FDA 510(k) Decisions During April, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K173519 04/23/2018 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company Hilary B. Hovde
K172630 04/03/2018 Kisses Plus Implant System ACHIMHAI Medical Corporation Ji Ho Jung
K180096 04/16/2018 GDT-1000 System AcuVu Inc. Sam Mostafavi
K180433 04/26/2018 ENNOVATE« Aesculap Implant Systems, LLC Melanie Burkert
K180914 04/17/2018 Aesculap Slim Clip Applier Aesculap, Inc. Paul Amudala
K180589 04/05/2018 DR 800 with MUSICA Dynamic Agfa HealthCare N.V. Wim Govaerts
K171720 04/19/2018 encevis AIT Austrian Institute of Technology GmbH Tilmann Kluge
K180669 04/27/2018 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal Alcon Laboratories, Inc. Sherri Lakota
K180398 04/10/2018 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal Alcon Laboratories, Inc. Sherri Lakota
K173715 04/23/2018 AlertWatch:OB AlertWatch, Inc. Justin Adams
K180699 04/13/2018 Voyant Open Fusion Device Applied Medical Resources Corporation Patricia Villarreal
K180305 04/13/2018 Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) Aquilabs US LLC Juan Salcedo
K173900 04/20/2018 Arthrex Univers Revers Modular Glenoid System Arthrex Inc. Courtney Smith
K173964 04/18/2018 OVOMotion Shoulder Arthroplasty System Arthrosurface, Inc. Dawn J. Wilson
K180566 04/03/2018 Unite Connect for Clinical Systems Ascom Sweden AB Ivan Liljegren
K180349 04/05/2018 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech (Hangzhou) Co., Ltd. Shisheng Ling
K172947 04/18/2018 HALF DOME Posterior Lumbar Interbody System Astura Medical Thomas Purcell
K172166 04/27/2018 OLYMPIC Navigated Instruments Astura Medical Troy Taylor
K172427 04/19/2018 AViTA Radar Thermo NT16 Series IR Thermometer Avita Corporation Steven Jhou
K180301 04/10/2018 AXIS 5.5 Lumbar Pedicle Screw System Axis Orthopaedics Craig Wilcox
K173867 04/05/2018 Axis Anterior Cervical Plate System Axis Orthopaedics Craig Wilcox
K173699 04/04/2018 The Pump by Babyation Babyation, LLC Jared Miller
K162525 04/25/2018 Oniko nail brace BEGUM SAGLIK HIZMETLERI TIBBI MALZEMELER DANISMANLIK LSTI FATMA GULRU ERDOGAN
K162499 04/13/2018 Best Instruminal Applicator BEST MEDICAL INTERNATIONAL, INC. MANNY SUBRAMANIAN
K173767 04/06/2018 A. L. P. S. Clavicle Plating System Biomet Inc. Dhaval Saraiya
K170901 04/13/2018 ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 BioSystems S.A. Teresa Maria Cortes
K180344 04/05/2018 TheraCal DC Bisco, Inc. Ryan Hobson
K180271 04/06/2018 NAVIOÖ Surgical System (NAVIO system) Blue Belt Technologies, Inc. Corrine Herlinger
K172955 04/26/2018 LungVision Tool Body Vision Medical Ltd. Dorian Averbuch
K180102 04/19/2018 Embozene Color-Advanced Microspheres Boston Scientific Heidi Shearer
K180795 04/12/2018 JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire Boston Scientific Nikki M. Ibis
K180530 04/10/2018 Imager II Urology Torque Catheter Boston Scientific Corporation Daniel FitzDaniel
DEN170081 04/20/2018 MALDI Biotyper CA System Bruker Daltonik GmbH Markus Kostrzewa
K173143 04/25/2018 Phasix ST Mesh C. R. Bard Inc Tony John
K172511 04/20/2018 Hickman TriFusion Catheter C.R. Bard, Inc Mona Shahrebani
K180548 04/26/2018 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology C.R. Bard, Inc (Bard has joined BD) Bryan Stone
K180069 04/27/2018 HDR MRI Lumen Marker C4 Imaging LLC Andrew Bright
DEN170028 04/26/2018 Cala ONE Cala Health, Inc. Scott A. Wilson
K173432 04/18/2018 ENZA-A Titanium ALIF Camber Spine Technologies Damian Heinz
K180416 04/17/2018 ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System Cardiovascular Systems Inc. Susan Wolf
K180667 04/13/2018 SmartGrid Carestream Health, Inc. Diane Koetter
