FDA 510(k) Decisions During December, 2017  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K172388 12/22/2017 VPOD ITPR Advanced Circulatory System, a wholly owned subsidiary of Anja Metzger
K172931 12/01/2017 DUS-6000 Digital Ultrasonic Diagnostic Imaging System Advanced Instrumentations, Inc. Jorge Millan
K172966 12/08/2017 CMS-2000 Central Monitoring System Advanced Instumentations, Inc. Jorge Millan
DEN170075 12/19/2017 ContainOR Advanced Surgical Concepts Ltd. Edward Hyland
K172529 12/05/2017 Vivaer ARC Stylus Aerin Medical, Inc. Shannon Scott
K173550 12/14/2017 Akros FibuLinkÖ Syndesmosis Repair Kit Akros Medical Charles Horrell
K173538 12/04/2017 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc Alcon Laboratories, Inc. Katryna Warren
K173502 12/13/2017 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit Alere Scarborough, Inc. Benjamin Crystal
K171581 12/22/2017 Neuro Omega System Alpha Omega Engineering Ltd, Maysana Mousa
K172732 12/14/2017 E-CUBE 8 ALPINION MEDICAL SYSTEMS Co., Ltd. Boyeon CHO
K170553 12/01/2017 Altus Spine Interbody Fusion System Altus Partners, LLC Mark Melton
K172908 12/07/2017 Q-Switched Nd:YAG Laser System AMI Inc. Hae Youn Lee
K171037 12/27/2017 PoreStar Patient Specific Implant Anatomics Pty Ltd Joanne Flatley
K172494 12/15/2017 PROTEUS PTA Balloon Catheter with Embolic Capture Feature Angioslide, Ltd. Eran Vickus
K173017 12/15/2017 Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Anhui Kindguard Medical Supplies Technology Co.,Ltd Chen Wei
K173008 12/26/2017 SCS 17-01 Anika Therapeutics, Inc. Steven Chartier
K171737 12/29/2017 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves Ansell Healthcare Products LLC Robert Mahler
K172052 12/13/2017 Arthrex DynaNite Nitinol Staple Arthrex Inc. Rebecca R. Homan
K170414 12/14/2017 Arthrex Univers Revers Apex Humeral Stems Arthrex Inc. David L. Rogers
K172383 12/22/2017 Arthrosurface Bone Screws Arthrosurface, Inc. Dawn J. wilson
K172228 12/15/2017 pioli IOL Delivery System AST Products, Inc. William Lee
K171584 12/22/2017 B. Braun Tear-Away Introducer Needle B. Braun Medical Inc. Kimberly Smith
K172922 12/21/2017 MMPC-4127F1 Barco N.V. Lieven De Wandel
K173480 12/11/2017 Crystalsert Lens Delivery System Bausch & Lomb, Inc Gary Rauvola
K172912 12/07/2017 MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 û 8 ?g/mL) Beckman Coulter Inc. Shannon Popson
K172255 12/01/2017 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) Beckman Coulter, Inc Shannon Popson
K172337 12/15/2017 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) Beckman Coulter, Inc. Teresa S. Wong
K173354 12/15/2017 BD Nexiva Diffusics Closed IV Catheter Systems Becton Dickinson Infusion Therapy Systems, Inc. Henry Boland
K171061 12/28/2017 MRSASelect II Bio-Rad Sylvie Fernez
K172731 12/08/2017 VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) bioMerieux, Inc. Esther Hernandez
K172944 12/19/2017 VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 û >=16 ?g/mL bioMerieux, Inc. Cherece L. Jones
K173374 12/13/2017 TSV BellaTek Encode Healing Abutments Biomet 3i Nichole OÆNeil
K170138 12/26/2017 NEURONAUTE BIOSERENITY Quang TRAN
K171185 12/01/2017 IR Type Implant System Biotem Co., Ltd. Hong Koo Yeo
K172311 12/15/2017 BioFlux Device Biotricity Inc. Spencer LaDow
K172330 12/21/2017 Blustone Synergy Silica System Blustone Synergy Lisa Peterson
