FDA 510(k) Decisions During February, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K173435 02/09/2018 3M Attest Rapid Readout Biological Indicator 3M Company Nadia Battah
K181838 12/20/2018 Sinusway Dilation System 3NT Medical Ltd. Ehud Bendory
K172294 02/22/2018 Osteotomy Truss System (OTS) 4Web, Inc. Jessee Hunt
K173579 02/12/2018 ThoreconÖ Fixation System A&E Medical Corporation Dana Rodriguez
K183128 12/12/2018 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 Abbott Cody Johnson
K172885 02/20/2018 HydroPICC Access Vascular, Inc Elizabeth Kinnal
K171646 02/16/2018 ACISTCVi« Contrast Delivery System ACIST Medical Systems, Inc. Melissa Sommerfeld
K171629 02/01/2018 ABCcolla Bone Graft ACRO Biomedical Co., Ltd. Dar-Jen Hsieh
K172512 02/02/2018 ACRO HCG Pregnancy Rapid Test ACRO Biotech, Inc. Joseph Fan
K181908 12/03/2018 Action Trackchair Action Manufacturing Inc. Alan Macht
K171557 02/06/2018 AcQRef Introducer Sheath Acutus Medical, Inc. Brenda Clay
K181405 12/10/2018 Hailie Sensor Adherium (NZ) Ltd Chris Mander
K172324 02/23/2018 Axiostat Chitosan Hemostatic Dressing Advamedica Inc. Leo Mavely
K180244 02/28/2018 EnsoETM Advanced Cooling Therapy, Inc. d/b/a Attune Medical Erik Kulstad
K180244 02/28/2018 EnsoETM Advanced Cooling Therapy, Inc. d/b/a Attune Medical Erik Kulstad
K182404 12/27/2018 STERRAD VELOCITY Biological Indicator Advanced Sterilization Products (ASP) Sun Choi
K170683 02/20/2018 Aesculap Video Assisted Thoracic Surgery (VATS) INstruments Aesculap, Inc. Jessica Stigliano
K182032 12/21/2018 SterilContainer S System Aesculap, Inc. Paul Amudala
K172348 02/16/2018 AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 Aesku Diagnostics GmbH & Co. KG Sandra Reuter
K182664 12/07/2018 FiXcision Agency for Medical Innovations GmbH Martin Hohlrieder
K182902 12/11/2018 Precision1 Alcon Laboratories, Inc. Alicia Plesnarski
K173303 02/23/2018 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) Alfa Scientific Designs, Inc Naishu Wang
K173212 02/15/2018 Instant-view-PLUS immunochemical Fecal Occult Blood Test Alfa Scientific Designs, Inc. Wen Hua Fan
K170623 02/27/2018 ACE Hemoglobin A1c (HbA1c) Reagent ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC Barbara Phillips
K180826 12/21/2018 Natrelle 133 Plus MICROCELL Tissue Expander Allergan Melissa Pathmajeyan
K172042 02/27/2018 NeuroNav System, NeuroSmart System Alpha Omega Engineering Ltd. Maysana Mousa
K182845 12/27/2018 minisono Alpinion Medical Systems Co., Ltd. Boyeon CHO
K180867 12/28/2018 AmCAD-UO AmCad BioMed Corporation Jack Yang
K172953 02/06/2018 Acid Etchant American Orthodontics Trang Adams
K172058 02/13/2018 CT6485, CT12885 Analogic Corporation Karen Provencher
K171375 02/06/2018 Gammex PI Breach Detect Powder Free Surgical Glove Ansell Healthcare Products LLC Robert Mahler
K182593 12/18/2018 KET-1 Blood Ketone Monitoring System Apex Biotechnology Corp. Lisa Liu
K172624 02/13/2018 Voyant 5mm Fusion Device Applied Medical Resources Corporation Andrew Nguyen
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
K180118 02/12/2018 Arthrex NanoSuture Anchor Arthrex Inc. Rebecca R. Homan
K180118 02/12/2018 Arthrex NanoSuture Anchor Arthrex Inc. Rebecca R. Homan
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
K171933 02/12/2018 ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K182878 12/18/2018 Integra Salto Total Ankle System Ascension Orthopedics Divya Savant
K173324 02/27/2018 ALTA Anterior Cervical Interbody Spacer Astura Medical Thomas Purcell
K180138 02/15/2018 AtriCure cryoICE cryo-ablation probe (CRYO2) AtriCure, Inc. Melissa Smallwood
K180138 02/15/2018 AtriCure cryoICE cryo-ablation probe (CRYO2) AtriCure, Inc. Melissa Smallwood
K180137 02/15/2018 AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) AtriCure, Inc. Melissa Smallwood
K180137 02/15/2018 AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) AtriCure, Inc. Melissa Smallwood
