FDA 510(k) Applications Received During September, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K182644 09/24/2018 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 Abbott Cody Johnson
K182687 09/26/2018 Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System ACCURAY INCORPORATED Keith Picker
K182477 09/10/2018 Cervical Spacer Additive Implants, LLC Jeff Horn
K182466 09/10/2018 AOS Calcaneal Plating System Advanced Orthopaedic Solutions Elaine Nguyen
K182404 09/04/2018 STERRAD VELOCITY Biological Indicator Advanced Sterilization Products (ASP) Sun Choi
K182527 09/14/2018 ELAN 4 Tools Aesculap, Inc. Kathy A. Racosky
K182664 09/25/2018 FiXcision Agency for Medical Innovations GmbH Martin Hohlrieder
K182746 09/28/2018 ATEC ALIF and LLIF Spacer System Alphatec Spine, Inc. Cynthia Adams
K182594 09/20/2018 E-CUBE i7 Alpinion Medical Systems Co., Ltd. Boyeon Cho
K182593 09/20/2018 KET-1 Blood Ketone Monitoring System Apex Biotechnology Corp. Lisa Liu
K182653 09/25/2018 Voyant Maryland Fusion Device Applied Medical Resources Corp. Andrew Nguyen
K182409 09/04/2018 Applied Tissue Technologies PWDÖ Platform Wound Dressing Applied Tissue Technologies LLC Michael Broomhead
K182681 09/26/2018 AC5 Topical Gel Arch Therapeutics, Inc. Terrence W. Norchi
K182391 09/04/2018 ASI Automated ASI RPR Test for Syphilis on the ASI Evolution Arlington Scientific, Inc. (ASI) David Binks
K182420 09/05/2018 ASAHI Corsair Pro XS Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K182418 09/05/2018 V3 Segmental Plating System Atlas Spine, Inc. Thomas Smith
K182565 09/18/2018 AtriCure cryoICE cryoSPHERE cryoablation probe AtriCure, Inc. Jonathan McElwee
K182392 09/04/2018 Frozen C B.M. Tech. Worldwide Co., Ltd. Jenny Cho
K182651 09/24/2018 HbA1c Advanced Beckman Coulter Ireland Inc. Catriona Hourigan
K182692 09/27/2018 BD MAX CTGCTV2, BD MAX System Becton, Dickinson and Company Katie Edwards
K182600 09/21/2018 Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Better Care Plastic Technology Co., Ltd Zhu Chuyan
K182764 09/28/2018 Biop Digital Colposcope Biop Medical Ltd. Ilan Landesman
K182706 09/27/2018 External upper limb tremor stimulator Cala Health, Inc. Scott A. Wilson
K182415 09/04/2018 Alphenix, INFX-8000F/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K182546 09/17/2018 Alphenix, INFX-8000H/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K182427 09/06/2018 Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System Canon Medical Systems Corporation Paul Biggins
K182679 09/26/2018 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 Canon Medical Systems Corporation Paul Biggins
K182601 09/21/2018 Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation Paul Biggins
K182596 09/20/2018 Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System Canon Medical Systems Corporation Paul Biggins
K182397 09/04/2018 Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Cardiovascular Systems Inc. Kris Miller
K182424 09/06/2018 NuFACE FIX Skin Toning Device Carol Cole Company dba NuFACE Donald Ellis
K182500 09/12/2018 Catalyst CSR Press-Fit Humeral Components Catalyst OrthoScience, Inc. Dale Davison
K182721 09/28/2018 Choice Spine Navigation System Choice Spine, LP. Kim Finch
K182757 09/28/2018 Espire Elbow Pro, Espire Elbow Hybrid College Park Industries, Inc. Deborah Mackmin
K182621 09/24/2018 CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver ConMed Corporation Diana L. Nader-Martone
K182446 09/07/2018 TruShot with Y-Knot All-Suture Anchor ConMed Corporation Diana L. Nader-Martone
K182439 09/07/2018 TruShot with Y-Knot Shallow All-Suture Anchor ConMed Corporation Diana L. Nader-Martone
K182709 09/27/2018 One-Step Suprapubic Introducer Cook Incorporated Carly Powell
K182451 09/07/2018 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Covidien, LLC Rebecca Clark
K182741 09/28/2018 SculpSure Cynosure Amy Tannenbaum
K182422 09/06/2018 Lucitone Denture Base Materials Dentsply Sirona Karl Nittinger
K182405 09/04/2018 Dexcom Pro Q Continuous Glucose Monitoring System Dexcom, Inc Luke Olson
