FDA 510(k) Applications Received During January, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K150172 01/26/2015 ACCLARENT SE Inflation Device ACCLARENT, INC. JAMES PATRICK GARVEY II
K150069 01/13/2015 Fine Structure Analysis(fineSA) Acuitas Medical Ltd. John Heinrich
K150062 01/13/2015 Excia Total Hip System AESCULAP IMPLANT SYSTEMS, LLC JULIE TOM WING
K150163 01/26/2015 Otowave 202 Portable Tympanometer AMPLIVOX, LTD. Chris Roerig
K150043 01/09/2015 Transcutaneous Electrical Nerve Stimulators (TENS) ANDON HEALTH CO.,LTD Liu Yi
K150089 01/16/2015 NanoKnife System ANGIODYNAMICS, INC. Suzanne Goodman
K150111 01/20/2015 Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series APEX MEDICAL CORP. Frank Lin
K150034 01/09/2015 AMT Enteral Transition Adapters APPLIED MEDICAL TECHNOLOGY, INC. JOSHUA MEINKE
K150109 01/20/2015 Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology Arrow International ( a subsidiary of Teleflex, Inc.) Karl J Nittinger
K150140 01/22/2015 MCL 31 Dermablate ASCLEPION LASER TECHNOLOGIES GMBH Antje Katzer
K150129 01/21/2015 AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) Aseptico, Inc. Cherie Tregoning
K150138 01/22/2015 Aspen Laser Systems Therapy Laser System ASPEN LASER SYSTEMS, LLC PAUL SCHWEN
K150184 01/27/2015 Dymaxeon Spine System Back 2 Basics Direct, LLC Scot Miller
K150059 01/13/2015 BD FlowSmart Set BECTON, DICKINSON COMPANY AVITAL MERL
K150191 01/28/2015 GammaBeam 500 Best Theratronics Limited Mike de van der Schueren
K150198 01/29/2015 CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel Bio-Detek, Inc. Chuck Kolifrath
K150055 01/12/2015 OneStep Pediatric CPR Multi-Function Electrode BIO-DETEK, INC. CHUCK KOLIFRATH
K150125 01/20/2015 Elite Nitinol Fixation System BioMedical Enterprises, Inc. Joe Soward
K150186 01/27/2015 Chariot Guiding Sheath BOSTON SCIENTIFIC CORP. KURTIS HUNSBERGER
K150051 01/12/2015 Exilite BTL Industries, Inc. Jan Zarsky
K150083 01/15/2015 Sidecar External Working Channel C2 THERAPEUTICS THERESA BRANDNER-ALLEN
K150016 01/05/2015 Vertessa Lite CALDERA MEDICAL, INC. Vicki Gail
K150023 01/06/2015 Vertessa Lite Y-Mesh CALDERA MEDICAL, INC. Vicki Gail
K150124 01/20/2015 Cardinal Health NPWT PRO HC CARDINAL HEALTH TATYANA BOGDAN
K150151 01/23/2015 SmartGownTM surgical gown CARDINAL HEALTH 200, INC. Lavenia Ford
K150010 01/02/2015 Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port Cedic S.r.l. Tiziana Melis
K150053 01/12/2015 STALIF C; STALIF C-Ti Centinel Spine, Inc. John Parry
K150042 01/09/2015 PleuraFlow System ClearFlow, Inc. Dov Gal
K150137 01/22/2015 SpiroThor Cohero Health LLC Melissa Manice
K150218 01/30/2015 Fill-Up! COLTENE/WHALEDENT AG SILKE WALLASCHEK
K150041 01/09/2015 CORA (Coagulation Resonance Analysis) System Coramed Technologies, LLC Norman E Brunner
K150187 01/27/2015 ELITECROSS Support Catheter Cordis Corporation, A Johnson & Johnson Company Michelle Ragozzino Rodgers
K150007 01/02/2015 Modified Bencox Hip System Corentec Co., Ltd Goon Hee Lee
K150063 01/13/2015 One Step hCG Pregnancy Test Coretests, Inc. Wen Li
K150084 01/15/2015 Argyle? Polyvinyl Chloride (PVC) and Kangaroo? Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector COVIDIEN SONA MANICKAM
K150012 01/05/2015 CreoDent Solidex Customized Abutment CREODENT PROSTHETICS, LTD. CALVIN SHIM
K150033 01/09/2015 Air Compressible Limb Therapy System DAESUNG MAREF CO., LTD. JAE-WHA LEE
K150196 01/29/2015 DD cubeX2 DENTAL DIREKT GMBH UWE GREITENS
K150040 01/09/2015 Implanova DENTAL EVOLUTIONS INC. PARSA T ZADEH
K150076 01/14/2015 Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L DONG IL TECHNOLOGY LTD. DONG BUM KIM
