FDA 510(k) Decisions During December, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K181838 12/20/2018 Sinusway Dilation System 3NT Medical Ltd. Ehud Bendory
K183128 12/12/2018 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 Abbott Cody Johnson
K181908 12/03/2018 Action Trackchair Action Manufacturing Inc. Alan Macht
K181405 12/10/2018 Hailie Sensor Adherium (NZ) Ltd Chris Mander
K182404 12/27/2018 STERRAD VELOCITY Biological Indicator Advanced Sterilization Products (ASP) Sun Choi
K182032 12/21/2018 SterilContainer S System Aesculap, Inc. Paul Amudala
K182664 12/07/2018 FiXcision Agency for Medical Innovations GmbH Martin Hohlrieder
K182902 12/11/2018 Precision1 Alcon Laboratories, Inc. Alicia Plesnarski
K180826 12/21/2018 Natrelle 133 Plus MICROCELL Tissue Expander Allergan Melissa Pathmajeyan
K182845 12/27/2018 minisono Alpinion Medical Systems Co., Ltd. Boyeon CHO
K180867 12/28/2018 AmCAD-UO AmCad BioMed Corporation Jack Yang
K182593 12/18/2018 KET-1 Blood Ketone Monitoring System Apex Biotechnology Corp. Lisa Liu
K181756 12/18/2018 Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle AprioMed AB Katrin Svensson
K182681 12/14/2018 AC5 Topical Gel Arch Therapeutics, Inc. Terrence W. Norchi
K182280 12/10/2018 ARK Tramadol Assay ARK Diagnostics, Inc. Cherry Mun
K181935 12/04/2018 Endoform Reconstructive Template - Non Absorbable Aroa Biosurgery Ltd. Tina O'Brien
K182361 12/18/2018 Arthrex Compression FT Screws Arthrex Inc. Rebecca R. Homan
K181555 12/21/2018 Arthrex Fracture Adapter Hemi Shoulder Prosthesis Arthrex Inc. David L. Rogers
K180768 12/14/2018 Arthrex SwiveLock Anchors Arthrex Inc. Jessica L. Singelais
K182420 12/20/2018 ASAHI Corsair Pro XS Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K182878 12/18/2018 Integra Salto Total Ankle System Ascension Orthopedics Divya Savant
K183065 12/04/2018 Coolrail Linear Pen AtriCure, Inc. Caitlin Wunderlin
K182012 12/21/2018 ADVIA Centaur Calcitonin (CALCT) assay Axis-Shield Diagnostics Limited Claire Dora
K182320 12/20/2018 BD Contoured Base Pen Needle Becton, Dickinson and Company Meriam Youssef
K181766 12/10/2018 VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance bioMerieux, Inc Cherece L. Jones
K181412 12/21/2018 VITEK MS bioMerieux, Inc. Jennifer Jines
K183162 12/14/2018 Affixus Hip Fracture Nail Biomet Inc. Dhaval Saraiya
K183265 12/13/2018 Selectra Catheters, Selectra Accessory Kit Biotronik, Inc. Jon Brumbaugh
K183080 12/10/2018 Mega Plus Spine System BK Meditech Co., Ltd Meredith Lee May
K182065 12/13/2018 EVOLUX CAD/CAM PMMA BLOCKS Blue Dent Dental Adriana Paula T I Gomes
K181785 12/19/2018 Modified BrainScope One BrainScope Company Inc. Michael E Singer
K180359 12/13/2018 BTL-FR2000 BTL Industries, Inc. David Chmel
K182601 12/14/2018 Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation Paul Biggins
K181174 12/11/2018 Cardinal Health Sterilization Wrap Cardinal Health 200 LLC Jillian Connery
K182790 12/14/2018 Cardio-TriTest v6.5 Cardio-Phoenix Inc. Marc Bisnaire
K182397 12/13/2018 Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Cardiovascular Systems Inc. Kris Miller
K183000 12/29/2018 ViperCath XC Peripheral Exchange Catheter Cardiovascular Systems, Inc. Erika Huffman
K182424 12/18/2018 NuFACE FIX Skin Toning Device Carol Cole Company dba NuFACE Donald Ellis
K182149 12/19/2018 FFRangio System CathWorks Ltd Miriam Ivenshitz
K180014 12/21/2018 Creme de La Femme Feminine Lubricant Cewal, Inc. dba Premiere Enterprises Jerome Vozoff
K181344 12/14/2018 C.T.M Mobility Scooter CHIEN TI ENTERPRISE CO., LTD. Vivian Lo
