Medical Devices | 510(k)s | Clinical Trials

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  • Click here to download the following list of 510(k)s with clinical trial data in Excel sheet.
  • 173 510(k)s

Device Name

Applicant

510(K)

Number

Decision

Date

Rhythmia Mapping System Rhythmia Medical, Inc

K130750

07/22/2013

Emerge Monorail Ptca Dilatation Catheter Boston Scientific Corp.

K130391

07/10/2013

Lyric2 Phonak Llc

K130790

06/27/2013

Viky Up Endocontrol

K122820

06/18/2013

Dr Long Length Imaging Software Carestream Health, Inc.

K130567

06/11/2013

Medient Middle Turbinate Implant; (Singl Entrigue Surgical, Inc.

K130354

05/29/2013

Breathid Hp System Exalenz Bioscience Ltd.

K130524

05/22/2013

Sauflon Multipurpose Solution Sauflon Pharmaceuticals, Ltd.

K130734

05/15/2013

Bard Denali Filter System- Femoral Deliv C.R. Bard, Inc.

K130366

05/15/2013

Lsh (Mangofilcon A) Sphere Soft (Hydroph The Lagado Corp.

K120756

05/13/2013

Jetstream Xc 2.4/3.4 System; Jetstream X Medrad, Inc.

K130637

04/10/2013

Gore Acuseal Vascular Graft W.L. Gore & Associates,Inc

K130215

04/09/2013

Xtag Gastrointestinal Pathogen Panel(Gpp Luminex Molecular Diagnostics, Inc.

K121894

03/21/2013

Shuntcheck Neurodx Development Llc

K123554

03/07/2013

Artas System From Restoration Robotics Restoration Robotics, Inc

K123154

02/19/2013

Genasis Scanview System Applied Spectral Imaging, Ltd.

K122554

02/07/2013

Clearpath Ds-120(R) Lens Fluorescence Bi Freedom Meditech, Inc.

K112880

01/31/2013

Mini Trek Rx Coronary Dilatation Cathete Abbott Vascular

K123279

01/30/2013

Progress Guide Wire Family, Pilot Guide Abbott Vascular Inc.

K123067

01/29/2013

Axera 2 Access System Model Axe200 Arstasis, Inc.

K123135

01/28/2013

Zerona 2.0 Laser Erchonia Corporation

K123237

01/25/2013

Ivue With Normative Database Optovue, Inc.

K121739

01/18/2013

Cardiac Vx Ge Medical Systems, Llc

K121762

01/18/2013

Xtag Gastrointestinal Pathogen Panel (Gp Luminex Molecular Diagnostics, Inc.

K121454

01/14/2013

Icam Fundus Camera Optovue, Inc.

K122572

01/11/2013

Brainsway Deep Tms System Brainsway, Ltd

K122288

01/07/2013

Intrabeam System With Intrabeam Spherica Carl Zeiss Meditec, Inc.

K121653

12/27/2012

Bio-Seal Lung Biopsy Tract System Angiotech

K082438

12/19/2012

Igrow Ii Hair Growth System Apira Science, Inc.

K122248

12/05/2012

Ahip Internal Trigger Point Wand Model: National Center For Pelvic Pain Research

K100934

11/20/2012

Ocelot System Avinger, Inc.

K122380

11/07/2012

Altis Single Incision Cling System Coloplast A/S

K121562

11/05/2012

The Ablation System Halt Medical Inc.

K121858

11/05/2012

Renew Insert Renew Medical, Inc.

K122003

10/26/2012

Jetstream Navitus L System Jeystream Nav Medrad, Inc.

K122916

10/19/2012

Embryogen Origio A/S

K120136

09/26/2012

Transonic Costatus Cardiac Output System Transonic Systems, Inc.

K113821

09/07/2012

Focus Touch Conception System Intimate Bridge 2 Conception, Inc

K112200

09/06/2012

Clever Choice Simple Diagnostics, Inc.

K120921

08/21/2012

Nupro Sensodyne Prophylaxis Paste With N Dentsply International Inc.

K121698

08/06/2012

Trevo Retriever Concentric Medical, Inc.

