FDA 510(k) Applications Received During July, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
K161841 07/05/2016 D2P 3D SYSTEMS, INC. KIM TORLUEMKE
K161922 07/13/2016 XP202 3M DEUTSCHLAND GMBH RUEDIGER FRANKE
K161884 07/11/2016 Ortho System 3Shape A/S Hanne Nielsen
K161874 07/08/2016 Audit MicroControls Linearity DROP LQ Blood Glucose AALTO SCIENTIFIC, LTD. ROBERT BURDA
K161985 07/19/2016 Steerable Guide Catheter ABBOTT VASCULAR Makena Mc Gowan
DEN160032 07/11/2016 Accelerate Pheno system, Accelerate Phenotest BC Kit ACCELERATE DIAGNOTICS MAUREEN MENDE
K161867 07/07/2016 On Call Pro Blood Glucose Monitoring System ACON LABORATORIES Qiyi Xie
K162005 07/20/2016 Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A. Bonafini
K161918 07/13/2016 SREE MRI Transport Incubator ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS RAVI SRINIVASAN
K161913 07/12/2016 AOS Small Fragment Plating System ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) ALEX BHASKARLA
K162007 07/20/2016 STERRAD NX Sterilizer Advanced Sterilization Products Nazanin Yacobi
K161994 07/19/2016 Aerin Medical Stylus Aerin Medical, Inc. Scott Wolf
K161853 07/06/2016 proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System AESCULAP INC. KATHY A. RACOSKY
K161834 07/05/2016 One Drop Blood Glucose Monitoring System AgaMatrix, Inc. David Olsen
K162070 07/27/2016 JOINIX CANNULAR SYSTEM AJU Pharm Co.,Ltd. Kim Jung Gil
K161984 07/19/2016 Interlocked Circular Small Field Collimators, Elekta Integrated AKTINA MEDICAL CORPORATION TONY SPACCAROTELLA
K162013 07/21/2016 Eusol-C AL.CHI.MI.A. S.r.l. Mauro Beccaro
K161981 07/19/2016 Olive Plus AMA NETWORK INC YONG BAIK KIMM
K161996 07/19/2016 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE Amend Surgical, Inc. Robert Lane
K161842 07/05/2016 Overwatch Spine System Amendia, Inc. Bruce Hooper
DEN160033 07/15/2016 ARK Voriconazole II Assay Test System ARK DIAGNOSTICS, INC Kenneth C. Kasper
K162032 07/22/2016 Arrowhead Mini-Rail Fixator Arrowhead DE, LLC Thomas J. Twardzik
K162074 07/27/2016 Werewolf RF20000 Controller, FLOW 50 Wand ARTHROCARE CORPORATION SHIRLEY HYINK
K161912 07/12/2016 ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip ASAHI INTECC CO., LTD. Yasuyuki Kawahara
K162034 07/22/2016 OBS Electrosurgical Generator (Model: OBS-350A) Baisheng Medical Co.,Ltd. Peter Mao
K161880 07/08/2016 NIVR58-T kit Barco N.V. Lieven De Wandel
K161986 07/19/2016 SIDEKICK and USHER Support Catheters BARD PERIPHERAL VASCULAR, INC. Melanie Hadlock
K161819 07/01/2016 NNR06 Multi-Purpose Solution Bausch & Lomb Incorporated Glenn Davies
K161808 07/01/2016 Solution Set with 1.2 Micron Air Eliminating Filter Baxter Healthcare Corporation John Lamela
K161949 07/15/2016 OsteoCool V-3 RF Ablation System Baylis Medical Company Inc. Meghal Khakhar
K161878 07/08/2016 PORTAGE System Baylis Medical Company Inc. Meghal Khakhar
K161837 07/05/2016 ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer BECKMAN COULTER INC. GERALDINE FUENTESPINA
K161810 07/01/2016 BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial BECTON DICKINSON Ashanti C. Brown
K162081 07/27/2016 BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe Becton, Dickinson and Company Murtaza Rana
K161925 07/13/2016 CO2 Laser Therapy Machine Beijing ADSS Development Co., Ltd Gao Yurong
