FDA 510(k) Applications Received During April, 2017

FDA 510(k) Number Submission Date Device Name Applicant Contact
K171003 04/04/2017 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader 3M Company Hilary B. Hovde
K171116 04/14/2017 3MÖ VFlexÖ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S 3M Health Care Linda Johnsen
K171225 04/26/2017 Sorbact Wound Dressing-Ribbon Gauze ABIGO Medical AB Annica Corbe
K171086 04/12/2017 Accuray Precision Treatment Planning System Accuray Incorporated Shweta Kaushik
K171176 04/21/2017 M-CATH Microcatheter Acrostak (Schweiz) AG Carmen Herraez
K171254 04/28/2017 LeEject 2 Dental Syringe and Needle System Advanced Technology and Capital, Inc. Alexander Lee
K171001 04/04/2017 Monosyn Quick Synthetic Absorbable Surgical Suture Aesculap, Inc. Kathy A. Racosky
K171256 04/28/2017 Quingo Flyte Mobility Scooter Agile Distributors LLC Steven Mahaffy
K171148 04/19/2017 Aleo BME Liquid Bandage Aleo BME Inc. Chao Liu
K171041 04/07/2017 SilverSeal Alliqua BioMedical, Inc Johanna Reinert
K171242 04/27/2017 Alma LipoFlow System Alma Lasers Inc. Rekha Anand
K171037 04/06/2017 PoreStar Patient Specific Implant Anatomics Pty Ltd Joanne Flatley
K171062 04/10/2017 BP5S Wireless Blood Pressure Monitor Andon Health Co., Ltd. Liu Yi
K171172 04/21/2017 Skyn Original Polyisoprene Lubricated Male Condom - Flavored Ansell Healthcare Products LLC. Robert Mahler
K171231 04/27/2017 Endoform Topical Matrix Aroa Biosurgery Tina OÆBrien
K171146 04/19/2017 Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. Arrow International, Inc. (Subsidiary of Telelflex Inc.) Fallon Young
K171020 04/05/2017 Arthrex Knotless SutureTak Anchor Arthrex Inc. David L Rogers
K171141 04/18/2017 Arthrex SwiveLock Anchors Arthrex Inc. David L. Rogers
K170978 04/03/2017 Embrace Neonatal MRI System Aspect Imaging Ltd. Israel Citron
K171039 04/06/2017 Assut Filbloc Permanent Sutures Assut Europe S.p.A. Gloria Aggio
K171250 04/28/2017 BRIDALVEIL Occipital Cervical Thoracic System Astura Medical Troy Taylor
K171243 04/28/2017 audifon Tinnitus-Module audiofon USA Inc. Jane E. Perrone
K170987 04/03/2017 Captus Vascular Retrieval System Avantec Vascular Corporation Nicholas deBeer
K170989 04/03/2017 Dymaxeon Spine System Back 2 Basics Direct, LLC Mitchell Bass
K170974 04/03/2017 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK Becton, Dickinson and Company Li Zhou
K171047 04/07/2017 Sterile Polyisoprene Powder Free Surgical Gloves Better Care Plastic Technology Co.,Ltd. Zhu Chunyan
K171026 04/05/2017 Mytens Model: BW-TSX Bewell Connect Corp. Jacob Chen
K171061 04/10/2017 MRSASelect II Bio-Rad Sylvie Fernez
K171054 04/10/2017 Biomet Knee Joint Replacement Prostheses Biomet, Inc Jason Heckaman
K170997 04/03/2017 CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath Biosense Webster, Inc. John Jimenez
K171185 04/24/2017 IR Type Implant System Biotem Co., Ltd. Hong Koo Yeo
K171179 04/24/2017 BR Type Implant System Biotem Co.,Ltd. Hong Koo Yeo
K171147 04/19/2017 REVEAL Bulk Bisco, Inc. Ryan Hobson
K171139 04/18/2017 LaparoLight Veress Needle Buffalo Filter, LLC Kyrylo Shvetsov
