FDA 510(k) Applications Received During October, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K182784 10/01/2018 MUTYH-Associated Polyposis (MAP) 23andMe, Inc. Sarah Rys
K183015 10/31/2018 PuraSinus 3-D Matrix, Inc. Lisa Spirio
K182835 10/09/2018 WOLF Thrombectomy Device 880 Medical, LLC Micheal P. Wallace
K182818 10/03/2018 LOQTEQ VA Calcaneus Plate 3.5 aap Implantate AG Annesha Lahiri
K182785 10/01/2018 LOQTEQ VA Foot Plates 2.5 aap Implantate AG Annesha Lahiri
K182981 10/29/2018 Confirm Rx Insertable Cardiac Monitor Abbott Laura Sparks
K182950 10/23/2018 Acare Suction Unit Acare Technology Co., Ltd. Kevin Tsai
K183011 10/31/2018 Additive Orthopaedics Patient Specific 3D Locking Lattice Plates Additive Orthopaedics Gregory Kowalczyk
K182820 10/04/2018 The POD Advanced Facialdontics LLC Scott Simonetti
K182782 10/01/2018 DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric Alcon Laboratories, Inc. Martina Heim
K182902 10/16/2018 Precision1 Alcon Laboratories, Inc. Alicia Plesnarski
K182988 10/29/2018 Afinion HbA1c Dx on Afinion 2 Alere Technologies AS Monica Vallestad
K182808 10/03/2018 Aspida« Anterior Lumbar Plating System Alphatec Spine, Inc. Ruby Zheng
K182845 10/09/2018 minisono Alpinion Medical Systems Co., Ltd. Boyeon CHO
K182948 10/23/2018 Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs Ansell Healthcare Products, LLC. Don Cronk
K182992 10/29/2018 BGM014 Blood Glucose Monitoring System Apex Biotechnology Corp. Lisa Liu
K182804 10/02/2018 Traditional Length GJ Feeding Device Applied Medical Technology, Inc. Joy Tubero
K182815 10/03/2018 XVWeb 3D Apteryx, Inc. Mark Gniewek
K182779 10/01/2018 ARK EDDP Assay ARK Diagnostics, Inc. Cherry Mun
K182799 10/02/2018 Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads Arthrex Inc. David L Rogers
K182844 10/09/2018 ASAHI SASUKE Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K182878 10/15/2018 Integra Salto Total Ankle System Ascension Orthopedics Divya Savant
K182965 10/25/2018 BL-Cart IOL Delivery Cartridge AST Products, Inc. William Lee
K182982 10/29/2018 BridalVeil Navigated Instruments Astura Medical Parker Kelch
K182877 10/15/2018 HALF DOME Posterior Lumbar Interbody System Astura Medical, LLC Parker Kelch
K182971 10/26/2018 SpaceOAR Vue Hydrogel Augmenix, Inc Marcus Garcia
K182870 10/12/2018 Introcan Safety 3 Closed IV Catheter B. Braun Medical Inc. Tracy Larish
K182918 10/19/2018 Ballast 088 Long Sheath Balt USA LLC Bilal Chamas
K182886 10/15/2018 Cytomics FC 500 Series (MPL or MCL) Flow Cytometer Beckman Coulter Samy Puccio
DEN180055 10/09/2018 CARPEDIEM System Bellco srl (now part of Medtronic, Inc) Matteo Chiappini
K182919 10/19/2018 SI-Restore« Sacroiliac Joint Fixation System Biofusion Medical Rylan Reed
K182917 10/19/2018 FluoroCal Bisco, Inc Ryan Hobson
K182975 10/25/2018 MAKO 7 Boston Scientific Corporation Ibhina Sherchan
K182796 10/01/2018 WavelinQ 4F EndoAVF System C. R. Bard, Inc. Kulveen Dhatt
K182942 10/23/2018 Canon OCT-A1 Canon Inc. Tatsuya Yamazaki
K182901 10/16/2018 Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE Canon Medical Systems Corporation Paul Biggins
K183013 10/31/2018 Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation Paul Biggins
K182830 10/05/2018 Cardinal HealthTM Poly-Coated Open-Back Protective Gown Cardinal Health 200, LLC Caroline Miceli
K182790 10/01/2018 Cardio-TriTest v6.5 Cardio-Phoenix Inc. Marc Bisnaire
K183000 10/30/2018 ViperCath XC Peripheral Exchange Catheter Cardiovascular Systems, Inc. Erika Huffman
