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Auris Medical Robotics (Robotic Endoscopy)
Device: Auris Robotic Endoscopy System (ARES)
510(k): K152319 (link to summary)
Decision Date: 05/26/2016
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
CardioLogs (ECG analysis devices) [510(k) in progress]
Device: TBD
510(k): TBD (link to summary)
Decision Date:
Cardiva Medical (Vascular access site closure devices)
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
DyAnsys, Inc. (ECG pattern recognition systems)
Device: Electrocardiograph
510(k): K071168 (link to summary)
Decision Date: 08/31/2007
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

Device: EsophyX system w
510(k): K142113 (link to summary)
Decision Date: 07/22/2009

eNeura (migraine headache treatment devices) [510(k) in progress]
Device: TBD
510(k): TBD (link to summary)
Decision Date:
Fluoptics (imaging devices)
Device: Confocal Optical Imaging
510(k): K132475 (link to summary)
Decision Date: 05/07/2014
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
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
JS Vascular, Inc. (Guide wire vise)
Device: Vascular Guide Wire
510(k): K032411 (link to summary)
Decision Date: 10/07/2003
Kerberos, Inc. / Proximal Solutions, Inc. (Coronary and other catheters)
Device: Catheter
510(k): K041151 (link to summary)
Decision Date: 7/22/2004
LAAx, Inc. (Left Atrial Appendage exclusion devices)
Device: Staple, Implantable, GOW
510(k): K101961 (link to summary)
Decision Date: 09/13/2010

Device: Staple, Implantable
510(k): K111064 (link to summary)
Decision Date: 05/18/2011

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