K183065 12/04/2018 Coolrail Linear Pen AtriCure, Inc. Caitlin Wunderlin
K171476 02/27/2018 SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) Awareness Technology, Inc. Steve Andrus
K182012 12/21/2018 ADVIA Centaur Calcitonin (CALCT) assay Axis-Shield Diagnostics Limited Claire Dora
DEN170045 02/14/2018 Banyan BTI Banyan Biomarkers, Inc. Steven P. Richieri
K173381 02/22/2018 Nexxis OR Barco n.v. Eric Caus
K171671 02/23/2018 Prismaflex System 8.10 Baxter Healthcare Corporation Rick Lukacovic
K182320 12/20/2018 BD Contoured Base Pen Needle Becton, Dickinson and Company Meriam Youssef
K173523 02/09/2018 BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) Becton, Dickinson and Company Monica E. Giguere
K172789 02/01/2018 Specimen Retrieval Bag Beijing HangTian KaDi Technology R&D Institute Liying Zhang
K171361 02/05/2018 BETTERCARE PLATFORM - ADVANCED WEB CLIENT Bettercare S.L. Bernat Sales
K173643 02/24/2018 Trilor Disks, Blocks and Arches Bioloren S.R.L. Ratti Umberto
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
K173411 02/08/2018 Comprehensive Segmental Revision System (SRS) Biomet Manufacturing Corp. Patricia Sandborn Beres
K173826 02/07/2018 THP Hip Fracture Plating System Biomet, Inc. Annette Minthorn
K171179 02/09/2018 BR Type Implant System Biotem Co.,Ltd. Hong Koo Yeo
K183265 12/13/2018 Selectra Catheters, Selectra Accessory Kit Biotronik, Inc. Jon Brumbaugh
K173569 02/23/2018 Ultrasound System 1300 BK Medical ApS Karen Provencher
K183080 12/10/2018 Mega Plus Spine System BK Meditech Co., Ltd Meredith Lee May
K172390 02/18/2018 Optima Coil System Blockade Medical, LLC (d.b.a. Balt USA) Rebecca K. Pine
K182065 12/13/2018 EVOLUX CAD/CAM PMMA BLOCKS Blue Dent Dental Adriana Paula T I Gomes
K180107 02/09/2018 Blue Sky Bio Aligner Blue Sky Bio LLC Albert Zickmann
K180107 02/09/2018 Blue Sky Bio Aligner Blue Sky Bio LLC Albert Zickmann
K173400 02/09/2018 ORISE Tissue Retractor System Boston Scientific Thomas Hirte
K173877 02/15/2018 BOWA Neutral Electrodes BOWA-electronics GmbH & Co. KG Wolf-Ruediger Fritz
K181785 12/19/2018 Modified BrainScope One BrainScope Company Inc. Michael E Singer
K180359 12/13/2018 BTL-FR2000 BTL Industries, Inc. David Chmel
K173800 02/02/2018 Camber Spine Technologies SPIRA - VÖ Open Matrix Corpectomy Cage Camber Spine Technologies Michael Black
K173689 02/23/2018 Ophthalmic Software Platform RX Canon Inc. -Medical Equipment Group Shinji Mori
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
K173924 02/05/2018 DRX-Revolution Nano Mobile X-ray System Carestream Health, Inc. Victoria A. Wheeler
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
K173145 02/28/2018 CereMetrix Silver CereMetrix Corp John A Kelley
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
K171637 02/26/2018 OpClear System Cipher Surgical Ltd Justin Buch
K182339 12/12/2018 LEUCADIA AUTOLOKÖ Pedicle Screw System ClearView Orthopedic Development, LLC Hartmut Loch
K172490 02/06/2018 eUnity Client Outlook Inc. Christie Eby
K182116 12/19/2018 BA310 Abutment, BIA310 Implant/Abutment Cochlear Americas Beth Murray
K173501 02/09/2018 Meridian Vaginal Positioning System (VPS) Coloplast Diane Brinza
K180070 02/02/2018 SpeediCath Flex Coude Pro Coloplast Troy Thome
K180070 02/02/2018 SpeediCath Flex Coude Pro Coloplast Troy Thome
K173527 02/12/2018 Digitex Delivery Device Coloplast A/S Nikita Basandra
K182831 12/10/2018 SabreLine and SabreGuard Laser Fibers Coloplast Corp Cori Ragan
K173352 02/15/2018 Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) Concentric Medical, Inc. Rhoda M. Santos
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
K171662 02/01/2018 Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ure Cook Incorporated Carly Powell
K171600 02/16/2018 Renal Access Cobra Catheter, Kumpe Access Catheter Cook Incorporated Samuel Engelman
K180830 12/20/2018 Reuter Tip Deflecting Wire Guide Cook Incorporated Jennifer L. Allman