K182339 12/12/2018 LEUCADIA AUTOLOKÖ Pedicle Screw System ClearView Orthopedic Development, LLC Hartmut Loch
K182116 12/19/2018 BA310 Abutment, BIA310 Implant/Abutment Cochlear Americas Beth Murray
K182831 12/10/2018 SabreLine and SabreGuard Laser Fibers Coloplast Corp Cori Ragan
K181120 12/21/2018 2.8 mm/3.3 mm PopLok Suture Anchors ConMed Corporation Diana L. Nader-Martone
K182446 12/19/2018 TruShot with Y-Knot All-Suture Anchor ConMed Corporation Diana L. Nader-Martone
K181529 12/06/2018 Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection Contego Medical, LLC Elizabeth Saylors
K181463 12/13/2018 DuraSheath Introducer Sheath System Contract Medical International GmbH Jan Kloboucnik
K180846 12/19/2018 Arterial Pressure Monitoring Set/Tray Cook Incorporated Johnathan Liu
K183036 12/20/2018 Dilator Sets Cook Incorporated David Lehr
K182709 12/26/2018 One-Step Suprapubic Introducer Cook Incorporated Carly Powell
K180830 12/20/2018 Reuter Tip Deflecting Wire Guide Cook Incorporated Jennifer L. Allman
K181920 12/11/2018 Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker CooperVision, Inc. Marie Dutton
K183239 12/19/2018 CoreLink F3DÖ Lateral System Corelink, LLC Steven Mounts
K183369 12/28/2018 COR12 ECG Corscience GmbH & Co. Karlheinz Trost
K182008 12/14/2018 Phasix ST Mesh with Echo 2 Positioning System CR Bard Inc. Shirin Mate
K180820 12/14/2018 Tono Vue Non-Contact Tonometer Crystalvue Medical Corporation Oliver Lin
K180797 12/14/2018 Xcess Guiding Catheter Curatia Medical Co. Jessica Chiu
K181589 12/20/2018 Curiteva Lumbar Interbody Fusion System Curiteva, LLC Eric Linder
K182997 12/12/2018 enlighten III Laser System Cutera, Inc. Julia Brown
K180859 12/13/2018 PYRAMIDION Dental Implants and Prostheses DenTack Implants Ltd Tali Hazan
K180657 12/07/2018 Resin for Temporary Crown & Bridge Dentis Co., Ltd. Dong-Hun Jang
K182422 12/18/2018 Lucitone Denture Base Materials Dentsply Sirona Karl Nittinger
K182783 12/26/2018 DePuy Synthes Trauma Orthopedic Nail Implants DePuy Synthes Elizabeth Jacobs
K181231 12/06/2018 DePuy Synthes T-PAL Spacer System DePuy Synthes Spine Heta Shah
K182150 12/18/2018 Devon 52 Sequential Compression Device Devon Medical Products (Jiangsu) Ltd Neil Cheng
K182698 12/26/2018 LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device DiaSorin Inc. John C. Walter
K183223 12/19/2018 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack DiaSorin Molecular LLC Sharon Young
K181037 12/21/2018 DIO CAD/CAM Abutment DIO Corporation Jiae Park
K182194 12/14/2018 UV Active Implant System DIO Corporation Park Jiae
K180380 12/21/2018 vital signs monitor Edan Instruments, Inc. Alice Yang
K181498 12/10/2018 X-ray Imaging System for the McLaren Proton Treatment System EhmetDx, LLC Daniel Schoettlin
K182076 12/04/2018 Elekta Unity Elekta Limited Nicholas Power
K183037 12/04/2018 Monaco RTP System Elekta, Inc Kathryn Stinson
K183034 12/04/2018 MOSAIQ Oncology Information System Elekta, Inc Faiza Ahmed
K183012 12/21/2018 vascuCAP Elucid Bioimaging Inc. Andrew Buckler
K181861 12/20/2018 Embrace Empatica Srl Simone Tognetti
K183191 12/04/2018 6420 Ultrasound System Esaote, S.p.A. Massimo Polignano
K182680 12/06/2018 KerraContact Ag Perf Advanced Perforated Silver Wound Dressing Exciton Technologies, Inc. Melanie Ussyk
K183123 12/20/2018 microTargeting Guideline 4000 5.0 System FHC, Inc. Kelly Moeykens
K181690 12/21/2018 Clear-Jet Injection Catheter Finemedix Co. Ltd. Hee Kyung Kwon
K181583 12/07/2018 Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Si Flexicare Medical Limited Joel Biddle
