FDA 510(k) Applications Received During February, 2017

FDA 510(k) Number Submission Date Device Name Applicant Contact
K173940 12/26/2017 Astroid Planning App .decimal, LLC. Kevin Erhart
K170321 02/01/2017 3M Comply Hydrogen Peroxide Chemical Indicator 1248 3M COMPANY NADIA BATTAH
K170563 02/27/2017 3M Comply Hydrogen Peroxide Indicator Tape 3M Company Nadia Battah
K170330 02/02/2017 3M Protemp Cement Temporary Dental Cement 3M Company Gretchen Keenan
K170316 02/01/2017 ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM Abbott Laboratories Noah Lermer
K170320 02/01/2017 Alinity c ICT Sample Diluent Abbott Laboratories Zaman Khan
K170317 02/01/2017 Alinity i Total ?-hCG Reagent Kit, Alinity i System ABBOTT LABORATORIES LINDA SOHN
K170322 02/01/2017 Catalys Precision Laser System Abbott Medical Optics Inc. Audrey Munnerlyn
K173795 12/14/2017 HI-TORQUE TurnTrac Guide Wire Family Abbott Vascular Aniket Khakhadiya
K170394 02/08/2017 Kisses Mini ACHIMHAI Medical Corporation Ji Ho Jung
K170587 02/28/2017 On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis ACON Laboratories, Inc. Qiyi Xie
K170442 02/14/2017 Cranial Drill Bits and Accessories Ad-Tech Medical Instrument Corporation Lisa Theama
K170505 02/21/2017 SecurePortIV Catheter Securement Adhesive Adhezion Biomedical, LLC Richard G. Jones
K173947 12/27/2017 Lumbar Interbody Fusion System (OLLIF) Advanced Research Medical, LLC John D Siegel
K170434 02/13/2017 Enterprise Imaging XERO Viewer 8.1 Agfa HealthCare N.V. Jodi Coleman
K170520 02/22/2017 HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ Alcon Research, Ltd. Karen Mudd
K173932 12/26/2017 Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 Alere Scarborough, Inc. Angela Drysdale
K173715 12/04/2017 AlertWatch:OB AlertWatch, Inc. Justin Adams
K170591 02/28/2017 Altomed Malhotra Platinum Segments Altomed Limited Stuart March
K170553 02/24/2017 Altus Spine Interbody Fusion System Altus Partners, LLC Mark Melton
K170512 02/21/2017 Altus Spine Titanium Interbody Fusion System Altus Partners, LLC Claudia Hill
K173727 12/05/2017 Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor Ambu A/S Maja Brons
K170439 02/13/2017 AN87 Dosimeter Andersen Sterilizers, Inc. William K. Andersen
K170432 02/13/2017 Anprolene AN75 Ethylene Oxide Gas Sterilizer Andersen Sterilizers, Inc. William K. Andersen
K170429 02/13/2017 Tyvek Sterilization Pouches with Chevron Seal Andersen Sterilizers, Inc. William K. Andersen
K170426 02/13/2017 AN85/AN86 EO Indicators Andersen Sterilizers,Inc. William K. Andersen
K170427 02/13/2017 Anprolene SteriTest Andersen Sterilizers,Inc. William K. Andersen
K170437 02/13/2017 Sterisheet Sterilization Wrap Andersen Sterilizers,Inc. William K. Andersen
K173762 12/11/2017 AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters AngioDynamics, Inc. Teri Juckett
K170536 02/23/2017 ECG Disposable Lead Wire APK Technology Co., Ltd. Caifang Wang
K170319 02/01/2017 Low Profile Non-Balloon Feeding Device APPLIED MEDICAL TECHNOLOGY INC. SHRADDHA SAINI
K170382 02/07/2017 Arthrex Compression Screws Arthrex Inc. David L. Rogers
K173788 12/14/2017 Arthrex Corkscrew FT Arthrex Inc. David L Rogers
K173845 12/19/2017 Arthrex SwiveLock Arthrex Inc. David L Rogers
K170414 02/10/2017 Arthrex Univers Revers Apex Humeral Stems Arthrex Inc. David L. Rogers