K120961

08/03/2012

Contour Next Blood Glucose Meter Bayer Healthcare Llc

K121190

07/26/2012

Corpath 200 System Corindus Inc.

K120834

07/19/2012

Crux Vena Cava Filter System Crux Biomedical

K120402

07/13/2012

Contour Next Usb Blood Glucose Monitorin Bayer Healthcare

K121087

06/28/2012

Amigo Remote Catheter System (Rcs) & Acc Catheter Robotics Inc

K113628

06/12/2012

Bausch + Lomb Nesofilcon A Contact Lens Bausch & Lomb Incorporated

K113703

06/05/2012

Kd-936 Fully Automatic Wireless Blood Pr Andon Health Co.,Ltd

K120672

06/01/2012

Bigboss Catheters Mantatay Catheter Mant Bridgepoint Medical

K120533

05/22/2012

Srs Endoscopic Stapling System Medigus, Ltd.

K120299

05/18/2012

Microcam Capsule Endoscope System Intromedic Co., Ltd

K111450

05/18/2012

Model 7600 Regional Oximeter System With Nonin Medical, Inc.

K113215

05/14/2012

Mls, Zerona-Ad Erchonia Medical, Inc.

K120257

05/14/2012

Inratio2 Pi/Nr Monitoring System; Inrati Alere San Diego, Inc (Formally Biosite I

K110212

05/01/2012

Prostate Mechanical Imager Artann Laboratories, Inc

K093579

04/27/2012

Ct-Guide Needle Guidance System Activiews Ltd

K120300

04/13/2012

Finesse Personal Insulin Delivery Patch Calibra Medical, Inc.

K111924

04/10/2012

Dailies Total Dalies Total For Astigmati Ciba Vision Corporation

K113168

03/30/2012

Contour Link Blood Glucose Meter, Contou Bayer Healthcare, Llc

K110587

03/28/2012

Contour Next Link Wireless Blood Glucose Bayer Healthcare

K110894

03/28/2012

Visi Mobile Monitoring System Sotera Wireless, Inc

K112478

03/22/2012

Covidien Nellcor Respiration Rate Softwa Covidien

K111933

03/15/2012

Ifs Laser System Abbott Medical Optics Inc

K113151

03/08/2012

Contour (R) Next Blood Glucose Monitorin Bayer Healthcare

K111268

03/06/2012

Solitaire Fr Revascularization Device Micro Therapeutics Dba Ev3 Neurovascular

K113455

03/02/2012

Jetstream Navitus L System Pathway Medical Technologies, Inc.

K120242

02/24/2012

Stratify Jcv(Tm) Antibody Focus Diagnostics, Inc.

K112394

01/20/2012

Ag-608n Blood Glucose Monitoring System Andon Medical Co., Ltd.

K110017

01/18/2012

Prepex System Circ Medtech

K103695

01/10/2012

Synthecel Dura Replacement Devices Synthes

K113071

01/09/2012

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Deltaview Model 2.1 Riverain Medical Group,Llc

K111776

12/28/2011

Mysense Heart Cardiac Science Corporation

K113176

12/21/2011

Duofertility Cambridge Temperature Concepts Ltd.

K102499

12/20/2011

Presage St2 Assay Critical Care Diagnostics, Inc. (Dba Cri

K111452

12/09/2011

Aptus Steerable Endoguide With Obturator Aptus Endosystems, Inc.

K102333

11/21/2011

Multifunction Keito Aguiflai Iberica S.L.

K103058

11/10/2011

Spiderfx Embolic Protection Device Ev3 Inc

K111010

10/27/2011

Turbohawk Peripheral Plaque Excision Sys Ev3 Inc

K111723

10/27/2011

Scanview System Applied Spectral Imaging

K110345

10/19/2011

Roma (He4 Eia + Architect Ca 125 Ii) Fujirebio Diagnostics, Inc.

K103358

09/01/2011

Vitala Continence Control Device Convatec Inc.

K111365

08/19/2011

Wildcat Catheter Avinger, Inc.

K111338

08/11/2011

Embryoscope Unisense Fertilitech A/S

K111715

08/11/2011

Blood Glucose Monitoring System, Models Andon Medical Co., Ltd.

