FDA 510(k) Decisions During October, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
DEN180028 10/31/2018 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports 23andMe, Inc. Adam Odeh
K180941 10/17/2018 Ortho System 3Shape A/S Kristian Worziger Nielsen
K181607 10/12/2018 Thorecon Rigid Fixation System A&E Medical Corporation Dana Rodriguez
K182644 10/19/2018 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 Abbott Cody Johnson
K181527 10/03/2018 On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K182466 10/30/2018 AOS Calcaneal Plating System Advanced Orthopaedic Solutions Elaine Nguyen
K181739 10/26/2018 Invisalign System with Mandibular Advancement Feature Align Technology, Inc. Somi Ekwealor
K181617 10/11/2018 E-CUBE 8 Alpinion Medical Systems Co., Ltd. Boyeon CHO
K181910 10/15/2018 BracePaste MTP Light Cure Primer American Orthodontics Trang Adams
K181445 10/01/2018 AMSure Hydrophilic Intermittent Catheter Amsino International Inc. Zoe Wu
DEN180004 10/24/2018 picoAMH ELISA Ansh Labs LLC Ajay Kumar
K182244 10/11/2018 Voyant Electrosurgical Generator Applied Medical Resources Corp. Andrew Nguyen
K182034 10/17/2018 Arterys MICA Arterys Inc. Sharon Cholowsky
K182239 10/18/2018 OLYMPIC Posterior Spinal Fixation System Astura Medical, LLC Parker Kelch
K181725 10/05/2018 Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) Avenu Medical, Inc. Rebecca K. Pine
K180446 10/12/2018 b-ONE Total Knee System b-One Ortho Corp. Allison Gecik
K182392 10/30/2018 Frozen C B.M. Tech. Worldwide Co., Ltd. Jenny Cho
K182337 10/04/2018 HYBRID Guidewire Balt USA, LLC Nancy Xu
K181718 10/18/2018 BD FlowSmart Set/MiniMed Pro-Set Becton, Dickinson and Company Meriam Youssef
K181503 10/11/2018 Fingertip Pulse Oximeter Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao
K180688 10/25/2018 SLENDERTONE CoreFit Abs 8, Type 734 Bio-Medical Research Ltd Eoin Keating
K182070 10/10/2018 BioHorizons Tapered IM Implants BioHorizons Implant Systems, Inc. Michael Davis
K180605 10/24/2018 GastroFlush Bionix Development Corporation James Huttner
K182283 10/23/2018 FUSE Pedicle Screw System Black Box Medical Todd Stanaford
DEN180026 10/05/2018 Bose Hearing Aid Bose Corporation James Yeagle
K180487 10/26/2018 Peak.me Breathe me LTD Yoram Levy
K182106 10/23/2018 BTL 799-2T BTL Industries, Inc. David Chmel
K182281 10/24/2018 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech C.R. Bard Sari Stevens
K182706 10/25/2018 External upper limb tremor stimulator Cala Health, Inc. Scott A. Wilson
K180980 10/27/2018 ORTHROSÖ Posterior Stabilization System; ORTHROSÖ MIS Posterior Stabilization System Camber Spine Technologies LLC Tom Zamorski
K182546 10/17/2018 Alphenix, INFX-8000H/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K182679 10/31/2018 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 Canon Medical Systems Corporation Paul Biggins
K182282 10/19/2018 Vantage Orian 1.5T, MRT-1550, V4.5 Canon Medical Systems Corporation Paul Biggins
K182015 10/11/2018 Piccolo Composite« Plate System CarboFix Orthopedics Ltd. Yael Rubin
K181196 10/03/2018 Caretaker Remote Display App and Caretaker Software Library Caretaker Medical, LLC Jeff Pompeo
K181116 10/25/2018 CONVIVO Carl Zeiss Meditec AG Christian Muenster
K182318 10/24/2018 Retina Workplace Carl Zeiss Meditec, Inc Maria Golovina
K181008 10/11/2018 NuFACE Trinity Carol Cole Company dba NuFACE Donald Ellis
K181863 10/10/2018 Elvie Pump Chiaro Technology Limited Jonathan O'Toole
K180258 10/25/2018 SpeediCath Standard Coloplast Ngoc Linh Pham Latchman