K173900 12/22/2017 Arthrex Univers Revers Modular Glenoid System Arthrex Inc. Courtney Smith
K170547 02/24/2017 Arthrex Mesh Plate System Arthrex, Inc. Ivette Galmez
K170326 02/02/2017 dynaMX Intramedullary Implant Arthrex, Inc. Howard L. Schrayer
K170440 02/14/2017 KISSloc Suture System Arthrosurface, Inc Dawn J. Wilson
K173964 12/29/2017 OVOMotion Shoulder Arthroplasty System Arthrosurface, Inc. Dawn J. Wilson
K170350 02/03/2017 ToeMATE« Hammertoe Correction System Arthrosurface, Inc. Phani Puppala
K173760 12/11/2017 Monarch Endoscopy Platform (Monarch Platform) Auris Surgical Robotics, Inc. Joy Sacmar
K170407 02/10/2017 BD ChloraShield IV Dressing with CHG Antimicrobial Avery Dennison Belgie BVBA Lisa Bartakovics
K173862 12/20/2017 Pantheris System Avinger, Inc. Thomas Lawson
K170539 02/23/2017 Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm Avitus Orthopaedics, Inc Maxim Budyansky
K173867 12/20/2017 Axis Anterior Cervical Plate System Axis Orthopaedics Craig Wilcox
K170574 02/27/2017 Diacap Pro Dialyzer B. Braun Avitum AG Giuliana Gavioli
K170595 02/28/2017 IV Administration Sets B. Braun Medical Inc. Nancy Skocypec
K173803 12/15/2017 Omnican fine B. Braun Medical Inc. Kimberly Smith
K173699 12/04/2017 The Pump by Babyation Babyation, LLC Jared Miller
K170537 02/23/2017 Nexxis OR, Nexxis Barco n.v. Eric Caus
K170476 02/16/2017 Nio Color 5.8MP (MDNC-6121) Barco NV Helena Soenen
K170483 02/16/2017 Bausch + Lomb Sensitive Eyes Plus Saline Solution Bausch & Lomb Incorporated Melissa Thomas
K173780 12/12/2017 EchoMD Automated Ejection Fraction Software Bay Labs, Inc. Charles Cadieu
K173773 12/12/2017 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Bayer Medical Care Inc. Lisa A Ewing
K173913 12/22/2017 MEDRAD« Imaging Bulk Package Transfer Set Bayer U.S. LLC Leslie S. O'Nan
K170524 02/22/2017 Access AMH Beckman Coulter, Inc. Debbie Kidder
K173873 12/20/2017 BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial Becton Dickinson and Company Ashanti Brown
K170386 02/08/2017 BD Ultra-FineÖ Insulin Syringe, BD Ultra-FineÖ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-FineÖ needle and BD Insulin Syringes with Micro-FineÖ IV Needle Becton, Dickinson & Company Riddhish Patel
K170308 02/01/2017 BD MAX Extended Enteric Bacterial Panel, BD MAX System BECTON, DICKINSON AND COMPANY LAURA STEWART
K170336 02/02/2017 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector Becton, Dickinson and Company Kimberly Geisler
K170345 02/03/2017 SOFTDISO Best Nomos Vineet Gupta
K173973 12/29/2017 TV-100 Bio-Med Devices, Inc. Ken Close
K170413 02/10/2017 BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set Bio-Rad Laboratories Juang Wang
K170509 02/21/2017 BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set Bio-Rad Laboratories Arlene Carillo
K173767 12/11/2017 A. L. P. S. Clavicle Plating System Biomet Inc. Dhaval Saraiya
K173826 12/18/2017 THP Hip Fracture Plating System Biomet, Inc. Annette Minthorn
K173682 12/01/2017 L300 Go System Bioness, Inc. Mercedes Bayani
K173977 12/29/2017 CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module Biosense Webster, Inc. Phuong Chau
K173978 12/29/2017 CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module Biosense Webster, Inc. Phuong Chau