K182967 10/26/2018 Visor System Cerebrotech Medical Systems, Inc. Dawnel Scott
K182831 10/09/2018 SabreLine and SabreGuard Laser Fibers Coloplast Corp Cori Ragan
K182882 10/15/2018 CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control Conmed Corporation Orjada Dervishleri
K182955 10/24/2018 EZStart Interference Screw ConMed Corporation Jeremy Walter
K182832 10/09/2018 Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set Cook Incorporated Kotei Aoki
K182985 10/29/2018 Roadrunner PC Wire Guide, Olcott Torque Device Cook Incorporated Daniel J. Corbin
K182980 10/29/2018 Zilver 518 Biliary Stent, Zilver 635 Biliary Stent Cook Ireland Ltd Cathrina McHale
K182959 10/25/2018 Wallace Dual Lumen Oocyte Recovery System CooperSurgical Inc. Roaida Johnson
K182813 10/03/2018 COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT Cotton High Tech, SL Anna Garcia Llado
K182861 10/11/2018 Shiley Neonatal/Pediatric Tracheostomy Tube Covidien Yaara Basevitch
K182772 10/01/2018 Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil Covidien Jennie van Diemen
K182868 10/12/2018 INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor Covidien llc Samir Ibrahim
K182891 10/15/2018 TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants CS Medical L.L.C. Kendall Ashe
K182997 10/30/2018 enlighten III Laser System Cutera, Inc. Julia Brown
K182875 10/12/2018 DeepCT Deep01 Limited William Lai
K182783 10/01/2018 DePuy Synthes Trauma Orthopedic Nail Implants DePuy Synthes Elizabeth Jacobs
K182966 10/26/2018 PLANET Onco Dose DOSIsoft Marc Uszynski
K182977 10/26/2018 Isolette 8000 Plus Draeger Medical Systems, Inc. Karen Otrupchak
K182859 10/11/2018 Babyleo TN500 Dragerwerk AG & Co. KGaA Dr. Bettina Mobius
K183012 10/31/2018 vascuCAP Elucid Bioimaging Inc. Andrew Buckler
K182976 10/26/2018 SpringTMS eNeura« Inc. David Rosen
K182915 10/18/2018 ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube ENvizion Medical Ltd. Doron Besser
K182991 10/29/2018 EPIC Extremity Fusion Plate System EPIC Extremity, LLC Dan Schwartzbauer
K182873 10/12/2018 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices Ethicon, Inc. Ariell Joiner
K182773 10/01/2018 Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps Faulhaber Pinzetten OHG Dorothea Faulhaber
K183004 10/30/2018 WEGO-PGA RAPID Foosin Medical Supplies Inc., Ltd Lei Tang
K183001 10/30/2018 WEGO-PGLA RAPID Foosin Medical Supplies Inc., Ltd Lei Tang
K182836 10/09/2018 FUJIFILM Endoscope Model EG-740N FUJIFILM Corporation Randy Vader
K182825 10/04/2018 FUJIFILM Ultrasonic Endoscope FUJIFILM Corporation Randy Vader
K182854 10/10/2018 GC FujiCEM 2 (Improved) GC America Inc. Mark Heiss
K182819 10/04/2018 Decanting Device Gcmedica Enterprise Ltd., (WUXI) Mona Zhang
K182951 10/23/2018 Pristina Serena 3D GE Healthcare Nicole Landreville
K182838 10/09/2018 Geistlich Derma-Gide Geistlich Pharma AG Marco Steiner
K182811 10/03/2018 gel-e Flex+ gel-e, Inc. Elsa Abruzzo
K182987 10/29/2018 Genesys Spine 3DP Lumbar Interbody System Genesys Spine William W. Sowers
K182880 10/15/2018 Halifax Imaging Kit Halifax Biomedical, Inc. Crystal Jones
K183009 10/31/2018 HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES Hemostatix Medical Technologies, LLC Jeff Cobb
K182793 10/01/2018 AP3600 Automated Instrument Hitachi Chemical Diagnostics, Inc. Donald Postel
K182927 10/22/2018 Pulmonary Cytology Brush Hobbs Medical, Inc. Carlos O. Acosta
DEN180057 10/25/2018 IB-Stim Innovative Health Solutions (IHS), Inc. Tom Carrico
