FDA 510(k) Applications Received During May, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
K161403 05/20/2016 A.R.C. Laser Surgical Fibers and Probes A.R.C. LASER GMBH ANGELA THYZEL
K161240 05/02/2016 Rhythm View Workstation (non-streaming) Abbott Electrophysiology Dennis Pozzo
K161278 05/06/2016 Cerafix Dura Substitute ACERA SURGICAL, INC. Matthew MacEwan
K161445 05/25/2016 PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C ADAPTA MEDICAL, INC Adrian Elfe
K161354 05/16/2016 MELODY, Remote Control System for Ultrasound Probe AdEcho Tech Nicolas LEFEBVRE
K161368 05/17/2016 DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) Agfa HealthCare N.V. Koen Vervoort
K161241 05/02/2016 e-fix E35/E36 Alber GmbH MICHAEL VENT
K161391 05/19/2016 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives ALCON LABORATORIES, INC. Sherri Lakota
K161288 05/09/2016 LenSX Laser System ALCON LABORATORIES, INC. JAMES ARGANDA
K161247 05/03/2016 Relizorb Alcresta Therapeutics, Inc. Robert Gallotto
K161375 05/18/2016 Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit ALERE SCARBOROUGH, INC. Ashley Lucas
K161364 05/17/2016 BinaxNOW G6PD Test ALERE SCARBOROUGH, INC. Angela Drysdale
K161457 05/26/2016 XEN Glaucoma Treatment System Allergan, Inc. Barbara A. Niksch
K161363 05/17/2016 Arsenal Spinal Fixation System ALPHATEC SPINE, INC RENEE MURPHY
K161439 05/24/2016 E-CUBE 11 ALPINION MEDICAL SYSTEMS CO., LTD. DONGHWAN KIM
K161405 05/20/2016 Valeo II Interbody Fusion Device System AMEDICA CORP. William D. Jordan
K161414 05/23/2016 Anatomic Total Knee System AMPLITUDE MIREILLE LEMERY
K161342 05/13/2016 Sonic Window ANALOGIC CORPORATION MICHAEL J. DOYLE
K161270 05/05/2016 CephSimulation ANATOMAGE, INC Changxin Xu
K161299 05/09/2016 BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System APEX BIOTECHNOLOGY CORP. Hsue-mei Lee
K161413 05/23/2016 Low Profile Balloon Feeding Device APPLIED MEDICAL TECHNOLOGY, INC. Michelle Scott
K161315 05/11/2016 Vein Clamps, Artery Clamps AROS Surgical Instruments Corporation Fred Phleps
K161427 05/23/2016 Pirouette 035 ArraVasc Limited Aoife Donoghue
K161313 05/10/2016 ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) JULIE LAWSON
K161481 05/31/2016 Ambient HipVac 50 Wand with Integrated Finger Switches ARTHROCARE CORPORATION Ashley M. Johnston
K161351 05/16/2016 NanoBone SBX Putty ARTOSS GMBH Walter Gerike
K161362 05/16/2016 ASAHI Corsair Armet Asahi Intecc Co., Ltd. Carroll Councilman
K161257 05/04/2016 MultiPulse HoPLUS ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K161239 05/02/2016 MTA2.2 MATERIAL AVALON BIOMED INC. CAROLYN PRIMUS
K161229 05/02/2016 Mammo Tomosynthesis (MDMG-5221) BARCO N.V. Lieven De Wandel
K161231 05/02/2016 FacilisÖ Spinal System BAUI BIOTECH CO., LTD. BETTY YEN
K161323 05/11/2016 Solution Set for Epidural Use BAXTER HEALTHCARE CORPORATION Tiffany Lin
K161297 05/09/2016 Beta-2-Microglobulin Beckman Coulter Ireland Inc. Eimear Carr
K161306 05/10/2016 BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial BECTON DICKINSON ASHANTI C. BROWN
K161286 05/09/2016 IPL Therapy Machine BEIJING ADSS DEVELOPMENT CO., LTD YURONG GAO
K161324 05/11/2016 Raycell Mk2 Best Theratronics Limited MIKE DE VAN DER SCHUEREN