K172565 12/20/2017 Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device Boston Scientific Corporation Anand Patel
K173251 12/19/2017 LumiCoil Platinum Fiducial Marker Boston Scientific Corporation Lindsay Forys
K171271 12/15/2017 Polyform Synthetic Mesh Boston Scientific Corporation Michelle Berry
K172932 12/13/2017 True Flow Valvuloplasty Perfusion Catheter C. R. Bard, Inc. Aaron Conovaloff
K173652 12/28/2017 Piccolo Composite Nailing System CarboFix Orthopedics Ltd. Yael Rubin
K171552 12/19/2017 Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV Cepheid Yi-Ping Lin
K171186 12/08/2017 Cerebrotech CMS-5000 Cerebrotech Medical Systems Dawnel Scott
K171956 12/12/2017 Sterile Endoscope Biopsy Sampling Needle Changzhou Detain Medical Devices Co., Ltd. Zhengrong Ding
K172561 12/05/2017 Disposable Circular Stapler Changzhou Kangdi Medical Stapler Co., Ltd. Eve Zhou
K171877 12/21/2017 SLM-1ER, SLM-2ER, SLM-3ER Chongqing Kanghua Ruiming S&T Co., Ltd. Xi You
K172465 12/15/2017 IdysÖ TLIF 3DTi Cages CLARIANCE, SAS Pascal Rokegem
K171677 12/08/2017 Clear Guide SCENERGY Clear Guide Medical Jack Kent
K173148 12/01/2017 ACIF coLigne, AG Robert Lange
K171043 12/21/2017 Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters Coloplast Corp Cori Ragan
K172986 12/19/2017 Zmachine Synergy Consolidated Research of Richmond, Inc. dba General Sleep Co Richard Kaplan
K172217 12/13/2017 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath Cook Incorporated Andrew Breidenbach
K171275 12/20/2017 Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design Cook Incorporated Daniel J. Corbin
K173685 12/20/2017 Peel-Away Introducer Set Cook Incorporated Colin Jacob
K172321 12/21/2017 Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters Cook Incorporated Naomi Funkhouser
K173687 12/15/2017 Strange Bile Duct Stone Exploration Set Cook Incorporated Colin Jacob
K170898 12/12/2017 Wittich Nitinol Stone Basket Cook Incorporated Erum B. Nasir
K172707 12/05/2017 Renamel Microfill Cosmedent, Inc Mary Nowak
K172482 12/15/2017 The Nellcor pulse oximetry monitor interface cable Covidien Mia M. Ware
K172432 12/12/2017 SporView Rapid Read Biological Indicator Crosstex/SPSmedical, A Division of Cantel Medical Megan Skaar
K172085 12/04/2017 PhotoFix Decellularized Bovine Pericardium CryoLife, Inc. Heather Emerick
K171909 12/17/2017 HAL for Medical Use (Lower Limb Type) CYBERDYNE Inc. Yohei Suzuki
K170005 12/21/2017 FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) DAKO DENMARK A/S LASSE POST MOLLER
K170028 12/21/2017 FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) DAKO DENMARK A/S Lasse Post Moller
K171530 12/21/2017 Deltaven XiV Max, Deltaven XiV Max FF Delta Med SpA Raschi Olga
K170104 12/27/2017 COMPACT S, COMPACT S (LED) DMETEC CO., LTD. Lee Seung Dae
K171729 12/13/2017 Fixtemp C&B Dreve Dentamid GmbH Reiner Altmann
K171174 12/18/2017 PERIO-FLOW nozzle E.M.S. Electro Medical Systems S.A. Suzanne Fassio-Hardy
K172888 12/15/2017 EIT Cellular Titanium« Cervical Cages, EIT Cellular Titanium« PLIF Cages, EIT Cellular Titanium« TLIF Cages, EIT Cellular Titanium« ALIF Cages EIT Emerging Implant Technologies GmbH Barbara Wirth
K172270 12/07/2017 gammaCore-2 eletroCore, LLC Mike Romaniw
K173073 12/26/2017 AltiVate Anatomic to Reverse Conversion Module Encore Medical, L.P. Teffany Hutto
K172651 12/13/2017 FMP Extended Liners Encore Medical, L.P. Teffany Hutto
K172722 12/10/2017 Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) EUROIMMUN US, Inc. Michael A. Locke
