FDA 510(k) Applications Received During July, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K151822 07/06/2015 ab medica irrigation/suction gravity system AB MEDICA S.A.S. ALEXANDRE BLANC
K151783 07/01/2015 COMPACT INTUITIV Multiple-Use Pack Abbott Medical Optics Inc. Priya Viswanathan
K151858 07/08/2015 Caiman Seal and Cut Technology Aesculap, Inc. Denise Adams
K151935 07/14/2015 Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only ALERE SAN DIEGO, INCORPORATED JOSEPH DE LA ROSA
K151809 07/02/2015 Alere Afinion HbA1c, Alere Afinion AS100 Analyzer Alere Technologies AS Kari Skinnemoen
K152003 07/20/2015 iHealth BP3L Wireless Blood Pressure Monitor ANDON HEALTH CO.,LTD Liu Yi
K151877 07/09/2015 MicroTract Access System ARSTASIS, INC. Debra Cogan
K151897 07/10/2015 MultiFIX« P Knotless Fixation Device ArthroCare Corporation Laura Kasperowicz
K151998 07/20/2015 TraceIT Tissue Marker - 3mL AUGMENIX, INC. NOEL ROLON
K152032 07/22/2015 ELUMI 810 + 980 Soft Tissue Laser AZENA MEDICAL, LLC ALEX DI SESSA
K152052 07/23/2015 Ultrasound Scanner System bk2300 BK MEDICAL APS Michael J. Doyle
K151801 07/02/2015 Arc Endocuff Vision BODDINGTONS PLASTICS LTD PAUL BLACKMORE
K151990 07/20/2015 Tissue Removal System BOEHRINGER LABORATORIES LLC CHRIS RADL
K151802 07/02/2015 Resolution Clip BOSTON SCIENTIFIC CORPORATION ELENA NIEVES
K151957 07/16/2015 BOX DICOM Viewer BOX INC. CRISPEN MAUNG
K151774 07/01/2015 CARESTREAM Vue Motion CARESTREAM HEALTH, INC. CAROLYN L WAGNER
K152033 07/22/2015 Cook ECM Powder Cook Biotech Incorporated Perry W Guinn
K152044 07/23/2015 Flexor Radial Hydrophilic Introducer Access Set COOK INCORPORATED SARAH REEVES
K152072 07/27/2015 CrossRoads Screw System CrossRoads Extremity Systems, LLC Vernon Hartgegen
K151854 07/07/2015 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display D-VIEW DISPLAY TECHNOLOGY CO., LTD. JIANFEI SUN
K151795 07/02/2015 ML24000 UVA-1 Phototherapy Cabinet DAAVLIN DISTRIBUTING CO. MICHELE THIEL
K151885 07/09/2015 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System DEPUY SYNTHES, Inc. Karen K Sylvia
K151867 07/09/2015 STA R MAX DIAGNOSTICA STAGO S.A.S. ARNAUD COLLIN
K151860 07/08/2015 Infinity CentralStation Wide Draeger Medical Systems, Inc. Thomas Ostrowski
K151883 07/09/2015 5MP Monochrome LCD Monitor, RadiForce GX540 EIZO CORPORATION HIROAKI HASHIMOTO
K152070 07/27/2015 BioZorb LP Marker Focal Terapeutics George Hermann
K151944 07/14/2015 Luggie Super Freerider Corporation Arthur Wang
K151859 07/08/2015 Synapse Cardiovascular FUJIFILM MEDICAL SYSTEMS U.S.A., INC. JYH-SHYAN LIN
K152133 07/31/2015 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System GALIL MEDICAL LTD LYNNE DAVIES
K151968 07/16/2015 Cryocare CS-3 Surgical System version 5 HEALTHTRONICS SCOTT EDEN
K152097 07/28/2015 Retraction Aspirator INARI MEDICAL EBEN GORDON
K151949 07/15/2015 Disposable Insulin Syringe JIANGYIN CAINA TECHNOLOGY CO., LTD. JUN LU
K152015 07/21/2015 Pyrenees Cervical Plate System K2M, INC. NANCY GIEZEN
K152080 07/27/2015 Metacross OTW PTA Balloon Dilatation Catheter Kaneka Corporation Toshihiko Motomine
K152098 07/28/2015 ODALYS Pedicle Screw System Kisco International Hiroko Ito
K151947 07/15/2015 LightSheer Desire Light Laser System LUMENIS LTD ELISSA BURG
K151850 07/07/2015 McKesson Cardiology MCKESSON ISRAEL LTD. GILBERT WONG
K152054 07/23/2015 Confida Adaptive Sheath Medtronic, Inc. Matthew Lobeck
K152116 07/30/2015 5.5 F Worley Advanced LVI Lateral Vein Introducer MERIT MEDICAL SYSTEMS, INC. ALINA STUBBS
K151776 07/01/2015 Central Venous Pressure System Mespere LifeSciences Inc. Helen Tan
K151869 07/09/2015 Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND GERHARD FRICK
K151861 07/08/2015 JUSHA-C23C LCD Monitor NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MA JING