K182801 10/02/2018 Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable Integra LifeSciences Corporation Jennifer Siu
K182809 10/03/2018 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation MaryBeth Carson
K182956 10/24/2018 Puffin Lite Infant Resuscitation System International Biomedical Amy Pieper
K182946 10/23/2018 Invacare TDX SP2-HD with Captain's Seat Invacare Corporation Elijah Wreh
K182900 10/16/2018 3880 MRI Patient Monitoring System Iradimed Corporation Francis X. Casey
K182865 10/11/2018 Neodent Instruments Kits JJGC Industria e Comercio de Materiais Dentarios S.A. Julianne de Oliveira Capucho Lechechem
K182944 10/23/2018 Dr. Amplatz Micro Plug KA Medical, LLC John Oslund
K182789 10/01/2018 KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. Jennifer Damato
K182889 10/15/2018 KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. Jennifer Damato
K182840 10/09/2018 Element Pediatric Wheelchair Leggero llc Gabriela Romero
K182916 10/18/2018 Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr LeMaitre Vascular John N. Bradsher
K182795 10/01/2018 LENSAR Laser System - fs 3D (LLS-fs 3D) Lensar, Inc. Keith Peck
K182922 10/19/2018 MTS Omadacycline 0.002-32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K182853 10/10/2018 HORIZON TMS Therapy System Magstim Company Ltd. Tom Campbell
K182862 10/11/2018 Servo Guard Maquet Critical Care AB Elise Brun
K182887 10/15/2018 Masimo Rad-67 Pulse CO-Oximeter and Accessories Masimo Corporation Sindura Penubarthi
K182986 10/29/2018 Boston Keratoprosthesis, Type I Lucia Massachusetts Eye and Ear Infirmary d/b/a Boston James Chodosh
K182914 10/18/2018 MC3 Vascular Access Kit 21030 MC3 Incorporated Adam Viitala
K182837 10/09/2018 M.U.S.T. Mini Extension Medacta International SA Stefano Baj
K182794 10/01/2018 BionicGym Powered Muscle Stimulator Medical Currents Ltd Louis Crowe
K182812 10/03/2018 Medline Cautery Electrode (SILICONE) Medline Industries, Inc. Matt Clausen
K182941 10/23/2018 HEALIX ADVANCE SP PEEK Anchor Medos International SARL Elizabeth Messana
K182848 10/09/2018 ROSA ONE Spine application Medtech S.A. Serge Tabet
K182885 10/15/2018 AtlantisÖ Anterior Cervical Plate, DivergenceÖ Anterior Cervical Fusion System, PremierÖ Anterior Cervical Plate, VentureÖ Anterior Cervical Plate, ZephirÖ Anterior Cervical Plate System and ZevoÖ Anterior Cervical Plate System Medtronic Sofamor Danek USA, Inc. Kanesha Hines
K182928 10/22/2018 CD HorizonÖ Spinal System Medtronic Sofamor Danek USA, Inc. Raphael McInnis
K182957 10/24/2018 Heli-FX EndoAnchor System Medtronic Vascular, Inc. Janelle Wong Keller
K182810 10/03/2018 Distal Radius Plating System Miami Device Solutions, LLC Michelle Montesino
K182910 10/17/2018 Segmented Esophageal Stent System Micro-Tech (Nanjing) Co., Ltd. Becky Li
K182829 10/05/2018 Scepter Mini Occlusion Balloon Catheter MicroVention Inc. Marina Emond
K182929 10/22/2018 BIO-RAY A-1 Anchor Screw System Microware Precision Co., Ltd. Harrison Du
K182930 10/22/2018 PerioLase Nd:YAG Pulsed Dental Laser System Millennium Dental Technologies, Inc. Robert H. Gregg
K182989 10/29/2018 AURORAÖ Screw System MiRus, LLC Jordan Bauman
K182970 10/26/2018 EUROPAÖ Pedicle Screw System MiRus, LLC Jordan Bauman
K182920 10/19/2018 MiRusÖ Lumbar Interbody Fusion System consisting of CALLISTOÖ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERIONÖ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSOÖ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARESÖ PEEK Anterior Lumbar MiRus, LLC Jordan Bauman