K173371 04/13/2018 VisuMax Femtosecond Laser Carl Zeiss Meditec, Inc. Todd Otani
K180121 04/11/2018 Rafugen DBM Cellumed Co., Ltd. JooWoong (Albert) Jang
K173398 04/26/2018 Xpert Xpress Strep A Cepheid Yi-Ping Lin
K172151 04/09/2018 Hysteroscopy System Chongquin Jinshan Science & Technology (Group) Co., Ltd. Qing Xu
K172258 04/27/2018 Novasight Hybrid System Conavi Medical Inc. Sam Mostafavi
K180616 04/25/2018 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens Contamac Ltd. Rob McGregor
K172588 04/19/2018 Balloon Catheter and Balloon Ureteral Dilator Set Cook Incorporated Carly Powell
K171603 04/16/2018 Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set Cook Incorporated Erum B. Nasir
K171917 04/23/2018 Frova Intubating Introducer Cook Incorporated Kotei Aoki
K173686 04/11/2018 Guardia Access Embryo Transfer Catheter Sets and Sydney IVF« Transfer Catheter Cook Incorporated Naomi Funkhouser
K172635 04/03/2018 High-Flo Silver Polyethylene Catheter Cook Incorporated Jessica Swafford
K173103 04/13/2018 Pivet and Soft-Pass Embryo Transfer Catheter Sets Cook Incorporated Naomi Funkhouser
K180081 04/18/2018 RAILWAY Sheathless Access System Cordis Corporation Michelle Ragozzino Rodgers
K171847 04/05/2018 Corin Optimized Positioning System (OPSÖ) Plan Corin USA Limited Kathy Trier
K173880 04/11/2018 Corin TriFit CF Hip Stem Corin USA Limited Rachel King
K172206 04/10/2018 NAJAÖ Ligament Correction System Cousin Biotech S.A.S. Mathilde Collet
K180037 04/26/2018 Beacon EUS Access System Covidien llc Rachel Silva
K180007 04/19/2018 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter Creagh Medical, Ltd. Shane Costello
K180252 04/24/2018 Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank Crown Porcelain Dental Technology Co., Ltd. Chu Lien Fan
DEN170047 04/03/2018 Curetis Unyvero LRT Application Curetis GmbH Gail E. Radcliffe
K180561 04/04/2018 MobileX Portable X-ray System Denterprise International, Inc. Claude Berthoin
K172239 04/04/2018 SIMPLANT 18 Dentsply Sirona Karl Nittinger
K170339 04/26/2018 Summit Hip System DePuy Orthopaedics, Inc. Carol S. Ming
K173072 04/04/2018 Algidex Ag Silver Alginate Wound Dressing DeRoyal Industries, Inc. Sarah Bennett
K172154 04/19/2018 Isolette 8000 plus Draeger Medical Sytems, Inc. Gale Winarsky
K171562 04/13/2018 Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono Dreve Dentamid GmbH Reiner Altmann
K162408 04/05/2018 Nano Varnish, Plaquit, Lightpaint on Surface DREVE DENTAMID GMBH REINER ALTMANN
K170776 04/10/2018 DTI-1 SLA IMPLANT SYSTEM DTI Implant Sistemleri Sanayi Ticaret Anonim Sirketi Fatih Ormeci
K180408 04/13/2018 U60 Diagnostic Ultrasound System Edan Instruments, Inc. Crystal Cai
K173586 04/05/2018 VAMP Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC Ye Seul Kim
K172173 04/06/2018 DiaSpect Tm, DiaSpect Tm Cuvettes EKF-diagnostic GmbH Mick Fenton
K172244 04/20/2018 EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern Euroimmun US, Inc. Daniel Castellanos
K172252 04/20/2018 EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern Euroimmun US, Inc. Daniel Castellanos
K172919 04/19/2018 EV-804 OTC Pain Relief TENS Everyway Medical Instruments Co., Ltd. Paul Hung
K180636 04/30/2018 ExactVu High Resolution Micro-Ultrasound System Exact Imaging Inc. Randy AuCoin
K173775 04/06/2018 Clench Compression Staple F & A Foundation LLC d.b.a. Reign Medical Daniel Lanois
K180208 04/09/2018 Disposable Endoscopic Trocar Fengh Medical Co., Ltd. Jun Zhou
K180704 04/13/2018 SonoSite iViz Ultrasound System FUJIFILM SonoSite, Inc. Sudipta Chakrabarti
K173226 04/16/2018 CardiMax Electrocardiograph Fukuda Denshi USA, Inc. Doug Blakely
K172382 04/02/2018 GC Fuji Direct GC America Inc. Mark Heiss