K183307 12/11/2018 Magma Spark Pro (Magma Spark Plus, Alpha) Formatk Systems Ltd. Amit Goren
K183059 12/21/2018 3nethra neo Forus Health Pvt. Ltd. Shruti Kashinath
K180831 12/10/2018 CATSmart Fresenius Kabi AG Barry G. Hicks
K180615 12/04/2018 AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter Fresenius Kabi USA LLC Kim Forch
K182419 12/14/2018 Centricity Universal Viewer GE Healthcare Renee Webb
K183116 12/06/2018 Unity Network ID GE Healthcare Brandon O'Shea
K182750 12/21/2018 4D View GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K181727 12/06/2018 Vivid iq GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K181663 12/20/2018 ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel GenMark Diagnostics, Incorporated Alan Maderazo
K182690 12/21/2018 ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel GenMark Diagnostics, Incorporated Beth Stofka
K180679 12/07/2018 CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Conc Global Scientific Technologies, LLC William J. Griswold, Jr.
K181357 12/06/2018 PATRIOT« Lumbar Spacers, SUSTAIN« Spacers Globus Medical Inc. Kelly Baker
K180909 12/18/2018 REVEL Spacers Globus Medical Inc. Kelly J. Baker
K182701 12/03/2018 Wondfo T-Cup Multi-Drug Urine Test Cup Guangzhou Wondfo Biotech Co., Ltd. Bin Chen
K181087 12/18/2018 Apex Locator, DPEX III Guilin Woodpecker Medical Instrument Co., Ltd. Xunxian Wu
K183068 12/21/2018 Nitrile Glove Powder Free White Haining Medical Products Co., Ltd. Zhiming Yao
K182068 12/13/2018 Erran Dental Zirconia Hangzhou Erran Technology Co., Ltd. Tingkai Li
K180578 12/12/2018 Harvest Dental Polymer Blocks Harvest Dental Products, LLC Sasha Der Avanessian
K182035 12/06/2018 FFRct HeartFlow, Inc Windi Hary
K183253 12/18/2018 ValPro 2 Plus, VaPro 2 Plus Pocket Hollister Incorporated Michelle Schiltz-Taing
K182006 12/06/2018 Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths Hologic, Inc Rachelle D. Fitzgerald
K181294 12/14/2018 Honda Walking Assist Device Honda Motor Company, Ltd. Kazushi Hamaya
K182479 12/04/2018 NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus Hycor Biomedical Tara Viviani
K182373 12/06/2018 PowerLook Tomo Detection V2 Software iCAD Inc. John DeLucia
K182167 12/21/2018 The ICHOR Panacea Vascular Embolectomy Catheter System ICHOR Vascular, Inc. Jeff Blair
K180670 12/07/2018 ICONN Campbell Interference Screw ICONN Orthopedics, LLC Whitt Israel
K183145 12/13/2018 IlluminOss Photodynamic Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K183198 12/17/2018 FlowTriever Retrieval/Aspiration System Inari Medical Eben Gordan
K181703 12/28/2018 Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments Institut Straumann AG Viviana Horhoiu
K182809 12/07/2018 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation MaryBeth Carson
K183107 12/11/2018 Intuitive Surgical Vessel Sealer Extend Intuitive Surgical, Inc. Kunal Gunjal
K182946 12/11/2018 Invacare TDX SP2-HD with Captain's Seat Invacare Corporation Elijah Wreh
K182900 12/14/2018 3880 MRI Patient Monitoring System Iradimed Corporation Francis X. Casey
K182130 12/27/2018 iSchemaView RAPID iSchemaView, Inc. Jim Rosa
K181374 12/14/2018 NRFit Syringe Jiangsu Caina Medical Co., Ltd Jun Lu
K181331 12/21/2018 JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White Juvora, Ltd. Tim Leyva
K182473 12/12/2018 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems K2M Inc. Nancy Giezen
K182688 12/18/2018 SKR 3000 KONICA MINOLTA, INC. Tsutomu Fukui
K181958 12/06/2018 MagnetOs Putty Kuros Biosciences B.V. Yvonne P. Bovell