K171118 04/14/2017 Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) Cair L.G.L Delphine Molinari
K171117 04/14/2017 Carefusion NeutraClear Needle-free connector (EL-NC1000) Cair L.G.L Delphine Molinari
K171132 04/17/2017 Carefusion NeutraClear Needle-free connector CAIR LGL Delphine Molinari
K171194 04/24/2017 AS-10, CXDI-401RF Canon, Inc. Shinji Mori
K171099 04/13/2017 EON Portable Reverse Osmosis Water Purification System Cantel Mike Halliday
K171052 04/10/2017 Ultimate Contour, Ultimate Contour Mini CAO Group, Inc. Robert K. Larsen
K171007 04/04/2017 Fluorescence Mode Carl Zeiss Suzhou Co., Ltd. Huang XiaoDong
K171186 04/24/2017 Cerebrotech CMS-5000 Cerebrotech Medical Systems Dawnel Scott
K171245 04/28/2017 Presygen/si-1 Christie Medical Holdings, Inc. Salwa Rezk
K170983 04/03/2017 NIOX VERO Circassia AB Susanne Parks
K171088 04/12/2017 Cochlear Baha SoundArc Cochlear Americas Beth Murray
K171008 04/04/2017 Anorganic Bone Mineral with Collagen in Delivery Applicator Collagen Matrix, Inc. Danielle Lindner
K171043 04/07/2017 Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters Coloplast Corp Cori Ragan
K171077 04/11/2017 HEXA100 (hexafocon A) Daily Wear Contact Lenses CONTAMAC Ltd. Rob McGregor
K171017 04/05/2017 Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T Convaid Products llc. Donald Griggs
K170981 04/03/2017 NeuroQuant CorTechs Labs, Inc Kora Marinkovic
K171066 04/10/2017 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Covidien, llc Sharon McDermott
K171251 04/28/2017 014 Hydrophilic Coated PTA Balloon Dilatation Catheter Creagh Medical Shane Costello
K171087 04/12/2017 AXON IR Heat Lamp Crystal Medtech, LLC Nelson Marquina
K171024 04/05/2017 ShockPulse-SE Lithotripsy System Cybersonics, Inc. Samradni Patil
K171111 04/14/2017 Sculpsure Cynosure, Inc Amy Tannenbaum
K171038 04/06/2017 Hearing Healthcare Pro dB Diagnostic Systems, Inc. Steven Levine
K171027 04/05/2017 Dentis Dental Implant System Dentis Co.,Ltd. Sun Chul Shin
K171126 04/17/2017 Implantium II Dentium Co., Ltd. Yoon Spyoon
K171115 04/14/2017 3D Endo Software Dentsply Sirona Karl Nittinger
K171122 04/17/2017 CEREC Ortho Software Dentsply Sirona Karl J. Nittinger
K171015 04/04/2017 Citryte Di-Chem, Inc. Keith Buchholz
K171161 04/20/2017 Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) Dimensional Bioceramics LLC David Delaney
K171137 04/17/2017 EVS 2430W, EVS 2430GW DRTECH Corporation Choul-Woo Shin
K171004 04/04/2017 Hintermann Series H2 Total Ankle System Dt MedTech LLC Shawn T Huxel
K171189 04/24/2017 AIR-FLOW PLUS Prophylaxis powder E.M.S. Electro Medical Systems S.A. Suzanne Fassio-Hardy
K171174 04/21/2017 PERIO-FLOW nozzle E.M.S. Electro Medical Systems S.A. Suzanne Fassio-Hardy
K171178 04/21/2017 Central Monitoring System Edan Instruments, Inc. Alice Yang
K170995 04/03/2017 Electrocardiograph Edan Instruments, Inc. Alice Yang
K171123 04/17/2017 Leksell Vantage Stereotactic System Elekta Instrument AB Matilda Forsberg
K171247 04/28/2017 epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test Epocal Inc. Jennifer Armstrong
