Approvals

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)

Device: CardioLogs ECG Analysis Platform
510(k): K170568 (link to summary)
Decision Date: 06/26/2017

Cardiva Medical (Vascular access site closure devices)

Device: CATALYST
510(k): K130124 (link to summary)
Decision Date: 01/16/2013

Device: VASCADE
PMA: Summary
           Labeling
           Other Consumer Info
           S001            S002            S003            S004            S005            S006            S007            S008            S009            S010            S011            S012            S013            S014            S015            S016            S018

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)

Device: Spring TMS
510(k): K162797 (link to summary)
Decision Date: 06/26/2017

Fluoptics (imaging devices)

Device: Confocal Optical Imaging
510(k): K132475 (link to summary)
Decision Date: 05/07/2014

Device: Parathyroid Autofluorescence Imaging Device
510(k): DEN170092 (link to summary)
Decision Date: 11/02/2018

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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