FDA 510(k) Decisions During July, 2016  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K153357 07/08/2016 i-STAT Alinity System with i-STAT Sodium test ABBOTT POINT OF CARE INC. MELISSA ROBINSON
K153674 07/01/2016 Sorbact Foam Gentle Border, Sorbact Superabsorbent ABIGO Medical AB Annica Corbe
K153055 07/11/2016 ACE Electrosurgical Resection and Vaporization Electrodes Series Ace Medical Devices Pvt. Ltd. Vikas Sethi
K152189 07/20/2016 EVOTECH ECR Advanced Sterilization Products (ASP) Nazanin Yacobi
K153700 07/08/2016 Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments AESCULAP IMPLANT SYSTEMS, LLC Paul Amudala
K152960 07/22/2016 ELAN 4 Motor System AESCULAP, INC. PETER STOLL
K153117 07/28/2016 AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM AESKU. SYSTEMS GMBH & CO. KG TOM STECKLUM
K160755 07/27/2016 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap AHLSTROM NONWOVENS LLC GARY JACKSON
K160123 07/12/2016 Apinator Allen J. Moses, DDS LTD Allen J Moses
K152920 07/08/2016 Savannah-T« Pedicle Screw System AMENDIA, INC. KRISTEN ALLEN
K160758 07/11/2016 PeriCoach OTC ANALYTICA LTD. GEOFF DALY
K160399 07/25/2016 Skyn Original Polyisoprene Lubricated Male Condom Ansell Healthcare Products, LLC Robert Mahler
K153017 07/06/2016 Voyant Fine Fusion APPLIED MEDICAL RESOURCES JESSICA CHO
K152905 07/20/2016 ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer ARC DEVICES LIMITED GARY BROGAN
K161427 07/30/2016 Pirouette 035 ArraVasc Limited Aoife Donoghue
K160830 07/06/2016 Integra External Fixation System Ascension Orthopedics Jayana Kenana
K161044 07/06/2016 AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) ASSURE TECH (HANGZHOU) CO., LTD. SHISHENG LING
DEN160003 07/22/2016 Quantidex qPCR BCR-ABL IS Kit ASURAGEN, INC. FAYYAZ MEMON
K160757 07/26/2016 ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) AXIS-SHIELD DIAGNOSTICS LIMITED CLAIRE I. DORA
K161012 07/06/2016 Easy-Load Lens Delivery System Bausch and Lomb, Inc. Joyce Zhong
K161553 07/06/2016 BD SafeAssist BECTON, DICKINSON AND COMPANY Meriam Youssef
K151870 07/08/2016 BD U-500 INSULIN SYRINGE BECTON, DICKINSON AND COMPANY LUISA F. METRIO
K160984 07/20/2016 MultiScan G-Arm System BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD SHARON FAN
K160747 07/28/2016 Angel Catheter BIO2 MEDICAL, INC. CHRISTOPHER E. BANAS
K160101 07/27/2016 SinuBand BIOINSPIRE TECHNOLOGIES, INCORPORATED DORNA HAKIMIMEHR
K161669 07/28/2016 Waterlase Express Biolase, Inc. Alicia Mszyca
K161227 07/20/2016 VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) BIOMERIEUX, INC CHERECE L. JONES
K152622 07/08/2016 Alta ACDF System BIOMET SPINE ALEXANDRA BECK
K150932 07/22/2016 Sheath Introducer BIOTEQUE CORP. Simon Lin
K161256 07/29/2016 TheraCem BISCO, INC. Ryan Hobson
K161722 07/26/2016 VITRUVIAN ULTIMATE ASPIRATOR BLACK & BLACK SURGICAL, INC. CYNTHIA REES
K152764 07/13/2016 EXACTECH GPS BLUE ORTHO ANTHONY BOYER
K161461 07/25/2016 BostonSight PD Prosthetic Device BostonSight Gene Guselli
K161558 07/29/2016 Bovie 3.3mm Disposable Bipolar Ablator 90?, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55?, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60?, Non-Aspirating BOVIE MEDICAL CORPORATION Rubiela Maldonado
K153473 07/22/2016 Braemar Telemetry Patch System Braemar Manufacturing, LLC Kent Sayler
K152113 07/21/2016 BioHPP - breCAM.BioHPP Bredent GmbH & Co.KG Stefanie Bochtler