K161227 05/02/2016 VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) BIOMERIEUX, INC CHERECE L. JONES
K161437 05/24/2016 VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) BIOMERIEUX, INC. KAREN RUSSELL
K161273 05/05/2016 StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis Biomet, Inc. Carmen Albany
K161255 05/03/2016 meso-relle (AAL34, AAL36, AM30G) BIOTEKNE SRL Fabio Tassi
K161256 05/04/2016 TheraCem BISCO, INC. Ryan Hobson
K161461 05/26/2016 BostonSight PD Prosthetic Device BostonSight Gene Guselli
K161277 05/06/2016 ConvertX Nephroureteral Stent System BRIGHTWATER MEDICAL BOB SMOUSE
K161424 05/23/2016 Phasix Mesh C.R. BARD INC. JANNA BABSON
K161328 05/12/2016 Cantab Mobile CAMBRIDGE COGNITION LTD., US AGENT: CLEMENTI ASSOCIATES LTD. Nancy D. Clementi
K161418 05/23/2016 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set CARDINAL HEALTH Judith Harbour
K161245 05/03/2016 EP-TRACER System CARDIO TEK, BV OLIVER ROTH
K161410 05/20/2016 VT?One, VT?One 60days CARILEX MEDICAL, INC. Henry Kao
K161415 05/23/2016 SteriTite Containers System & MediTray Products CASE MEDICAL, INC. TANIA LUPU
K161408 05/20/2016 Compass Cast and MAP CENTURION MEDICAL PRODUCTS CORPORATION MATTHEW K. PRICE
K161446 05/25/2016 Biopor Porous Polyethylene Implants Ceremed , Inc. Chelsea Mitchell
K161329 05/12/2016 Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel Chrono-log Corp. Nicholas J Veriabo
K161406 05/20/2016 Navident ClaroNav Inc. Doron Dekel
K161471 05/27/2016 MR Syringe Dual Pack for Solaris Injectors Coeur, Inc. Priscilla Clinner
K161366 05/17/2016 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) CONFORMIS, INC. AMITA SHAH
K161344 05/13/2016 GentleCath Glide Intermittent Catheter CONVATEC LIMITED ELINOR JONES
K161236 05/02/2016 Universa Firm Ureteral Stents and Stent Sets COOK INCORPORATED JAMIE RIDNER
K161296 05/09/2016 Cool Renewal COOL RENEWAL, LLC ASHLEY RAINS
K161347 05/16/2016 Signia sterilization tray COVIDIEN KATHERINE Y. CHOI
K161281 05/06/2016 Dentalis Bio Solution Implants DENTALIS BIO SOLUTION IMPLANTS LLC Osnat Yanai
K161244 05/03/2016 s-Clean OneQ-SL Narrow Implant System Dentis Co., Ltd. Sun Chul Shin
K161269 05/05/2016 CELTRA Press DENTSPLY SIRONA HELEN LEWIS
K161330 05/12/2016 Pour Acrylic Dentsply Sirona Helen Lewis
K161382 05/18/2016 LVivo Software Application DIACARDIO, LTD. Michal Yaacobi
K161444 05/25/2016 DBSWIN and VistaEasy Imaging Software Duerr Dental AG Oliver Lange
K161320 05/11/2016 EMG Pink Nitrile Examination Glove Powder Free ECO MEDI GLOVE SDN. BHD. Suresh Kumar
K161300 05/09/2016 Acclarix AX8 Diagnostic Ultrasound System EDAN INSTRUMENTS INC. ERICO LI
K161302 05/09/2016 PC ECG EDAN INSTRUMENTS, INC. ERICO LI
K161443 05/25/2016 EksoÖ (version 1.1) and Ekso GTÖ (version 1.2) EKSO BIONICS, INC. Thomas Looby
K161305 05/10/2016 Habib EUS RFA EMCISION LTD. FRANCOIS POULIN
K161482 05/31/2016 EndoChoice Water Bottle Cap Irrigation System ENDOCHOICE, INC. DAINEL HOEFER
K161359 05/16/2016 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System Esaote S.p.A Massimo Polignano
K161238 05/02/2016 S-scan Esaote S.p.A. Donatella Ragghianti
K161472 05/27/2016 Walk-O2-Bout ESSEX INDUSTRIES, INC. RUSS JACOBSMEYER
K161349 05/16/2016 Everyway Incontinence Stimulation System EVERYWAY MEDICAL INSTRUMENT CO., LTD. ROBERT TU