K172357 12/29/2017 Disposable Powder Free Vinyl Exam Glove, Clear/Yellow EVER GROWTH (VIETNAM) CO., LTD Che-Min Lee
K171781 12/13/2017 eVox System Evoke Neuroscience, Inc. David Hagedorn
K173375 12/21/2017 Anterior Cervical Plate System Evolution Spine, LLC Douglas Davis
K172960 12/21/2017 easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use Ezisurg Medical Co., Ltd. Sheng Tian
K171193 12/18/2017 Certa Catheter Ferrosan Medical Devices SP. Z O.O. Elzbieta Porebska-Guillemant
K172819 12/01/2017 LightWalker Laser System Family Fotona d.o.o. Marko Berdajs
K172238 12/14/2017 CAREline Airless Hemodialysis Blood Tubing Sets Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K172713 12/10/2017 Lumipulse G BòRòAòHòMòS PCT Immunoreaction Cartridges, Lumipulse G BòRòAòHòMòS PCT Calibrators set Fujirebio Diagnostics, Inc. Stacey Dolan
K171834 12/19/2017 G Surgical OCT Spinal System G Surgical LLC Donald Grafton
K173287 12/21/2017 Elite HV Radial Galt Medical Corp. David Derrick
K173555 12/20/2017 LOGIQ E10 GE Healthcare Bryan Behn
K173612 12/11/2017 Optima XR646 HD GE Hualun Medical Systems Co., Ltd Kenny Ma
K172010 12/07/2017 gel-e Bandage gel-e, Inc. (formerly Remedium Technologies, Inc.) Matthew Dowling
K170276 12/11/2017 Safety Blood Collection Device for Single Use Gemtier Medical (Shanghai) Inc. Lenny Cao
K172714 12/08/2017 LipiVage Genesis Biosystems, Inc. Jim Lafferty
K171108 12/29/2017 AUTOBAHN Nailing System Globus Medical Inc. Kelly J. Baker
K173115 12/20/2017 COALITION« and COALITION« TPS, COALITION MIS« and COALITION MIS« TPS, COALITION AGX« and COALITION AGX« TPS Globus Medical Inc. Kelly J. Baker
K171848 12/21/2017 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Globus Medical Inc. Lori Burns
K172445 12/08/2017 RoyalGuard Surgical Gown, i600, Breathable GRI Medical & electrical Technology Co., Ltd Martin D. Paugh
K163550 12/20/2017 Pobling MIITY 2 HABALAN MED & BEAUTY CO.,LTD RAY JEON
K172861 12/19/2017 Digital thermometer(with disposable thermometer cover) Hangzhou Hua'an medical&health instruments Co.,Ltd Ahneo Yang
K173137 12/12/2017 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) Hartalega Sdn. Bhd. Kuan Kam Hon
K171336 12/07/2017 Cystoscope 4.0mm autoclavable 0? WL 302mm; Hysteroscope 4.0mm autoclavable 0? WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath Henke-Sass, Wolf GmbH Anna Reifschneider
K171049 12/26/2017 Real Time Image Gating System for Proton Beam Therapy Systems Hitachi, Ltd. Healthcare Tomoyuki Seino
K172629 12/04/2017 Panther Fusion AdV/hMPV/RV Assay Hologic, Inc. Anila K Tarte
K170988 12/12/2017 DropSafe Safety Pen Needle HTL-Strefa S.A. Aleksandra Prazmowska-Wilanowska
K173131 12/08/2017 Rexious Spinal Fixation System Huvexel Co., Ltd Sung Hee-Lee
K171480 12/13/2017 NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
DEN160062 12/19/2017 IlluminOss Bone Stabilization System IllminOss Medical, Inc. Fred Tobia
K173038 12/01/2017 CuRAS Nd:YAG Laser Ilooda Co., Ltd. Yun-Jung HA
K172507 12/22/2017 SOZO ImpediMed Limited Catherine Kingsford
K173470 12/04/2017 ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical Eben Gordon
K170881 12/14/2017 ISP Safety Huber Needle Infusion Set Infusion Safety Products, Inc. Alan P. Reid
K173126 12/05/2017 ArisstosÖ Spinal System Ingenium Spine David Brumfield
K172302 12/08/2017 InMode PLUS System InMode MD Ltd. Amit Goren