K161926 07/13/2016 ND YAG Q-switch Laser Therapy Machine Beijing ADSS Development Co., Ltd Gao Yurong
K162089 07/28/2016 Blood Pressure Monitor BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. LEI CHEN
K161898 07/11/2016 Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set BEIJING FERT TECHNOLOGY CO., LTD MENG ZHANG
K161892 07/11/2016 Slimming Treatment Device BEIJING HONKON TECHNOLOGIES CO., LTD Li Yanzhe
DEN160029 07/05/2016 SkinPen Precision System BELLUS MEDICAL, LLC. JENNIFER BLOCK
K161844 07/05/2016 Matrix Pre-Treatment Controller BETTER WATER, LLC. MIKE CLINE
K161974 07/18/2016 SLENDERTONE« Connect Abs, Type 570 Bio-Medical Research Ltd. Anne-Marie Keenan
K161816 07/01/2016 BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO bioMerieux, Inc. Jolyn Tenllado
K162076 07/27/2016 chromID MRSA bioMerieux, Inc. Karen Russell
K161896 07/11/2016 Biomet Microfixation Sternal Closure System BIOMET MICROFIXATION LAUREN JASPER
K162017 07/21/2016 Ross Ru Wound Dressing Gel BIOTD, S.A. Lawrence Pratt
K161960 07/18/2016 bk2300 BK MEDICAL APS MICHAEL J. DOYLE
K162014 07/21/2016 Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) BLUEPOINT MEDICAL GMBH & CO. KG BERND LINDNER
K161971 07/18/2016 Bindex BI-2 BONE INDEX FINLAND, LTD. Janne Karjalainen
K162010 07/20/2016 HPM-6000U BTL Industries, Inc. Jan Zarsky
K161967 07/18/2016 FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm Callisyn Biomedical, Inc. Shallwei Sun
K161910 07/12/2016 Cardinal Health Sterilization Wrap CARDINAL HEALTH 200, LLC MEGAN MIDDAUGH
K161833 07/05/2016 LATEX EXAMINATION GLOVE POWDER FREE CAREGLOVE GLOBAL SDN BHD LIM KWEE SHYAN
K161848 07/05/2016 Family of Steam sterilizers B17 B22 Series CEFLA S.C. Silvia Sansavini
K161900 07/11/2016 HYPERION X5 CEFLA SC SILVIA SANSAVINI
K161905 07/11/2016 Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO.,LTD. Boping Ma
K162103 07/29/2016 Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine Interbody Fusion System (HarrierÖ), Choice Spine Vertebral Body Replacement System (HawkeyeÖ) CHOICE SPINE, LP KIM FINCH
K161915 07/12/2016 Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant CHURCH & DWIGHT CO.,INC. Lisa Burns
K161959 07/18/2016 ClearView cCAD ClearView Diagnostics Inc. Christine Podilchuk
K162057 07/26/2016 ConceptoMed Luer-Jack Slip 10ml ConceptoMed AS Marit Martinsen
K162041 07/25/2016 Airworks Nebulizer pe1200m Convexity Scientific LLC Paul Reiferson
K162104 07/29/2016 C-Flex Ureteral Stent Set COOK INCORPORATED MINJIN CHOI
K162109 07/29/2016 Kwart Retro-Inject Ureteral Stent COOK INCORPORATED KARA KANORR
K161822 07/01/2016 Torcon NB Advantage Catheters Cook Incorporated Jennifer Allman
K162110 07/29/2016 CORGRIP NG/NI Tube Retention System CORPAK MedSystems, Inc. a Division of Haylard Health Stephanie Wasielewski
K162047 07/25/2016 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated COVIDIEN CELSO DURAN
K161963 07/18/2016 Monoject Enteral Syringe with ENFit Connector COVIDIEN SONA MANICKAM
K162064 07/26/2016 CrossBay IVF Embryo Transfer Catheter Set CrossBay Medical Inc. Piush Vidyarthi
K161937 07/14/2016 CuattroDR Cuattro, LLC Matthew Taylor
K161919 07/13/2016 UltraScan 650 CyberLogic, Inc. Jonathan J. Kaufman
K162044 07/25/2016 Dentca Denture Base II DENTCA, Inc. Jason Lee
K162107 07/29/2016 TPH Spectra+ Universal Composite Restorative DENTSPLY SIRONA HELEN LEWIS