K171045 04/07/2017 Exactech« TruliantÖ Line Extensions Exactech, Inc. Patrick Hughes
K171056 04/10/2017 WAVE Clinical Platform Excel Medical Electronics, LLC Lance Burton
K171018 04/05/2017 Axis Charcot Fixation System, 4.5 to 8.5mm Screw System Extremity Medical, LLC. Brian Smekal
K171193 04/24/2017 Certa Catheter Ferrosan Medical Devices SP. Z O.O. Elzbieta Porebska-Guillemant
K171163 04/20/2017 Contact Lens Case Round Glasses FiftyTwoWays Ltd Jos Reinders
K171227 04/26/2017 StarWalker Fotona d.o.o. Stojan Trost
K171096 04/13/2017 Fujifilm Diathermic Slitter (FlushKnife) FUJIFILM Medical Systems U.S.A., Inc. Jeffrey Wan
K171207 04/25/2017 FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M FUJIFILM Medical Systems U.S.A., Inc. Jeffrey Wan
K171103 04/13/2017 Lumipulse G TSH-III Immunoreaction Cartridges Fujirebio Diagnostics, Inc. Stacey Dolan
K171013 04/04/2017 Revolution ACT GE Hangwei Medical Systems, Co., Ltd. Wang Xing
K171028 04/05/2017 CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories GE Healthcare Finland OY Anna Pehrsson
K171128 04/17/2017 SIGNA Premier GE Medical Systems, LLC Mary A. Mayka
K171050 04/07/2017 Geistlich Fibro-Gide Geistlich Pharma AG Marco Steiner
K171191 04/24/2017 Hexagen Derm Global Health Solutions, LLC Bradley Burnam
K171108 04/14/2017 AUTOBAHN Nailing System Globus Medical Inc. Kelly J. Baker
K171049 04/07/2017 Real Time Image Gating System for Proton Beam Therapy Systems Hitachi, Ltd. Healthcare Tomoyuki Seino
K170988 04/03/2017 DropSafe Safety Pen Needle HTL-Strefa S.A. Aleksandra Prazmowska-Wilanowska
K171241 04/27/2017 Pulse Oximeter Hunan Accurate Bio-Medical Technology Co., Ltd. Zhou Le
K171079 04/11/2017 Q-Switched Nd:YAG Laser System IDS, Ltd. C. J. Park
K171169 04/21/2017 Aquarius 8600 1417TG and Aquarius 8600 1717TG Imaging Dynamics Company Ltd. Nicole Wherry
K171175 04/21/2017 Aquarius 8600 1417WC Imaging Dynamics Company Ltd. Nicole Wherry
K170993 04/03/2017 QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer Inova Diagnostics, Inc. Roger Albesa
K171092 04/12/2017 XiniWave II Model ECS322P International Trade Group, Inc. Brent C. Reider
K171083 04/11/2017 iChemVELOCITY Automated Urine Chemistry System Iris Diagnostics, a Division of Iris International Inc Nancy Nadler
K171224 04/26/2017 Arctic Sperm Cryopreservation Medium Irvine Scientific Sales Co., Inc. Jayme Yamaguchi-Owens
K171102 04/13/2017 Ives MR Conditional Cup Electrode Ives EGG Solutions John Ives
K171012 04/04/2017 Veraview X800 J.Morita USA, Inc. Keisuke Mori
K170979 04/03/2017 ARIX Ankle Fibula Hook Plate System Jeil Medical Corporation Sejin RYU
K171097 04/13/2017 MOJAVE Expandable Interbody System K2M, Inc. Nancy Giezen
K171238 04/27/2017 KARL STORZ ICG Imaging System Karl Storz Endoscopy- America, Inc. Winkie Wong
K171035 04/06/2017 Katalyst Mark 1 Muscle Stimulation System Katalyst Inc. Amish Patel
K171040 04/06/2017 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range Koelis Laetitia GERVAIS
K171171 04/21/2017 KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) Koon Seng Sdn. Bhd. Koon Seng Sdn. Bhd.