K182698 09/27/2018 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
K182467 09/10/2018 Simplexa GBS Direct, Simplexa GBS Positive Control Pack DiaSorin Molecular LLC Sharon Young
K182480 09/10/2018 Earlens Contact Hearing Aid Earlens Corporation Judith A. Brimacombe
K182591 09/20/2018 RadiForce RX360, RX360-AR EIZO Corporation Hiroaki Hashimoto
K182490 09/11/2018 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Sonia Callegaro
K182444 09/07/2018 ERBEFLO Olympus Scope Port Connector Erbe USA, Inc. John Tartal
K182744 09/28/2018 HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High EUROTROL B.V. Mylene de Boer
K182753 09/28/2018 A6 OTC Pain Relief TENS Everyway Medical Instruments Co., Ltd. Paul Hung
K182767 09/28/2018 V2 OTC Pain Relief TENS Everyway Medical Instruments Co., Ltd. Paul Hung
K182478 09/10/2018 Whistler Modular Pedicle Screw System Evolution Spine, LLC Douglas Davis
K182462 09/10/2018 Exactech Alteon Highly Polished Femoral Stem Exactech, Inc. Zach Sharrah
K182536 09/14/2018 Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap Exactech, Inc. Zach Sharrah
K182680 09/26/2018 KerraContact Ag Perf Advanced Perforated Silver Wound Dressing Exciton Technologies, Inc. Melanie Ussyk
K182663 09/25/2018 Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System FineMEC Co., Ltd. William H. McGrail
K182684 09/26/2018 HammerTechTM Fixation System Fusion Orthopedics, LLC Eli Jacobson
K182590 09/20/2018 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA GE Healthcare Veronica Meridith
K182419 09/05/2018 Centricity Universal Viewer GE Healthcare Renee Webb
K182504 09/12/2018 3.0T Air MP M, 3.0T Air MP L GE Healthcare Coils (USA Instruments, Inc.) Veronica A. Meridith
K182626 09/24/2018 OEC One GE Hualun Medical Systems Co., Ltd. Lifeng Wang
K182750 09/28/2018 4D View GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K182450 09/07/2018 Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K182690 09/27/2018 ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel GenMark Diagnostics, Incorporated Beth Stofka
K182701 09/27/2018 Wondfo T-Cup Multi-Drug Urine Test Cup Guangzhou Wondfo Biotech Co., Ltd. Bin Chen
K182528 09/14/2018 Nitrile Glove Powder Free Black Haining Medical Products Co., Ltd. Zhiming Yao
K182569 09/18/2018 Spectralis HRA+OCT and variants with High Magnification Module Heidelberg Engineering GmbH Arianna Schoess
K182727 09/28/2018 Trident HD Specimen Radiography System Hologic, Inc. Meghan Wakeford
K182479 09/10/2018 NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus Hycor Biomedical Tara Viviani
K182453 09/07/2018 ICOONE h (also referred to as ICOONE LASER and ICOONE ûh LASER) I-TECH INDUSTRIES SRL Paolo Abbreviato
K182402 09/04/2018 CoLink View Plating System In2Bones USA, LLC Christine Scifert
K182531 09/14/2018 ClotTriever Thrombectomy System Inari Medical Eben Gordon
K182630 09/24/2018 Omnipod Insulin Management System, Omnipod DASH Insulin Management System Insulet Corporation Julie Perkins
K182545 09/17/2018 Tamper Evident Cap with Male Luer Lock International Medical Industries, Inc. Kathleen Lavender
K182561 09/18/2018 UroNav (Version 3.0) Invivo Corporation Kenneth M. Revennaugh
K182550 09/17/2018 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd. Meng Li
K182551 09/17/2018 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd. Meng Li
K182649 09/24/2018 Enteral Feeding Syringes with Enfit Connectors Jiangsu Kangbao Medical Experiment Co., Ltd Qian Li
K182498 09/12/2018 Advanced Skin Renewing Device Jiangsu Unimed Laser Technology Co., Ltd. Simon Wang
K182620 09/24/2018 MRI Compatibility for Existing Neodent Implant System JJGC Industria e Comercio de Materiais Dentarios SA Julianne Lachechem
K182539 09/14/2018 2MP Color LCD Monitor CL-R211 JVC Kenwood Corporation Masafumi Yugami
K182473 09/10/2018 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems K2M Inc. Nancy Giezen
K182652 09/24/2018 COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 Kangfu Medical Equipment Factory Zelong Cao
K182696 09/27/2018 Telepack X LED KARL STORZ Endoscopy-America, Inc Winkie Wong