K160256 07/29/2016 Polux , Minerva and Atropos PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd. Tina Yin
K152731 07/20/2016 XP1100 RF BTL INDUSTRIES, INC JAN ZARSKY
K161137 07/20/2016 Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload CARDICA, INC. Greg Watson
K160339 07/28/2016 Cardinal Health Isolation Gown Cardinal Health 200, LLC Caroline Miceli
K160875 07/11/2016 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating CARDINAL HEALTH, INC. Megan Middaugh
K160411 07/25/2016 Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating CARDINAL HEALTH, INC. Megan Middaugh
K153234 07/07/2016 AirLife Adult Heated Wire Circuit CAREFUSION INC ERIKA FERNANDEZ
K150208 07/21/2016 Dakin's Skin and Wound Cleanser CENTURY PHARMACEUTICALS, INC. Stephen Deardorff
K160988 07/14/2016 Biopor, AOC Porous Polyethylene, Cerepor CEREMED, INC. CHELSEA MITCHELL
K161507 07/29/2016 Cianna Medical SAVI Scout Reflector and SAVI Scout System CIANNA MEDICAL, INC. GARY MOCNIK
K160629 07/26/2016 InPen COMPANION MEDICAL, INC. JASPER BENKE
K161668 07/15/2016 ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) CONFORMIS, INC. AMITA SHAH
K160859 07/13/2016 OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) CONTAMAC LTD. ROB MCGREGOR
K161048 07/26/2016 Conventus Orthopaedics Ulna Fixation System CONVENTUS ORTHOPAEDICS, INC. KENT LIND
K160887 07/26/2016 Cook Intraosseous Infusion Needles COOK INCORPORATED JULIA FERGUSON
K161801 07/29/2016 CrossCath Support Catheter Cook Incorporated Jessica Swafford
K161218 07/22/2016 Gianturco-Roehm BirdÆs Nest Vena Cava Filter COOK INCORPORATED Jessica Swafford
K161296 07/06/2016 Cool Renewal COOL RENEWAL, LLC ASHLEY RAINS
K160803 07/13/2016 Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens CooperVision, Inc. Roya Borazjani
K153074 07/06/2016 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal COVIDIEN Karin Desjardins
K152913 07/21/2016 GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL ORLA HICKEY
K160385 07/27/2016 Precision Screw CRYPTYCH PTY LTD GREG ROGER
K161557 07/26/2016 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K160088 07/07/2016 Cydar EV Cydar Ltd. John Clarke
K160470 07/21/2016 SculpSure CYNOSURE, INC. Aastha Kohli
K153328 07/20/2016 SUNCO Mechanical Wheelchair, model SKW-9003 DANYANG SUNCO MACHINERY CO., LTD JEN KE-MIN
K152385 07/27/2016 Zeramex P6 Dental Implant System DENTALPOINT AG Viktor Lienhard
K153268 07/20/2016 NR Line Implant System DENTIUM CO., LTD. YOUNJUNG YUK
K161118 07/28/2016 SIMPLANT Online Case Review and SIMPLANT Editor DENTSPLY SIRONA HELEN LEWIS
K160907 07/19/2016 DePuy Actis DuoFix Hip Prosthesis DEPUY (IRELAND) Jaime Weeks
K161382 07/28/2016 LVivo Software Application DIACARDIO, LTD. Michal Yaacobi
K161139 07/22/2016 LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set DIASORIN, INC. JOHN WALTER
K160704 07/15/2016 myPatch-s DMS-SERVICE LLC LYNDA COLE
K161771 07/28/2016 Medilas H Laser Fibers DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K160996 07/06/2016 Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm Dunamis LLC Prithvi Raj Chavan
K151978 07/15/2016 EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control EDAN INSTRUMENTS, INC. TRACY YUE
K161302 07/01/2016 PC ECG EDAN INSTRUMENTS, INC. ERICO LI
K161443 07/19/2016 EksoÖ (version 1.1) and Ekso GTÖ (version 1.2) EKSO BIONICS, INC. Thomas Looby