K173956 12/28/2017 Biowy PlCC Catheter Biowy Corporation Andre von Muller
K170360 02/06/2017 NAVIO Blue Belt Technologies, Inc. Richard G. Confer
K173820 12/18/2017 OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation Mugdha Dongre
K173837 12/18/2017 RHYTHMIA HDx Mapping System (with software Version 2.0) Boston Scientific Corporation Gregory Neal
K173877 12/21/2017 BOWA Neutral Electrodes BOWA-electronics GmbH & Co. KG Wolf-Ruediger Fritz
K173800 12/14/2017 Camber Spine Technologies SPIRA - VÖ Open Matrix Corpectomy Cage Camber Spine Technologies Michael Black
K170550 02/24/2017 Coveris Cervical Cage System Camber Spine Technologies Ryan Gaffney
K173839 12/18/2017 Tissue of Origin Test Kit-FFPE Cancer Genetics, Inc. Janet Graff
K173689 12/01/2017 Ophthalmic Software Platform RX Canon Inc. -Medical Equipment Group Shinji Mori
K170332 02/02/2017 DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS Canon, Inc. SHINJI MORI
K170401 02/09/2017 Piccolo Composite« Plate System CarboFix Orthopedics Ltd. Yael Rubin
K170506 02/21/2017 ECG Check - Universal, ECG Check - Universal Plus Cardiac Designs, Inc. James Tassone
K170568 02/27/2017 CardioLogs ECG Analysis Platform Cardiologs Technologies Quentin de Snoeck
K170405 02/10/2017 BD Curve Ascites Shunt CareFusion Tamara Brey
K170580 02/28/2017 Carestream Vue PACS Carestream Health, Inc. Diane Koetter
K173924 12/26/2017 DRX-Revolution Nano Mobile X-ray System Carestream Health, Inc. Victoria A. Wheeler
K173771 12/11/2017 IOLMaster 700 Carl Zeiss Meditec AG Christian Muenster
K173812 12/15/2017 Catalyst CSR 3 Peg Glenoids Catalyst OrthoScience, Inc Dale Davison
K170369 02/06/2017 Disposable Electrosurgical Pencils Cathay Manfacturing Corp. Ren Ren
K173904 12/22/2017 CATS Tonometer Prism CATS Tonometer, LLC Sean J. McCafferty
K173942 12/26/2017 Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Central Medicare Sdn. Bhd. Arivalagan Subramaniam
K173840 12/18/2017 Xpert CT/NG Cepheid Yi-Ping Lin
K170363 02/06/2017 Ceribell Pocket EEG Device Ceribell, Inc. Josef Parvizi
K170374 02/07/2017 SonoBook Series Diagnostic Ultrasound System CHISON Medical Imaging Co., Ltd. Qifei Liu
K170423 02/13/2017 DentureID Microchip CMP Industries LLC Devon O. Howe
K170375 02/07/2017 Nobilplast Denture Resin CMP Industries LLC Devon O. Howe
K173848 12/19/2017 Model WP-3840 and WP-3040 CNMC Co., Inc. Thomas Kraus
K170431 02/13/2017 CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip Coeur, Inc. Priscilla Clinner
K170541 02/23/2017 Anorganic Bone Mineral in Delivery Applicator Collagen Matrix, Inc. Danielle Lindner
K170422 02/13/2017 BIOSOFT DUO DOUBLE LOOP URETERAL STENTS Coloplast Corp Cori Ragan
K170531 02/22/2017 Ureteral Dilators and Percutaneous Nephrostomy Dilators Coloplast Corp Cori Ragan
K170362 02/06/2017 VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS Coloplast Corp Cori Ragan
K170501 02/21/2017 CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver ConMed Corporation Diana L. Nader-Martone
K170344 02/03/2017 Tahoe Uni Knee System Consensus Orthopedics, Inc Zac Johnson
K170323 02/01/2017 Entuit Start Initial Placement Gastrostomy Set Cook Incorporated Erum B. Nasir
K173686 12/01/2017 Guardia Access Embryo Transfer Catheter Sets and Sydney IVF« Transfer Catheter Cook Incorporated Naomi Funkhouser