K101307

08/09/2011

Trusignal R Spo2 Peditip Sensor; Trusign Ge Healthcare Finland Oy

K103802

08/02/2011

Sleepminder Breathing Frequency Indicato Biancamed Limited

K103631

07/21/2011

Ag-695 Single And Multi Blood Glucose Mo Andon Medical Co., Ltd.

K093755

07/15/2011

Lipflow Thermal Pulsation System (Former Tearscience, Inc.

K093937

06/28/2011

Ct-Guide Needle Guidance System Activiews Ltd

K110812

06/21/2011

Mini Trek Rx 1.20 Mm Coronary Dilatation Abbott Vascular

K110617

06/02/2011

Jetstream G3 (R) Sf 1.6 System Pathway Medical Technologies, Inc.

K111229

06/01/2011

Hairmax Lasercomb Lexington International, Llc

K110233

05/27/2011

Rps Adeno Detector Plus Rapid Pathogen Screening, Inc.

K110722

05/17/2011

Alcon Multi-Pirpose Disinfecting Solutio Alcon Research, Ltd.

K102860

05/10/2011

Ge Lunar Visceral Fat Software Ge Medical Systems Ultrasound And Primar

K103730

05/06/2011

Reveal Xt Insertable Cardiac Monitor, Mo Medtronic Inc.

K103764

05/04/2011

Transtek Glass Body Analyzer; Transtek G Zhongshan Transtek Electronics Co., Ltd.

K102191

05/02/2011

Emboshield Nav6 Embolic Protection Syste Abbott Laboratories

K110909

04/29/2011

Solarc / Solrx E-Series Ultraviolet Phot Solarc Systems Inc.

K103204

04/27/2011

Pressure Right, Single-Use, Disposable, Therapeutics 101, Inc (Dba Pressure Poin

K110563

04/08/2011

Trojan Supra Lubricated Polyurethane Mal Church & Dwight Co., Inc.

K100767

04/05/2011

The Artas System From Restoration Roboti Restoration Robotics, Inc

K103428

04/04/2011

Acclarent Tympanostomy Tube And Tympanos Acclarent, Inc.

K103595

04/01/2011

Stellar 300 Larsen & Toubro Limited

K103763

03/11/2011

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K102939

02/23/2011

Vascular Positioning System Tm (Vps Tm S Vasonova Inc.

K103255

02/18/2011

Vascular Positioning System (Vps System) Vasonova Inc.

K103260

02/18/2011

Miradry System Miramar Labs, Inc.

K103014

01/28/2011

Stayhealthy Body Composition Monitor-Bcm Stayhealthy, Inc.

K101807

01/26/2011

Surecall Emg Labor Monitor Reproductive Research Technologies, Lp

K090145

01/25/2011

Soundbite Hearing System By Sonitus Sonitus Medical Inc

K100649

01/14/2011

Fore-Sight Absolute Cerebral And Somatic Cas Medical Systems, Inc.

K094030

12/23/2010

Vitala Continence Control Device Convatec Inc

K102536

12/01/2010

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K102690

11/24/2010

Scanview Her2/Neu Fish System Applied Spectral Imaging, Ltd.

K101291

11/23/2010

Bgm Galectin -3 Bg Medicine, Inc.

K093758

11/17/2010

Atricure Bipolar System Including Isolat Atricure, Inc.

K101174

11/12/2010

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K102930

11/03/2010

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K102906

10/29/2010

Sprinter Legend 1.25mm Rx And Sprinter L Medtronic Ireland

K103095

10/22/2010

Pillcam Express Video Capsules Delivery Given Imaging Ltd.

K101200

09/30/2010

Intelliwave3 Art Optical Contact Lens, Inc.

K100221

09/14/2010

Blood Pressure Meter, Model Ch-658 Citizen Systems Japan Co., Ltd.

K102303

09/10/2010

Blood Pressure Meter, Model Ch-609 Citizen Systems Japan Co., Ltd.

K100055

08/30/2010

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K101010

07/30/2010

Ag-608 Blood Glucose Monitoring System A Andon Medical Co., Ltd.

K093262

07/13/2010

Lensar Laser System Lensar, Inc.