K182995 10/30/2018 Bariatric Power Positioning System (BPPS) Motion Concepts Dona Bhamra
K182999 10/30/2018 General Cutting Contra Handpiece Nakanishi Inc. Kimihiko Satoh
K182776 10/01/2018 Neocis Guidance System Neocis Inc. Thomas E. Claiborne
K182958 10/24/2018 1.5T 16ch Breast Coil NeoCoil, LLC Katie Gonzalez
K182940 10/23/2018 Surdial DX Hemodialysis System Nipro Medical Corporation Jessica Oswald-McLeod
K182921 10/19/2018 Infinix Universal Composite Nobio Ltd. Inbal Beinglass Peled
K182907 10/17/2018 SPY Elite Intraoperative Perfusion Assessment System Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga
K182974 10/26/2018 NuVasive Reline System NuVasive, Incorporated Joseph De La Rosa
K182949 10/23/2018 HealixÖ Compression Screw System Nvision Biomedical Technologies, LLC Diana Langham
K182943 10/23/2018 VERTEX Nitinol Staple System Nvision Biomedical Technologies, LLC Diana Langham
K182851 10/10/2018 SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs O & M Halyard, Inc. Angela L. Bunn
K183016 10/31/2018 SteriCap Mini Needle OcuJet, LLC Rebecca K Pine
K182834 10/09/2018 CS-series-FP with Optional ROI Accessory CA-100S Omega Medical Imaging, LLC John Newman Newman
K182984 10/29/2018 MaxiTears Contacts PF Omnivision AG Joachim Kolter
K182964 10/25/2018 ROSA Knee System Orthosoft Inc. (d/b/a Zimmer CAS) Eric DesRosiers
K182881 10/15/2018 Bone Screw, Bone Tack Osstem Implant Co., Ltd. Jungmin Yoo
K183017 10/31/2018 Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer Osteoremedies LLC Chris Hughes
K182898 10/16/2018 TenoTac Soft Tissue Fixation System Paragon 28, Inc Eric Lintula
K182846 10/09/2018 PENTAX Medical EPK-3000 Video Imaging System PENTAX of America, Inc. William Goeller
DEN180056 10/11/2018 GSP Neonatal Creatine Kinase - MM kit PerkinElmer Inc. Brian Ciccariello
K183007 10/31/2018 EliA SmDP Immunoassay Phadia AB Carina Magnusson
K182926 10/22/2018 IntelliSpace Radiology Philips Healthcare Informatics, Inc. Paige Gridack
K182973 10/26/2018 DigitalDiagnost C90 Philips Medical Systems DMC GmbH Ming Xiao
K182888 10/15/2018 MRCAT Pelvis Philips Medical Systems MR Finland Janne Marvola
K182979 10/26/2018 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 Philips Medizin Systeme Boeblingen GmbH Markus Stacha
K182857 10/10/2018 EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. Kym Rupp
K182774 10/01/2018 STOP U (Packed Black USA), STOP U (Packed White USA) Pollogen Ltd. Einat Shammai
K182781 10/01/2018 PTS Professional Chemistry Kit Polymer Technology Systems, Inc. d/b/a PTS Diagnostics Samuel Engelman
K182855 10/10/2018 ProKnow DS ProKnow LLC Salvadore Gerace
K183018 10/31/2018 VPro5 Propel Orthodontics LLC Bryce Way
K182814 10/03/2018 Rael Tampon Rael, Inc. Binna Won
K182805 10/02/2018 RCT800 RAY Co., Ltd Changhwan Lee
K182960 10/25/2018 ReliefBand ReliefBand Technologies LLC Barbara Whitman
K182778 10/01/2018 LC GLOSSFILL XR S&C Polymer Silicon- und Composite Spezialitaeten GmbH Christian Boettcher
K182780 10/01/2018 XP Composite S&C Polymer Silicon- und Composite Spezialitaeten GmbH Christian Boettcher
K182892 10/15/2018 TRAUS Dental Handpieces Saeshin Precision Co., Ltd. Choi Jong Woo
K182894 10/15/2018 HM70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Scully Kim
K182932 10/22/2018 RS85 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K182905 10/16/2018 UniPulse Seaward Group Jim Wallace