K161089 07/08/2016 sensiLight Mini EL GLOBAL TRADE LTD YAEL LIEBES-PEER
K161305 07/07/2016 Habib EUS RFA EMCISION LTD. FRANCOIS POULIN
DEN150004 07/15/2016 EPIC ClearView System EPIC RESEARCH & DIAGNOSTICS, INC. NANCY RIZZO
K161359 07/19/2016 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System Esaote S.p.A Massimo Polignano
K161238 07/08/2016 S-scan Esaote S.p.A. Donatella Ragghianti
K161726 07/12/2016 E-Pack Procedure Kit ETHICON, INC. ENZA DESERIO
K160722 07/07/2016 CorticaLINK Spinal Fusion Platform FACETLINK DBA LINKSPINE MASSIMO CALAFIORE
K161314 07/06/2016 FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE FLEXICARE MEDICAL LIMITED JOEL BIDDLE
K160308 07/15/2016 Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) Fudakang Industrial Co., Ltd Bob Yu
K161055 07/12/2016 Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji û 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 Fuji Dynamics Ltd Kam Tim Ng
K153145 07/05/2016 Lumipulse G TP-N Immunoreaction Cartridge Set Fujirebio Diagnostics, Inc. Diana Dickson
K153533 07/05/2016 Tearaway Introducer Sheath, MicroSlide Tearaway Introducer GALT MEDICAL CORP. DAVID DERRICK
K153325 07/12/2016 Gradia Plus GC America Inc. Mark Heiss
K153231 07/06/2016 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer GC AMERICA, INC. Mark Heiss
K161631 07/28/2016 MAMMI GENERAL EQUIPMENT FOR MEDICAL IMAGING JOSE MONTES
K152099 07/28/2016 Genesys Spine Apache« Anchored Cervical Interbody Fusion System GENESYS SPINE BEN KELLER
K161404 07/21/2016 Genesys Spine Apache« Lateral Lumbar Interbody Fusion System Genesys Spine Dave Lamb
K160144 07/21/2016 rainbow LS Block GENOSS CO., LTD. HAN YEIN
K161223 07/15/2016 TransContinental« M Spacers and InterContinental« Plate-Spacers GLOBUS MEDICAL INC. KELLY J. BAKER
K161008 07/28/2016 POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE HARTALEGA SDN. BHD. KUAN KAM HON
K160102 07/14/2016 Amber Mill Series and Amber Press Series HASS CORP. YONGSU KIM
K160557 07/06/2016 Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO.,LTD. SARAH SU
K160448 07/12/2016 ARTLINE HEALTH LINE INTERNATIONAL CORPORATION JOEL FAULKNER
K151626 07/21/2016 ET III Bio-SA Fixture System HiOSSEN Inc. David Kim
K161163 07/13/2016 PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory HITACHI, LTD. Naoya Nishimura
K152087 07/29/2016 HeatLux Pro II HOME SKINOVATIONS LTD. Ahava Stein
K153557 07/19/2016 ABPM 7100, Hypertension Management Software I.E.M. GMBH Hella Witt
K153296 07/29/2016 MEDINAUT Kyphoplasty System IMEDICOM Co., Ltd. Bonggu Ha
K153568 07/12/2016 InMode Plus System InMode MD Ltd. Ahava Stein
K153137 07/08/2016 HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls INSTRUMENTATION LABORATORY CO. Carol Marble
K153484 07/27/2016 Dillard Airway Dilatation System INTUIT MEDICAL PRODUCTS, LLC JACK GRIFFIS
K161271 07/11/2016 da Vinci Xi Surgical System Intuitive Surgical, Inc. Brandon Hansen
K153544 07/25/2016 cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System IQuum, Inc. Lingjun Chen
K153070 07/26/2016 Watch-PAT200U ITAMAR MEDICAL, LTD. KOBY SHEFFY
K153087 07/14/2016 IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved Ivy Sports Medicine, LLC John Dichiara
K160077 07/12/2016 RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set JBW7 Innovations, LLC Jason B Wynberg