K170986 04/03/2017 KATANA Zirconia Block Kuraray Noritake Dental Inc. Yasujiro Ohara
K170984 04/03/2017 LG BEAUTY LED MASK LG Electronics Jooyong Kim
K171136 04/17/2017 LIA Pregnancy Test LIA Diagnostics Anna Couturier
K171113 04/14/2017 LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module LiNA Medical ApS Natalia Szychulska
K171135 04/17/2017 Lipogems System Lipogems International SpA Carlo Russo
K171188 04/24/2017 Ossler Exam Scope LR Med Inc Prashant Deshpande
K171009 04/04/2017 LASEMD Laser System Lutronic Corporation Jhung Won Vojir
K171051 04/10/2017 HORIZON Therapy System Magstim Company Ltd. Tom Campbell
K171121 04/17/2017 Masimo Root Monitoring System and Accessories Masimo Corporation Marguerite Thomlinson
K171131 04/17/2017 MHC Standard and NRFit Tip Syringes Mazza Healthcare, LLC. Michael A. Mazza
K171129 04/17/2017 CO Check Pro, CO Screen MD Diagnostics Limited Glen Hillsley
K171170 04/21/2017 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws Medacta International SA Stefano Baj
K171058 04/10/2017 Medacta Shoulder System: Threaded Glenoid Baseplate Medacta International SA Stefano Baj
K171144 04/19/2017 Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel Medbio LLC. Jatin Rajani
K171237 04/27/2017 FMS VUE II Fluid Management and Tissue Debridement System Medos International SARL Tatyana Korsunsky
K171114 04/14/2017 HEALIX ADVANCE KNOTLESS Anchor Medos International SARL Julie Vafides
K171253 04/28/2017 Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead Medtronic Debra Taitague
K171031 04/06/2017 CRESCENTÖ Spinal System Medtronic Sofamor Danek Ankit K. Shah
K171107 04/14/2017 CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System Medtronic Sofamor Danek USA, Inc. Julie Bassett
K171109 04/14/2017 Praxiject 0.9% NaCl MedXL Inc. Premala Premanathan
K171068 04/10/2017 OrthoView 7.2 Meridian Technique Ltd Barbara March
K171150 04/19/2017 AW-100 Micron Corporation Takashi Terui
K171181 04/24/2017 PROCOTYL« PRIME E-CLASSÖ XLPE Liner MicroPort Orthopedics, Inc. Sarah Evonne Stroupe
K171255 04/28/2017 Monteris Medical NeuroBlate System Monteris Medical, Inc. David H. Mueller
K171257 04/28/2017 ClearPoint System MRI Interventions, Inc. Pete Piferi
K171155 04/20/2017 Surgical Angle Handpiece, Surgical Straight Handpiece Nakanishi Inc. Kimihiko Satoh
K171183 04/24/2017 OmniTom NeuroLogica Corporation, Ninad Gujar
K171085 04/12/2017 GMR40 NeuroLogica Corporation, a Subsidiary of Ninad Gujar
K171112 04/14/2017 Trifore(tm) Cervical Plating System NeuroStructures, Inc. Kathleen Wong
K171198 04/24/2017 NeuViz 16 Essence Multi-slice CT Scanner System Neusoft Medical Systems Co., Ltd. Shao Xiancheng
K171201 04/24/2017 NeuViz Prime Multi-slice CT Scanner System Neusoft Medical Systems Co., Ltd. Shao Xiancheng
K171022 04/05/2017 Ablation Confirmation NeuWave Medical, Inc. Dan Kosednar
K171140 04/18/2017 Matrixx System Nexxt Spine LLC Andy Elsbury
K171124 04/17/2017 Nihon Kohden Wireless Input Unit WEE-1200 Nihon Kohden Corporation Tom Bento
K171244 04/28/2017 Physiotrace NimbleHeart, Inc. Sonal Tambe
K171142 04/18/2017 Healing Cap Multi-Unit Titanium Nobel Biocare AB Charlemagne Chua
K171059 04/10/2017 Nova StatSensor Creatinine Hospital Meter System Nova Biomedical Corporation Paul W. MacDonald
K171130 04/17/2017 Nucleus Image Management System NucleusHealth, LLC Linda Moore
K171206 04/25/2017 D'Vill Introducer NuMED, Inc. Nichelle LaFlesh
K171158 04/20/2017 Single Use Electrosurgical knife Olympus Medical Systems Corp. Toshiyuki Nakajima
K171232 04/27/2017 PeriView FLEX Olympus Surgical Technologies America Mary Anne Patella
K171156 04/20/2017 OMNI Anseris Hip Stem OMNIlife science Christina Rovaldi
K171167 04/21/2017 Prodigio Stain Powder OperArt LLC Domenico Cascione