DEN150002 01/02/2015 EarLens Contact Hearing Device EARLENS CORPORATION SUZANNE LEVY
K150220 01/30/2015 STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast EB NEURO, S.P.A. Christiano Pineider
K150190 01/27/2015 IntraTemp Solution Warmer Ecolab Inc. Michelle Nivala
K150106 01/20/2015 2MP Color LCD Monitor, RadiForce RS240 EIZO CORPORATION HIROAKI HASHIMOTO
K150074 01/14/2015 Elevate Moisturizing Spray ELEVATE ORAL CARE STEVE PARDUE
K150029 01/08/2015 Habib EUS RFA EMCISION, LTD. FRANCOIS POULIN
K150020 01/06/2015 Irritrol, EDS Combo-Rinse ESSENTIAL DENTAL SYSTESM, INC. JEFFREY WAN
K150026 01/07/2015 Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler ETHICON ENDO-SURGERY, LLC Marjorie Medina
K150130 01/21/2015 Ascendant TM Cervical Spacer System EXACTECH, INC. DAWN DAVISSON
K150066 01/13/2015 Exactech Alteon Monobloc Revision Stem EXACTECH, INC. Patrick Hughes
K150152 01/23/2015 The Octane Straight Intervertebral Fusion Device, Ti Coated EXACTECH, INC. Dawn Davisson
K150166 01/26/2015 Extremity Medical Suture Anchor EXTREMITY MEDICAL LLC Brian Smekal
K150223 01/30/2015 Facet-Link Stabilization Platform FACET-LINK, INC. Massimo Calafiore
K150221 01/30/2015 EPX-4440HD and EPX-4400HD with FICE FUJIFILM MEDICAL SYSTEM U.S.A., INC. MARY MOORE
K150030 01/08/2015 Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor Fukuda Denshi USA, Inc. Doug Blakely
K150128 01/20/2015 GC Ortho Connect, GC Ortho Etching Gel GC Orthodontics America Inc. Mark Heiss
K150193 01/28/2015 Customer Remote Console (CRC) GE MEDICAL SYSTEMS, LLC John W. Jaeckle
K150085 01/15/2015 GE EchoPAC GE VINGMED ULTRASOUND AS Bryan Behn
K150087 01/15/2015 Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System GE VINGMED ULTRASOUND AS BRYAN BEHN
K150171 01/26/2015 Tinnitus Sound Generator Module GN RESOUND A/S Lars Hagander
K150179 01/27/2015 CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids GUANGZHOU WONDFO BIOTECH CO., LTD. BEN CHEN
K150022 01/06/2015 Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream Guangzhou Wondfo Biotech Co., Ltd. Ben Chen
K150024 01/07/2015 Bissinger Monopolar Cables GUENTER BISSINGER MEDIZINTECHNIK GMBH Matthias Bissinger
K150113 01/20/2015 Fusion Black Powder-Free Nitrile Exam Glove Halyard Health Christine L Macauley
K150110 01/20/2015 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin P HARTALEGA NGC SDN. BHD. Kuan Mun Leong
K150103 01/20/2015 Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs HARTALEGA SDN BHD Kuan Kam Hon
K150096 01/20/2015 Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC Jianqiu Fang
K150056 01/12/2015 Luxisse+ HEANY INDUSTRIES INC Cliff Rabidoux
K150119 01/20/2015 PALACOS R pro HERAEUS MEDICAL GMBH ASTRID MARX
K150169 01/26/2015 Sertera Biopsy Device Hologic, INC Brenda Geary
K150175 01/26/2015 HeatLux Pro I HOME SKINOVATIONS LTD. Ahava Stein
K150112 01/20/2015 HS AMICA DEVICES FAMILY HS HOSPITAL SERVICE SPA Laura Lenzi
K150183 01/27/2015 ApexM InControl Medical, LLC Jessica Andreshak
K150180 01/27/2015 InTone INCONTROL MEDICAL, LLC. JESSICA ANDRESHAK
K150155 01/23/2015 NOVA Lite DAPI ANA Kit INOVA DIAGNOSTICS, INC. Gabriella Lakos
K150174 01/26/2015 EMMA INRANGE SYSTEMS, INC. Christopher E Bossi
K150164 01/26/2015 Monobond Etch & Prime IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K150009 01/02/2015 Baide Jiangsu Baide Medical Intrument Co.,Ltd. Mr.Kang Shui
K150199 01/29/2015 Neodent Implant System JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S Jacson Cambruzzi
K150182 01/27/2015 Neodent Implant System- CM Drive Implants JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S Jacson Cambruzzi
