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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

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

SinuSys ("Sinus dilation systems / ENT devices")
Device: Instrument, Ent Manual Surgical
510(k):K133016 (link to summary)
Decision Date: 12/09/2013

 

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

 

 

 

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