K161987 07/19/2016 UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure DIO CORPORATION SANGIN PARK
K161929 07/14/2016 Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove Dipped Products (Thailand) Limited Nilaksha Pushpakumara
K162088 07/28/2016 Ecomed Disposable Angiographic Syringes ECOMED SOLUTIONS, LLC DAVID YUREK
K162055 07/25/2016 Acclarix LX8 Diagnostic Ultrasound System EDAN INSTRUMENTS INC Alice Yang
K161962 07/18/2016 VAMP Venous/Arterial Blood Management Protection System Edwards Lifesciences LLC Jennifer Wilbur
K162071 07/27/2016 IllumiFlow Laser Cap EGLOBAL, LLC WAYNE DESTEFANO
K161906 07/12/2016 SCIg60 Infuser EMED TECHNOLOGIES CORPORATION PETER KOLLINGS
K162024 07/22/2016 AltiVate Anatomic Shoulder System ENCORE MEDICAL, L.P DESIREE WELLS
K161945 07/15/2016 EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) ENCORE MEDICAL, L.P. TEFFANY HUTTO
K161973 07/18/2016 G-scan Brio, S-scan Esaote S.p.A. Maria Marzapane
K161940 07/14/2016 Guidewire 0.6 Single Use FIGON GMBH Dirk Mucha
K161877 07/08/2016 Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tam FIRST QUALITY HYGIENIC, INC. Melanie Leibowitz
K162068 07/26/2016 ARROW Anatomical Porous glenoid Fournitures Hospitalieres Industrie Patricia Donnard
K162045 07/25/2016 SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System FUJIFILM SonoSite, Inc. Jordan Grimmer
K161980 07/18/2016 Fuselier Intraoral Nighttime Device (FIND) FUSELIER ENTERPRISES, LLC BRIAN FUSELIER
K162012 07/21/2016 CARESCAPE Central Station V2 GE HEALTHCARE ROBERT CASARSA
K162052 07/25/2016 Sentinella 102, Sentinella 102 Horus GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- JOSE MONTES
K161815 07/01/2016 FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band Genesee BioMedical, Inc. Woodrow G. Mathison
K161914 07/12/2016 Genesys Spine TiLock Cortical Spinal System Genesys Spine William W. Sowers
K162059 07/26/2016 EZEE RETRIEVAL GENICON, INC KATLYN KACHMAN
K162023 07/22/2016 CardioDay V2.5 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG BERT SCHADOW
K161904 07/11/2016 GEO Bone Screw System GRAMERCY EXTREMITY ORTHOPEIDICS, LLC MICHAEL P. SIMPSON
K161886 07/11/2016 Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD ADA ZHANG
K161825 07/01/2016 PK AIM GYRUS ACMI INC. GRAHAM A.L. BAILLIE
K162073 07/27/2016 Dental Implants OKTAGON Tissue Level and Bone Level HAGER & MEISINGER GMBH MELANIE MAY
K162048 07/25/2016 EZstim*III Peripheral Nerve Stimulator/Nerve Locator HALYARD HEALTH - IRVINE Maria Pronina
K162117 07/29/2016 NIRO-200NX DP Hamamatsu Photonics K.K. Susumu Suzuki
K162079 07/27/2016 TRILLIUM Oval Head Coil 32 HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K161829 07/05/2016 Huvitz Imaging System HUVITZ CO., LTD. KIM EUN-JO
K162085 07/27/2016 i-CAT FLX V series / KaVo 3D eXam+ V series IMAGING SCIENCES INTERNATIONAL Ruth Pui
K161831 07/05/2016 IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set Immunodiagnostic Systems Ltd Mick Henderson
K161947 07/14/2016 Chagas Detect Plus Rapid Test INBIOS INTERNATIONAL, INC. ESTELA RAYCHAUDHURI
K162099 07/29/2016 IBS Implant System II InnoBioSurg Co., Ltd. Bo-reum Yoo
K161827 07/05/2016 Reprocessed Response Diagnostic Electrophysiology Catheters INNOVATIVE HEALTH, LLC. SHARON HIGGINS
K161818 07/01/2016 GEM Premier 3000 Instrumentation Laboratory Co. Nikita Malladi