K161246 05/03/2016 Ez3D-i / E3 EWOO SOFT CO., LTD. Young Seok Kim
K161266 05/05/2016 Athena Breast Pump EXPLORAMED NC7, INC JOHN CHANG
K161373 05/17/2016 Nunchaku FCI (FRANCE CHIRURGIE INSTRUMENTATION) THIERRY FETICK
K161412 05/20/2016 F&P BrevidaÖ Nasal Pillows Mask Fisher & Paykel Healthcare Ltd. Amelia Ortiz
DEN160020 05/24/2016 CipherOx CRI Tablet Flashback Technologies, Inc. Gordon Van Dusen
K161314 05/11/2016 FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE FLEXICARE MEDICAL LIMITED JOEL BIDDLE
K161449 05/25/2016 HammerTech Fixation System Fusion Orthopedics, LLC Adam Cundiff
K161397 05/19/2016 MAGiC GE Medical Systems, LLC Mary A. Mayka
K161261 05/04/2016 Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase Genea Biomedx Pty Ltd Kea Dent
K161438 05/24/2016 Genesys Spine Apache« Anterior Lumbar Interbody Fusion System GENESYS SPINE BRIAN BERGERON
K161404 05/20/2016 Genesys Spine Apache« Lateral Lumbar Interbody Fusion System Genesys Spine Dave Lamb
K161316 05/11/2016 George King Coumadin Plasma GEORGE KING BIO-MEDICAL, INC. BARBARA YOUNG
K161379 05/18/2016 ELSA Spacers GLOBUS MEDICAL, INC. KELLY J. BAKER
K161376 05/18/2016 DragonFly Surgical Drill System Grace Medical, Inc. William Graham
K161232 05/02/2016 ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit HALYARD HEALTH GWENDOLYN GEORGE
K161450 05/25/2016 HAMILTON-C3 HAMILTON MEDICAL AG Katrin Vogt
K161251 05/03/2016 CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests Hangzhou Clongene Biotech Co., Ltd Zheng Shujian
K161469 05/27/2016 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module Hospira, Inc Keith Dunn
K161237 05/02/2016 HyperView Hyperspectral Tissue Oxygenation Measurement System HYPERMED IMAGING, INC. Carlyn Reynolds
K161426 05/23/2016 NeoSpan Compression Staple Impant w/instruments IN2BONESUSA, LLC JOE CLIFT
K161458 05/26/2016 Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care Indiba USA Inc. Carles Janer
K161262 05/05/2016 Super Distal Access (SDA) INNEUROCO, INC Marc Litzenberg
K161464 05/26/2016 Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters Innovative Health, LLC Rafal Chudzik
K161393 05/19/2016 Reprocessed Orbiter ST Steerable Diagnostic EP Catheter Innovative Health, LLC. Rafal Chudzik
K161258 05/04/2016 NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit INOVA DIAGNOSTICS, INC. Gabriella Lakos
K161271 05/05/2016 da Vinci Xi Surgical System Intuitive Surgical, Inc. Brandon Hansen
K161355 05/16/2016 invendoscopy E200 System Invendo Medical GmbH Oliver V. Ruepprecht
K161335 05/12/2016 Dual Top Screw System JEIL MEDICAL CORPORATION SEUNGYOUNG LEE
K161421 05/23/2016 Single Use Surgical Suction Irrigator JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD. Vivian Sun
K161378 05/18/2016 joimax Electrosurgical Instruments JOIMAX GMBH WOLFGANG RIES
K161332 05/12/2016 NILE Proximal Fixation Spinal System K2M, INC. NANCY GIEZEN
K161369 05/17/2016 EVEREST Spinal System K2M, Incorporated NANCY GIEZEN
K161470 05/27/2016 Internal Distraction - Sterile KLS MARTIN LP JENNIFER DAMATO
K161259 05/04/2016 KLS Martin Cannulated Headless Screws KLS MARTIN LP JENNIFER DAMATO
K161434 05/24/2016 Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) LI-TEK ELECTRONICS TECHNOLOGIES BARRY YUAN