K172468 12/06/2017 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm InNeuroCo, Inc Marc Litzenberg
K170993 12/22/2017 QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer Inova Diagnostics, Inc. Roger Albesa
K171773 12/01/2017 Straumann n!ce Glass Ceramic A14 Blocks Institut Straumann AG Shokoufeh Khodabandeh
K173403 12/29/2017 GEM Premier 5000 Instrumentation Laboratory Co. Carol Marble
K170029 12/15/2017 FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile INTERNATIONAL BIOPHYSICS CORPORATION Geoff Marcek
K171102 12/21/2017 Ives MR Conditional Cup Electrode Ives EGG Solutions John Ives
K171012 12/19/2017 Veraview X800 J.Morita USA, Inc. Keisuke Mori
K172008 12/01/2017 ARIX Humerus System Jeil Medical Corporation Sejin Ryu
K170846 12/13/2017 Disposable Insulin Pen Needle Jiangsu Caina Technology Co., Ltd. Jun Lu
K172989 12/20/2017 Electric Breast Pump Joytech Healthcare Co., Ltd. Ren Yunhua
K173434 12/14/2017 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 JVC KENWOOD Corporation Masafumi Yugami
K172009 12/14/2017 Cascadia Interbody System K2M, Inc. Nancy Giezen
K172918 12/18/2017 DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) KaVo Dental Technologies, LLC Frank Ray
K171748 12/14/2017 Vitrification Kit and Thawing Kit Kitazato Corporation Futoshi Inoue
K173696 12/19/2017 TBL-ABI System LD Technology LLC Albert Maarek
K173286 12/14/2017 Cannulated Screw Internal Fixation System Life Spine Inc. Randy Lewis
K172973 12/21/2017 Life Spine Foot and Ankle Plating System Life Spine Inc. Randy Lewis
K173182 12/20/2017 ProLift« Expandable System Life Spine Inc. Randy Lewis
K170046 12/07/2017 Lilium a-200E Lilium Otsuka Co., Ltd. Hiroaki Takahashi
K173484 12/11/2017 CorticaLINK Spinal Fusion Platform LinkSPINE Inc Nickolas Kriska
K173307 12/19/2017 Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 ?g/mL Liofilchem s. r. l. Fabio Brocco
K172737 12/12/2017 MESIRE - Balloon Sinus Dilatation System M/s. Meril Life Sciences Private Limited Umesh Sharma
K172844 12/15/2017 Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
K171928 12/08/2017 Med-Hot Thermal Imaging Systems Med-Hot Thermal Imaging Inc. Carol Chandler
K173267 12/07/2017 MasterLoc Stem: Lateralized Plus Medacta International SA Stefano Baj
K171058 12/13/2017 Medacta Shoulder System: Threaded Glenoid Baseplate Medacta International SA Stefano Baj
K171483 12/15/2017 ArchFlo CT Midline Medcomp (dba Medical Components, Inc.) Courtney Nix
K170497 12/15/2017 V10 Mediana Co., Ltd. Kim Min-hye
K170934 12/06/2017 C3 Wave System Medical Components, Inc (Dba Medcomp_ Courtney Nix
K172677 12/19/2017 Advantage Plus Pass-Thru Medivators Inc. Megan Skaar
K173664 12/29/2017 Medtronic O-arm O2 Imaging System Medtronic Inc. Dean Honkonen
K173125 12/20/2017 T2 STRATOSPHEREÖ Expandable Corpectomy System Medtronic Sofamor Danek Kanesha Hines
K171866 12/20/2017 Sentrant Introducer Sheath with Hydrophilic Coating Medtronic Vascular, Inc. Wee Wen Leow
K171109 12/21/2017 Praxiject 0.9% NaCl MedXL Inc. Premala Premanathan
K170389 12/14/2017 TAURUS PEEK Cage System Medyssey USA, Inc. Shawn Kim
K172756 12/08/2017 Varian cage Medyssey USA, Inc. Shawn Kim
K173475 12/08/2017 Merge PACS Merge Healthcare Incorporated Carol Nakagawa
K173621 12/13/2017 Advocate PTA Catheter Merit Medical Systems Inc. Mark Mullaney
K173124 12/18/2017 PEEK Biosolution Merz Dental GmbH Claudia Bobrowski
K172848 12/27/2017 MEVION S250i Proton Beam Radiation Therapy Device Mevion Medical Systems Thomas H. Faris