K173685 12/01/2017 Peel-Away Introducer Set Cook Incorporated Colin Jacob
K173687 12/01/2017 Strange Bile Duct Stone Exploration Set Cook Incorporated Colin Jacob
K170560 02/27/2017 SAGE Vitrification Kit and SAGE Vitrification Warming Kit CooperSurgical Inc Tove Kjµr
K173731 12/06/2017 SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) CooperSurgical, Inc Tove Kjaer
K173880 12/21/2017 Corin TriFit CF Hip Stem Corin USA Limited Rachel King
K170359 02/06/2017 TrinityÖ Dual Mobility System Corin USA Limited Zak Akhoonjee
K173884 12/21/2017 Unity Total Knee System Corin USA Limited Lorraine Mander
K173806 12/15/2017 CorPath GRX System Corindus, Inc. Robert Lavado
K170348 02/03/2017 Signia Four-Bay Smart Charger (to be used with Signia Stapler) Covidien Katherine Y. Choi
K173922 12/26/2017 C-PTFETM Surgical Suture CP Medical Inc. John Hartigan
K173710 12/04/2017 MotoBAND CP Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K173814 12/15/2017 DeGen Medical E3 MIS Pedicle Screw System Degen Medical Craig Black
K170540 02/23/2017 DM-Density Densitas, Inc. Mo Abdolell
K170529 02/22/2017 Delight, Delight ortho, B&Lite S DENTALL Co., Ltd. Jonghyuk Lee
K170384 02/07/2017 Dentium NR Line CAD/CAM Abutments Dentium Co., Ltd. Sangpil Yoon
K170487 02/17/2017 Navina Classic System Dentsply Sirona Karl Nittinger
K170500 02/21/2017 SIROLaser Advance+ Dentsply Sirona Karl J. Nittinger
K170339 02/02/2017 Summit Hip System DePuy Orthopaedics, Inc. Carol S. Ming
K173785 12/13/2017 Custom Clear Aligner System Derby Dental Laboratory Reed Nunnally
K173846 12/19/2017 DermaScalp Laser Cap DermaScalp LLC John Carullo
DEN170088 12/08/2017 Dexcom G6 Continuous Glucose Monitoring System Dexcom, Inc. Neeta Sharma
K173683 12/01/2017 LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers DiaSorin Inc. John C Walter
K173798 12/14/2017 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack DiaSorin Molecular LLC Sharon Young
K173975 12/29/2017 UF(II) Wide Fixture DIO Corporation Jiae Park
K173769 12/11/2017 DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid DMAX CO., LTD. Hyeon Seok Cho
K173876 12/21/2017 Cybird LED Curing Light DXM Co., Ltd Seung Hyun Kim
K170391 02/08/2017 ANSiStim-PP DyAnsys Inc Srini Nageshwar
K173861 12/20/2017 Drug Relief DyAnsys, Inc. San Mateo
K173843 12/18/2017 illumiflow 148 Laser Cap EGlobal, LLC Wayne De Stefano
K170503 02/21/2017 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages EIT Emerging Implant Technologies GmbH Barbara Wirth
K170499 02/17/2017 sensiLift EL GLOBAL TRADE LTD Yael Liebes-Peer
K173789 12/14/2017 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon Elekta Instrument AB Alf Laurell
K173791 12/14/2017 Leksell GammaPlan Elekta Instrument AB Matilda Forsberg
K170573 02/27/2017 Empowr CR Knee Tibial Insert Encore Medical, L.P. Desiree Wells
K173723 12/05/2017 EMPOWR Universal Tibial Baseplate Encore Medical, L.P. Teffany Hutto
K170548 02/24/2017 InSure ONE Enterix Inc. Michele Houldsworth
K173923 12/26/2017 Temporary Cardiac Pacing Wire Ethicon, Inc. Joice Pappan
K170575 02/27/2017 Disposable Powder Free Vinyl Exam Glove, Clear/Yellow Ever Global (Vietnam) Enterprise Corp Jerry Lin
K173863 12/20/2017 Ez3D-i /E3 Ewoo Soft Co., Ltd. Young Seok Kim
K173777 12/12/2017 BreathID Hp Lab System Exalenz Bioscience Ltd. Raffi Werner