K173816 04/17/2018 NM/CT 850, NM/CT 860 GE Healthcare George Mashour
K180666 04/12/2018 48CH Head Coil GE Healthcare Coils (USA Instruments, Inc.) Veronica A. Meridith
K180225 04/24/2018 GSI Viewer with GSI Fat Option GE Medical Systems SCS Peter Uhlir
K180782 04/20/2018 Aria GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC Nicole Landreville
K180318 04/11/2018 PET Digital Gating GE Medical Systems, LLC Lee Bush
K180304 04/20/2018 Geri Embryo Incubator and Geri Dish Genea Biomedx Pty Ltd Kea Dent
K173885 04/03/2018 Genesys Spine Binary Lumbar Plate System Genesys Spine Brian J. Bergeron
K180836 04/18/2018 Genistrong Genicon, Inc Katlyn Kachman
K180210 04/02/2018 CREO« Stabilization System Globus Medical Inc. Kelly J. Baker
K171379 04/10/2018 Digital Automatic Wrist Blood Pressure Monitor MD4300 Grandway Technology (Shenzhen) Limited Patrick Chow
K173757 04/19/2018 VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set Greiner Bio-One NA Inc Manfred Abel
K172887 04/19/2018 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) Guangzhou Xinbo Electronic Co., Ltd. Sammy Li
K172368 04/05/2018 Bipolar Micro-Coagulation Forceps Gunter Bissinger Medizintechnik GmbH Matthias Bissinger
K172727 04/16/2018 Hemoclip Hangzhou AGS MedTech CO., Ltd Chunqi Han
K171821 04/26/2018 2 Face / Face Evolution Heat In A Click Guy Levi
K180233 04/10/2018 Eviva Stereotactic Guided Breast Biopsy System Hologic, Inc Brenda M Geary
K173201 04/26/2018 UNITY Sacroiliac Joint Fixation System Huvexel Co., Ltd Sung Hee-Lee
K170463 04/13/2018 KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System i-SENS, Inc. Joon Ho Jung
K180125 04/05/2018 PowerLook Density Assessment Software iCAD, Inc John DeLucia
K172306 04/19/2018 SuperSlyde Personal Lubricant ICM Pharma Pte Ltd Dennis Fortich
DEN180001 04/11/2018 IDx-DR IDx, LLC Michael D. Abramoff
K162314 04/24/2018 IMACTIS CT-Navigation system IMACTIS, SAS MADY BATAILH
K180126 04/16/2018 SOZO ImpediMed Limited Catherine Kingsford
K180329 04/09/2018 ClotTriever Thrombectomy System Inari Medical Eben Gordon
K172416 04/19/2018 Synermed Opiate Enzyme Immunoassay Infrared Laboratory Systems, LLC (dba Synermed) Julie Paschal
K172167 04/19/2018 Zenith Flex System InNeuroCo, Inc. Marc Litzenberg
K180140 04/20/2018 ProFlex Laser Fibers InnovaQuartz LLC Stephen E Griffin
K180078 04/17/2018 Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System Innovasis, Inc. Marshall McCarty
K173935 04/16/2018 Mediant Anterior Cervical Plating System Intelligent Implant Systems, LLC Michael Nutt
K180033 04/06/2018 8mm Monopolar Curved Scissors Intuitive Surgical, Inc Gayle Perry
K173842 04/23/2018 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc Brandon Hansen
K173337 04/26/2018 Intuitive Surgical EndoWrist Vessel Sealer Extend Intuitive Surgical, Inc. Crystal Ong
K172329 04/23/2018 Patient Status Engine Isansys Lifecare Ltd Julian Jones
K172477 04/19/2018 iSchemaView RAPID iSchemaView, Inc. Jim Rosa
K172598 04/19/2018 Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE ITW Contamination Control Electronics Steve Cook
K173902 04/20/2018 Neodent Implant System û GM Line JJGC Industria e Comercio de Materiais Dentarios S.A. Julianne de Oliveira Capucho Lechechem
K171713 04/05/2018 Neodent Instrument Kits JJGC Industria e Comercio de Materiais Dentarios S.A. Julianne de Oliveira Capucho Lechechem
K180299 04/10/2018 ACUVUE OASYS (senofilcon A) with Photochromic Additive Johnson & Johnson Vision Care, Inc. Victoria Brennand
K180376 04/05/2018 K2M Patient Specific Rods K2M, Inc. Nancy Giezen
K180146 04/17/2018 KARL STORZ ICG Imaging System KARL STORZ Endoscopy America, Inc. Winkie Wong
K173362 04/03/2018 DSM Biomedical Calcium Phosphate Cement Kensey Nash Corporation dba DSM Biomedical Susan Pileggi