K172786 12/08/2017 MDS Plating System Miami Device Solutions, LLC Michelle Montesino
K172448 12/21/2017 Riptide Aspiration System Micro Therapeutics, Inc., d/b/a ev3 Neurovascular Ryan Kenney
K173420 12/27/2017 Radiomics App v1.0 Microsoft Corp. Ivan Tarapov
K172505 12/28/2017 MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments MIS Implants Technologies Ltd. Arbel Shezaf
K170165 12/29/2017 Osteo-P Bone Graft Substitute Molecular Matrix, Inc. Charles Lee
K173492 12/22/2017 MRDx BCR-ABL Test, MRDx BCR-ABL Test Software MolecularMD Corporation Kevin Hawkins
K173392 12/12/2017 Pure-Vu System Motus GI Medical Technologies Ltd. Hagit Ephrath
K173043 12/14/2017 Holycon Synthetic Absorbable Sutures Nantong Holycon Medical Devices Co., Ltd. Feng Lu
K172743 12/19/2017 Natus VikingQuest Natus Neurology Incorporated Shane T. Sawall
K173087 12/28/2017 UroLift System (UL400 and UL500) NeoTract, Inc. Louis-Pierre Marcoux
K171198 12/07/2017 NeuViz 16 Essence Multi-slice CT Scanner System Neusoft Medical Systems Co., Ltd. Shao Xiancheng
K172854 12/14/2017 NobelPerfect Abutments Nobel Biocare AB Charlemagne Chua
K173129 12/01/2017 PRECICE System NuVasive Specialized Orthopedics, Inc. Lance Justice
K173117 12/07/2017 NuVasive« VersaTieÖ System NuVasive, Inc. Marysa Loustalot
K172623 12/21/2017 NuVasive Navigation Instruments NuVasive, Incorporated Manthan J. Damani
K172676 12/14/2017 NuVasive« Modulus-C Interbody System NuVasive, Incorporated Marysa E. Loustalot
K173153 12/06/2017 Vertera SpineÖ CoalesceÖ Thoracolumbar Interbody Fusion System NuVasive, Incorporated Michelle Cheung
K173091 12/06/2017 Boundary Anterior Lumbar Buttress Plate Nvision Biomedical Technologies, LLC Diana L. Langham
K172734 12/07/2017 Single Use Electrosurgical Snare SD-400 Olympus Medical Systems Corp. Toshiyuki Nakajima
K172618 12/05/2017 SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K172467 12/21/2017 OMNI ARC Anteverted Neck Hip Stem OMNIlife science Christina Rovaldi
K171167 12/13/2017 Prodigio Stain Powder OperArt LLC Domenico Cascione
K173458 12/07/2017 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Orthofix Srl Gianluca Ricadona
K172425 12/06/2017 OrthoPediatrics Wrist Fusion Plate OrthoPediatrics, Inc. Adam Cargill
K172573 12/15/2017 ReBOSSIS85 Orthorebirth Co., Ltd. Yasutoshi Nishikawa
K171269 12/28/2017 X-PSI Knee System Orthosoft Inc. (d/b/a Zimmer CAS) Guylaine Roy
K170972 12/20/2017 Apex Tibial Nailing System OrthoXel Aisling O'Sullivan
DEN160014 12/22/2017 remOVE System OVESCO ENDOSCOPY AG Med.Marc O. Schurr
K173646 12/19/2017 FS Ergo PaloDEx Group Oy Anni Lundholm
K172886 12/20/2017 Breakaway Screw System Paragon 28 Eric Lintula
K173467 12/12/2017 Advanced Diffusion Analysis (ADA) application Philips Medical Systems Nederland B.V. Yoram Levy
K172904 12/26/2017 IntelliVue Capnography Extension, IntelliVue Microstream Extension Philips Medizin Systeme Boeblingen GmbH Markus Stacha
K172349 12/14/2017 InFill« Interbody Fusion Device Pinnacle Spine Group, LLC Zach Sowell
K163328 12/28/2017 Planmed Clarity Planmed Oy Lars Moring
K173130 12/19/2017 Reform« Midline Cortical Screw System Precision Spine, Inc. Michael C. Dawson
K172893 12/21/2017 SafeSept Needle Free Transseptal Guidewire Pressure Products Medical Device Manufacturing LLC Andrew Armour
DEN170024 12/21/2017 AQUABEAM System PROCEPT BioRobotics Corporation Michael Nketiah