K150060 01/13/2015 J2A Dental Implant System, J2C Dental Implant System KJ MEDITECH CO., LTD Goong-san Nam
K150098 01/20/2015 LightStim Professional 2-Panel Light LED INTELLECTUAL PROPERTIES, LLC STEVE MARCHESE
K150126 01/20/2015 Life Spine Cannulated Screws LIFE SPINE INC. Randy Lewis
K150214 01/30/2015 OneTouch Verio Flex Blood Glucose Monitoring System LIFESCAN EUROPE Alison Wilson
K150134 01/21/2015 Basic, Dominant Flex, KV-6 MEDELA AG ORLANDO ANTUNES
K150049 01/12/2015 PASS LP Spinal System MEDICREA INTERNATIONAL Audrey Vion
K150216 01/30/2015 Synergy Cranial MEDTRONIC NAVIGATION, INC. KAYE E. WAITE
K150178 01/26/2015 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC MICHAEL SCOTT
K150135 01/21/2015 DIVERGENCE-L Anterior/Oblique Lumbar Fusion System MEDTRONIC SOFAMOR DANEK USA, INC. LILA JOE
K150200 01/29/2015 CD HORIZON Growth Rod Conversion Set MEDTRONIC SOFAMOR DANEK USA, INCORPORATED LEE GRANT
K150117 01/20/2015 Medtronic Patient Asistant Medtronic, Inc. Eric Kalmes
K150031 01/08/2015 hemoFISH Masterpanel MIACOM DIAGNOSTICS GMBH EVE BLOMEKE
K150107 01/20/2015 Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR Phuong Chau
K150133 01/21/2015 PROFEMUR Preserve Size 1-3 Hip Stems MICROPORT ORTHOPEDICS, INC. BYRON LEDBETTER
K150146 01/22/2015 Biogel PI Micro Indicator Underglove MOLNLYCKE HEALTH CARE US, LLC Megan Bevill
K150205 01/29/2015 LED Curing Light MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
K150005 01/02/2015 Checkpoint, Checkpoint Head & Neck NDI Medical, LLC Robert Rogers
K150145 01/22/2015 MD322C8 31.5 Diagnostic Imaging LCD Monitor NEC DISPLAY SOLUTIONS LTD. SATORU KOTANI
K150052 01/12/2015 TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System Nipro Diagnostics, Inc Simeon Simone
K150143 01/22/2015 Normal Saline Flush NURSE ASSIST, INC. Brian Cox
K150212 01/30/2015 DeScribe Transparent PFD Patch ON Light Sciences, Inc. David Sell
K150064 01/13/2015 Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) ORTHOGEM LTD PAUL Z MARKGRAF
K150067 01/13/2015 OTSC Proctology OVESCO ENDOSCOPY AG Marc O Schurr
K150088 01/16/2015 Evacore Fully Disposable Vacuum Assist Biopsy Device Pin-Point Care Corp. Jeff M Hathaway
K150206 01/29/2015 InFill Interbody Fusion Devices PINNACLE SPINE GROUP, LLC REBECCA K. PINE
K150139 01/22/2015 Rachel's Remedy Rachel's Remedies, LLC Rachel E. Jackson
K150150 01/23/2015 1717SGN / 1717SCN Digital Flat Panel X-ray Detector Rayence Co., Ltd Kevin Kim
K150108 01/20/2015 Reverse Medical Micro Vascular Plug System REVERSE MEDICAL CORPORATION LAURA HEATON
K150092 01/16/2015 STERISPINE PS Pedicle Screw SAFE ORTHOPAEDICS PIERRE DUMOUCHEL
K150165 01/26/2015 GC85A SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K150097 01/20/2015 GM60A-32S & GM60A-40S SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K150014 01/05/2015 Serenity SANUTHERA, INC. JEFFERY DIGIOVANNI
K150002 01/02/2015 iNSIGHT Color Doppler Ultrasound System SASET (CHENGDU) INC. Dong Chyuan Liu
K150158 01/23/2015 Schoelly Cystoscopes/Hysteroscopes and Accessories Schoelly Fiberoptic GmbH Sandra Baumann
K150095 01/16/2015 ReDs Wearable System SENSIBLE MEDICAL INNOVATIONS LTD. Inbal Ben-Tzvi
K150093 01/16/2015 Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 SHENZHEN CREATIVE INDUSTRY CO., LTD. JIA WANG
K150204 01/29/2015 DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANG ZHAOHUI
K150080 01/15/2015 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Zhai Pei
K150082 01/15/2015 Panorama Patient Monitoring Network SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Yanhong Bai