K173772 12/12/2017 BreathID Hp System Exalenz Bioscience Ltd. Raffi Werner
K173775 12/12/2017 Clench Compression Staple F & A Foundation LLC d.b.a. Reign Medical Daniel Lanois
K170367 02/06/2017 Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo Fisher and Paykel Healthcare Limited Danica Tung
K173929 12/26/2017 CipherOx CRI M1 Flashback Technologies, Inc. Gregory Z. Grudic
K170502 02/21/2017 Patient Positioning System Forte Automation Systems, Inc. Phil Reece
DEN170089 12/14/2017 Curve Positive Airway Pressure System FRESCA Medical Mary Lou Mooney
K173972 12/29/2017 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K173718 12/05/2017 Liberty Cycler Set Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K170451 02/15/2017 FDX Console (DR-ID300CL) Software FUJIFILM Medical Systems U.S.A., Inc. Peter Altman
K173684 12/01/2017 g.Estim PRO g.tec medical engineering GmbH Christoph Guger
K170445 02/14/2017 LOGIQ S8 GE Healthcare Bryan Behn
K173816 12/15/2017 NM/CT 850, NM/CT 860 GE Healthcare George Mashour
K170498 02/17/2017 Gems Oocyte Retrieval Buffer ORB-20, ORB-50 Genea Biomedx Pty Ltd Kea Dent
K170557 02/24/2017 GenePOC GBS LB GenePOC Inc. Guy Sevigny
K170558 02/24/2017 revogene GenePOC Inc. Guy Sevigny
K173885 12/21/2017 Genesys Spine Binary Lumbar Plate System Genesys Spine Brian J. Bergeron
K170596 02/28/2017 TN-Brush GENOSS Co. Ltd. Hyeyoung Moon
K173722 12/05/2017 PATRIOT COLONIAL Spacer, SUSTAIN Spacer Globus Medical Inc. Kelly Baker
K173757 12/11/2017 VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set Greiner Bio-One NA Inc Manfred Abel
K170514 02/21/2017 Central Monitoring System Guangdong Biolight Meditech Co., Ltd. Jin Liang
K173703 12/04/2017 Sonata Sonography-Guided Transcervical Fibroid Ablation System Gynesonics, Inc. Diane King
K173819 12/18/2017 MyPlant II Implant System Hager & Meisinger GmbH Adam Tomczak
K173955 12/28/2017 Mic-Key* SF Over-the-Wire Stoma Measuring Device Halyard Health, Inc. David M Lee
K173903 12/22/2017 Granada Medium Hardy Diagnostics Rianna Malherbe
K170481 02/16/2017 Strep B Carrot Broth Kit Hardy Diagnostics Rianna Malherbe
K170586 02/28/2017 Strep B Carrot Broth One-Step Hardy Diagnostics Christopher Massey
K170421 02/13/2017 ET Hybrid Abutment Hiossen Inc. David Kim
K173739 12/07/2017 ALOKA ARIETTA 850 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K173901 12/22/2017 MyoSure MANUAL Tissue Removal Device Hologic, Inc. Anne-Marie Keefe
K170466 02/15/2017 Automatic Blood Pressure Monitor Model LD-518 & LD-537 Honsun(Nantong) Co., Ltd. Selina Qian
K170454 02/15/2017 Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U Honsun(Nantong) Co., Ltd. Selina Qian
K170353 02/03/2017 ABX MICROS ES 60 OT and ABX MICROS ES 60 CT HORIBA ABX SAS Caroline Ferrer
K170511 02/21/2017 NeoFuse HA Enhanced PLIF/TLIF HT Medical, LLC Robert Compton
K170318 02/01/2017 NeoFuse Ti3D PLIF/TLIF/Cervical Interbody HT Medical, LLC Robert Compton
K173919 12/22/2017 HX Device Human Extension Ltd. Dalit Doron
K170463 02/15/2017 KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System i-SENS, Inc. Joon Ho Jung
K170325 02/02/2017 SECRET RF Ilooda Co., Ltd. Yun Jung Ha
K170551 02/24/2017 ImPACT Quick Test ImPACT Applications, Inc. Michael Zagorski
K170594 02/28/2017 I.B.S. osteosynthesis screws In2Bones SAS Morgane Grenier