K182431 09/06/2018 Konicaminolta DI-X1 Konica Minolta, Inc. Tsutomu Fukui
K182688 09/26/2018 SKR 3000 KONICA MINOLTA, INC. Tsutomu Fukui
K182699 09/27/2018 Selethru PTCA Balloon Dilatation Catheter Kossel Medtech (Suzhou) Co., Ltd. Zane Wang
K182674 09/26/2018 Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia Largan Medical Co., Ltd Amy Tien
K182523 09/13/2018 Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens Largan Medical Co., Ltd. Amy Tien
K182470 09/10/2018 Plateau Spacer System Life Spine Angela Batker
K182557 09/17/2018 MTS Eravacycline 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K182540 09/14/2018 DiLumen Endolumenal Interventional Platform Lumendi, LLC Dennis Daniels
K182434 09/06/2018 LaparoGuard Mariner Endosurgery Inc. Mitch Wilson
K182574 09/18/2018 Freedom Ultra-Congruent CR Tibial Liner Maxx Orthopedics, Inc. Priscilla Herpai
K182610 09/21/2018 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device Medtronic Kari Christianson
K182497 09/12/2018 OsteoCool RF Ablation System Medtronic Sofamor Danek USA, Inc. Laveeda Leflore
K182436 09/07/2018 POWEREASE System Medtronic Sofamor Danek USA, Inc. Ankit K. Shah
K182586 09/20/2018 DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port Medtronic, Inc. Linda L. Julia Davila
K182559 09/17/2018 PREMIER Platinum HpSA PLUS Meridian Bioscience, Inc. Jack Rogers
K182538 09/14/2018 Merit RadialFlo Arterial Catheter Merit Medical Singapore Pte. Ltd. Xing Ting Seow
K182556 09/17/2018 SureClip Repositionable Hemostasis Clip Micro-Tech (Nanjing) CO., Ltd. Becky Li
K182472 09/10/2018 Cepheid Xpert GBS LB Control Panel Microbiologics, Inc. Tina Sobania
K182624 09/24/2018 MIM - MRT Dosimetry MIM Software Inc. Lynn Hanigan
K182766 09/28/2018 Cufitec Surgical Mask NBC Meshtec Inc. Tomokazu Nagao
K182518 09/13/2018 AHMED ClearPath Glaucoma Drainage Device New World Medical, Inc. Mukesh Sabarad
K182508 09/12/2018 SaxxonyÖ Posterior Cervical Thoracic System Nexxt Spine LLC Andy Elsbury
K182616 09/21/2018 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System NinePoint Medical, Inc. Eman Namati
K182549 09/17/2018 StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation Khushboo Surendran
K182552 09/17/2018 StatStrip Xpress Glucose Hospital Meter System Nova Biomedical Corporation Khushboo Surendran
K182606 09/21/2018 PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies ULC (now a part of Stryker) Agatha Szeliga
K182387 09/04/2018 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) Novo Nordisk Inc. Elizabeth D'Amato
K182454 09/07/2018 O2 Concepts Oxlife Independence Model 301-0001 O2 Concepts LLC Kathryn G. Forgione
K182587 09/20/2018 Device Electrosurgical Generator ESG-150 Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K182481 09/10/2018 HEM-6410T-ZM Wrist Blood Pressure Monitor Omron Healthcare, Inc. Renee Thornborough
K182735 09/28/2018 Paragonix SherpaPak Cardiac Transport System Paragonix Technologies Lisa M. Anderson
K182464 09/10/2018 PeekMed Peek Health, S.A. Sara Silva
K182522 09/13/2018 Penumbra System (Modified 110 Aspiration Tubing) Penumbra, Inc. Micaela Victoria
K182747 09/28/2018 EliA RF IgM Immunoassay Phadia AB Carina Magnusson
K182529 09/14/2018 Xperius Ultrasound System Philips Ultrasound, Inc. Deep Pal
K182533 09/14/2018 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels Pixxgen Corporation John Ross
K182581 09/19/2018 PlayMakar Sport Muscle Stimulator, Model PRO-500 PlayMakar Inc. Mike Williams
K182675 09/26/2018 Polygon Resection Device Polygon Medical, Inc. Ronald Adams
K182598 09/20/2018 VersaLinkÖ Fixation System Premia Spine Ltd. Ron Sacher
K182670 09/25/2018 FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute Prosidyan, Inc Charanpreet S. Bagga
K182501 09/12/2018 Hair Laser Headband Pulsaderm LLC Gloria Avendano
K182521 09/13/2018 FastPack IP Sex Hormone Binding Globulin Immunoassay Qualigen, Inc. Wajdi Abdul-Ahad
K182669 09/25/2018 Youlaser CO2 Quanta System SpA Francesco Dell'Antonio
K182564 09/18/2018 Quantib ND Quantib BV Floor van Leeuwen