K171604 02/15/2018 R÷sch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip Cook Incorporated Ian Herrman
K171994 02/22/2018 Silicone Peripherally Inserted Central Venous Catheter Set/Tray Cook Incorporated Johnathan Liu
K171601 02/23/2018 Ultraxx Nephrostomy Balloon Catheter Cook Incorporated Minjin Choi
K172044 02/27/2018 Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Cook Ireland Ltd Laura Graham
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
K173288 02/15/2018 CorPath GRX System Corindus, Inc. Robert Lavado
K183369 12/28/2018 COR12 ECG Corscience GmbH & Co. Karlheinz Trost
K173678 02/28/2018 Diode Laser Cap Cosmo Far East Technology Limited Bob An
K172361 02/16/2018 EEA Circular Stapler with Tri-Staple Technology Covidien Sarah Tang
K173270 02/20/2018 Tri-Staple 2.0 Reinforced Reload Covidien Rebecca Magnanimo
K173244 02/08/2018 superDimension Navigation System V7.2 Covidien LLC Kristi Fox
K182008 12/14/2018 Phasix ST Mesh with Echo 2 Positioning System CR Bard Inc. Shirin Mate
K173710 02/12/2018 MotoBAND CP Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K180820 12/14/2018 Tono Vue Non-Contact Tonometer Crystalvue Medical Corporation Oliver Lin
K173185 02/14/2018 SEURATÖ Universal Pedicle Screw System CTL Medical Corporation Tosan Onosode
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
K173199 02/07/2018 PicoSure Workstation Cynosure, Inc Avinash Purohit
K162727 02/08/2018 SENYINT Remote Consultation System Dalian Senyint Digital Medical System Co., Ltd. Yinghui Miao
K170540 02/23/2018 DM-Density Densitas, Inc. Mo Abdolell
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
K173528 02/06/2018 Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System Devon Medical Products (Jiangsu) Ltd. Julian Chu
K171521 02/16/2018 DUS R-50S (Urine Chemistry system) DFI Co., Ltd. Bella Cho
K173683 02/27/2018 LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers DiaSorin Inc. John C Walter
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
K172828 02/01/2018 Double Medical Cage System Double Medical Technology Inc Yan Zuo
K172284 02/09/2018 NAPA LP-15 Airway Pressure Monitor DRW Medical, LLC Dan Tatum
K173644 02/15/2018 Gazelle Polypropylene Suture and Delivery Device Dura Tap LLC Ann R. Lee
K173335 02/08/2018 Gazelle PTFE and Suture Delivery Device Dura Tap LLC Ann R. Lee
K180380 12/21/2018 vital signs monitor Edan Instruments, Inc. Alice Yang
K172423 02/20/2018 PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) Edwards Lifescience LLC Bedalin T. Lugo Rodriguez
K181498 12/10/2018 X-ray Imaging System for the McLaren Proton Treatment System EhmetDx, LLC Daniel Schoettlin
K180193 02/21/2018 DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) El.En Electronic Engineering S.p.A. Paolo Peruzzi
K180193 02/21/2018 DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) El.En Electronic Engineering S.p.A. Paolo Peruzzi
K173791 02/09/2018 Leksell GammaPlan Elekta Instrument AB Matilda Forsberg
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
K173587 02/16/2018 Magseed Magnetic Marker Systtem Endomagnetics Ltd. Andrew Shawcross
K183191 12/04/2018 6420 Ultrasound System Esaote, S.p.A. Massimo Polignano
K173315 02/13/2018 SupaChair Powered Wheelchair Eurogreen International Inc. David Hsieh
K173313 02/13/2018 SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP Eurogreen International Inc. David Hsieh
K173186 02/28/2018 S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D Everyway Medical Instruments Co., Ltd. Paul Hung
K173863 02/23/2018 Ez3D-i /E3 Ewoo Soft Co., Ltd. Young Seok Kim
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
K180082 02/11/2018 geko T-2 and geko Plus R-2 Firstkind Ltd Neil Buckley
K180082 02/11/2018 geko T-2 and geko Plus R-2 Firstkind Ltd Neil Buckley
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
