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
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
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
K171557 02/06/2018 AcQRef Introducer Sheath Acutus Medical, Inc. Brenda Clay
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
K170683 02/20/2018 Aesculap Video Assisted Thoracic Surgery (VATS) INstruments Aesculap, Inc. Jessica Stigliano
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
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
K172042 02/27/2018 NeuroNav System, NeuroSmart System Alpha Omega Engineering Ltd. Maysana Mousa
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
K172624 02/13/2018 Voyant 5mm Fusion Device Applied Medical Resources Corporation Andrew Nguyen
K180118 02/12/2018 Arthrex NanoSuture Anchor Arthrex Inc. Rebecca R. Homan
K171933 02/12/2018 ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter Asahi Intecc Co., Ltd. Yasuyuki Kawahara
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
K180137 02/15/2018 AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) AtriCure, Inc. Melissa Smallwood
K171476 02/27/2018 SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) Awareness Technology, Inc. Steve Andrus
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
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
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
K173569 02/23/2018 Ultrasound System 1300 BK Medical ApS Karen Provencher
K172390 02/18/2018 Optima Coil System Blockade Medical, LLC (d.b.a. Balt USA) Rebecca K. Pine
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
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
K173924 02/05/2018 DRX-Revolution Nano Mobile X-ray System Carestream Health, Inc. Victoria A. Wheeler
K173145 02/28/2018 CereMetrix Silver CereMetrix Corp John A Kelley
K171637 02/26/2018 OpClear System Cipher Surgical Ltd Justin Buch
K172490 02/06/2018 eUnity Client Outlook Inc. Christie Eby
K173501 02/09/2018 Meridian Vaginal Positioning System (VPS) Coloplast Diane Brinza
K180070 02/02/2018 SpeediCath Flex Coude Pro Coloplast Troy Thome
K173527 02/12/2018 Digitex Delivery Device Coloplast A/S Nikita Basandra
K173352 02/15/2018 Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) Concentric Medical, Inc. Rhoda M. Santos
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
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
K173288 02/15/2018 CorPath GRX System Corindus, Inc. Robert Lavado
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
K173710 02/12/2018 MotoBAND CP Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K173185 02/14/2018 SEURATÖ Universal Pedicle Screw System CTL Medical Corporation Tosan Onosode
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
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
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
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
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
K173587 02/16/2018 Magseed Magnetic Marker Systtem Endomagnetics Ltd. Andrew Shawcross
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
K180082 02/11/2018 geko T-2 and geko Plus R-2 Firstkind Ltd Neil Buckley
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
K172180 02/09/2018 OSCAR 15 Genoray Co.,Ltd Ji-Yeon Choi
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
K180255 02/28/2018 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
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
K173739 02/28/2018 ALOKA ARIETTA 850 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
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
K180036 02/02/2018 SMAXEL CO2 Surgical Laser System IDS, LTD. Kwang Yeong Ahn
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
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
K171649 02/22/2018 Straumann CARES M-Series CAD/CAM System Institut Straumann AG Andreas Petermann
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
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
K172941 02/12/2018 CASCADIA Interbody System K2M 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
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.
K173443 02/01/2018 AEON Endoscopic Stapler Lexington Medical Inc. Donna Gasper
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
K173817 02/28/2018 Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 ?g/mL Liofilchem s. r. l. Fabio Brocco
K173067 02/22/2018 LightForce LTS Model 1000, 1500, 2500, and 4000 LiteCure, LLC Eric Rock
K172146 02/01/2018 MERISTEEL M/s. Meril Endo Surgery Private Limited Umesh Sharma
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
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
K172541 02/22/2018 Medline Catheter Specimen Collector Medline Industries, Inc. Dinah Rincones
K173537 02/08/2018 CONCORDE LIFTÖ Medos International, SARL Karen Sylvia
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
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
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
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
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
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
K180123 02/16/2018 Breast BI 7 MR Coil 1.5T Mammavention Noras MRI products GmbH Jens Heidenmann
K173236 02/22/2018 Sentry IVC Filter Novate Medical Ltd. Gordon Crowley
K173025 02/08/2018 NuVasive« MLX« û Medial Lateral Expandable Lumbar Interbody System; NuVasive« AP Expandable XLIF System NuVasive, Incorporated Cynthia Adams
K180237 02/27/2018 Rezum System NxThera, Inc. Kathy Simpson
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
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
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
K161222 02/07/2018 PENTAX MEDICAL ED-3490TK, Video Duodenoscope PENTAX MEDICAL KANCHANA IYER
K173433 02/05/2018 ProxiDiagnost N90 Philips Medical Systems DMC GmbH Ming Xiao
K173729 02/28/2018 REVIAN RED PhotonMD, Inc William A Knape
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
K171620 02/21/2018 PiCCO Catheter PULSION Medical Systems SE Ingrid Rohm
K180158 02/14/2018 Surgical Laser fibers Quanta System SPA Francesco Dell'Antonio
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
K172647 02/21/2018 Reprocessed ArthroCare ENT Coblator ReNovo, Inc. Mark K. Wells
K172751 02/09/2018 iVitri Straw Reprobitech Corp. Huai L. Feng
K171605 02/20/2018 Elecsys CA 15-3 II Roche Diagnostics Adennis Cora
K173204 02/05/2018 RS85 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
K173334 02/22/2018 SeaSpine Spinous Process System SeaSpine Orthopedics Corporation Gina Flores
K171861 02/07/2018 CAPILLARYS Hb A1c Sebia Karen Anderson
K172839 02/13/2018 ENDOSOLV Septodont Jaimie Woodruff
K172797 02/28/2018 ECG Cable/Leadwires Shenzhen Coreray Technology., Ltd Simon Fan
K172883 02/12/2018 Home Use Hair Removal Device/T1, T2, T3 Shenzhen Mareal Tech Co., Ltd Libin Liu
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
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
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
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
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
K171287 02/01/2018 Sporview VH202 BI SPSmedical Supply Corp. A Division of Cantel Medical Brent Geiger
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
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
K180327 02/26/2018 Stryker iVAS 13g Bone Biopsy Kit 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
K173272 02/09/2018 Ergonomic Handle Symmetry Surgical Inc. Christopher Smith
K172338 02/21/2018 Catasyn Advanced Technology Wound Hydrogel Synedgen, Inc Shenda Baker
K170131 02/10/2018 TAV Medical Dental Implants System Tav Medical Ltd. Revital Shabtai
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
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
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
K173367 02/28/2018 MC 300* Nebulizer Trudell Medical International Marianne Tanton
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
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
K172509 02/01/2018 Sentosa SA201 HSV 1/2 Qualitative PCR Test Vela Diagnostics USA Inc. Donald Henton
K171668 02/26/2018 Bluetooth blood pressure monitor Visiomed Group SA Eric Sebban
K171208 02/05/2018 Trans-anal Introducer Visionsense Ltd. Alex Chanin
DEN170073 02/13/2018 ContaCT Viz.Al, Inc. Gregory Ramina
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
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