K173811 12/15/2017 TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System In2Bones SAS Morgane Grenier
K170518 02/21/2017 In2Bones Fracture and Correction System In2BonesUSA, LLC Joe Clift
K173709 12/04/2017 Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm InNeuroCo, Inc Marc Litzenberg
K170311 02/01/2017 Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC. Amy Stoklas-Oakes
K170474 02/16/2017 Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter Innovative Health, LLC. Amy Stoklas-Oakes
K170420 02/13/2017 n!ce Glass Ceramic Blocks for Amann Girrbach Institut Straumann AG Christopher Klaczyk
K173961 12/28/2017 Straumann BLX Implant System Institut Straumann AG Viviana Horhoiu
K170354 02/06/2017 Straumann Variobase Abutments Institut Straumann AG Christopher Klaczyk
K170356 02/06/2017 Straumann Variobase Abutments Institut Straumann AG Christopher Klaczyk
K173968 12/29/2017 Straumann Variobase for Bridge/Bar Cylindrical Institut Straumann AG Gordon Dodds
K170314 02/01/2017 ACL AcuStar INSTRUMENTATION LABORATORY CO. NIKITA MALLADI
K173717 12/05/2017 Integra TITAN Reverse Shoulder System Integra LifeSciences Corporation Kathleen McGuire
K173935 12/26/2017 Mediant Anterior Cervical Plating System Intelligent Implant Systems, LLC Michael Nutt
K170371 02/06/2017 DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe INTERVENE Group Limited Homer Trieu
K170438 02/13/2017 MiroCam Capsule Endoscope System IntroMedic Co., Ltd. Jinyoung Lee
K173721 12/05/2017 SureForm 60 and SureForm 60 Reloads Intuitive Surgical Nadine Nasr
K173842 12/18/2017 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc Brandon Hansen
K173906 12/22/2017 da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc. Elaine Lee
K170508 02/21/2017 EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads Intuitive Surgical, Inc. Cheryl Wu
K170507 02/21/2017 Invacare« TDX« SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx Invacare Corporation Elijah N. Wreh
K170364 02/06/2017 Collagen Meniscus Implant XL Ivy Sports Medicine, LLC John Dichiara
K173808 12/15/2017 VoutiaÖ Jeffrey Ward Cash, DDS Jeffrey Ward Cash
K170313 02/01/2017 ARIX Ankle Distal Tibia System Jeil Medical Corporation Sejin RYU
K170368 02/06/2017 Sterile NS System Jeil Medical Corporation Seungyong Lee
K173902 12/22/2017 Neodent Implant System û GM Line JJGC Industria e Comercio de Materiais Dentarios S.A. Julianne de Oliveira Capucho Lechechem
K170358 02/06/2017 joimax Endovapor 2 joimax GmbH Wolfgang Ries
K170342 02/03/2017 Ocata Anterior Cervical System Kalitec Direct, LLC Scott Winn
K170462 02/15/2017 KARL STORZ ShuntScope KARL STORZ Endoscopy-America, Inc. Susie S. Chen
K173730 12/06/2017 Kinsa QuickCare Thermometer KINSA, Inc. David Gal
K170521 02/22/2017 TRINITY/3D PROSTATE SUITE KOELIS Laetitia GERVAIS
K170397 02/09/2017 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy D Kossan International Sdn. Bhd. Cho Sow Fong
K170486 02/13/2017 CATHTONG II PICC Catheter L&Z US, Inc. Jenella Coutts
K173886 12/21/2017 CPRmeter 2 CPR Feedback Device Laerdal Medical AS Mari Kaada
K170366 02/06/2017 Laser Peripherals, LLC Family of Bare Laser Fibers Laser Peripherals, LLC Jeff Stein
K173696 12/01/2017 TBL-ABI System LD Technology LLC Albert Maarek
K170576 02/27/2017 LENSAR Laser System - fs 3D (LLS-fs 3D) LENSAR, Inc. Keith Peck
