ziplinemedical.com