K173669 04/02/2018 K-D Balance King-Devick Technologies, Inc. Lori Grover
K180320 04/03/2018 dpl IIa Panel LED Technologies, Inc. Lloyd Nelson
K170761 04/13/2018 LIGHTSonic BUBM Lightmed USA, Inc. Katrina Hsu
DEN170010 04/20/2018 LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay Lin-Zhi International, Inc. Chris Wang
K180339 04/04/2018 Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K180576 04/19/2018 Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) LPI, Inc. Christopher Steadman
K173304 04/30/2018 Finessis Intense Polyisoprene Surgical Glove Lucenxia Prescience Ag Robert Hill
K173386 04/09/2018 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs Lucenxia Prescience AG Robert Hill
K173317 04/17/2018 DiLumen C2; DiLumen Tool Mount Lumendi, LLC Dennis Daniels
K180597 04/03/2018 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO Lumenis Ltd. Amaya De Levie
K172963 04/04/2018 Master-Frank N95 Particulate Respirator Master & Frank Enterprise Co., Ltd Shuge Zhao
K180307 04/30/2018 Mazor X Mazor Robotics Ltd. Shiran Conforti
K171326 04/13/2018 Piezosurgery White Mectron S.p.a Franco Zunino
K172460 04/27/2018 ADHEAR System MED-EL Elektromedizinische Geraete GmbH Elizabeth Gfoeller
K180089 04/05/2018 Medacta Shoulder System Short Humeral Diaphysis Medacta International SA Stefano Baj
K173472 04/19/2018 MySpine Pedicle Screw Placement Guides û MC and Drill Pilot Instruments Medacta International SA Stefano Baj
K172956 04/06/2018 Medicant Mucosal Atomizer Medica Holdings, LLC George Reed
K180567 04/12/2018 C3 Wave System Medical Components, Inc. (dba Medcomp) Courtney Nix
K173506 04/03/2018 LigaPASS Medicrea International S.A. David Ryan
K173782 04/25/2018 UNiD Patient Specific 3D printed cage Medicrea International S.A. David Ryan
K180090 04/23/2018 CureÖ Lumbar Plate System Meditech Spine, LLC Bruce Dunaway
K173889 04/09/2018 Medline Cautery Electrode (PTFE) Medline Industries, Inc. Matt Clausen
K180696 04/30/2018 Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) Medline Industries, Inc. Pauline Maralit
K173859 04/11/2018 HEALIX ADVANCE Anchor with DYNACORD Suture Medos International SARL Tatyana Tatyana Korsunsky
K173526 04/05/2018 SENTIO MMG Gen 2 Medos International, SARL Karen Sylvia
K180222 04/24/2018 Reaxon Plus Medovent GmbH Peter Meier
K180851 04/18/2018 VERTEXÖ Reconstruction System Medtronic Sofamor Danek USA, Inc Ankit K Shah
K173515 04/12/2018 Admiral Xtreme Medtronic Vascular Maddalena Pinsi
K173855 04/20/2018 Sharpsite AC Rigid Endsocope Medtronic Xomed Inc. Shravan Chawla
K180873 04/19/2018 Medtronic Model 53401 External Pulse Generator (EPG) Medtronic, Inc. Brenna Loufek
K180030 04/24/2018 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) Medtronic, Inc. Nancy Cameron
K172866 04/27/2018 NeuroCap Memory MD INC Abdus-Salaam Muwwakkil
K172930 04/13/2018 mCare Powder-free Blue Nitrile Examination Gloves Mercator Medical (Thailand) LTD. Dariusz Jan Krezymon
K180723 04/17/2018 PreludeSYNC DISTAL Radial Compression System Merit Medical Systems, Inc Susan Christensen
K172014 04/05/2018 Wedge Microcatheter Micro Vention, Inc. Chet Jones
K172880 04/18/2018 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K172464 04/24/2018 XD880A Ultrasonic Osteotomy Surgical System Morley Research Consortium Suzan Davis
K172764 04/27/2018 Keymill Mycone Dental Supply Company, Inc. (aka Keystone Industries) Priscilla Herpai
K173865 04/24/2018 trophon2 Nanosonics Limited Ruth Cremin
K180257 04/25/2018 InCore« Lapidus System Nextremity Solutions, Inc. Greg Denham
K180503 04/03/2018 PRECICE STRYDE System NuVasive Specialized Orthopedics, Inc. Lance Justice