K151972 07/16/2015 JUSHA-C43 LCD Monitor Nanjing Jusha Display Technology Co., Ltd Ma Jing
K152069 07/27/2015 Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter NAVILYST MEDICAL, INC. MICHAEL P. HANLEY
K152031 07/22/2015 New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with NEW DEANTRONICS TAIWAN, LTD. JANE LIU
K151797 07/02/2015 Nuocande Plastic Manual Wheelchair Model NKD L07 NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD. CHARLES SHEN
K151982 07/17/2015 Stat Profile Prime ABG Analyzer System NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K152071 07/27/2015 NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) NOVABONE PRODUCTS, LLC RICHARD A. DAVIS
K151979 07/17/2015 STARband, STARlight ORTHOMERICA PRODUCTS, INC. DAVID C. KERR
K151951 07/15/2015 Destino Reach Oscor Inc. Jan Flegeau
K151929 07/14/2015 PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE PERSYST DEVELOPMENT CORPORATION DARI DARABBEIGI
K151830 07/06/2015 Hummingbird Tympanostomy Tube PRECEPTIS MEDICAL Keith Leland
K151863 07/08/2015 Precision Spine Interspinous Plate System PRECISION SPINE, INC. MICHAEL C. DAWSON
K152030 07/22/2015 Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) Qingdao Hisense Medical Equipment Co., Ltd. Liu Zhitang
K151829 07/06/2015 Atlas SPEEDER Header/Neck Quality Electrodynamics, LLC KATHLEEN ARAS
K151924 07/13/2015 Q-Rad Radiographic System with Auto-Tracker Option QUANTUM MEDICAL IMAGING DIVISON OF CARESTREAM MARK CAMIRAND
K151880 07/09/2015 Wingman Crossing Catheter REFLOW MEDICAL REBECCA K PINE
K152131 07/31/2015 Reliance Spinal Screw System Reliance Medical Systems, LLC BRET M BERRY
K151786 07/01/2015 Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet Roche Diagnostics Kelli Turner
K151808 07/02/2015 3D/5D Viewer SAMSUNG MEDISON CO., LTD KIM JIYOUNG
K151856 07/08/2015 ABL80 FLEX CO-OX with AQURE connectivity SENDX MEDICAL INC. Vibeke Agerlin
K151849 07/07/2015 Seneka I Polyscrew Pedicle Fixation System Senecka Spine Khalid Sethi
K151887 07/10/2015 syngo VSim SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K151902 07/10/2015 REDAPT? Revision Femoral System SMITH & NEPHEW, INC. Natalie P. Williams
K151813 07/02/2015 Sniper Spine System SPINE WAVE, INC. Ronald K Smith
K152076 07/27/2015 PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority Stryker Jonathan Schell
K151879 07/09/2015 VariAx 2 One-Third Tubular Plating System STRYKER GMBH HEIKE GUSTKE
K152081 07/27/2015 Weck Auto Endo5 Hem-o-lok Ligating Clip Applier Teleflex Medical, Inc. Ashlea Ricci
K151952 07/15/2015 Synergy ODM TOPCON MEDICAL SYSTEMS, INC. Michael Gusel
K151837 07/06/2015 CS 3D Imaging TROPHY MARIE-PIERRE LABAT-CAMY
K152064 07/24/2015 Astringedent Clear ULTRADENT PRODUCTS, INC. COREY JASEPH
K151889 07/10/2015 Infinity ERCP Sampling Device UNITED STATES ENDOSCOPY GROUP, INC. CARROLL MARTIN
K152018 07/21/2015 Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets VARIAN MEDICAL SYSTEMS, INC. Peter J. Coronado
K151981 07/17/2015 Turnpike catheter VASCULAR SOLUTION, INC. BEKA VITE
K151904 07/13/2015 SyncVision System VOLCANO CORPORATION ELAINE ALAN
K151961 07/16/2015 Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens Volk Optical Inc. Meghan M Leonard
K151777 07/01/2015 Intradermal Adapter WEST PHARMACEUTICAL SERVICES INC. JEFFREY RAVEL
K151838 07/06/2015 PRO-TOE Hammertoe Fixation System Wright Medical Technology, Inc. Michael Mullins
K152045 07/23/2015 SALVATION« External Fixation System WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE REDDEN
K152132 07/31/2015 X-spine Pedicle Screw System X-spine Systems, Inc. David Kirschman
K151963 07/16/2015 SmartSite Vented Vial Access Device YUKON MEDICAL, LLC CARL DUPPER
K151818 07/06/2015 SImmetry Sacroiliac Joint Fusion System Zyga Technology, Inc. Diane Brinza


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