K152166 07/11/2016 JSM Insulin Pen Needle JEESUNG MEDICAL CO LTD CHOI YONG HYUN
K153727 07/21/2016 INTRAcel Premium Fractional RF Micro Needle (FRM) System JEISYS MEDICAL, INC. HYOSEOK LEE
K161028 07/22/2016 K2M Growing Spine System K2M, Inc. Nancy Giezen
K161369 07/21/2016 EVEREST Spinal System K2M, Incorporated NANCY GIEZEN
K160631 07/15/2016 Keos Lumbar IBFD KEOS MARK F. SCHENK
K160863 07/28/2016 PBS(-), Phosphate Buffered Saline KITAZATO BIOPHARMA CO., LTD. FUTOSHI INOUE
K161951 07/22/2016 KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay KRONUS, INC. Brian Deis
K153439 07/21/2016 PathLoc-C Posterior Cervical Fixation System L&K BIOMED CO., LTD. Yerim An
K160956 07/06/2016 LD-Oxi system LD TECHNOLOGY LLC Albert MAAREK
K153399 07/05/2016 LightStim Professional LED Bed LED Intellectual Properties LLC Steve Marchese
K160518 07/14/2016 LEONI ORION System LEONI CIA CABLE SYSTEM AURELIE GENHO
K161659 07/15/2016 FlexSeal Introducer Sheath with Hydrophilic Coating LIBRA MEDICAL INC. SEW-WAH TAY
K161175 07/12/2016 Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL LIOFILCHEM S.R.L. FABIO BRACCO
K160477 07/29/2016 The Luco Hybrid OSA Appliance LUCO HYBRID OSA APPLIANCE INC. Ken Luco
K160893 07/27/2016 HANAROCare ReJu M.I.TECH CO.,LTD HWANG MI-SUNG
K160605 07/21/2016 MectaLIF Anterior Stand-Alone MEDACTA INTERNATIONAL MICHAEL G. LOITERMAN
K160431 07/13/2016 ActiveCare Home MEDICAL COMPRESSION SYSTEMS (DBN) LTD. YAKI BARAK
K152461 07/08/2016 The Time Machine Series Lasers MEDICAL LASERS MANUFACTURER INC. BRUCE SCHOENGOOD
K161149 07/11/2016 PASS OCT Spinal System MEDICREA INTERNATIONAL S.A David Ryan
K161627 07/29/2016 PASS LP Spinal System MEDICREA INTERNATIONAL S.A. DAVID RYAN
K160604 07/01/2016 CureÖ Anterior Cervical Plate (ACP) System MEDITECH SPINE, LLC BRUCE DUNAWAY
K160846 07/14/2016 AmplifEYE MEDIVATORS, INC. Jeff Kasoff
K153124 07/26/2016 DuraLazeTM HoLEP Laser Fiber MedKey, LLC Jeff Zerfas
K152564 07/07/2016 Gemini Sterilization Wrap MEDLINE INDUSTRIES, INC. Jennifer Mason
K160904 07/01/2016 Expedium Spine System, VIPER and VIPER 2 Systems MEDOS INTERNATIONAL SARL Karen Sylvia
K160804 07/19/2016 INTRAFIX(TM) Advance Tibial Fastener System MEDOS INTERNATIONAL SARL KRISTINE CHRISTO
K152703 07/08/2016 PlasmaBlade TnA Tonsil and Adenoid Dissection Device MEDTRONIC ADVANCED ENERGY LYDIA SAKAKEENY
K160961 07/30/2016 Mozec NC-Rx PTCA Baloon Dilatation Catheter MERIL LIFE SCIENCES PRIVATE LIMITED Utpal Thakor
K160107 07/29/2016 DiamondTOUCH Inflation Device and Fluid Dispensing Syringe Merit Medical Systems, Inc. Dan W Lindsay
K161058 07/29/2016 Cannulated Screw MIAMI DEVICE SOLUTIONS, LLC MARKKU BIEDERMANN
DEN150029 07/27/2016 Permaseal MICRO INTERVENTIONAL DEVICES, INC. LINDA MORGAN
K153097 07/15/2016 BelvedereÖ Lateral Plating System NEUROSTRUCTURES, INC. Moti Altarac
K161499 07/29/2016 VertiForm Posterior Fixation System NEXT ORTHOSURGICAL ELLEN YARNALL
K160367 07/27/2016 Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Nissin-Metec China Co., Ltd. Xiwei Shen
K153786 07/11/2016 PROW FUSION-V NLT SPINE LTD Eti Zinger
K160158 07/25/2016 NobelProcera HT ML FCZ Implant Bridge and Framework Nobel Biocare AB Charlemagne Chua
K161337 07/12/2016 CryoDose H or Similar NUANCE MEDICAL, LLC MARC LIEBERMAN
K153105 07/11/2016 MLXÖ - Medial Lateral Expandable Lumbar Interbody System NuVasive, Incorporated Olga Lewis