K170565 02/27/2017 LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L LifeWatch Services, Inc Stefanie Martinez-Koenig
K170473 02/16/2017 C2 femoral stem Limacorporate S.p.A. Antonio Soleti
DEN170010 02/21/2017 LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay Lin-Zhi International, Inc. Chris Wang
K170416 02/10/2017 LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators Lin-Zhi International, Inc. Bernice Lin
K173817 12/15/2017 Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 ?g/mL Liofilchem s. r. l. Fabio Brocco
K170410 02/10/2017 Longeviti PMMA Static Cranial Implant Longeviti Neuro Solutions, LLC Kevin Lee
K170492 02/17/2017 xTAG CYP2D6 Kit v3 Luminex Molecular Diagnostics, Inc. Jennifer Grimes
K170446 02/14/2017 LT-300 SD Digital Video Colposcope Lutech Industries, Inc. Leanna Vachula
K173700 12/04/2017 PICOPLUS Laser System Lutronic Corporation Jhung Won Vojir
K170584 02/28/2017 Mako Partial Knee Application MAKO Surgical Corp. Shikha Khandelwal
K170593 02/28/2017 Mako Total Hip Application MAKO Surgical Corp. Shikha Khandelwal
K170581 02/28/2017 Mako Total Knee Application MAKO Surgical Corp. Shikha Khandelwal
K173805 12/15/2017 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
K173970 12/29/2017 Materialise PKA Guide System Materialise NV Oliver Clemens
K170419 02/13/2017 SurgiCase Viewer Materialise NV Oliver Clemens
K170513 02/21/2017 MAUSER PG II Sharps Container Mauzer USA LLC Tatiana Smoleeva
DEN170009 02/13/2017 Bonebridge MED-EL Elektromedizinische Geraete GmbH Elizabeth Gfoeller
K173794 12/14/2017 AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared Medacta International SA Stefano Baj
K173890 12/21/2017 GMK Sphere - Kinematic Alignment Medacta International SA Stefano Baj
K170455 02/15/2017 MectaLIF Anterior Stand Alone Medacta International SA Stefano Baj
K170452 02/15/2017 Medacta Shoulder System Medacta International SA Stefano Baj
K170497 02/17/2017 V10 Mediana Co., Ltd. Kim Min-hye
K173969 12/29/2017 Medicalgorithmics Unified Cardiac Rehabilitation System Medicalgorithmics S.A. Marek Dziubinski
K173782 12/13/2017 UNiD Patient Specific 3D printed cage Medicrea International S.A. David Ryan
K170470 02/16/2017 Digital Eye Anterior Camera Medimaging Integrated Solution Inc. (MiiS) Yi-Ying Chen
K170395 02/08/2017 Talos« Lumbar (HA) PEEK IBF Devices Meditech Spine, LLC Bruce Dunaway
K173911 12/22/2017 Medline Burn and Wound Dressing Medline Industries, Inc. Bethany Benoit-DiMaria
K173889 12/21/2017 Medline Cautery Electrode (PTFE) Medline Industries, Inc. Matt Clausen
K170415 02/10/2017 Medline Hemo-Force DVT Compression Sleeve Medline Industries, Inc. Matt Clausen
K173859 12/20/2017 HEALIX ADVANCE Anchor with DYNACORD Suture Medos International SARL Tatyana Tatyana Korsunsky
K173787 12/14/2017 X-MESH« Expandable Cage System, OCELOT« Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE« System, CONCORDE« Inline Lumbar Interbody System, CONCORDE« Curve Lumbar Interbody Medos International SARL Sheree Geller
K170543 02/24/2017 VIPER PRIMEÖ Screws with Fenestrations Medos International, SARL Karen Sylvia
K170453 02/15/2017 Medrobotics Flex Robotic System Medrobotics Corporation John D. Bonasera
K170381 02/07/2017 Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini Medtronic Advanced Energy Heather Valley