K182122 10/04/2018 Ureteric Catheters Coloplast Corp Cori Ragan
K181248 10/22/2018 Comarch e-Care Platform Comarch Healthcare SA Irmina Serafin
K181566 10/22/2018 Nutrifill Contamac Ltd. Rob McGregor
K180205 10/19/2018 AVELLE Negative Pressure Wound Therapy System ConvaTec Limited Justin Lovelace
K180291 10/26/2018 Cook Silicone Balloon HSG Catheter Cook Incorporated Yan Li
K180302 10/24/2018 GuardiaÖ Access Malleable Obturator, GuardiaÖ Obturator, Soft-PassÖ Obturator, Soft-Trans Malleable Obturator, GuardiaÖ ETS Embryo-Tested Syringe, Flushing Catheter Cook Incorporated Naomi Funkhouser
K180300 10/26/2018 Margolin HSG Cannula, Goldstein Sonohysterography Catheter Cook Incorporated Naomi Funkhouser
K182066 10/30/2018 O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set Cook Incorporated Carly Powell
K180286 10/26/2018 Polyethylene Catheter Cook Incorporated Jessica Swafford
K180054 10/05/2018 Royal Flush Plus High-Flow Catheter Cook Incorporated Jessica Swafford
K181038 10/10/2018 CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) CorMatrix Cardiovascular, Inc. Wendy Perreault
K180622 10/23/2018 Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port Covidien Alexis Erazo
K182151 10/11/2018 MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate CTL Medical Corporation Andrea Wilcox
K182365 10/24/2018 TempSure System Cynosure, Inc Amy Tannenbaum
K182215 10/29/2018 ClearLink Controlled Phototherapy Equipment Daavlin Distributing Company Michele Thiel
K181578 10/11/2018 DemeTECH PTFE Nonabsorbable Surgical Suture Demetech Corporation Linda Hernandez
K181520 10/11/2018 Sirona Dental CAD/CAM System Dentsply Sirona Karl J. Nittinger
K182041 10/26/2018 Dexcom G6 Glucose Program Continuous Glucose Monitoring System Dexcom, Inc. Luke Olson
K180209 10/04/2018 Diazyme 1,5-AG Assay Diazyme Laboratories Inc. Abhijit Datta
K180568 10/16/2018 KidCap Eastern Cranial Affiliates, LLC Joseph Terpenning
K180516 10/19/2018 EchoS Echolight Spa Sergio Casciaro
K180275 10/24/2018 VAMP Optima closed blood sampling system Edwards Lifesciences LLC Jennifer Wilbur
K181644 10/12/2018 EIT Cellular Titanium« Lumbar Cage LLIF EIT Emerging Implant Technologies GmbH Barbara Wirth
K182591 10/18/2018 RadiForce RX360, RX360-AR EIZO Corporation Hiroaki Hashimoto
K181867 10/02/2018 Deka Smartxide2 Trio El.En Electronic Engineering Spa Paolo Peruzzi
K180559 10/29/2018 HSV 1 & 2 ELITe MGB Kit; ELITe InGenius ELITechGroup Terry Trimingham
K181941 10/18/2018 Swift System Emblation Ltd Mairi MacFadyen
K182490 10/09/2018 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Sonia Callegaro
K180620 10/12/2018 Endophys Pressure Sensing Sheath Kit Endophys Holdings, LLC Phillip Purdy
K181488 10/30/2018 LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier Ethicon Endo-Surgery, LLC Sigfrido Delgado
K182753 10/26/2018 A6 OTC Pain Relief TENS Everyway Medical Instruments Co., Ltd. Paul Hung
K182767 10/26/2018 V2 OTC Pain Relief TENS Everyway Medical Instruments Co., Ltd. Paul Hung
K182536 10/12/2018 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
K181642 10/05/2018 B-Laser Atherectomy System Eximo Medical Ltd. Yossi Muncher
K182087 10/31/2018 DynaMesh-POSTERIOR FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft Stefan Schneemelcher
K182088 10/31/2018 XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro Fotona d.o.o. Marko Berdajs
K182051 10/02/2018 FUJIFILM Duodenoscope Model FUJIFILM Corporation Randy Vader
K181815 10/15/2018 DynaBridge Fusion Orthopedics, LLC Adam Cundiff