K173651 02/14/2018 Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
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
K172180 02/09/2018 OSCAR 15 Genoray Co.,Ltd Ji-Yeon Choi
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
K171450 02/02/2018 Glooko Mobile Insulin Dosing System Glooko, Inc Tejasvi Pasi
K172750 02/28/2018 Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) Guangzhou Sonostar Technologies Co., Ltd. Weizhong Cai
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
K180255 02/28/2018 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K180255 02/28/2018 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K182068 12/13/2018 Erran Dental Zirconia Hangzhou Erran Technology Co., Ltd. Tingkai Li
K172870 02/13/2018 Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J Hangzhou Hua'an medical&health instruments Co.,Ltd Ahneo Yang
K171568 02/22/2018 SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty Hans Biomed Corporation Lucy Choi
K180578 12/12/2018 Harvest Dental Polymer Blocks Harvest Dental Products, LLC Sasha Der Avanessian
K182035 12/06/2018 FFRct HeartFlow, Inc Windi Hary
K173739 02/28/2018 ALOKA ARIETTA 850 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
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
K170866 02/21/2018 Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 Honsun(Nantong)Co.,Ltd Selina Qian
K171825 02/13/2018 Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument Hunan Handlike Minimally Invasive Surgery Co., Ltd Hu hanhan
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
K180036 02/02/2018 SMAXEL CO2 Surgical Laser System IDS, LTD. Kwang Yeong Ahn
K180036 02/02/2018 SMAXEL CO2 Surgical Laser System IDS, LTD. Kwang Yeong Ahn
K183145 12/13/2018 IlluminOss Photodynamic Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K171516 02/05/2018 Flip Lube Imquest Biosciences Inc. Karen W. Buckheit
K173491 02/23/2018 RTS Lesser MTP Implant System In2Bones USA, LLC Rebecca Wahl
K183198 12/17/2018 FlowTriever Retrieval/Aspiration System Inari Medical Eben Gordan
K173672 02/05/2018 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter Inari Medical Eben Gordon
K173677 02/23/2018 InMode VLaze InMode MD Ltd. Amit Goren
K181703 12/28/2018 Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments Institut Straumann AG Viviana Horhoiu
K171649 02/22/2018 Straumann CARES M-Series CAD/CAM System Institut Straumann AG Andreas Petermann
K182809 12/07/2018 CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation MaryBeth Carson
K173567 02/14/2018 Sera Interacoustics A/S Amy Yanta
K170112 02/02/2018 IMD's Lumbar Puncture Needle INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD) WALTER ZOHMANN
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
K173228 02/20/2018 U-MED Powder Free Polyethylene Examination Gloves,Blue Color Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. Chen Ye
K171535 02/15/2018 SURGICAL ISOLATION GOWN Jingzhou Haixin Green Cross Medical Products Co., Ltd Rarda L
K173565 02/14/2018 Sunrise 6200, Sunrise 7200 JK-Holding GmbH Juergen Gerstenmeier
K173553 02/08/2018 LUCAS 3 Chest Compression System Jolife AB Malin Melander
K181331 12/21/2018 JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White Juvora, Ltd. Tim Leyva
K172941 02/12/2018 CASCADIA Interbody System K2M Nancy Giezen
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
K171402 02/02/2018 KARL STORZ Slim Nasopharyngolaryngoscope KARL STORZ Endoscopy-America, Inc. AnnaLisa Smullin
K173320 02/23/2018 KLS Martin L1 MMF System KLS Martin LP Jennifer Damato
K182688 12/18/2018 SKR 3000 KONICA MINOLTA, INC. Tsutomu Fukui
K180084 02/08/2018 Ultrasound System SONIMAGE MX1 Konica Minolta, Inc. Tsutomu Fukui
K180084 02/08/2018 Ultrasound System SONIMAGE MX1 Konica Minolta, Inc. Tsutomu Fukui
K171171 02/22/2018 KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) Koon Seng Sdn. Bhd. Koon Seng Sdn. Bhd.