K161279 05/06/2016 Life Spine Metatarsal Hemi Implant LIFE SPINE INC. RANDY LEWIS
K161341 05/13/2016 LIFESYS PACS LIFETRACK MEDICAL SYSTEMS, INC. ERIC SCHULZE
K161226 05/02/2016 Revision Femoral Stem LIMACORPORATE S.P.A. EMANUELE BUTTAZZONI
K161476 05/27/2016 SMR Shoulder System Limacorporate S.p.A. Sara Viel
K161282 05/06/2016 FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W MEDICO ELECTRODES INTERNATIONAL LTD. AMIT SETH
K161473 05/27/2016 Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) MEDLINE, INDUSTRIES, INC. Jennifer Mason
K161400 05/20/2016 ImagingRing System MEDPHOTON GMBH Daniel Schaffarzick
K161294 05/09/2016 Compound W Wart Removal System Dual Power MEDTECH PRODUCTS INC. JEAN BOYKO
K161274 05/06/2016 Bondiloxs Topical Hemostatic Granules MEDTRADE PRODUCTS LTD. Andrew Whitton
K161249 05/03/2016 Streamline 6495 Bipolar Temporary Myocardial Pacing Lead Medtronic Debra Taitague
K161370 05/17/2016 Durepair Dura Regeneration Matrix Medtronic Neurosurgery Manas Lele
K161287 05/09/2016 DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak MEDTRONIC VASCULAR Nisarg Shah
K161361 05/16/2016 HawkOne Directional Atherectomy System Medtronic Vascular, Inc. Rupali Gupta
K161402 05/20/2016 Bullfrog Micro-Infusion Device MERCATOR MEDSYSTEMS, INC. Kirk P. Seward
K161392 05/19/2016 Elation Pulmonary Balloon Dilation MERIT MEDICAL SYSTEMS, INC. DAVID THOMAS
K161409 05/20/2016 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem Mermaid Medical A/S Pia Wissing Jensen
K161292 05/09/2016 Distal Radius Plating System MIAMI DEVICE SOLUTIONS, LLC MARKKU BIEDERMANN
K161372 05/17/2016 The Red Head Collection Device, The Jordy Connection System MIAMI FAT SUPPLY Donnell Mark Jordan
K161463 05/26/2016 SureClip(TM) Repositionable Hemostasis Clip Micro-Tech (Nanjing) CO., Ltd. Becky Li
K161367 05/17/2016 HydroCoil Embolic System (HES) MICROVENTION, INC. SAPNA SINGH
K161452 05/26/2016 MicroPlex Coil System (MCS) - HyperSoft 3D MICROVENTION, INC. SAPNA SINGH
K161465 05/27/2016 CardioConfirm MORTARA INSTRUMENT, INC. Margaret Mucha
K161425 05/23/2016 APEX Manual Wheelchair Motion Composites Stephane Le Beau
K161303 05/10/2016 dynaMXÖ Compression Plate MX ORTHOPEDICS, CORP. Howard L. Schrayer
K161485 05/31/2016 Nanovis Intervertebral Body Fusion System and Forticore(R) NANOVIS LLC MATTHEW HEDRICK
K161431 05/24/2016 SimplECG Nanowear Inc. Venkatesh Varadan
K161430 05/23/2016 Myoject Luer Lock Needle Electrode Natus Manufacturing Limited Michael Galvin
K161228 05/02/2016 Radiance Ultra Series ZeroWire Embedded NDS SURGICAL IMAGING, LLC. Jim Leng
K161399 05/20/2016 Neocis Guidance System Neocis Inc. Alon Mozes
K161304 05/10/2016 EndoPur Filter Nephros Inc. Hollie Johnson
K161467 05/27/2016 HydraGuard 10 UltraFilter NEPHROS INC. JAMES SUMMERTON
K161285 05/09/2016 Ablation Confirmation NEUWAVE MEDICAL, INC. DAN KOSEDNAR
K161448 05/25/2016 Footmotion Plating System NEWCLIP TECHNICS Gaelle Lussori
K161307 05/10/2016 NICO Myriad NICO CORPORATION SEAN SPENCE
K161416 05/23/2016 Multi-unit Abutment Plus NOBEL BIOCARE AB Charlemagne Chua
K161435 05/24/2016 Temporary Snap Abutment Nobel Biocare AB Charlemagne Chua
K161346 05/16/2016 NormaTec PCD-T and PCD-B NormaTec Industries, LP Peter Novello