K182059 10/04/2018 Prase MIS Spinal System GBS Commonwealth Co., Ltd. Jimmy Kim
K182590 10/19/2018 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA GE Healthcare Veronica Meridith
K182504 10/12/2018 3.0T Air MP M, 3.0T Air MP L GE Healthcare Coils (USA Instruments, Inc.) Veronica A. Meridith
K181685 10/25/2018 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K182450 10/19/2018 Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K180554 10/22/2018 ANTHEM Fracture System Globus Medical Inc. Kelly J. Baker
K182880 10/31/2018 Halifax Imaging Kit Halifax Biomedical, Inc. Crystal Jones
K181192 10/22/2018 PIP Fix Hand Biomechanics Lab, Inc. Dustin Dequine
K180240 10/17/2018 Full Automatic(NIBP) Blood Pressure Monitor Health & Life Co. Ltd. J. S. Hsu
K182569 10/18/2018 Spectralis HRA+OCT and variants with High Magnification Module Heidelberg Engineering GmbH Arianna Schoess
K181468 10/25/2018 Hybrid3D Hermes Medical Solutions AB Joakim Arwidson
K180991 10/12/2018 AG 100s Hospitech Respiration Ltd. Yoram Levy
K182264 10/19/2018 ICONN Revolution Knotless Suture Anchor ICONN Orthopedics, LLC Whitt Israel
K181868 10/05/2018 SHINY RPL System IDS, Ltd. C.J. Park
K181553 10/31/2018 Immunalysis Ethyl Alcohol Enzyme Assay Immunalysis Corporation Weying (Jessica) Zhu
K180202 10/19/2018 Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts Immuno Concepts, NA, Ltd. Eric S Hoy
K181223 10/20/2018 ImPACT ImPACT Applications, Inc. Michael Zagorski
K182233 10/15/2018 Apiration Guide Catheter ; FlowTriever Catheter Inari Medical Eben Gordon
K182531 10/10/2018 ClotTriever Thrombectomy System Inari Medical Eben Gordon
K182112 10/05/2018 Sense System with IBT Electrodes Infinite Biomedical Technologies, LLC Rahul Kaliki
K181354 10/25/2018 074 Zenith Flex System InNeuroCo Inc. Marc Litzenberg
K181458 10/27/2018 Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter Innovative Health, LLC. Amanda Babcock
K181618 10/18/2018 Reprocessed Torqr Diagnostic EP Catheter Innovative Health, LLC. Amanda Babcock
K180971 10/16/2018 QUANTA Flash Calprotectin and Fecal Extraction Device Inova Diagnostics, Inc. Roger Albesa
K181902 10/25/2018 Codman Certas Plus Electronic Tool Kit Integra LifeSciences Corp. Nancy MacDonald
K181999 10/12/2018 Integra TITAN Reverse Shoulder System Integra Lifesciences Corporation Blesson Abraham
K182140 10/24/2018 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc Brandon Hansen
K182561 10/19/2018 UroNav (Version 3.0) Invivo Corporation Kenneth M. Revennaugh
K182550 10/17/2018 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd. Meng Li
K182551 10/17/2018 Wireless Digital Flat Panel Detector iRay Technology Taicang Ltd. Meng Li
K180972 10/03/2018 ARIX Clavicle System Jeil Medical Corporation Seungyong Lee
K181426 10/11/2018 Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) Jiangsu Micsafe Medical Technology Co., Ltd Tony Yang
K182117 10/06/2018 Vinyl Patient Examination Gloves Jiangxi Zhonghong Pulin Medical Products Co., Ltd Joe Zhang
K180555 10/11/2018 Ergoline Prestige 1600 Hybrid Performance JK Holding GmbH Juergen Gerstenmeier
K181081 10/02/2018 Infrared Ear Thermometer Joytech Healthcare Co., Ltd. Ren Yunhua
K181239 10/29/2018 Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer Joytech Healthcare Co.,Ltd Ren Yunhua
K182539 10/03/2018 2MP Color LCD Monitor CL-R211 JVC Kenwood Corporation Masafumi Yugami
K181603 10/05/2018 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System K2M Inc. Nancy Giezen
K180735 10/31/2018 Endomat Select Karl Storz SE & Co. KG Serkan Sezer