K161265 07/15/2016 NuVasive« VersaTie System NUVASIVE, INCORPORATED CYNTHIA ADAMS
K152599 07/20/2016 PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System OK BIOTECH CO., LTD. KE-MIN JEN
K160038 07/29/2016 UniStrip1 Generic Blood Glucose Test Strips OK BIOTECH CO., LTD. KE-MIN JEN
K153267 07/22/2016 ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash ORIGIO A/S Tove Kjaer
K153048 07/08/2016 AcceleDent Aura ORTHOACCEL TECHNOLOGIES, INC. Zaffer Syed
K161138 07/20/2016 St. Louis Band ORTHOMERICA PRODUCTS, INC. DAVID C. KERR
K161052 07/20/2016 OsteoFab Patient Specific Facial Device OXFORD PERFORMANCE MATERIALS, INC. Leigh Ayres
K160577 07/25/2016 PacEndo Chlorhexidine PAC-DENT INTERNATIONAL, INC. Wenying Zhu
K152952 07/13/2016 E-Cath PAJUNK GmbH Medizintechnologie Christian G.H. Quass
K153422 07/14/2016 Panpac Disposable Pessary Fitting Set Panpac Medical Corporation YEN-MING PAN
K161523 07/01/2016 INDIGO Aspiration System Penumbra, Inc. Aditi Kolla
K161640 07/12/2016 Penumbra System ACE 68 Reperfusion Catheter Penumbra, Inc. Charles DeNault
K161899 07/28/2016 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 07/29/2016 2D Quantitative Analysis PHILIPS MEDICAL SYSTEMS NEDERLAND BV JEANETTE BECKER
K161563 07/29/2016 Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland BV Jeanette Becker
K161531 07/01/2016 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600 Philips Medizin Systeme Boeblingen GmbH Markus Stacha
K151790 07/14/2016 PMT Platinum Depthalon Depth Electrode PMT CORPORATION KIM SCHMELZER
K160977 07/13/2016 PolyDev Soft Contact Lenses Polydev Ltd. John Mulvihill
K160569 07/06/2016 NeuGuide POP Medical Solutions Guy Ohad
K161920 07/15/2016 Comfort Cover PRECISION DYNAMICS CORPORATION SWARNA MUKUND
K160425 07/15/2016 CAD/CAMouflage Milling Bock Prismatik Dentalcraft, Inc. ARMIN ZEHTABCHI
K152511 07/11/2016 Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula PROSURG, INC ASHVIN DESAI
K160082 07/29/2016 Puritan Opti-Tranz Cary-Blair Collection and Transport System PURITAN MEDICAL PRODUCTS LLC MEHDI KARAMCHI
K153732 07/29/2016 Powder Free Blue Nitrile Examination Glove QUBE MEDICAL PRODUCT SDN BHD TEO SIONG YAM
K160848 07/14/2016 Wingman 18 Crossing Catheter ReFlow Medical, Inc. Rebecca K Pine
K153272 07/09/2016 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set RELIEVANT MEDSYSTEMS ADAM SAVAKUS
K160504 07/18/2016 RI Witness Embryology Heated Plate RESEARCH INSTRUMENTS LIMITED Wendy Hassan
K161020 07/28/2016 XSTAT-12, 3-Pack, XSTAT-12, 1-Pack REVMEDX, INC. AMY K. POINTER
K160987 07/22/2016 ReWalk(TM) REWALK ROBOTICS INC. JOHN HAMILTON
K160192 07/28/2016 Atteris Antimicrobial Skin & Wound Cleanser ROCHAL INDUSTRIES LLC WILLIAM J. COULSTON
K160684 07/26/2016 Atteris No-Sting Skin Protectant ROCHAL INDUSTRIES LLC WILLIAM J. COULSTON
K160910 07/28/2016 Elecsys Syphilis ROCHE DIAGNOSTICS ANGELO PEREIRA
K161817 07/27/2016 Tina-quant Cystatin C Gen.2 Roche Diagnostics Operations (RDO) Patrick Stimart
K160997 07/06/2016 GC85A SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K160271 07/15/2016 N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 SAN-M PACKAGE CO., LTD. Shogo Nagao
K161345 07/06/2016 RadPRO« Mobile 40kW; RadPRO« Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR SEDECAL SA Ma Luisa Gomez de Aguero
K161805 07/19/2016 EnCor MRI Introducer Set, EnCor Probe Introducer SENORX, INC. SARAH MCCARTNEY