K161882 07/11/2016 CUSA Clarity Ultrasonic Surgical Aspirator System INTEGRA LIFESCIENCES CORPORATION RESHAM RAMSAY
K161992 07/19/2016 Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems INTEGRA LIFESCIENCES CORPORATION JENNIFER SIEGEL
K162037 07/22/2016 Eclipse with VEMP INTERACOUSTICS A/S Erik Nielsen
K162001 07/20/2016 1.5T and 3.0T 16 CH GE Shoulder Coils INVIVO CORPORATION KEN REVENNAUGH
K162053 07/25/2016 PhotonBlade Invuity Inc. John Kang
K161865 07/07/2016 iSage Rx (iSage Rx Basal Insulin Titration) iSag Rx, Inc. RYAN SYSKO
K161991 07/19/2016 Curasite IZUN PHARMACEUTICALS JACK TALLEY
K161864 07/07/2016 ARIX Foot System JEIL MEDICAL CORPORATION SEJIN RYU
K161979 07/18/2016 ENFit enteral syringe JIANGYIN CAINA TECHNOLOGY CO., LTD. JUN LU
K161895 07/11/2016 2MP Color LCD Monitor CCL214 (CL21214) JVC KENWOOD Corporation Tsukasa Tashiro
K161933 07/14/2016 The Braun ThermoScan« 3 High Speed Compact Ear Thermometer Kaz USA, Inc., A Helen of Troy Company AMY LIU
K161897 07/11/2016 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings KCI USA, INC. (KINETIC CONCEPTS, INC.) MARGARET MARSH
K161923 07/13/2016 J2A SLA Dental Implant System KJ Meditech Co., Ltd. Goong-san Nam
K162065 07/26/2016 Ultrasound System SONIMAGE HS1 KONICA MINOLTA, INC. Tsutomu Fukui
K161951 07/15/2016 KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay KRONUS, INC. Brian Deis
K162098 07/29/2016 LED Phototherapy Device LI-TEK ELECTRONIC TECHNOLOGY CORPORATION Barry Yuan
K162106 07/29/2016 Micro-current Wrinkle Reduction Facial service, model EP-400 Li-Tek Electronic Technology Corporation Barry Yuan
K162067 07/26/2016 VX130 Ophthalmic Diagnostic Device LUNEAU SAS ISABELLE DURAND
K162035 07/22/2016 GMK Sphere Medacta International SA Stefano Baj
K162061 07/26/2016 M.U.S.T. Pedicle Screw System MEDACTA INTERNATIONAL SA Stefano Baj
K162084 07/27/2016 MOTO Partial Knee System Medacta International SA Stefano Baj
K161861 07/06/2016 APTUS« Coronoid 2.0 Medartis AG Andrea Schweizer
K161811 07/01/2016 Medela Low Dose Enteral Syringe Medela, Inc. Fergie Ferguson
K161916 07/12/2016 TelePatch Cardiac Monitor MEDICOMP, INC. Sean Marcus
K162097 07/29/2016 InTRAkit Medtronic Vascular Nisarg Shah
K162027 07/22/2016 TRAcelet Compression Device MEDTRONIC VASCULAR COLLEEN MULLINS
K162016 07/21/2016 Affinity NT Oxygenator with Cortiva BioActive Surface MEDTRONIC, INC. RENEE CVEYKUS
K162054 07/25/2016 Medtronic Temporary External Pacemaker 53401 MEDTRONIC, INC. SYED SUMRAN MOHIUDDIN
K161921 07/13/2016 SwiftNINJA Microcatheter MERIT MEDICAL SYSTEMS, INC. LUKE MEIDELL
K161879 07/08/2016 Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K162077 07/27/2016 Laparoscopic Spray Applicator with Spinning Luers MICROMEDICS INC. (D/B/A NORDSON MEDICAL) AMY L. PETERSON
K162026 07/22/2016 EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions MicroPort Orthopedics, Inc. Byron Ledbetter
K161909 07/12/2016 IQvitals Zone Midmark Corporation Asad Abu-Tarif
K161883 07/11/2016 CompuFlo Epidural Computer Controlled Anesthesia System MILESTONE SCIENTIFIC, INC. STEPHEN SOLOMON
K161902 07/11/2016 Meridian M110 Fetal Monitoring System MINDCHILD MEDICAL JIM ROBERTSON
K161871 07/07/2016 EVA (Enhanced Visual Assessment) System MobileODT Ltd. Jen Acobas
K161939 07/14/2016 Avance Abdominal Dressing Kit Molnlycke Health Care US, LLC Megan Bevill
K161935 07/14/2016 Avance Foam Dressing Kit - XL MOLNLYCKE HEALTH CARE, US LLC MEGAN BEVILL