K172056 12/13/2017 InnoSight Diagnostic Ultrasound System Qisda Corporation Johnson Sheu
K173002 12/13/2017 2940 nm Er:Yag Laser Handpiece Quanta System S.p.A. Francesco DellÆAntonio
K171976 12/21/2017 Sofia Strep A+ FIA, Sofia 2 Analyzer Quidel Corporation Edward C. Brehm
K173250 12/21/2017 Solana GBS Assay Quidel Corporation Ronald H. Lollar
K171352 12/01/2017 EZFluence Radformation, Inc. Kurt Sysock
K173662 12/20/2017 speX Support Catheter ReFlow Medical, Inc. Rebecca K Pine
K173102 12/29/2017 Reliance Cervical IBF System Reliance Medical Systems, LLC Bret M. Berry
K172503 12/01/2017 MR Conditional Cup Electrode, MR Conditional Webb Electrode Rhythmlink International, LLC Daniel McCoy
K170960 12/25/2017 CoaguChek Vantus System Roche Diagnostics Justin Davis
K170392 12/01/2017 S.I.N. Implant System S.I.N. û Sistema de Implante Nacional S.A. Denis Oliveira
DEN160037 12/28/2017 dermaPACE System SANUWAVE, INC. PETER STEGAGNO
K173260 12/04/2017 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e?POD System SeaSpine Orthopedics Corporation Gina Flores
K172926 12/21/2017 SeaSpine Vu cPOD, Zuma-C, Complete Cervical SeaSpine Orthopedics Corporation Gina Flores
K173000 12/07/2017 Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) Flower Cai
K173462 12/08/2017 Wireless Pain Relieve Device Model: LT5018C Shenzhen Dongdixin Technology Co.,Ltd. Siping Yuan
K172171 12/21/2017 Digital Blood Pressure Monitor Models: B01, B02, B05 & B06T Shenzhen Jamr Medical Technology CO., Limited Li Xue
K173369 12/13/2017 DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Jean Lei
K171381 12/13/2017 Adhesive Electrodes ShenZhen Quality Medical Technology Co.,Ltd Grace Zhao
K172222 12/08/2017 8ch Flex Suite Shenzhen RF Tech Co., Ltd. Ke Xi
K172530 12/06/2017 BEAUTIFIL Flow Plus X Shofu Dental Corporation Mauro Malzyner
K172286 12/18/2017 Automated Blood Coagulation Analyzer CS-2500 Siemens Healthcare Diagnostic Products Gmbh Nils Neumann
K171771 12/04/2017 ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay Siemens Healthcare Diagnostics Inc. Alan Haley
K173618 12/19/2017 ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Siemens Medical Solutions USA, Inc. HyunJung Lee
K173578 12/20/2017 Biograph mCT Family of PET/CT Systems Siemens Medical Solutions USA, Inc. Tabitha Estes
K173600 12/19/2017 MAGNETOM Amira Siemens Medical Solutions USA, Inc. Martin Rajchel
K173332 12/21/2017 OMNI Surgical System Sight Sciences, Inc. Anne-Marie Ripley
K171434 12/21/2017 ROCCIA« MultiLIF Silony Medical GmbH Bircan Yilmaz
K172688 12/22/2017 Align Radial Head System Skeletal Dynamics, LLC Ana M. Escagedo
K172876 12/04/2017 PowerDot PD-01M Smartmissimo Technologies Pte Ltd Alexey Pisarev
K172785 12/22/2017 CONQUEST FN Smith & Nephew Allison Chan
K170720 12/07/2017 Portex Blue Line Ultra Paediatric Tracheosomy Tube Smiths Medical ASD, Inc. James Taufen
K170862 12/19/2017 Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope Solace Therapeutics, Inc. Scott Blood
K171935 12/01/2017 Alevicyn SG Antimicrobial Gel Sonoma Pharmaceuticals, Inc. Brian W. Martin
K173058 12/01/2017 P10 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp. Toki Wu
K172993 12/05/2017 P20 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp. Toki Wu
K170790 12/13/2017 SAM CRRT Unit, SAM Cassette CRRT Spectral Medical Inc. Danijela Domljanovic
K172594 12/15/2017 Proficient« Posterior Cervical Spine System Spine Wave, Inc. Amy Noccioli