K161525 07/13/2016 TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd Wu Zicui
K160935 07/28/2016 8ch Foot Ankle Coil Shenzhen RF Tech Co., Ltd. Ke Xi
K152294 07/15/2016 FDR Visionary Suite SHIMADZU CORPORATION TOSHIO KADOWAKI
K160596 07/27/2016 BEAUTIFIL II LS SHOFU DENTAL CORPORATION Mauro Malzyner
K160086 07/21/2016 SHOFU Enamel Conditioner SHOFU DENTAL CORPORATION MAURO MALZYNER
K161685 07/11/2016 syngo«.via protoNeo (Version VA10A) SIEMENS HEALTHCARE GMBH LAUREN BENTLEY
K161787 07/28/2016 ACUSON NX2 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc. Shelly Pearce
K161155 07/19/2016 Origin Coxa Vara Hip Stem SIGNATURE ORTHOPAEDICS PTY LTD. Declan Brazil
K160613 07/14/2016 Soberlink Cellular Device and Sober Sky Web Portal SOBERLINK HEALTHCARE LLC JENNA COSTA
K161395 07/06/2016 SPEC Model M13 Source Production and Equipment Co.,Inc. Kelley Richardt
K161333 07/08/2016 TightRail Sub-C Rotating Dilator Sheath Spectranetics, Inc. Stephanie Byrum
K160465 07/28/2016 Spinal Elements' Spinous Process Plate System Spinal Elements Inc. Julie Lamothe
K153621 07/15/2016 Juliet« Ti SPINEART FRANCK PENNESI
K160906 07/14/2016 Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device SPINEOLOGY INC. JACQUELINE A HAUGE
K161694 07/15/2016 ThresholdÖ Pedicular Fixation System Spineology Inc. JACQUELINE A. HAUGE
K161154 07/23/2016 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs SPR THERAPEUTICS, LLC Kathryn Stager
K160433 07/06/2016 V-PRO« 1 Plus and V-PRO« maX Low Temperature STERIS CORPORATION BILL BRODBECK
K160908 07/22/2016 Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS CORPORATION ANTHONY PIOTRKOWSKI
K160016 07/15/2016 Steth IO STRATOSCIENTIFIC, INC. SUMAN MULUMUDI
K160955 07/21/2016 Tritanium« PL Cage STRYKER Deirdre Jayko
K153240 07/07/2016 Styrker OrthoMap Express Knee System STRYKER CORPORATE Becky Ditty
K160715 07/08/2016 AccuLIF TL and PL Cage STRYKER CORPORATION AAKASH JAIN
K160978 07/08/2016 LITe BIO Delivery System STRYKER CORPORATION Meriam Gabera
K160813 07/26/2016 EasyStep STRYKER GMBH Garry T. Hayeck
K161407 07/15/2016 Ascential IBD PEEKc Spacer Stryker Spine Tina Mornak
K152803 07/12/2016 SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE SUNG SHIM MEDICARE CO., LTD. KIM YOUNG KWAN
K160031 07/14/2016 Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) SUNRISE MEDICAL (US) LLC LAURIE H ROBERTS
K160439 07/06/2016 SunTech CT40 Spot-check Vital Signs Device SUNTECH MEDICAL CHUCK SETZER
K160333 07/20/2016 Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider SURGICAL INSTRUMENT SERVICE AND SAVINGS INC BRANDI J. PANTELEON
K160744 07/13/2016 LOOK PTFE Suture Surgical Specialties Corporation Karen Sanchez
K153067 07/27/2016 Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress SYBRON DENTAL SPECIALTIES Courtney Clark
K160607 07/05/2016 PicoWay Laser System SYNERON CANDELA CORPORATION Ruthie Amir
K160896 07/08/2016 ULTRASHAPE POWER SYSTEM SYNERON MEDICAL LTD Ruthie Amir
K152787 07/22/2016 ST Internal Fixture System T-PLUS IMPLANT TECH. CO., LTD. DANA CHENG
K161849 07/29/2016 Bright Tanda Beauty Canada Inc. Bobae Kim
K160056 07/25/2016 t:slim Insulin Delivery System Tandem Diabetes Care, Inc. Michael Sarrasin
K160482 07/13/2016 t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater Tandem Diabetes Care, Inc. Michael Sarrasin
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