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
K173443 02/01/2018 AEON Endoscopic Stapler Lexington Medical Inc. Donna Gasper
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
K172105 02/02/2018 The Plateau-LO Spacer System Life Spine Inc. Randy Lewis
K173047 02/01/2018 The Solstice OCT System Life Spine, Inc. Randy Lewis
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
K173817 02/28/2018 Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 ?g/mL Liofilchem s. r. l. Fabio Brocco
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
K173067 02/22/2018 LightForce LTS Model 1000, 1500, 2500, and 4000 LiteCure, LLC Eric Rock
K180945 12/10/2018 LUTRONIC GENIUS Radiofrequency System Lutronic Corporation Jhung Won Vojir
K172146 02/01/2018 MERISTEEL M/s. Meril Endo Surgery Private Limited Umesh Sharma
K182434 12/13/2018 LaparoGuard Mariner Endosurgery Inc. Mitch Wilson
K170175 02/26/2018 ENDOSEAL MTA MARUCHI Jang Sung Wook
K173805 02/08/2018 NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Ti Marvao Medical Devices, Ltd. Christopher Davey
K173445 02/02/2018 Materialise TKA Guide System Materialise NV Oliver Clemens
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
K180242 02/28/2018 HeRO Symphony, HeRO ES, HeRO solo/duet Medical Predictive Science Corporation Will King
K180242 02/28/2018 HeRO Symphony, HeRO ES, HeRO solo/duet Medical Predictive Science Corporation Will King
K180091 02/08/2018 UNiD Spine Analyzer Medicrea International David Ryan
K180091 02/08/2018 UNiD Spine Analyzer Medicrea International David Ryan
K172541 02/22/2018 Medline Catheter Specimen Collector Medline Industries, Inc. Dinah Rincones
K182812 12/12/2018 Medline Cautery Electrode (SILICONE) Medline Industries, Inc. Matt Clausen
K173537 02/08/2018 CONCORDE LIFTÖ Medos International, SARL Karen Sylvia
K182610 12/19/2018 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device Medtronic Kari Christianson
K173460 02/16/2018 NeuroEEG MemoryMD Inc. Abdus-Salaam Muwwakkil
K180004 02/22/2018 Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens Menicon Co., Ltd. Kenichi Tanaka
K180004 02/22/2018 Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens Menicon Co., Ltd. Kenichi Tanaka
K173750 02/15/2018 Prelude IDeal Hydrophilic Sheath Introducer Merit Medical Systems, Inc. David Thomas
K171641 02/06/2018 Accula Flu A/Flu B Test Mesa Biotech, Inc. Barbara E. Stevens
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
K173963 02/21/2018 DRI Benzodiazepine Assay Microgenics Corporation Minoti Patel
K173195 02/13/2018 DRI Hydrocodone Assay Microgenics Corporation Minoti Patel
K171384 02/01/2018 Micromed BRAIN QUICK system Micromed S.P.A Monica Camillo
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
K173512 02/05/2018 MFI-Cardiac MultiFunctional Imaging, LLC Dan Kadrmas
K173763 02/28/2018 iovera system Myoscience, Inc Kent Jones
K173580 02/15/2018 Vinyl Patient Examination Glove (Yellow) Nature Medical Products Co.,Ltd. Chao Kevin
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
K180181 02/22/2018 Natus Quantum Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK) Sanjay Mehta
K180181 02/22/2018 Natus Quantum Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK) Sanjay Mehta
K172422 02/09/2018 Kohli Urinary Drainage Catheter Nellie Medical, LLC Ronald Adams
K173450 02/07/2018 PRESS DUO elite, PRESS DUO elite AG Nemoto Kyorindo Co., Ltd. Jim Knipfer
K173402 02/22/2018 Neocis Guidance System (NGS) with Chairside Splint Neocis Inc Alon Mozes
K182776 12/21/2018 Neocis Guidance System Neocis Inc. Thomas E. Claiborne
K173409 02/16/2018 Wireless Audio System NeoCoil, LLC Michael Leigh
K173077 02/23/2018 Cavetto-SA Cervical Cage System NeuroStructures, Inc. Kathleen Wong
K172320 02/26/2018 Neurostructures Cavetto« Cervical Cage System NeuroStructures, Inc. Kathleen Wong
K172208 02/16/2018 NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet NeVap, Inc. Brenton Hanlon
K173746 02/27/2018 Activmotion Range Newclip Technics Gaelle LUSSORI
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
K180123 02/16/2018 Breast BI 7 MR Coil 1.5T Mammavention Noras MRI products GmbH Jens Heidenmann
K180123 02/16/2018 Breast BI 7 MR Coil 1.5T Mammavention Noras MRI products GmbH Jens Heidenmann
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
K173236 02/22/2018 Sentry IVC Filter Novate Medical Ltd. Gordon Crowley