K182002 10/23/2018 Cumulus Remover Kitazato Corporation Futoshi Inoue
K181373 10/18/2018 Extended Lipid Panel Assay Laboratory Corporation of America Holdings Suzette Warner
K180680 10/11/2018 Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray Laclede, Inc. Michael Pellico
K182348 10/18/2018 14HK701G-W LG Electronics Inc. Jinhwan Jun
K181717 10/12/2018 Life Spine Laminoplasty System Life Spine Inc. Angela Batker
K182540 10/30/2018 DiLumen Endolumenal Interventional Platform Lumendi, LLC Dennis Daniels
K180046 10/23/2018 Masimo Rad-97 and Accessories Masimo Corporation Sindura Penubarthi
K180249 10/11/2018 OmniPore DUROMAX Surgical Implants Matrix Surgical Holdings, LLC/Matrix Surgical USA John O'Shaughnessy
K182177 10/26/2018 Accipiolx MaxQ-Al Ltd. Joshua Schulman
K182914 10/29/2018 MC3 Vascular Access Kit 21030 MC3 Incorporated Adam Viitala
K181254 10/22/2018 Quadra P Medacta International SA Stefano Baj
K181803 10/18/2018 Medax Biopsy Systems III Medax Srl Unipersonale Stefano Cavalieri
K181937 10/16/2018 Pump In Style Advanced, Advanced Personal Double Breastpump Medela LLC PJ Pasia
K182240 10/17/2018 PASS LP Spinal System Medicrea International S.A. David Ryan
K181949 10/04/2018 SYMPHONYÖ OCT System Medos International SARL Sheree Geller
K181622 10/01/2018 StrataMR guider tool Medtronic Neurosurgery Xiaojian Sun
K182436 10/04/2018 POWEREASE System Medtronic Sofamor Danek USA, Inc. Ankit K. Shah
K182586 10/19/2018 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
K181026 10/17/2018 OsteoBridgeÖ IDSF System Merete GmbH Paul Munch
K181186 10/25/2018 Solitare Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K180418 10/15/2018 Reliant(TM) Multistage Dilatation Balloon Catheter Micro-Tech (Nanjing) CO., Ltd. Becky Li
K181883 10/03/2018 FIREFLY« Midline Navigation Guide Mighty Oak Medical Inc. Mark A. Wylie
K182036 10/15/2018 NeuroBlate System Monteris Medical David H. Mueller
K181138 10/03/2018 IS-III active System Neobiotech Co., Ltd. Young-Ku Heo
K181330 10/11/2018 NeoMatriX Wound Matrix NeXtGen Biologics, Inc. Jonelle L. Toothman
K181621 10/19/2018 Stable-C Interbody System Nexus Spine, LLC Jared Crocker
K182261 10/16/2018 NvisionVLE Imaging System, NvisionVLE Optical Probe NinePoint Medical, Inc. Eman Namati
K180899 10/31/2018 Universal Base Abutment Nobel Biocare AB Charlemagne Chua
K181860 10/05/2018 NuVasive Cohere Thoracolumbar Interbody System NuVasive, Incorporated Olga Lewis
K181240 10/04/2018 Rhino-Laryngo Fiberscope Olympus ENF-GP2 Olympus Medical Systems Corp. Toshiyuki Nakajima
K181994 10/31/2018 Single Use Aspiration Needle NA-U201H Olympus Medical Systems Corp. Toshiyuki Nakajima
K181460 10/11/2018 OnePacs System OnePacs, LLC Justin Falk
K182085 10/31/2018 Balanced Knee Revision System Trabecular Tibial Cone Augments Ortho Development Corporation Adrienne von Foller
K181569 10/12/2018 BKS Revision Sleeves System Ortho Development Corporation Dan Petersen
K182072 10/30/2018 VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides Ortho-Clinical Diagnostics, Inc. Marlene Hanna
K182063 10/30/2018 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System Ortho-Clinical Diagnostics, Inc. Marlene Hanna
K181936 10/25/2018 DyeVert PLUS EZ Contrast Reduction System Osprey Medical, Inc. Vic Fabano
K181539 10/12/2018 OSSDSIGN Cranioplug OssDsign AB Ulrik Birgersson
K182735 10/19/2018 Paragonix SherpaPak Cardiac Transport System Paragonix Technologies Lisa M. Anderson
K181220 10/12/2018 Juell 3D Volo Base Park Dental Research Corporation Ronald A Bulard
