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EndoGastric Solutions, Inc. (Transoral GERD and bariatric devices)
Device: Endoscope and/or Accessories
510(k): K062875 (link to summary)
Decision Date: 03/09/2007

Device: Implantable Fasteners
510(k): K071651 (link to summary)
Decision Date: 09/14/2007

Device: Stomaphyx
510(k): K073644 (link to summary)
Decision Date: 06/27/2008

Device: Esophyx2 system wi
510(k): K092400 (link to summary)
Decision Date: 11/06/2009

Device: Stomaphyx system w
510(k): K091832 (link to summary)
Decision Date: 07/22/2009

Kerberos, Inc. / Proximal Solutions, Inc. (Coronary and other catheters)
Device: Catheter
510(k): K041151 (link to summary)
Decision Date: 7/22/2004
Smith Kline Diagnostics (SKD), Inc. (Immunochemical IVDs)
Device: Campylobactor Pylori
510(k): K934863 (link to summary)
Decision Date: 05/18/1994
Gynecare, Inc. / FemRx, Inc. (Endometrial ablation & fluid mngmnt devices)
Device: FemRX Focused Monopolar (FAP)
510(k): K964441 (link to summary)
Decision Date: 03/28/1997

Device: FemRX Morcellator System
510(k): K963872 (link to summary)
Decision Date: 01/17/1997

Device: Specialized Tissue Aspirating Respectoscope
510(k): K962506 (link to summary)
Decision Date: 09/16/1996

Device: Flo-Start Fluid Monitor System
510(k): K954775 (link to summary)
Decision Date: 05/10/1996

Device: FemRX Operastar System
510(k): K954648 (link to summary)
Decision Date: 03/14/1996
JS Vascular, Inc. (Guide wire vise)
Device: Vascular Guide Wire
510(k): K032411 (link to summary)
Decision Date: 10/07/2003
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

Coalescent Surgical, Inc. (Anastomotic clips)
Device: U-Clip and Accessories
510(k): K040821 (link to summary)
Decision Date: 04/23/2004

Device: Modification to U-Clip
510(k): K031623 (link to summary)
Decision Date: 07/03/2003

Device: U-Clip And Accessories
510(k): K024366 (link to summary)
Decision Date: 01/17/2003

Device: U-Clip and Accessories (2)
510(k): K023125 (link to summary)
Decision Date: 12/18/2002

Device: U-Clip or Other TB
510(k): K021407 (link to summary)
Decision Date: 07/03/2002

Device: U-Clip
510(k): K013664 (link to summary)
Decision Date: 01/24/2002

Device: U-Clip (2)
510(k): K012317 (link to summary)
Decision Date: 08/31/2001

Device: U-Clip Delivery and Disposal
510(k): K003958 (link to summary)
Decision Date: 02/06/2001

Device: Sutured-Clip
510(k): K994160 (link to summary)
Decision Date: 02/04/2000
Intuitive Surgical, Inc. (Surgical robotics)
Device: Endoscopic Instrument
510(k): K990144 (link to summary)
Decision Date: 07/11/2000

Device: Stereo View Endoscopic
510(k): K990188 (link to summary)
Decision Date: 04/01/1999

Device: Monarch Laparoscopic
510(k): K965001 (link to summary)
Decision Date: 07/31/1997
NeoGuide Systems, Inc. (Partially automtd colonoscopy devcs & NOTES)
Device: Colonoscope
510(k): K052930 (link to summary)
Decision Date: 01/31/2006
DyAnsys, Inc. (ECG pattern recognition systems)
Device: Electrocardiograph
510(k): K071168 (link to summary)
Decision Date: 08/31/2007
BridgePoint Medical, Inc.(Coronary and peripheral catheters)
Device: Catheter
510(k): K081130 (link to summary)
Decision Date: 05/14/2009

Device: Catheter
510(k): K080987 (link to summary)
Decision Date: 02/06/2009

Device: Guide Wire Catheter
510(k): K081187 (link to summary)
Decision Date: 10/08/2008
LAAx, Inc.(Left atrial appendage exclusion clips)
Device: Staple, Implantable, GOW
 510(k): K101961 (link to summary)
Decision Date: 09/13/2010
Mauna Kea Technologies(Confocal laser systems imaging)
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

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

 

Cardiva Medical(Vascular access site closure devices)
Device: Hemostasis, Vascular
 PMA: P120016
Decision Date: 01/31/2013

 

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