K183168 12/11/2018 OpenLoc-L Spinal Fixation System L&K Biomed Co., Ltd. Jihyeon Seo
K183348 12/17/2018 Reusable Silicone Cover CPRmeter 2 Laerdal Medical AS Mari Kaada
K182045 12/27/2018 Lotus III Multi-Pulsed Er: Yag Laser System Laseroptek Co., Ltd. Hong Chu
K183102 12/07/2018 BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody Leica Biosystems Newcastle Limited Jeremy Allen
K183100 12/07/2018 Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra Leica Biosystems Newcastle Limited Jeremy Allen
K182795 12/21/2018 LENSAR Laser System - fs 3D (LLS-fs 3D) Lensar, Inc. Keith Peck
K183286 12/07/2018 17HK701G-W LG Electronics Inc. Jinhwan Jun
K181625 12/11/2018 Life Spine ResoluteÖ Threaded Cage System Life Spine Inc. Angela Batke
K182099 12/26/2018 Delta TT Pro Limacorporate S.p.A. Roberto Gabetta
K181159 12/03/2018 LZI Fentanyl Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K182354 12/14/2018 SafeAir Telescopic Smoke Pencil LiNA Medical ApS Natalia Szychulska
K183115 12/20/2018 MTS Levofloxacin 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K182922 12/14/2018 MTS Omadacycline 0.002-32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K180945 12/10/2018 LUTRONIC GENIUS Radiofrequency System Lutronic Corporation Jhung Won Vojir
K182434 12/13/2018 LaparoGuard Mariner Endosurgery Inc. Mitch Wilson
K181826 12/10/2018 Glenoid Polyaxial Non-locking Screws Medacta International SA Stefano Baj
K181970 12/04/2018 MectaLIF Posterior Extension Medacta International SA Stefano Baj
K182812 12/12/2018 Medline Cautery Electrode (SILICONE) Medline Industries, Inc. Matt Clausen
K182610 12/19/2018 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device Medtronic Kari Christianson
K182242 12/26/2018 VO200 û NeurOs Cerebral Oximetry System Mespere LifeSciences Inc. Rebecca S. Li
K180772 12/17/2018 Met One Czar Anterior Cervical Plate System Met One Technologies Evan Carbonell
K182810 12/10/2018 Distal Radius Plating System Miami Device Solutions, LLC Michelle Montesino
K183185 12/18/2018 Riptide Aspiration System (Riptide Large Bore Aspiration System) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Nancy Drew
K182556 12/14/2018 SureClip Repositionable Hemostasis Clip Micro-Tech (Nanjing) CO., Ltd. Becky Li
K182125 12/06/2018 EVOLUTION Stemmed CS Femur MicroPort Orthopedics Inc. Hunter Ethan Williams
K182624 12/18/2018 MIM - MRT Dosimetry MIM Software Inc. Lynn Hanigan
K182207 12/14/2018 TR90BH MinXray, Inc Keith Kretchmer
K182016 12/06/2018 Simplicit90Y Mirada Medical Ltd. Sarah Bond
DEN180007 12/21/2018 Miris Human Milk Analyzer Miris AB Elin Hallen
K182989 12/18/2018 AURORAÖ Screw System MiRus, LLC Jordan Bauman
K180828 12/20/2018 Natureplex Warm Touch Warming Jelly Natureplex, LLC Pamela Hopkins
K182178 12/13/2018 neoBLUE blanket LED Phototherapy System Natus Medical Incorporated Judy Buckham
K182776 12/21/2018 Neocis Guidance System Neocis Inc. Thomas E. Claiborne
K181695 12/07/2018 Nihon Kohden NKV-550 Series Ventilator System Nihon Kohden OrangeMed, Inc. Sheryl Higgins
K183069 12/04/2018 NobelZygoma 0? Nobel Biocare AB Charlemagne Chua
K181869 12/12/2018 On1 Universal Abutment Nobel Biocare AB Charlemagne Chua
K183169 12/27/2018 Pulse 2.0, Pulse Pro 2.0 NormaTec Industries, LP Albert G. Sanford
K183328 12/21/2018 Pulse Rx 2.0, Pulse Pro Rx 2.0 NormaTec Industries, LP Albert G. Sanford
K182549 12/13/2018 StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation Khushboo Surendran
K182552 12/13/2018 StatStrip Xpress Glucose Hospital Meter System Nova Biomedical Corporation Khushboo Surendran