K182464 10/25/2018 PeekMed Peek Health, S.A. Sara Silva
K180285 10/26/2018 PENTAX Medical Video Colonoscope EC34-i10T Series PENTAX Medical of America, Inc James W. Monroe
K180292 10/12/2018 PENTAX Video Upper G.I. Scope EG34-i10 PENTAX Medical of America, Inc James W. Monroe
K182522 10/12/2018 Penumbra System (Modified 110 Aspiration Tubing) Penumbra, Inc. Micaela Victoria
K181945 10/18/2018 QuickScreen Pro Multi Drug Screening Test, Model 9395Z Phamatech Inc. Robert Merlock
K180940 10/24/2018 KODEX EPD System Philips Medical Systems Nederland B.V. Gina Crossetta
K182529 10/23/2018 Xperius Ultrasound System Philips Ultrasound, Inc. Deep Pal
K182115 10/03/2018 Vinyl Patient Examination Gloves Ping An Medical Products Co., Ltd. Fu Dong Zhang
K180020 10/29/2018 HemoScreen Hematology Analyzer PixCell Medical Technologies, Ltd. Yaaya Ben-Yosef
K182533 10/04/2018 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels Pixxgen Corporation John Ross
K181031 10/26/2018 TSI Transseptal Introducer Pressure Products Medical Device Manufacturing LLC Andrew Armour
K182501 10/26/2018 Hair Laser Headband Pulsaderm LLC Gloria Avendano
K182189 10/04/2018 Encompass SRS Headframe ; Encompass MR SRS Headframe Qfix Alexandra Low Smythe
K182669 10/17/2018 Youlaser CO2 Quanta System SpA Francesco Dell'Antonio
K181651 10/12/2018 Radial Medical Compression System Radial Medical, Inc. Eric Johnson
K182042 10/23/2018 Randox Calcium (Ca) Randox Laboratories Ltd. Pauline Armstrong
K182614 10/16/2018 RCT700 RAY Co.,Ltd Changhwan Lee
K182647 10/24/2018 GC70 Samsung Electronics Co., Ltd. Jaesang Noh
K182622 10/23/2018 GU60A, GU60A-65 SAMSUNG ELECTRONICS CO., LTD. Jaesang NOH
K182237 10/12/2018 uMI 550 PET/CT System Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K181370 10/03/2018 uMR 780 Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K181371 10/03/2018 uMR 790 Shanghai United Imaging Healthcare Co.,Ltd. Xin GAO
K182289 10/10/2018 Sterile High-pressure Angiographic Syringes for Single-use Shenzhen Baoan Medical Supplies Co., Ltd Mingan Mu
K181728 10/17/2018 Muscle Trainer Shenzhen Kentro Medical Electronics Co., Ltd Zewu Zhang
K182018 10/06/2018 Bluetooth blood pressure monitor Shenzhen Kingyield Technology Co., Ltd. Dacheng Gong
K180788 10/24/2018 Gas Module 3 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Yanhong Bai
K182423 10/04/2018 MAGLUMI 2000 FT4 Shenzhen New Industries Biomedical Engineering Co., Ltd Jie Rao
K180467 10/10/2018 SBG Blue Nitrile Powder Free Medical Examination Glove Showa Best Glove, Inc Jeffrey Richardson
K180468 10/10/2018 SBG Black Nitrile Powder Free Medical Examination Glove Showa Best Glove, Inc. Jeffrey Richardson
K182299 10/26/2018 MAGNETOM Aera Siemens Medical Solutions USA Inc. Martin Rajchel
K181550 10/30/2018 Cios Spin Siemens Medical Solutions USA, Inc. Patricia D. Jones
K182050 10/03/2018 Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch Siemens Medical Solutions USA, Inc. Martin Rajchel
K181322 10/05/2018 MAGNETOM Sola Siemens Medical Solutions USA, Inc. Cordell L. Fields
K182129 10/12/2018 MAGNETOM Sola Siemens Medical Solutions USA, Inc. Cordell L. Fields
K181433 10/19/2018 MAGNETOM Vida Siemens Medical Solutions USA, Inc. Martin Rajchel
K181560 10/24/2018 Cios Alpha Siemens Medical Systems USA, Inc. Patricia D. Jones
K181530 10/24/2018 World Total Knee System Signature Orthopaedics Pty Ltd. Declan Brazil
K181881 10/03/2018 Outlet Sacroiliac Joint Fusion System SIJ Surgical Daniel Hoehn