K180458 04/17/2018 FOCUS Pedicle Screw System Nvision Biomedical Technologies, LLC Diana Langham
K172726 04/30/2018 EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D Olympus Medical Systems Corp. Toshiyuki Nakajima
K172610 04/17/2018 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S Olympus Medical Systems Corp. Toshiyuki Nakajima
K180200 04/26/2018 ESG-300, APU-300, Pressure Reducer, MAPC Probes Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K171692 04/02/2018 Instrument basket, for EndoEYE Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K180630 04/06/2018 PTFE SURGICAL SUTURE OMNIA SPA Roberto Cerioli
K173390 04/27/2018 hipEOS oneFIT Medical Camille Vernay
K180378 04/05/2018 Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module Optomed Oy Jyri Leskela
K172699 04/23/2018 Agile Nail Orthofix Srl Gianluca Ricadona
K173525 04/06/2018 NovoGro OsteoNovus, Inc. Brian M. Schlossberg
K173615 04/18/2018 Stryker Universal Select Sterilization Tray System Paragon Medical Rebecca Walker
K180651 04/12/2018 Uroview FD II Pausch Medical GmbH Christian Stoian
K171872 04/26/2018 P50 Series Dental Operative Unit and Accessories Pelton & Crane Frank Ray
K172156 04/05/2018 PENTAX Medical EPK-3000 Video Imaging System Pentax Medical William Goeller
K173614 04/17/2018 Penumbra Coil 400, Ruby Coil System, POD System Penumbra, Inc. Aditi Kolla
K173726 04/16/2018 ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut Phadia AB Ulf Karlberg
K173079 04/04/2018 Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 Philips Medical Systems Nederland B.V. Jan van de Kerkhot
K172365 04/19/2018 Panoramic Oxygen Mask (POM) Pom Medical, LLC Jeff Voss
K172495 04/11/2018 Reform« POCT System Precision Spine, Inc. Michael C. Dawson
K180080 04/06/2018 FIBERGRAFT BG Matrix Bone Graft Substitute Prosidyan, Inc Charanpreet S Bagga
K172636 04/30/2018 VitaMESH Macroporous PP Surgical Mesh Proxy Biomedical Ltd. Adrienne Tierney
K173258 04/20/2018 Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Pt. Medisafe Technologies Deepak Bang
K180154 04/27/2018 QiF Blood and Fluid Warmer Quality In Flow Ltd. Neta Sherman
K180595 04/04/2018 SciMoCa Radialogica LLC Debra Vigil
K180379 04/25/2018 RayStation 7 RaySearch Laboratories AB (publ) David Hedfors
K180372 04/09/2018 Aurora Evacuator Rebound Therapeutics Jeffrey J. Valko
K173661 04/18/2018 Wingman 35 Crossing Catheter ReFlow Medical, Inc. Rebecca K Pine
K180206 04/24/2018 neuromate Gen III Renishaw Mayfield Sarl Stephane Vinot
K180637 04/04/2018 leva Pelvic Floor Trainer Renovia Inc. Gina Prochillo-Cawston
K172875 04/26/2018 Astral 100/150 ResMed Ltd Peter Jennings
K171409 04/09/2018 OT EQUATOR Rhein'83 SRL Claudia Nardi
K180684 04/19/2018 CoaguChek XS Plus System Roche Diagnostics Bin Sun
K180693 04/19/2018 CoaguChek XS Pro System Roche Diagnostics Angie Clements
K180753 04/20/2018 SafetyFix EasyOut System SafetyFix Medical Technologies, Inc. Michael Horwitz
K172047 04/11/2018 Riva Star SDI Limited Ray Cahill
K173606 04/13/2018 SeaSpine Vu aòPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aòPOD Prime Intervertebral Body Fusion Device SeaSpine Orthopedics Corporation Gina Flores
K172141 04/04/2018 Pulse Oximeter Shanghai Berry Electronic Tech Co., Ltd Xuezhi Yin
K172143 04/13/2018 uMI 780 PET/CT System Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K172998 04/05/2018 uWS-MI Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K173207 04/05/2018 SIC invent Dental Implant Systems SIC invent AG Cretia Arlene McNett
K172201 04/12/2018 Atellica IM Folate Assay Siemens Healthcare Diagnostics Inc. Darius Daruwala
K180563 04/25/2018 syngo.plaza Siemens Healthcare GmbH Vijay Ramadas
K173597 04/04/2018 Scenium VE20 Software Siemens Medical Solutions USA, Inc. Veronica Padharia