K161948 07/15/2016 Avance Gauze Dressing Kits MOLNLYCKE HEALTH CARE, US LLC MEGAN BEVILL
K161855 07/06/2016 LED Curing Light MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
K161835 07/05/2016 iovera system Myoscience, Inc Tracey Henry
K162113 07/29/2016 Powder Free Nitrile Examination Gloves (Blue) NAM VIET GLOVE JOINT STOCK COMPANY OOI LOON SENG
K161866 07/07/2016 BioFlo Midline Catheter NAVILYST MEDICAL, INC. ROBIN FULLER
K162060 07/26/2016 Ahmed Glaucoma Valve NEW WORLD MEDICAL, INC. SUHAIL ABDULLAH
K162075 07/27/2016 NICO TRIOwand NICO Corporation Sean Spence
K161860 07/06/2016 TG-970P CO2 Sensor Kit NIHON KOHDEN CORPORATION THOMAS BENTO
K162043 07/25/2016 NobelProcera HT ML FCZ Bridge Nobel Biocare AB Charlemagne Chua
K161856 07/06/2016 StatStrip Xpress Glucose Hospital Meter System Nova Biomedical Corporation Paul W. MacDonald
K161941 07/15/2016 Pulsaderm Acne Device NUTRA LUXE MD, LLC GLORIA AVENDANO
DEN160030 07/07/2016 Oculeve Intranasal Tear Neurostimulator Device OCULEVE, INC. ANDY DORAISWAMY
K162092 07/28/2016 Evolv Model BP7000 Upper Arm Blood Pressure Monitor OMRON HEALTHCARE, INC. RENEE THORNBOROUGH
K161828 07/05/2016 kneeEOS ONEFIT Medical Julien Simon
K162042 07/25/2016 OptiScanner 5000 Glucose Monitoring System OPTISCAN BIOMEDICAL CORP. DON WEBBER
K162039 07/22/2016 OptosAdvance 4.0 Software Optos Plc Paul Burns
K162020 07/21/2016 VITROS Chemistry Products Cl- Slides Ortho Clinical Diagnostics Marlene Hanna
K162087 07/28/2016 NovoGro OsteoNovus, Inc. Brian M. Schlossberg
K161832 07/05/2016 O2VENT T OVENTUS MANUFACTURING PTY LTD HEMANGI MALDE
K162086 07/27/2016 MultiStim ECO PAJUNK GmbH Medizintechnologie Christian Quass
K161966 07/18/2016 PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector PerkinElmer, Inc. Dawn Spooner
K161942 07/15/2016 PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector PERKINELMER, INC. Dawn Spooner
K161899 07/11/2016 ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve C PHADIA AB Ulf Karlberg
K161839 07/05/2016 2D Quantitative Analysis PHILIPS MEDICAL SYSTEMS NEDERLAND BV JEANETTE BECKER
K162025 07/22/2016 IntelliSpace Portal Platform PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. Ilana Ben Moshe
K162112 07/29/2016 CAAS MRV Pie Medical Imaging BV Annemiek Bouts
K161876 07/08/2016 Tritium« Sternal Cable Plate System Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Sarah Pleaugh
K161931 07/14/2016 Toricolors (hioxifilcon D) Soft Contact Lenses POLYDEV LTD. JOHN MULVIHILL
K161920 07/13/2016 Comfort Cover PRECISION DYNAMICS CORPORATION SWARNA MUKUND
K161809 07/01/2016 ShurFit CpTi-HA ACIF Interbody Fusion System Precision Spine, Inc. Michael C. Dawson
K161881 07/08/2016 PreXion3D Excelsior PreXion Corporation Shumpeita Torii
K161812 07/01/2016 Freedom Syringe Procedure Products, Inc. Doug Rowley
K161950 07/15/2016 Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle Promisemed Hangzhou Meditech Co., Ltd. Keshin Hu
K161807 07/01/2016 BEAMSCAN PTW-Freiburg Physikalisch Technische-Werksraetten Sandor-Csaba Ats
DEN160028 07/01/2016 ipsogen JAK2 RGQ PCR Kit QIAGEN INC LINDSEY HOWARD
K162029 07/22/2016 16ch T/R Knee Coil Quality Electrodynamics, LLC Kathleen Aras
K161814 07/01/2016 Solana Influenza A+B Assay Quidel Corporation Ronald H. Lollar