K171168 04/21/2017 VITROS Immunodiagnostic Products Insulin Calibrators Ortho Clinical Diagnostics Bradley P. Boyer
K171249 04/28/2017 EntradaÖ hip stem Ortho Development Corporation Drew Weaver
K171082 04/11/2017 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System Orthofix Inc. Jacki Koch
K171211 04/25/2017 OIC External Fixation System Orthopaedic Implant Company Douglas Fulton
K171173 04/21/2017 OrthoPediatrics Titanium PediPlates« System OrthoPediatrics, Corp. Adam Cargill
K170972 04/03/2017 Apex Tibial Nailing System OrthoXel Aisling O'Sullivan
K171217 04/26/2017 DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System Osprey Medical, Inc. Melanie Hess
K171011 04/04/2017 PENTAX Medical VIVIDEO ENT Videoscope Solution Pentax Medical James W. Monroe
K171184 04/24/2017 Persyst Mobile App Persyst Development Corporation Dari Darabbeigi
K171055 04/10/2017 Philips BlueControl Philips Electronics Nederland B.V. Gaozhen Hang
K171157 04/20/2017 PolyDev Soft Contact Lenses Polydev Ltd. John Mulvihill
K171162 04/20/2017 Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield Prestige Ameritech Rex Reese
DEN170024 04/17/2017 AQUABEAM System PROCEPT BioRobotics Corporation Michael Nketiah
K171133 04/17/2017 Qfix« Abdominal/Thoracic Motion Control System,Qfix« SBRT Solution and Accessories Qfix Alexandra Nicole Low
K171215 04/25/2017 QiF Blood and Fluid Warmer Quality In Flow Ltd. Neta Sherman
DEN170022 04/07/2017 QuantX Quantitative Insights, Inc Robert Tomek
K171229 04/27/2017 DELL UP3017 with QUBYX PerfectLum bundle Qubyx Software Technologies Inc. Marc Leppla
K170996 04/03/2017 Wingman 14C Crossing Catheter ReFlow Medical, Inc. Rebecca K. Pine
K171143 04/18/2017 Relievant Medsystems RF Generator Relievant Medsystems Alex DiNello
K171212 04/25/2017 AirFit N20 ResMed Ltd Kim Kuan LEE
K171235 04/27/2017 OmniCap Respirion, Inc. Ed Fadel
K171081 04/11/2017 Guider Catheter Introducer Rhythm Xience, Inc. (RXI) James Hassett
K171060 04/10/2017 OrthoButton AL Riverpoint Medical Nathan Cook
K171080 04/11/2017 ALP IFCC Gen.2 Roche Diagnostics Operations (RDO) Patrick Stimart
K171182 04/24/2017 ri-former Predictive Thermometer Rudolf Riester GmbH Artur Pfister
K171119 04/14/2017 GM85 Samsung Electronics Co.,Ltd. Chulsin Kim
K171048 04/07/2017 RS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K171070 04/10/2017 WS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Emily Woo
K171230 04/27/2017 My Dose Coach Sanofi Robert Ezzell
K171093 04/12/2017 STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE Sanrea Healthcare Products Pvt Ltd JOSE PAUL M.
K171165 04/20/2017 SmartByte Device Scientific Intake Marc Gibeley
DEN170023 04/17/2017 ThermoNeuroModulation Device, TNM Device Scion NeuroStim, LLC Robert Black
K171046 04/07/2017 SeaSpine Cambria System SeaSpine Orthopedics Corporation Gina Flores
K171214 04/25/2017 Infrared Thermometer Shenzhen Brav Electronic Technologies Co., Ltd. Aaron Wan
K171034 04/06/2017 M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Ma Chao
K171233 04/27/2017 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Zhai Pei
K171072 04/10/2017 N Latex Cystatin C; N Protein Standard UY Siemens Healthcare Diagnostics Products GmbH Christine Perkins
K171053 04/10/2017 syngo Dynamics Version VA30 Siemens Healthcare GmbH Lauren Bentley
K170992 04/03/2017 AcuNav V 10F Ultrasound Catheter Siemens Medical Solutions USA, Inc Shelly Pearce
K171005 04/04/2017 Silhouette Featherlift Silhouette Lift Inc. Anthony DiBernardo
K171073 04/11/2017 Smith & Nephew, Inc. REDAPT Augments Smith & Nephew, Inc. Kim Phan
K170977 04/03/2017 SURESHOT Distal Targeting System V4.0 Trauma Interface Smith & Nephew, Inc. Allison Chan