K173632 04/13/2018 SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO Siemens Medical Solutions USA, Inc. Kimberly Mangum
K180336 04/19/2018 syngo.MR Applications Siemens Medical Solutions USA, Inc. Cordell L Fields
K173897 04/05/2018 syngo.via MI Workflows Siemens Medical Solutions USA, Inc. Veronica Padharia
K173639 04/02/2018 Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax Siemens Medical Solutions, Inc Denise Adams
K180750 04/20/2018 World Knee System Signature Orthopaedics Pty Ltd. Declan Brazil
K180744 04/11/2018 Stablyx CMC Arthroplasty Implant System Skeletal Dynamics, LLC Ana M. Escagedo
K180614 04/06/2018 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Lavinia Tompkins
K180618 04/20/2018 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Lavinia Tompkins
K180277 04/24/2018 Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter Smith & Nephew, Inc. Allison Chan
K173384 04/10/2018 BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube Smiths Medical ADS, Inc. Donna M. Semlak
K173934 04/13/2018 Reza Band, Reflux Band Somna Therapeutics, L.L.C. James S. Miller
K173896 04/02/2018 Microcyn Antimicrobial Hydrogel Sonoma Pharmaceuticals, Inc. Brian Martin
K180694 04/05/2018 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. Travis Pittman
K180514 04/25/2018 VERITON NM Spectrum Dynamics Medical Ltd. Igor Naroditsky
K172967 04/10/2018 Mercury« Spinal System Spinal Elements Inc. Julie Lamothe
K171151 04/27/2018 ACRONÖ TLIF System SpineMED Ges.m.b.H Andreas Bernegger
K180002 04/25/2018 Rampart One Lumbar Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K172396 04/23/2018 EnSite Velocity Cardiac Mapping System v5.2 St. Jude Medical Melissa Frank
K172393 04/23/2018 Advisor HD Grid Mapping Catheter, Sensor Enabled St. Jude Medical, Inc. Jennifer Ruether
K172155 04/12/2018 StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing StatGuard, LLC Gary Mills
K180689 04/12/2018 Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device STERIS Corporation Tony Piotrkowski
K180342 04/04/2018 SYSTEM 1E Liquid Chemical Sterilant Processing System Steris Corporations Jennifer Nalepka
K173692 04/13/2018 D-Actor 200 Vibration Massage System Storz Medical AG Pavel Novak
K172315 04/12/2018 Rotarex S Catheter Set û 6F x 110 cm, Rotarex S Catheter Set û 6F x 135 cm, Rotarex S Catheter Set û 8F x 85 cm, Rotarex S Catheter Set û 8F x 110 cm, Drive System, Replacement Control Unit (with cord), Replacement Motor (with cord), Replacement Footswit Straub Medical AG Amy Ehlenfeldt
K173074 04/04/2018 ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor Stryker Jacob Scheenstra
K180451 04/20/2018 Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider Stryker Sustainability Solutions Scott English
K180499 04/23/2018 Reprocessed LigaSure Maryland Jaw Sealer/Divider Stryker Sustainability Solutions Scott English
K180677 04/03/2018 Surefire Spark Infusion System Surefire Medical, Inc. Lynne Aronson
K172187 04/11/2018 Inno-Hydrowire Suzhou Innomed Medical Device Co.,Ltd Jimmy Li
K171883 04/23/2018 Sysmex UF-5000 Fully Automated Urine Particle Analyzer Sysmex America, Inc. Sharita Brooks
K180588 04/17/2018 FAST1Ö Intraosseous Infusion System; FASTResponderÖ Sternal Intraosseous Device Teleflex Medical Ying Zhao
K173321 04/25/2018 StimuQuik 21G x 9cm (3.5ö) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5ö) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6ö) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6ö) Peripheral Nerve Block Needle, StimuQuik 21G x Teleflex Medical Kristen Bisanz
K180765 04/20/2018 Televere Podiatry X-Ray System HF Televere Systems, Inc. Randell Quaal
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