K182492 10/10/2018 Geminus Volar Distal Radius Plate System Skeletal Dynamics, LLC Ana M. Escagedo
K182082 10/31/2018 Tumark for Eviva, Tumark for Brevera Somatex Medical Technologies GmbH Burkhard Jakob
K181922 10/22/2018 Sonendo Material A Sonendo, Inc. Eric Simon
K181942 10/18/2018 Quantum Ventilation Module Spectrum Medical Ltd Mark Drain
K181596 10/24/2018 Spine Wave Navigated Instruments Spine Wave, Inc. Amy Noccioli
K181818 10/09/2018 Scarlet AL-T Spineart Franck Pennesi
K181531 10/05/2018 SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices SpineEX Inc. Andrew Rogers
K182322 10/24/2018 Duo Lumbar Interbody Fusion Device Spineology Inc Karen Roche
K181848 10/12/2018 ADAPT for Gamma3, Gamma3 Stryker GMBH Tina Mornak
K181091 10/11/2018 AxSOS 3 Ti Stryker GmbH Saad Attiyah
K182171 10/25/2018 SMV Scientific K-Wire and Pins Summit MedVentures Nephi Zufelt
K182588 10/31/2018 Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider Surgical Instrument Service and Savings Inc (dba Medline ReN Stephanie Boyle Mays
K182826 10/11/2018 Ormco Spark Aligner System Sybron Dental Specialties Mey Saied
K182154 10/16/2018 Depuy Synthes Femoral Neck System Synthes (USA) Products, LLC Stephan Jepards
K180213 10/19/2018 Titanium TomoFix Medial High Tibia Plate Anatomical Synthes (USA) Products, LLC Stephan Jepards
K182062 10/30/2018 Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device Sysmex America, Inc. Jessica Rivera-Montejo
K181774 10/10/2018 Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture Teleflex Medical Incorporated Andrea Curria
K181852 10/12/2018 Percuvance Percutaneous Surgical System Teleflex Medical, Inc. Kim Campbell
K180099 10/12/2018 Optilite High Sensitivity C-Reactive Protein Kit The Binding Site Group Ltd Kirsty Samuels
K180474 10/18/2018 TNI softFlow 50 TNI Medical AG Joseph P. McMenamin
K180718 10/30/2018 ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES TOMY, Inc. Jinichi Watanabe
K181587 10/05/2018 ORTHOLOC SPS Shoulder Plating System Tornier Inc. Renee Stoffel
K181517 10/09/2018 Senhance Surgical System TransEnterix, Inc. Kaitlyn Alexander
K181898 10/26/2018 Two-Step Implant System Trilliant Surgical Jon Olson
K180354 10/30/2018 UroGen Ureteral Catheter UroGen Pharma Ltd. James G. Ottinger
K180345 10/17/2018 Uroject12 Syringe Lever UroGen Pharma Ltd. Liz Schindel
K181903 10/03/2018 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device Varian Medical Systems, Inc. Peter J. Coronado
K180872 10/11/2018 SCARLET SRF Viol Co., Ltd. Chai Kyoung Woo
K181885 10/02/2018 Voyant System Viseon, Inc. Cora Sim
K181964 10/23/2018 JiveX Visus Health IT GmbH Axel Schreiber
K182247 10/12/2018 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) VizionFocus, Inc. Angus Shih
K180919 10/05/2018 GORE Tri-Lumen Catheter W.L. Gore and Associates Inc. Michael Ivey
K182381 10/30/2018 Wilson-Cook Mini Basket Wilson-Cook Medical, Inc Tiffanny A. Thomas
K180758 10/24/2018 Osteocera Resorbable Bone Substitute Wiltrom Corporation Limited Yi-Chun Su
K180736 10/04/2018 WishBone Medical Plate and Screw System WishBone Medical, Inc. Gary Barnett
K181640 10/12/2018 X-BOLT Hip Fracture Fixation System X-Bolt Orthopaedics Brian Thornes
K180708 10/18/2018 Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profi Xeridiem Medical Devices, A Spectrum Plastics Group Company Steve Murray
K181947 10/25/2018 Persona Revision Knee System Zimmer Inc. Nicole Meredith
K181892 10/09/2018 Ziostation2 Ziosoft, Inc. Tsuyoshi Nagata


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