K182387 12/17/2018 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) Novo Nordisk Inc. Elizabeth D'Amato
K182949 12/04/2018 HealixÖ Compression Screw System Nvision Biomedical Technologies, LLC Diana Langham
K182454 12/20/2018 O2 Concepts Oxlife Independence Model 301-0001 O2 Concepts LLC Kathryn G. Forgione
K183267 12/20/2018 DyeVertÖ NG Contrast Reduction System, DyeVertÖ PLUS EZ Contrast Reduction System, DyeTectÖ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVertÖ PLUS EZ Contrast Reduction System Osprey Medical, Inc. Melanie Hess
K182296 12/14/2018 HyperFil-LV Parkell, Inc. David Mott
K182747 12/18/2018 EliA RF IgM Immunoassay Phadia AB Carina Magnusson
K183007 12/24/2018 EliA SmDP Immunoassay Phadia AB Carina Magnusson
K182926 12/06/2018 IntelliSpace Radiology Philips Healthcare Informatics, Inc. Paige Gridack
K183101 12/31/2018 Zenition 50 Philips Medical Systems Nederland BV Sumit Kumar
K183040 12/06/2018 Zenition 70 Philips Medical Systems Nederland BV Sumit Kumar
K181825 12/04/2018 CAAS MR Solutions Pie Medical Imaging B.V. Annemiek Bouts
K182781 12/21/2018 PTS Professional Chemistry Kit Polymer Technology Systems, Inc. d/b/a PTS Diagnostics Samuel Engelman
K182670 12/20/2018 FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute Prosidyan, Inc Charanpreet S. Bagga
K183111 12/07/2018 Contour 24 Quality Electrodynamics, LLC Eric Yeh
K182564 12/27/2018 Quantib ND Quantib BV Floor van Leeuwen
K182668 12/14/2018 Rapid Reboot Compression Therapy System Rapid Reboot Recovery Products, LLC David Johnson
K182805 12/14/2018 RCT800 RAY Co., Ltd Changhwan Lee
K182007 12/07/2018 Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System Renovis Surgical Technologies Anthony DeBenedictis
K181372 12/13/2018 Argos Retia Medical, LLC Marc Zemel
K180999 12/11/2018 Mygen V-1000 RF System RF Medical Co., Ltd Kwang S. Choi
K181269 12/14/2018 iCertainty Rfpi Jeffery Basham
K181131 12/13/2018 Accu-Chek Guide Me Blood Glucose Monitoring System Roche Diabetes Care Ginger Emrich
K182512 12/10/2018 Route 92 Medical Delivery Catheter Route 92 Medical Inc. Kathy Tansey
K182183 12/07/2018 GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A Samsung Electronics Co., LTD. Jaesang Noh
K182595 12/18/2018 HERA W10 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K181336 12/04/2018 HS50 / HS60 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K182905 12/14/2018 UniPulse Seaward Group Jim Wallace
K180762 12/14/2018 CAPI 3 HEMOGLOBIN(E) SEBIA Karen Anderson
K182001 12/17/2018 Acucy Influenza A&B Test with the Acucy System Sekisui Diagnostics, LLC Shelly Harris
K181744 12/11/2018 BI-MENTUM dual mobility system Serf Jean-Lus Aurelle
K182938 12/18/2018 Emission Computed Tomography System Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K180878 12/17/2018 BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Tes Shanghai Venture Bio-Tech CO., Ltd. Longli Long
K180879 12/14/2018 BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use SHANGHAI VENTURE BIO-TECH CO., LTD. Longli Long
K182190 12/19/2018 Fetal Doppler Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao
K182755 12/21/2018 Disposable Temperature Probe Shenzhen Caremed Medical Technology Co., Ltd. Alan Xie
K182433 12/17/2018 Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff Shenzhen Caremed Medical Technology Co., Ltd. Alan Xie
K181967 12/10/2018 Disposable Temperature Probe Shenzhen Launch Electrical Co., LTD Jiaan Huang
K182075 12/10/2018 BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai
K182165 12/20/2018 Color Doppler Ultrasound System; Model: mEye1 and mEye2 Shenzhen Well.D Medical Electronics Co., LTD. Ning Bai
K181496 12/18/2018 VINTAGE PRO Shofu Dental Corporation Mauro Malzyner
K180754 12/07/2018 C-Zero Pedicle Screw System, Freedom Pedicle Screw System Signature Orthopaedics Pty Ltd. Declan Brazil
K181899 12/13/2018 ROCCIA« PLIF Silony Medical GmbH Bircan Tasdelen
K182146 12/03/2018 Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set Sol-Millennium Medical, Inc. James Barley
K180653 12/04/2018 Spartan eCoil System Spartan Micro, Inc Mark Dias
K182584 12/10/2018 Lucent« XP Spinal Elements Inc Cheryl Allen
K182954 12/12/2018 SalvoÖ Spine System Spine Wave, Inc. Amy Noccioli
K181865 12/14/2018 Acu-sInQ Complete Endoscope Cleaning Aid System STERIS Corporation Gregory Land
K182724 12/10/2018 CelerityTM 10 STEAM Chemical Indicator STERIS Corporation Eileen McCafferty
K182359 12/13/2018 HipCheck Stryker Corp. Cara Mellits
K181752 12/21/2018 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation Kristi Ashton
K182438 12/06/2018 Synthetic Polyisoprene Lubricated Male Condom - 5 senses Sxwell Usa LLC Robert Mahler
K182156 12/10/2018 Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs Syntex Healthcare Products Co., Ltd Qiao Zhiqiang
K180821 12/21/2018 TruMatch Graft Cage - Long Bone Synthes (USA) LLC Christopher J. Medberry
K181675 12/10/2018 FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System TaiDoc Technology Corporation Yvette Chang
K180863 12/19/2018 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator TaiDoc Technology Corporation Sylvia Liu
K182491 12/10/2018 Applanation tonometer AT-2 Takagi Seiko Co., Ltd. Shinya Kitamura
K182506 12/10/2018 LipiScan Dynamic Meibomian Imager TearScience, Inc. Christy Coleman
K182736 12/28/2018 OIC Suture Anchor System The Orthopaedic Implant Company Douglas Fulton
K182682 12/21/2018 OrthoGold 100 Tissue Regeneration Technologies John Warlick
K182461 12/27/2018 LATITUDE EV Total Elbow Arthroplasty Tornier Inc. Renee Stoffel
K180889 12/07/2018 Tractus Crossing Support Catheter Tractus Vascular LLC Janet Burpee
K183098 12/06/2018 Senhance Surgical System TransEnterix, Inc. Michele Jans
K181612 12/17/2018 Tyto Stethoscope (OTC) Tyto Care Ltd. Stella Raizelman Perry
K183383 12/12/2018 ANAXÖ OCT Spinal System U & I Corporation Young Eun Lee
K181824 12/13/2018 CBT Screw Fixation System U&i Corporation Jee-Ae Bang
K183212 12/07/2018 Nexus DR Digital X-ray Imaging System with stitching Varex Imaging Corporation Michael Van Ryn
K180175 12/07/2018 SignalMark Lung Biopsy Site Marker ViewPoint Medical, Inc. Thomas Kane
K180204 12/28/2018 CranioMaxillofacial Fixation (CMF) System - CMF Visionare Visionare LLC Mariane de Oliveira Quinzani
K181877 12/17/2018 Phoenix 2.4mm Atherectomy Plus System Volcano AtheroMed Inc. Jean Chang
K182972 12/20/2018 Phoenix Atherectomy System Volcano AtheroMed Inc. Jean Chang
K180533 12/10/2018 Procellera Composite Antibacterial Wound Dressing Vomaris Wound Care, Inc. Charmaine Sutton
K182038 12/10/2018 URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer YD Diagnostics Corporation Hyuckjoo Lee
K181641 12/24/2018 QuikClot Radial Z-Medica, LLC Sheila K. Wallin
K181107 12/06/2018 Elevo« Kit Snoring Intervention Device Zelegent, Inc. David C. Humbert
K181827 12/14/2018 Affixus Natural Nail System Humeral Nail Zimmer GmbH Robert Tommasini
K182048 12/07/2018 Avenir Complete Hip System Zimmer, Inc Rebecca D Noftz
K181761 12/26/2018 Zimmer Biomet Select Ceramic Heads Zimmer, Inc Carol Vierling


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