K090633

05/13/2010

C7 Xr Imaging System With C7 Dragonfly I Lightlab Imaging,Inc.

K093857

04/30/2010

Stellar 300 Larsen & Toubro Limited

K093017

04/29/2010

Illumina Beadxpress System Illumina, Inc.

K093128

04/28/2010

Illumina Verncode Genotyping Test For Fa Illumina, Inc.

K093129

04/28/2010

Vitala Continence Control Device Convatec

K083785

04/02/2010

Trusignal Spo2 Finger Sensor, Trusignal Ge Healthcare Finland Oy

K093881

03/12/2010

Didget World Reports Bayer Healthcare Llc

K093930

03/12/2010

Vrlxp, Model Xp Deep Breeze Ltd.

K091732

03/04/2010

Micronjet 600 Nanopass Technologies Ltd.

K092746

02/03/2010

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K092811

01/13/2010

Matrix Rf Applicator Syneron Medical Ltd.

K090025

01/08/2010

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K092510

12/23/2009

Foresee Home Notal Vision Ltd.

K091579

12/23/2009

Vpap Tx Resmed Ltd.

K092186

12/22/2009

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K093528

12/04/2009

Didget Blood Glucose Meter, Model 6181; Bayer Healthcare, Llc

K090628

12/04/2009

Bpz02 Multipurpose Solution Bausch & Lomb, Inc.

K083757

11/18/2009

Smartpill Gi Monitoring System, Version The Smartpill Corporation

K092342

10/30/2009

Guided Measurement Catheter (Gmc) Mediguide, Ltd.

K091780

10/16/2009

Guided Medical Positioning System (Gmps) Mediguide, Ltd.

K091781

10/16/2009

Mo.Ma Ultra Proximal Cerebral Protection Invatec S.P.A.

K092177

10/15/2009

Electrofluidgraph Akern Usa, Llc

K091369

10/14/2009

Vs-Sense Test Common Sense, Ltd.

K091287

08/31/2009

Contour Usb Blood Glucose Meter, Glucose Bayer Healthcare

K091820

08/26/2009

Modification To:fully Automatic Electron Andon Health Co.,Ltd

K091500

07/31/2009

Kneehab Xp Conductive Garment, Type 411 Bio-Medical Research, Ltd.

K083105

07/24/2009

Refresh Optive Lens Comfort Rewetting Dr Allergan, Inc.

K083812

07/09/2009

Provox Vega, Model 8130-8135 Atos Medical Ab

K090455

06/05/2009

Cortoss Bone Augmentation Material Orthovita, Inc.

K080108

06/05/2009

Backstop And Backstop Injector Pluromed, Inc.

K090430

06/02/2009

Depuy Spine Bengal, Concorde, Cougar, De Depuy Spine, Inc.

K081917

05/22/2009

Tearlab Osmolarity System Ocusense, Inc.

K083184

05/14/2009

A1cnow+ (10 Test Kit, Professional Use) Bayer Healthcare, Llc

K090413

05/14/2009

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K090963

04/30/2009

Steerable Guide Catheter Evalve Inc

K083793

04/27/2009

Wallflex Biliary Rx Partially-Covered St Boston Scientific Corp.

K083374

04/22/2009

Impella 5.0 Catheter Family Abiomed, Inc.

K083111

04/16/2009

Wallflex Biliary Rx Fully-Covered Stent Boston Scientific Corporation

K083627

04/07/2009

Gunther Tulip Vena Cava Filter, Cook Cel William Cook Europe Aps

K090140

04/03/2009

N-600x With Spd, Oximax N-600x Covidien

K083325

03/09/2009

Semi-Fully Automatic Electronic Blood Pr Andon Health Co.,Ltd

K083395

02/27/2009

Capnostream20 With Integrated Pulmonary Oridion Capnography, Inc.

K082268

02/06/2009

Gore Flow Reversal System W.L. Gore & Associates,Inc

K083300

02/04/2009

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K083317

01/29/2009

Fully Automatic Electronic Blood Pressur Andon Health Co.,Ltd

K083318

01/29/2009

Topcon 3d Oct-1000 Optical Coherence Tom Topcon Medical Systems, Inc.

K072971

01/13/2009