K182387 12/17/2018 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) Novo Nordisk Inc. Elizabeth D'Amato
K173025 02/08/2018 NuVasive« MLX« û Medial Lateral Expandable Lumbar Interbody System; NuVasive« AP Expandable XLIF System NuVasive, Incorporated Cynthia Adams
K182949 12/04/2018 HealixÖ Compression Screw System Nvision Biomedical Technologies, LLC Diana Langham
K180237 02/27/2018 Rezum System NxThera, Inc. Kathy Simpson
K180237 02/27/2018 Rezum System NxThera, Inc. Kathy Simpson
K182454 12/20/2018 O2 Concepts Oxlife Independence Model 301-0001 O2 Concepts LLC Kathryn G. Forgione
K171755 02/09/2018 CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System Omega Medical Imaging, LLC John Newman
K180130 02/23/2018 ELEOSÖ Bipolar Acetabular System Onkos Surgical, Inc. Jan Triani
K180130 02/23/2018 ELEOSÖ Bipolar Acetabular System Onkos Surgical, Inc. Jan Triani
K173707 02/28/2018 P200TE Optos plc Geoff Fatzinger
K173894 02/09/2018 Jade PTA Balloon Dilatation Catheter OrbusNeich Medical Trading Inc. John Pazienza
K172698 02/07/2018 G-Beam Fusion Beaming System Orthofix Srl Gianluca Ricadona
K173255 02/22/2018 Talon DistalFix Humeral Nail Orthopedic Designs North America, Inc. Robin Wilson
K173693 02/23/2018 Orbitum Bone Staple Implant, X and VI Orthovestments, LLC Robert Weinstein
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
K173967 02/22/2018 Remedy Acetabular Cup Osteoremedies LLC Chris Hughes
K171576 02/22/2018 The Panthera Anti-Snoring X3 Device Panthera Dental Inc. Martine Fortin
K182296 12/14/2018 HyperFil-LV Parkell, Inc. David Mott
K161222 02/07/2018 PENTAX MEDICAL ED-3490TK, Video Duodenoscope PENTAX MEDICAL KANCHANA IYER
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
K173433 02/05/2018 ProxiDiagnost N90 Philips Medical Systems DMC GmbH Ming Xiao
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
K173729 02/28/2018 REVIAN RED PhotonMD, Inc William A Knape
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
K171403 02/02/2018 OralTox Oral Fluid Drug Test Premier Biotech Inc Jacqueline Gale
K172934 02/16/2018 Needle Free Transseptal Cannula Pressure Products Medical Device Manufacturing LLC Andrew Armour
K172950 02/21/2018 TSN Transseptal Needle Pressure Products Medical Device Manufacturing LLC Andrew Armour
K182670 12/20/2018 FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute Prosidyan, Inc Charanpreet S. Bagga
K171620 02/21/2018 PiCCO Catheter PULSION Medical Systems SE Ingrid Rohm
K183111 12/07/2018 Contour 24 Quality Electrodynamics, LLC Eric Yeh
K180158 02/14/2018 Surgical Laser fibers Quanta System SPA Francesco Dell'Antonio
K180158 02/14/2018 Surgical Laser fibers Quanta System SPA Francesco Dell'Antonio
K182564 12/27/2018 Quantib ND Quantib BV Floor van Leeuwen
K180288 02/13/2018 QuickVue Influenza A+B Quidel Corporation Jennifer S. Rial
K180288 02/13/2018 QuickVue Influenza A+B Quidel Corporation Jennifer S. Rial
K173691 02/28/2018 Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack Quidel Corporation Jennifer S. Rial
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
K172647 02/21/2018 Reprocessed ArthroCare ENT Coblator ReNovo, Inc. Mark K. Wells
K172751 02/09/2018 iVitri Straw Reprobitech Corp. Huai L. Feng
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
K171605 02/20/2018 Elecsys CA 15-3 II Roche Diagnostics Adennis Cora
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
K173204 02/05/2018 RS85 Diagnostic Ultrasound System Samsung Medison Co., Ltd Ji Yea Lee
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
K173513 02/20/2018 WS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K173882 02/06/2018 SeaSpine Mariner Pedicle Screw System SeaSpine Orthopedics Corporation Gina Flores
K180176 02/20/2018 SeaSpine NewPort Spinal System SeaSpine Orthopedics Corporation Gina Flores
K180176 02/20/2018 SeaSpine NewPort Spinal System SeaSpine Orthopedics Corporation Gina Flores
K173334 02/22/2018 SeaSpine Spinous Process System SeaSpine Orthopedics Corporation Gina Flores
K182905 12/14/2018 UniPulse Seaward Group Jim Wallace
K180762 12/14/2018 CAPI 3 HEMOGLOBIN(E) SEBIA Karen Anderson
K171861 02/07/2018 CAPILLARYS Hb A1c Sebia Karen Anderson
K182001 12/17/2018 Acucy Influenza A&B Test with the Acucy System Sekisui Diagnostics, LLC Shelly Harris
K172839 02/13/2018 ENDOSOLV Septodont Jaimie Woodruff
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