K161337 05/13/2016 CryoDose H or Similar NUANCE MEDICAL, LLC MARC LIEBERMAN
K161451 05/26/2016 BIB Stent Placement Catheter NUMED, INC. Nichelle LaFlesh
K161442 05/25/2016 NuVasive« CoRoent« Small InterlockÖ System NUVASIVE INCORPORATED Cynthia Adams
K161230 05/02/2016 NuVasive Lumbar Interbody Implants NUVASIVE, INCORPORATED MARTIN YAHIRO
K161265 05/05/2016 NuVasive« VersaTie System NUVASIVE, INCORPORATED CYNTHIA ADAMS
K161479 05/31/2016 hipEOS ONEFIT MEDICAL Julien SIMON
K161263 05/05/2016 OptoMonitor II Opsens Inc Vanessa Mootoosamy
K161455 05/26/2016 Catalys Precision Laser System Optimedica Corporation Ankur Kaushal
K161280 05/06/2016 Cervical Stand Alone System Orthofix Inc. Natalia Volosen
K161466 05/27/2016 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System ORTHOFIX SRL Gianluca Ricadona
K161267 05/05/2016 Response BandLoc Spinal Fixation ORTHOPEDIATRICS CORP. MARK FOX
K161447 05/25/2016 HydroSet XT ORTHOVITA, INC. TINA MORNAK
K161225 05/16/2016 Paonan Armstrong Posterior Spinal Fixation System Paonan Biotech Co., Ltd. YI-JHEN TSAI
DEN160018 05/16/2016 reSet PEAR THERAPEUTICS, INC. NANDINI MURTHY
K161295 05/09/2016 MiniBox + PULMONE ADVANCED MEDICAL DEVICES, LTD Avi Lazar
K161480 05/31/2016 R2 Dermal Cooling System R2 Dermatology Kristine Tatsutani
K161334 05/12/2016 RASL Repair Kit RADICLE ORTHOPAEDICS, INC. EDWARD ROSENWASSER
K161454 05/26/2016 Propeller Sensor Model 2015-E Reciprocal Labs Corporation Taylor Mahan-Rudolph
K161254 05/03/2016 Renovo Life Small Bone IM Nail System Renovo Life LLC Harold Crowder
K161275 05/06/2016 EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip RESEARCH INSTRUMENTS LIMITED Wendy Hassan
K161487 05/31/2016 VPAP Adapt SV, VPAP Tx, S9 VPAP Tx ResMed Ltd Jasjit Baveja
K161411 05/20/2016 Care Cycle Connect Application RESPIRONICS, INC. Colleen Witt
K161234 05/02/2016 CASSI II Rotational Core Biopsy System Scion Medical Technologies, LLC Louis Li
K161345 05/13/2016 RadPRO« Mobile 40kW; RadPRO« Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR SEDECAL SA Ma Luisa Gomez de Aguero
K161356 05/16/2016 Matrix LS-40 CO2 Laser System SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD. Amy Lee
K161428 05/23/2016 PerfectSmooth SHEN ZHEN COSBEAUTY CO.,LTD. Nicole Hu
K161298 05/09/2016 ShenDa Sinuscope SHENYANG SHENDA ENDOSCOPE CO., LTD GAO FENG
K161384 05/19/2016 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable Shockwave Medical, Inc. NORA HADDING
K161312 05/10/2016 Sysmex Automated Blood Coagulation Analyzer CS-2100i SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH NILS NEUMANN
K161317 05/11/2016 Sysmex Automated Blood Coagulation Analyzer CS-5100 Siemens Healthcare Diagnostics Products GmbH Nils Neumann
K161289 05/09/2016 DURAFIBER Ag SMITH & NEPHEW MEDICAL LIMITED Samantha Neilson
K161233 05/02/2016 OXINIUM DH Fermoral Heads SMITH & NEPHEW, INC. MIKE SCOTT
K161264 05/05/2016 TRIGEN Low Profile Bone Screws SMITH & NEPHEW, INC. ALLISON CHAN
K161371 05/17/2016 Sonoma Fifth Metatarsal Repair System SONOMA ORTHOPEDIC PRODUCTS, INC. Rick Epstein
K161395 05/19/2016 SPEC Model M13 Source Production and Equipment Co.,Inc. Kelley Richardt
K161396 05/19/2016 SPEC Model M23 Source Production and Equipment Co.,Inc. Kelley Richardt