K172474 12/29/2017 Celerity 20 HP Biological Indicator Steris Corporation Anthony Piotrkowski
K172350 12/15/2017 AxSOS 3 Ti Stryker GmbH Kemine Hale
K170913 12/15/2017 Composite Removable Sinus Stent System STS Medical Lena Shlossberg
K172982 12/19/2017 SuperGrow 272, Ultimate 272 Super Grow Lasers Jeff Stanifer
K172978 12/22/2017 SurgeoBite Surgovations LLC Chris Menard
K172666 12/01/2017 CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor SutureEase, Inc. Scott Heneveld
K171889 12/19/2017 Reusable Blood Pressure Cuff Suzhou Minhua Medical Apparatus Supplies Co., LTD Yang Qidong
K172560 12/21/2017 PREMIUM ONE Implant Systems Sweden & Martina S.p.A Alessia Pezzato
K172473 12/15/2017 LifeStyles« SKYN« Intimate Moments Personal Lubricant SXWELL USA LLC Robert Mahler
K170818 12/07/2017 Craniomaxillofacial Distraction System (CMFD) Synthes USA Products, LLC Nicholas Fountoulakis
K173536 12/12/2017 T2Candida 1.1 Panel T2 Biosystems, Inc. Anne Marie Whalen
K172692 12/13/2017 Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens Tangible Science LLC Vic McCray
K172645 12/26/2017 iLux Instrument, iLux Disposable Tear Film Innovations, Inc. John Slate
K173441 12/13/2017 Neurosoft TMS (also CloudTMS) TeleEMG, LLC Joe F. Jabre
K173209 12/01/2017 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL Thermo Fisher Scientific Cynthia Knapp
K172863 12/14/2017 Infinix-i, INFX-8000V, V7.0 Toshiba Medical Systems Corporation Paul Biggins
K172276 12/12/2017 Xario 200 Diagnostic Ultrasound System V6.0 Toshiba Medical Systems Corporation Paul Biggins
K173349 12/20/2017 Operio Toul Meditech AB Tomas Hansson
K172405 12/11/2017 SNIPER STAPLE SYSTEM, NON-STERILE Trilliant Surgical Jon Olson
K172257 12/22/2017 TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) True Diagnostics, Inc Jerry Lee
K172185 12/21/2017 Tyber Medical PT Interbody Spacer System Tyber Medical LLC Mark F. Schenk
K173524 12/13/2017 ANAX 5.5Ö Spinal System U&I Corporation Jee Ae Bang
K172419 12/04/2017 VelofixÖ TLIF Cage U&i Corporation Jee-Ae Bang
K170279 12/12/2017 Disposable High Pressure Syringe Union Medical Shenzhen Co., Ltd. Wenguo Zhang
K163607 12/15/2017 ECG Acquisition Systems VALES & HILLS BIOMEDICAL TECH. LTD. Jianfang Liu
K173266 12/01/2017 Octane aspiration system Vascular Solutions Inc. Becky Astrup
K173532 12/15/2017 Raider Guidewire Vascular Solutions, Inc. Beka Vite
K170950 12/20/2017 Well-Root ST Vericom Co., Ltd. Hyoshin Chung
K171447 12/05/2017 OxyPure Color Silicone Hydrogel Soft Contact Lenses Visco Vision Inc Evan Huang
K171553 12/08/2017 W&H Assistina Twin W & H Dentalwerk Buermoos GmbH Mag. Anja Lindner
K170797 12/06/2017 wettrust D2care Wettrust Korea Co., Ltd. Sungho Lee
K172578 12/07/2017 Equipment Pouch WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd. Haobin Li
K171611 12/15/2017 Double Lumen Ovum Aspiration Needles William A. Cook Australia Pty Ltd Gordana Pozvek
K171513 12/07/2017 Lunderquist Extra Stiff Wire Guide William Cook Europe ApS Henriette Stordal Christiansen
K171573 12/29/2017 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush Wilson-Cook Medical, Inc. Sierra Lowe
K173013 12/14/2017 WishBone K-Wire System WishBone Medical, Inc. Gary Barnett
K172706 12/22/2017 GammaPod - Model A Xcision Medical Systems, LLC Daniel R. Plonski
K171858 12/18/2017 Sidus Stem-Free Shoulder Zimmer GmbH Roberto Tommasini


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