K172797 02/28/2018 ECG Cable/Leadwires Shenzhen Coreray Technology., Ltd Simon Fan
K181967 12/10/2018 Disposable Temperature Probe Shenzhen Launch Electrical Co., LTD Jiaan Huang
K172883 02/12/2018 Home Use Hair Removal Device/T1, T2, T3 Shenzhen Mareal Tech Co., Ltd Libin Liu
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
K180039 02/01/2018 ACUSON Juniper Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
K180039 02/01/2018 ACUSON Juniper Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
K173957 02/01/2018 ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
K180067 02/07/2018 ACUSON X800 Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
K180067 02/07/2018 ACUSON X800 Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
K173592 02/13/2018 MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit Siemens Medical Solutions USA, Inc. Cordell L. Fields
K173981 02/02/2018 ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Ultrasound Group Sulgue Choi
K172832 02/06/2018 Insight BD Siemens Medical Solutions, Inc Denise Adams
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
K172005 02/02/2018 PICO 7 Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Samantha Neilson
K172395 02/01/2018 Duatene bilayer mesh Sofradim Production Benjamin Rochette
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
K172160 02/09/2018 Southern Implants PEEK Abutments Southern Implants (Pty) Ltd Lauranda Breytenbach
K173343 02/27/2018 Zygomatic Implant System Southern Implants (Pty) Ltd Lauranda G. Breytenbach
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
K171797 02/26/2018 TRYPTIK2 C-Plate Anterior Cervical Plate System Spineart Franck Pennesi
K173224 02/23/2018 SPIN-SWI SpinTech, Inc. Kay Fuller
K180141 02/16/2018 SPIWay Endonasal Access Guide SPIWay, LLC Eugene Chen
K180141 02/16/2018 SPIWay Endonasal Access Guide SPIWay, LLC Eugene Chen
K171287 02/01/2018 Sporview VH202 BI SPSmedical Supply Corp. A Division of Cantel Medical Brent Geiger
K181865 12/14/2018 Acu-sInQ Complete Endoscope Cleaning Aid System STERIS Corporation Gregory Land
K173493 02/23/2018 Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 STERIS Corporation Anthony Piotrkowski
K173485 02/22/2018 Amsco Evolution Medium Steam Sterilizer STERIS Corporation Anthony Piotrkowski
K173490 02/22/2018 Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) STERIS Corporation Anthony Piotrkowski
K172752 02/09/2018 CELERITY 20 HP Biological Indicator Steris Corporation Jennifer Nalepka
K173634 02/12/2018 CELERITY 20 Steam Biological Indicator STERIS Corporation Anthony Piotrkowski
K173670 02/12/2018 CELERITY 20 Steam Incubator STERIS Corporation Anthony Piotrkowski
K173626 02/21/2018 Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles STERIS Corporation Anthony Piotrkowski
K173629 02/21/2018 CELERITY 20 Steam Process Challenge Device for Gravity Cycles STERIS Corporation Anthony Piotrkowski
K182724 12/10/2018 CelerityTM 10 STEAM Chemical Indicator STERIS Corporation Eileen McCafferty
K172755 02/09/2018 PRO-LITE Sterilization Trays Steris Corporation Tricia Cregger
K172754 02/09/2018 V-PRO maX 2 Low Temperature Sterilization System Steris Corporation Bill Brodbeck
K173633 02/28/2018 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 Corporation Jennifer Nalepka
K172753 02/09/2018 VERIFY VH2O2 Indicator Tape Steris Corporation Bill Brodbeck
K172746 02/09/2018 VERIFY« HPU Chemical Indicator and VERIFY« Vaporized VH2O2 Process Indicator Adhesive Label STERIS Corporation Bill Brodbeck
K172749 02/09/2018 Vis-U-All Low Temperature Sterilization Pouch/Tubing Steris Corporation Tricia Cregger
K172748 02/09/2018 VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack STERIS Corporations Jennifer Nalepka
K171520 02/07/2018 SteriZign Signatur Device Protection System SteriZign Precision Technologies, LLC Sonia Lutarewych
K182359 12/13/2018 HipCheck Stryker Corp. Cara Mellits
K180327 02/26/2018 Stryker iVAS 13g Bone Biopsy Kit Stryker Corporation Kristi Ashton
K180327 02/26/2018 Stryker iVAS 13g Bone Biopsy Kit Stryker Corporation Kristi Ashton
K181752 12/21/2018 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation Kristi Ashton
K173849 02/02/2018 Triathlon Total Knee System Stryker Orthopaedics Margaret Crowe Klippel
K173823 02/09/2018 Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System Summit Industries LLC Tom Boon
K170793 02/12/2018 SuRgical Planner (SRP) Surgical Theater, LLC Kevin Murrock