K150167 01/26/2015 V60 Anesthetic Vaporizer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD TANG HO
K150132 01/21/2015 IMMULITE IGF Control Module, IMMULITE Gastrin Control Module Siemens Healthcare Diagnostics Asha Gartland
K150039 01/09/2015 MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) Siemens Healthcare Diagnostics Inc. Shanon Popson
K150192 01/28/2015 Scenium SIEMENS MEDICAL SOLUTIONS USA, INC ALAINE MEDIO
K150050 01/12/2015 ACUSON P500 Diagnostic Ultrasound System SIEMENS MEDICAL SOLUTIONS USA, INC. Shelly Pearce
K150217 01/30/2015 ORTHOPHOS SL Sirona Dental Systems GMBH Thomas Diesch
K150078 01/15/2015 PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application) Smartmissimo Technologies Pte Ltd Alexey Pisarev
K150091 01/16/2015 Versatex Monofilament Mesh SOFRADIM PRODUCTION Benjamin Rochette
K150045 01/12/2015 S30/S40 Digital Color Doppler Ultraound System SONOSCAPE COMPANY LIMITED TOKI WU
K150065 01/13/2015 SoundCure Serenade Tinnitus Treatment System SoundCure, Inc. William Perry
K150201 01/29/2015 Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter SPECTRANETICS, INC. Christine Godleski
K150061 01/13/2015 Lucent; Lucent Ti-Bond Systems Spinal Elements Inc. Julie Lamothe
K150017 01/05/2015 SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System SpineFrontier, Inc. Manthan J Damani
K150036 01/09/2015 Blue Mountain Cervical Plate System SPINEWAY JULIEN THAO MY
K150185 01/27/2015 Mont Blanc Spinal System SPINEWAY Julien Thao My
K150127 01/20/2015 Laparoscopic Handles with peek Insulation Stryker Endoscopy Rebecca Goldberg
K150188 01/27/2015 SMV Scientific 4.5 mm Bone Screws SUMMIT MEDVENTURES NEPHI ZUFELT
K150099 01/20/2015 Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) SYNTHES (USA) PRODUCTS, LLC NICHOLAS FOUNTOULAKIS
K150148 01/23/2015 Terason uSmart3300 Ultrasound System TERATECH CORP. Steven R Broadstone
K150072 01/14/2015 TheyFit Male Condom THEYFIT MICHAEL CECIL
K150122 01/20/2015 TOMTEC-ARENA TTA2 TOMTEC IMAGING SYSTEMS, GMBH CHRISTINE KLEIN
K150003 01/02/2015 Aquilion LB, TSX-201A/3, V6.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K150105 01/20/2015 Klassic Knee System-Sombrero Patella TOTAL JOINT ORTHOPEDICS, INC. Chris Weaber
K150086 01/15/2015 Titan TZORA ACTIVE SYSTEMS LTD. Adi Shemer
K150147 01/22/2015 Lubrigyn cream UNIDERM FARMACEUTICI SRL Giorgio Chiozza
K150068 01/13/2015 Unimicro Veress Needle Unimicro Medical Systems (ShenZhen) Co.,Ltd. Weizhong Chen
K150161 01/23/2015 Venus Viva SR Device Venus Concept Ltd. Orit Ron Edoute
K150035 01/09/2015 V10 system VIORA LTD. OMRI KESLER
K150018 01/05/2015 VS3-IR-MMS System Visionsense Ltd. Alex Chanin
K150154 01/23/2015 ANAM Test System: Military Battery Vista LifeSciences, Inc. Lori White
K150104 01/20/2015 Vitrea CT Myocardial Perfusion Vital Images, Inc Parthiv Shah
K150162 01/26/2015 First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test W.H.P.M., Inc. John Wan
K150027 01/07/2015 CYMA WhiteCap Technologies LLC Dustin Synider
K150073 01/14/2015 MICRONAIL Distal Radius System Wright Medical Technology, Inc. Jeanine Redden
K150004 01/02/2015 SALVATION External Fixation System WRIGHT MEDICAL TECHNOLOGY, INC. Leslie Fitch
K150213 01/30/2015 Subtalar Spacer System (STS) WRIGHT MEDICAL TECHNOLOGY, INC. TARA CONRAD
K150021 01/06/2015 Z5m(t) Z-Systems AG Thomas Hug
K150090 01/16/2015 Zimmer Persona Personalized Knee System ZIMMER, INC. Keith Proctor
K150028 01/07/2015 Zimmer Segmental System XT Components ZIMMER, INC. KEITH J. PROCTOR
K150121 01/20/2015 Zimmer Periarticular Plating System ZIMMER,INC. PATRICK MCCULLAGH


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