K170982 04/03/2017 CADD«- Solis Ambulatory Infusion Pump with Wireless Communication; CADD«-Solis Infusion Pump, Model 2110; PharmGuard« Administrator Medication Safety Software; CADD« Administration Sets; Wireless Communication Module (CM) Smiths Medical ADS, Inc. Breanna Fautsch
K171098 04/13/2017 AXIS Image Management System Sonomed, Inc. Mark Wallace
K171164 04/20/2017 U-Lite EXP Sonoscanner Bruno Richard
K170999 04/03/2017 P50 Series Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K171000 04/03/2017 P60 Series Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K171151 04/20/2017 ACRONÖ TLIF System SpineMED Ges.m.b.H Andreas Bernegger
K170990 04/03/2017 Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator Spiration, Inc. Cheryl Frederick
K171228 04/26/2017 Fiji Anchor SportWelding GmbH Joerg Mayer
K171071 04/10/2017 StimSox(TM) System StimMed, LLC Peter G. Demakos
K171152 04/20/2017 Stryker Universal Neuro III System AXS Screw Stryker Jonathan Schell
K171149 04/19/2017 Altrix Temperature Management Wraps Stryker Medical Brian Orwat
K171105 04/13/2017 AIXPLORER« & AIXPLORER« Ultimate Ultrasound Systems Supersonic Imagine Laurence HERMITTE
K171019 04/05/2017 ScioCardio ECG Transmitter Synergen Technology Labs LLC Sunil Konda
K171125 04/17/2017 Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens Tangible Science LLC Vic McCray
K171078 04/11/2017 TRI-COMBO PARASITE SCREEN Techlab, Inc. Donna T. Link
K171014 04/04/2017 VICTUS Femtosecond Laser Platform Technolas Perfect Vision GmbH Friedrich Moritz
K170975 04/03/2017 Televere Digital Imaging System Televere Systems Randell Quaal
K171213 04/25/2017 One Touch Condom with Benzocaine Thai Nippon Rubber Industry Public Company Limited Pisut Chanwatarungkull (Pete)
K171234 04/27/2017 Mistral-Air Warming Unit The Surgical Company International BV (as The 37Company) Kees van Hassel
K171094 04/12/2017 Thermi Reusable Non-invasive RF Electrode ThermGen, L.L.C Suzanne Cheang
K170985 04/03/2017 Urbanek Device TMJ Services, LLC Anthony Urbanek
K171226 04/26/2017 TOKUYAMA UNIVERSAL BOND Tokuyama Dental Corporation Fumia Takahashi
K171010 04/04/2017 Latitude EV Total Elbow Arthroplasty Tornier Inc. Renee Stoffel
K171222 04/26/2017 Vitrea Software Toshiba Package; VSTP-001A Toshiba Medical Systems Corporation Paul Biggins
K171120 04/14/2017 Senhance Surgical Robotic System TransEnterix, Inc. Stephanie Fitts
K171239 04/27/2017 TULA Tube Delivery System Tusker Medical Pavan Sethi
K171021 04/05/2017 JO Agap? Personal Lubricant United Consortium Stephanie Morris
K171138 04/18/2017 Nexus DR Digital X-ray Imaging System Varex Imaging Corporation Catherine Mulcahy
K171029 04/06/2017 eCareCoordinator Visicu Inc. Daniel R. Plonski
K171208 04/25/2017 Trans-anal Introducer Visionsense Ltd. Alex Chanin
K170973 04/03/2017 VitalWatch Software User Interface VitalConnect, Inc. Kevin Potgieter
K171200 04/24/2017 Grandio blocs VOCO GmbH M. Th. Plaumann
K171223 04/26/2017 Quantum TTC Biliary Balloon Dilator Wilson-Cook Medical, Inc Tiffanny A. Thomas
K171067 04/10/2017 INVISION Total Ankle Revision System Wright Medical Technology, Inc. Val Myles
K171044 04/07/2017 Climax Personal Lubricant WSM Investment LLC, dba Topco Sales Adrian Mendoza
K171075 04/11/2017 Calix-C Cervical Interbody Spacer X-Spine Systems, Inc. Kriss Andersson
K171104 04/13/2017 Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) YTY INDUSTRY (MANJUNG) SDN BHD Punitha Samy
K171101 04/13/2017 Closed Male Luer Yukon Medical Todd Korogi
K171069 04/10/2017 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Shruti Jayakumar
K171076 04/11/2017 Medical Video Endoscope System Zhuhai Pusen Medical Technology Co., Ltd. Wang ChangShen
K171197 04/24/2017 Zuga Dental Implant System Zuga Medical, Inc. Chan Wang


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