K161333 05/12/2016 TightRail Sub-C Rotating Dilator Sheath Spectranetics, Inc. Stephanie Byrum
K161387 05/19/2016 Mont Blanc and Mont Blanc MIS Spinal Systems SPINEWAY S.A. NICOLAS ROTH
K161394 05/19/2016 HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux Sportarredo Group S.C. STEFANO IRIDIO
K161325 05/12/2016 CliniCloud Non-contact Thermometer, Model SPL1024 STETHOCLOUD PTY. LTD (CLINICLOUD) ANDREW LIN
K161432 05/24/2016 MyNeWT Negative Pressure Wound Therapy System Stortford Medical LLC Chris Daughtery
K161483 05/31/2016 Unger Quad Injector STRADIS HEALTHCARE Joseph Trznadel
K161311 05/10/2016 USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles STRUKMYER MEDICAL LLC ROBERT DELK
K161429 05/23/2016 Target Detachable Coils Stryker Neurovascular Kate Taylor
K161407 05/20/2016 Ascential IBD PEEKc Spacer Stryker Spine Tina Mornak
K161358 05/16/2016 Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds SURGICAL INSTRUMENT SERVICE AND SAVINGS INC BRANDI J. PANTELEON
K161272 05/05/2016 Supreme and Response Electrophysiology Catheters Surgical Instrument Service and Savings Inc Brandi J. Panteleon
K161327 05/12/2016 SYNTEC HUMERAL NAIL SYSTEM SYNTEC SCIENTIFIC CORPORATION KAVIN CHU
K161417 05/23/2016 DePuy Synthes MAXFRAME Multi-Axial Correction System SYNTHES USA, LLC STACEY BONNELL
K161357 05/16/2016 LipiFlow Thermal Pulsation System TEARSCIENCE, INC. Christy Coleman
K161318 05/11/2016 Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems TEDAN SURGICAL INNOVATIONS LLC John Willis
K161420 05/23/2016 MOVES SLC THORNHILL RESEARCH INC. KIPTON LADE
K161353 05/16/2016 ESTELITE BULK FILL Flow TOKUYAMA DENTAL CORPORATION KEITH A. BARRITT
K161468 05/27/2016 Transformair Indoor Air Purifier Transformair, LLC Jaya Rao
K161331 05/12/2016 HyperSound Tinnitus Module TURTLE BEACH CORPORATION JAMES A. BARNES
K161360 05/16/2016 U2 Total Knee System, PSA Tibial Insert UNITED ORTHOPEDIC CORPORATION KAREN HO
K161459 05/26/2016 Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED Catherine Mulcahy
K161336 05/13/2016 VSI StraitSet micro-introducer kit VASCULAR SOLUTIONS, INC. ADAM ETTL
DEN160019 05/23/2016 CINtec Histology (50 tests), CINtec Histology (250 tests) VENTANA MEDICAL SYSTEMS, INC ROXANE BONNER
K161250 05/03/2016 OC-FLEX Flexible IntraOral Cannula Venture Therapeutics, Inc. Marilyn A. Friedly
K161419 05/23/2016 Multi Modality Viewer VITAL IMAGES, INC. KATIE RYAN
K161433 05/24/2016 Insulia Diabetes Management Companion VOLUNTIS S.A. RAFFI KRIKORIAN
K161453 05/26/2016 WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A WELL-LIFE HEALTHCARE LIMITED CHIN-CHIH HSIEH
K161422 05/23/2016 DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WRP ASIA PACIFIC SDN. BHD. SARALA DEVI JAYARAMAN
K161385 05/19/2016 Just Like Me Personal Lubricant WTFN-dba Classic Erotica/Holiday Products Christina Zaragoza
K161478 05/31/2016 Xenco Medical Posterior Cervical System Xenco Medical, LLC Gustavo Prado
K161322 05/11/2016 CT CoPilot ZEPMED, LLC. Douglas J. Bates
K161390 05/19/2016 Vinyl Exam Gloves, Powder Free, Clear Zibo Hongchin Plastic and Rubber Co., Ltd James Ren
K161484 05/31/2016 ZIIP Device ZIIP,LLC David Mason


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