K182442 09/07/2018 MiniGuard Arterial Safety Valve Quest Medical, Inc. Tosan Onosode
K182668 09/25/2018 Rapid Reboot Compression Therapy System Rapid Reboot Recovery Products, LLC David Johnson
K182614 09/21/2018 RCT700 RAY Co.,Ltd Changhwan Lee
K182512 09/12/2018 Route 92 Medical Delivery Catheter Route 92 Medical Inc. Kathy Tansey
K182635 09/24/2018 Signal Catheter Safe Medical Design Raymond "Buzz" Bonneau
K182654 09/25/2018 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card Safecare Biotech (Hangzhou) Co., Ltd. Alex Qiu
K182647 09/24/2018 GC70 Samsung Electronics Co., Ltd. Jaesang Noh
K182622 09/24/2018 GU60A, GU60A-65 SAMSUNG ELECTRONICS CO., LTD. Jaesang NOH
K182595 09/20/2018 HERA W10 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K182632 09/24/2018 HS30 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Jee Young Ju
K182530 09/14/2018 BIOEASY Multi-Drug Test Cup Shenzhen Bioeasy Biotechnology Co.,Ltd. Wenhau Yan
K182755 09/28/2018 Disposable Temperature Probe Shenzhen Caremed Medical Technology Co., Ltd. Alan Xie
K182433 09/06/2018 Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff Shenzhen Caremed Medical Technology Co., Ltd. Alan Xie
K182636 09/24/2018 DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD Jiang Haosen
K182603 09/21/2018 Z6 Diagnostic Ultrasound System Shenzhen Mindray Bio-medical Electronics Co., LTD Jiang Xiaoyong
K182423 09/06/2018 MAGLUMI 2000 FT4 Shenzhen New Industries Biomedical Engineering Co., Ltd Jie Rao
K182715 09/27/2018 Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System Shenzhen Wisonic Medical Technology Co., Ltd. Jiang Xiaosan
K182517 09/13/2018 MULTIX Impact Siemens Medical Solutions, Inc. Denise Adams
K182492 09/11/2018 Geminus Volar Distal Radius Plate System Skeletal Dynamics, LLC Ana M. Escagedo
K182535 09/14/2018 R3 Anteverted Liners Smith & Nephew, Inc. Meenakshi Gupta
K182543 09/17/2018 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package snap40 Ltd Edwin Lindsay
K182489 09/11/2018 4CIS« Pinehurst Anterior Cervical Plate system Solco Biomedical Co., Ltd. Il Kim
K182648 09/24/2018 X5 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp. Toki Wu
K182484 09/11/2018 VERITON CT whole body SPECT/CT system Spectrum Dynamics Medical Ltd Igor Naroditsky
K182584 09/20/2018 Lucent« XP Spinal Elements Inc Cheryl Allen
K182604 09/21/2018 New Era Step Up Skin Laser, LLC Michelle Hokama
K182724 09/28/2018 CelerityTM 10 STEAM Chemical Indicator STERIS Corporation Eileen McCafferty
K182568 09/18/2018 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation Bill Brodbeck
K182425 09/06/2018 Universal Mesh - Sterile Stryker Leibinger GmbH & Co. KG Gregory Gohl
K182588 09/20/2018 Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider Surgical Instrument Service and Savings Inc (dba Medline ReN Stephanie Boyle Mays
K182438 09/07/2018 Synthetic Polyisoprene Lubricated Male Condom - 5 senses Sxwell Usa LLC Robert Mahler
K182389 09/04/2018 Sysmex XN-L Automated Hematology Analyzer Sysmex America, Inc. Sharita Brooks
K182491 09/11/2018 Applanation tonometer AT-2 Takagi Seiko Co., Ltd. Shinya Kitamura
K182506 09/12/2018 LipiScan Dynamic Meibomian Imager TearScience, Inc. Christy Coleman
K182736 09/28/2018 OIC Suture Anchor System The Orthopaedic Implant Company Douglas Fulton
K182548 09/17/2018 Accucuff Cuff Pressure Indicator Tianjin Medis Medical Device Co., Ltd. Yongzhi Wu
K182507 09/12/2018 Tigon Medical Tissue Anchors Tigon Medical Jeremy Clark
K182682 09/26/2018 OrthoGold 100 Tissue Regeneration Technologies John Warlick
K182461 09/10/2018 LATITUDE EV Total Elbow Arthroplasty Tornier Inc. Renee Stoffel
K182421 09/05/2018 Senhance Ultrasonic System TransEnterix, Inc. Stephanie M. Fitts
K182642 09/24/2018 GenesisZrÖ 4Y Zirconia United Dental Resources Corporation John Von Thaden
K182456 09/07/2018 Study Watch Verily Life Sciences LLC Shilpa Mydur
K182562 09/18/2018 Hair Boom 69 WonTech Gyuri (Erin) Park
K182514 09/12/2018 Surgical Face Mask Xiantao Zhibo Non-woven Products Co., Ltd Yao Sanyu


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