K162083 07/27/2016 RII Multi-function Infrared Thermometer, Model TH52Z Radiant Innovation Inc. Monica Chung
K162066 07/26/2016 Reliance Spinal Screw System Reliance Medical Systems, LLC Bret M. Berry
K162051 07/25/2016 Cryotec REPROLIFE INC. KOICHI TAKEDA
K161978 07/18/2016 AirFit N20 ResMed Ltd Kim Kuan Lee
K161817 07/01/2016 Tina-quant Cystatin C Gen.2 Roche Diagnostics Operations (RDO) Patrick Stimart
K161857 07/06/2016 Salvin Tenting Screw System Salvin Dental Specialties Jennifer Singer
K162094 07/28/2016 RS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd Kyeong-Mi Park
K161955 07/18/2016 5D Viewer SAMSUNG Medison Co., Ltd. Kyeong-Mi Park
DEN160037 07/25/2016 dermaPACE System SANUWAVE, INC. PETER STEGAGNO
K161928 07/14/2016 CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL Sebia Karen Anderson
K161805 07/01/2016 EnCor MRI Introducer Set, EnCor Probe Introducer SENORX, INC. SARAH MCCARTNEY
K161944 07/15/2016 Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD. CECILY SHENG
K161851 07/06/2016 Glass Ionomer Cement (Luting) SHANDONG HUGE DENTAL MATERIAL CORPORATION STEVEN SONG
K161845 07/05/2016 Electronic Blood Pressure Monitor Shenzhen Pango Electronic Co.,Ltd. Xiaoyun Yang
K161891 07/11/2016 HC Primer Shofu Dental Corporation Mauro Malzyner
K161893 07/11/2016 Neuromonitoring Kit SI-BONE, INC. ROXANNE DUBOIS
K161954 07/18/2016 Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) Siemens Healthcare Diagnostics Justin DiValentino
K161964 07/18/2016 ADVIA Centaur HAV IgM Assay Siemens Healthcare Diagnostics, Inc. Philip Liu
K162102 07/29/2016 MAGNETOM Avantofit, MAGNETOM Skyrafit SIEMENS MEDICAL SOLUTIONS, INC. JOHN URTZ
K162078 07/27/2016 EVOS Small Fragment Plating System SMITH & NEPHEW, INC. SAMANTHA STAUBACH
K162011 07/21/2016 MedDream SOFTNETA UAB LAURA BARONIENE
K162030 07/22/2016 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle SOL-MILLENNIUM MEDICAL, INC JIM BARLEY
K162108 07/29/2016 Pressio 2 ICP Monitoring System SOPHYSA, SA Jean-Christophe Audras
K161993 07/19/2016 Leva« Anterior Interbody System Spine Wave, Inc. Sanja Jahr
K161888 07/11/2016 JULIET« LL Lateral Lumbar Cage SPINEART FRANCK PENNESI
K161873 07/07/2016 Pacel Flow Directed Pacing Catheter St. Jude Medical Blair Schwartz
K161821 07/01/2016 Stryker Universal Mesh Stryker Jonathan Schell
K162062 07/26/2016 AVAmax Vertebral Balloon, AVAflex Vertebral Balloon STRYKER CORPORATION BECKY DITTY
K161863 07/06/2016 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) Stryker GmbH Saad Attiyah
K162046 07/25/2016 MINNE TIES MMF Suture System SUMMIT MEDICAL, INC. Nicole Dove
K161946 07/15/2016 DoseCHECK Sun Nuclear Corporation Rene' Hardee
K161999 07/20/2016 Aixplorer SUPERSONIC IMAGINE LAURENCE HERMITTE
K161894 07/11/2016 SurgTech Trauma System SURGTECH INC XUEGONG YU
K162028 07/22/2016 PREMIUM - SHELTA Prosthetic Components SWEDEN & MARTINA S.p.A. ALESSIA PEZZATO
K161989 07/19/2016 PREMIUM Implant Systems SHELTA Implant Systems SWEDEN & MARTINA S.p.A. Alessia Pezzato
K162004 07/20/2016 PREMIUM Implant Systems SHELTA Implant Systems SWEDEN & MARTINA S.p.A. Alessia Pezzato
K162063 07/26/2016 Steri-Cassette and Steri-Cage Sterilization Packaging System Sybron Dental Specialties Jennifer Dzidrums
K161952 07/15/2016 UltraShape System Syneron Medical Ltd. Ruthie Amir
K162021 07/21/2016 3.0 Dynamic TiBase TALLADIUM ESPANA, SL ESTEBAN XAM-MAR