K171869 02/23/2018 Sutter CURIS RF Generator Sutter Medizintechnik GmbH Ulrike Zeissler
K161989 02/01/2018 PREMIUM Implant Systems SHELTA Implant Systems SWEDEN & MARTINA S.p.A. Alessia Pezzato
K182438 12/06/2018 Synthetic Polyisoprene Lubricated Male Condom - 5 senses Sxwell Usa LLC Robert Mahler
K173272 02/09/2018 Ergonomic Handle Symmetry Surgical Inc. Christopher Smith
K172338 02/21/2018 Catasyn Advanced Technology Wound Hydrogel Synedgen, Inc Shenda Baker
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
K170131 02/10/2018 TAV Medical Dental Implants System Tav Medical Ltd. Revital Shabtai
K182506 12/10/2018 LipiScan Dynamic Meibomian Imager TearScience, Inc. Christy Coleman
K172775 02/12/2018 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle Teleflex Medical, Inc. Holly Hallock
K173545 02/14/2018 TEMED Gas Diffuser TEMED Katie Evans
K172868 02/28/2018 Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls The Binding Site Group Ltd. Kirsty Samuels
K172613 02/15/2018 Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit The Binding Site Group Ltd. Andrea Thomas
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
K173535 02/13/2018 Endoskeleton« TAS Interbody Fusion Device, Endoskeleton« TAS Hyperlordotic Interbody Fusion Device and Endoskeleton« TCS Interbody Fusion Device Titan Spine, LLC Jane Rodd
K173275 02/27/2018 OMNICHROMA Tokuyama Dental Corporation Keith A. Barritt
K182461 12/27/2018 LATITUDE EV Total Elbow Arthroplasty Tornier Inc. Renee Stoffel
K172504 02/09/2018 Tosama Biobased Applicator Tube Menstrual Tampon TOSAMA, d.o.o. Marjetka Kralj Kuncic
K173468 02/23/2018 Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 Toshiba Medical Systems Corporation Paul Biggins
K173736 02/28/2018 TrackX TrackX Technology, LLC Calley Herzog
K180889 12/07/2018 Tractus Crossing Support Catheter Tractus Vascular LLC Janet Burpee
K183098 12/06/2018 Senhance Surgical System TransEnterix, Inc. Michele Jans
K173367 02/28/2018 MC 300* Nebulizer Trudell Medical International Marianne Tanton
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
K171823 02/22/2018 U&U Indicator tape and strip U&U Medical Technology Co., Ltd Xuebo Wang
K173163 02/09/2018 ChlorCid, ChlorCid V, ChlorCid Surf Ultradent Products, Inc. Corey Jaseph
K183212 12/07/2018 Nexus DR Digital X-ray Imaging System with stitching Varex Imaging Corporation Michael Van Ryn
K171631 02/09/2018 Standard Catheter Set Varian Medical Systems, Inc. Peter J. Coronado
K173636 02/15/2018 Velocity Varian Medical Systems, Inc. Peter J. Coronado
K180128 02/16/2018 Warrior 14 guidewire Vascular Solutions, Inc Becky Astrup
K180128 02/16/2018 Warrior 14 guidewire Vascular Solutions, Inc Becky Astrup
K172509 02/01/2018 Sentosa SA201 HSV 1/2 Qualitative PCR Test Vela Diagnostics USA Inc. Donald Henton
K180175 12/07/2018 SignalMark Lung Biopsy Site Marker ViewPoint Medical, Inc. Thomas Kane
K171668 02/26/2018 Bluetooth blood pressure monitor Visiomed Group SA Eric Sebban
K180204 12/28/2018 CranioMaxillofacial Fixation (CMF) System - CMF Visionare Visionare LLC Mariane de Oliveira Quinzani
K171208 02/05/2018 Trans-anal Introducer Visionsense Ltd. Alex Chanin
DEN170073 02/13/2018 ContaCT Viz.Al, Inc. Gregory Ramina
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
K172439 02/14/2018 Siberian Fit Vydence Kevin Walls
K172899 02/26/2018 Vygon PICCs Vygon USA Jillian Mikovich
K171695 02/05/2018 First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana W.H.P.M., Inc. John Wan
K172040 02/05/2018 Aquilex Fluid Control System AQL-100S W.O.M. World Of Medicine GmbH Lucia Puetmann
K163377 02/21/2018 Captura Disposable Bronchoscope Biopsy Forceps Wilson-Cook Medical Inc. Ashley Howard
K172237 02/02/2018 Bicera Resorbable Bone Substitute Wiltrom Corporation Limited Yi-Chun Su
K171455 02/09/2018 AT-6XX Series Infrared Thermometer Xiamen Acurio Instruments Co., Ltd Angel Liu
K182038 12/10/2018 URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer YD Diagnostics Corporation Hyuckjoo Lee
K173561 02/12/2018 Vinyl Patient Examination Glove (Yellow) Yurun Glove Co., Ltd. Chao Kevin
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
K171495 02/12/2018 Zyston Strut Open Titanium Spacer System Zimmer Biomet Spine Inc. Megan Fessenden
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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