K182938 10/23/2018 Emission Computed Tomography System Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K183014 10/31/2018 uPMR 790 Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K182871 10/12/2018 Mini TENS Therapy Device Shenzhen Jumper Medical Equipment Co., Ltd. Tom Tom
K182839 10/09/2018 Lifetech Cardio Model 8301 Temporary Pacemaker Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Stephy Pan
K182821 10/04/2018 Accutorr 7/VS-900/VS-900c Vital Signs Monitor Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K182869 10/12/2018 Fit SA Shofu Dental Corporation Mauro Malzyner
K182983 10/29/2018 iFuse Implant System« SI-BONE, Inc. Roxanne Dubois
K182904 10/16/2018 syngo.MR Applications Siemens Medical Solutions USA, Inc. Cordell L. Fields
K182998 10/30/2018 Andorate Auxiliary Water Connector Smartdata Suzhou Co., Ltd Cindy Ye
K183010 10/31/2018 Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks Smith & Nephew, Inc. Brad Sheals
K182954 10/24/2018 SalvoÖ Spine System Spine Wave, Inc. Amy Noccioli
K182874 10/12/2018 Fenom Pro Nitric Oxide Test Spirosure, Inc. Ryan Leard
K182827 10/05/2018 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 STERIS Corporation Marcia L. Benedict
K182931 10/22/2018 VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag Steris Corporations Jennifer Nalepka
K182968 10/26/2018 Hoffmann LRF System Stryker GmbH Jackie Perri
K183019 10/31/2018 SIS Software version 3.3.0 Surgical Information Sciences, Inc. Ann Quinlan-Smith
K182828 10/05/2018 Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K182826 10/05/2018 Ormco Spark Aligner System Sybron Dental Specialties Mey Saied
K182947 10/23/2018 Dental Pain Eraser Synapse Dental, LLC Cosmo Haralambidis
K182817 10/03/2018 CottonDay Tampon Taebong Co., Ltd Ha Neul Jeong
K182934 10/22/2018 FORA P100 Blood Pressure Monitoring System TaiDoc Technology Corporation Diana Sung
K182822 10/04/2018 Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System Taiwan Aulisa Medical Devices Technologies, Inc. Paul Liu
DEN180058 10/29/2018 t:slim X2 insulin pump with interoperable technology Tandem Diabetes Care, Inc. Michael Sarrasin
K182847 10/09/2018 Hudson RCI Voldyne Volumetric Exerciser Teleflex Medical, Inc Sirisha Kommana
K182833 10/09/2018 ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer The Argen Corporation Craig Jolicoeur
K182797 10/01/2018 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 ?g/mL Thermo Fisher Scientific Cynthia Knapp
K182909 10/17/2018 Roth Net Retriever Product Line United States Endoscopy Group, Inc. Carroll Martin
K182937 10/22/2018 Upstream GoBack Crossing Catheter Upstream Peripheral Technologies, Ltd. Dan Rottenberg
K182876 10/12/2018 Uro-N Cystoscope UroViu Corporation Thomas Lawson
K182897 10/16/2018 Velano Vascular Q2 Extension Set Velano Vascular Tiffini Wittwer
K182798 10/02/2018 KIDScore D3 Vitrolife A/S Belinda Dueholm
K182972 10/26/2018 Phoenix Atherectomy System Volcano AtheroMed Inc. Jean Chang
K182872 10/12/2018 LINK GEMINI SL Total Knee System Waldemar Link GmbH & Co. KG Andre von Malotki
K182924 10/19/2018 Diode Laser Treatment System Weifang KM Electronics Co., LTD Andy Pang
K182895 10/15/2018 Wilson-Cook Achalasia Balloon Wilson-Cook Medical, Inc Theresa de Prat
K182823 10/04/2018 PRODENSE Bone Graft Substitute Wright Medical Technology, Inc. Alayne Melancon
K182908 10/17/2018 Ziacom Dental Implant Systems Ziacom Medical SL Olegario Cuevas
K182963 10/25/2018 emFieldPro Zimmer MedizinSysteme GmbH Ute Hauss


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