K161849 07/05/2016 Bright Tanda Beauty Canada Inc. Bobae Kim
K162080 07/27/2016 t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater Tandem Diabetes Care, Inc. Michael Sarrasin
K162022 07/21/2016 Collagentex Rx-1 Tanses Technologies inc. Kirk Kiremitci
K161968 07/18/2016 MicrUs TELEMED Yury Sokolov
K161932 07/14/2016 Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink Terang Nusa Sdn Bhd Robert Hill
K161953 07/18/2016 ReDe Mask TereoPneuma Warren G. Young
K161982 07/19/2016 C-Reactive Protein Kit for use on SPAPLUS THE BINDING SITE GROUP KIRSTY SAMUELS
K161854 07/06/2016 Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS THE BINDING SITE GROUP LTD ANDREA THOMAS
K162003 07/20/2016 IMSE Cervical Cage The Institute of Musculoskeletal Science & Education Ed McShane
K161972 07/18/2016 Slit Lamp SL-D301 TOPCON CORPORATION MICHAEL GUSEL
K161843 07/05/2016 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K161875 07/08/2016 LaserCap300, LaserCap224, LaserCap120, LaserCap80 TRANSDERMAL CAP, INC. MICHAEL RABIN
K161846 07/05/2016 Automatic Arm Bluetooth Blood Pressure Monitor TRULY INSTRUMENT LIMITED YANG JIAN-HO
K161961 07/18/2016 UniTex Non-Sterile, Powder-Free, Latex Examination Glove UG GLOBAL RESOURCES SDN BHD Wong See Keong
K161885 07/11/2016 The Cellfina System ULTHERA, INC. SUZON LOMMEL
K162018 07/14/2016 Surface Applicator Set Varian Medical Systems, Inc. Peter J. Coronado
K161901 07/11/2016 TrapLiner catheter Vascular Solutions, Inc. Beka Vite
K162008 07/20/2016 JiveX VISUS TECHNOLOGY TRANSFER GMBH AXEL SCHREIBER
K161970 07/18/2016 Follicle Aspiration Set VITROLIFE SWEDEN AB ANJA BENGTZELIUS
K161887 07/11/2016 Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip Volcano Corporation Brian Park
K161957 07/18/2016 W&H Implantmed SI-1015 incl. Accessories W&H DENTALWERK BURMOOS GMBH ANJA LINDNER
K161840 07/05/2016 LINK« SP-CL« Hip System PoroLink« (microporous) and HX« (CaP) coated & LINK« LCU« Hip System PoroLink« (microporous) and HX« (CaP) coated Waldemar Link GmbH & Co. KG Lorenz Runge
K161813 07/01/2016 Frova Intubating Introducer WILLIAM COOK EUROPE APS Henriette Stordal Christiansen
K162033 07/22/2016 SALVATION External Fixation System WRIGHT MEDICAL LESLIE FITCH
K161823 07/01/2016 Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs WRP ASIA PACIFIC SDN BHD SARALA DEVI JAYARAMAN
K161838 07/05/2016 Xenocor Xenoscope Laparoscopic System Xenocor, Inc Spencer Walker
K161907 07/12/2016 Pressure Therapy System XIAMEN SENYANG CO., LTD. XINJIE SHAO
K161859 07/06/2016 MagnetOs XPAND BIOTECHNOLOGY BV YVONNE P. BOVELL
K161938 07/14/2016 Fingertip Pulse Oximeter XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD YANLI LI
K162095 07/28/2016 Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) YTY INDUSTRY (MANJUNG) SDN. BHD., Punitha Samy
K162002 07/20/2016 Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay ZDi, Solutions, LLC Zachary A. Dutton
K162050 07/25/2016 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc Shruti Jayakumar
K161976 07/18/2016 Ziehm Solo FD ZIEHM IMAGING GMBH RICHARD L. WESTRICH
K161862 07/06/2016 ThermoPro Zimmer MedizinSysteme GmbH Armin Petraschka
K161830 07/05/2016 Zimmer M/L Taper Hip Prosthesis ZIMMER, INC. RHONDA MYER
K162114 07/29/2016 Photon, Photon Plus Zolar Technology & MFG Co. Inc. Paul Atkins


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