K170312 02/01/2017 IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools MEDTRONIC POWERED SURGICAL SOLUTIONS DEEP PAL
K170347 02/03/2017 CD HORIZONÖ Fenestrated Screw Set Medtronic Sofamor Danek USA Lee Grant
K173855 12/20/2017 Sharpsite AC Rigid Endsocope Medtronic Xomed Inc. Shravan Chawla
K170583 02/28/2017 Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface Medtronic, Inc. Gayatri Ghadge
K170341 02/03/2017 Medussa-PL Cage Medyssey USA, Inc. Shawn Kim
K170389 02/08/2017 TAURUS PEEK Cage System Medyssey USA, Inc. Shawn Kim
K173750 12/08/2017 Prelude IDeal Hydrophilic Sheath Introducer Merit Medical Systems, Inc. David Thomas
K170532 02/22/2017 True Form Reshapable Guide Wire Merit Medical Systems, Inc. Mark Mullaney
K170517 02/21/2017 Merits Model R106/R136 Rehab Wheelchair Merits Healthcare Industries (suzhou) Co., LTD. Guangyong Li
K173963 12/28/2017 DRI Benzodiazepine Assay Microgenics Corporation Minoti Patel
K170467 02/16/2017 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K173943 12/26/2017 Dental High-speed Handpiece and Accessories MicroP Technology (Taiwan), Inc. Ina Lin
K170444 02/14/2017 PROCOTYL« PRIME Acetabular Cup System MicroPort Orthopedics Inc Kaitlin Grove
K173776 12/12/2017 BIOLOX delta Option and Extra-long Heads MicroPort Orthopedics Inc. Allen Mamaril
K170449 02/15/2017 Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection Millennium Medical Technologies, Inc. Jim Barley
K173931 12/26/2017 MindMotion(TM) GO MindMaze SA Sylvian Bourriquet
K170441 02/14/2017 ElectroTek MobileMedTek Bryan Ehret
K170329 02/02/2017 Basic, Dominant Flex Modela AG Markus Butler
K173856 12/20/2017 Express 4 Sleep appliance/CPAP Sidekick appliance Moses Appliances LLC Allen J. Moses
K170564 02/27/2017 MyndMove System, MyndMove Functional Electrical Stimulator MyndTec Inc Alexa Granger
K173763 12/11/2017 iovera system Myoscience, Inc Kent Jones
K173905 12/22/2017 Surgic Pro, Surgic Pro+ Nakanishi Inc. Kimihiko Satoh
K173865 12/20/2017 trophon2 Nanosonics Limited Ruth Cremin
K173815 12/15/2017 Allergan Botox Needle Electrode Natus Manufacturing Limited Maria Connolly
K173690 12/01/2017 Grass TWin Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Shane Sawall
K173936 12/26/2017 Natus Photic Stimulator Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K173938 12/26/2017 IS-III HActive Fixture Neobiotech Co., Ltd. Young-Ko Heo
K170585 02/28/2017 Skylife NeoLight, LLC Sivakumar Palaniswamy
K173725 12/05/2017 NeuMoDx GBS Assay NeuMoDx Molecular, Inc. Kay Fuller
K173868 12/20/2017 Serenity Body Position Sensor, Serenity RIP Sensors Neurotronics, Inc. David Pezet
K173746 12/08/2017 Activmotion Range Newclip Technics Gaelle LUSSORI
K170310 02/01/2017 Alians Clavicle range Newclip Technics Gaelle Lussori
K173980 12/29/2017 Specular Microscope CEM-530 Nidek Co., Ltd. Yoneji Mizuno
K173797 12/14/2017 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K170464 02/15/2017 StatStrip Xpress Blood Glucose Monitoring System Nova Biomedical Corporation Eliza Wang
K170346 02/02/2017 PRECICE Intramedullary Limb Lengthening System NuVasive Specialized Orthopedics, Inc. Lance Justice
K170592 02/28/2017 NuVasive BASE Interfixated Titanium System NuVasive, Incorporated Cynthia Adams
K173892 12/21/2017 NuVasive« XLX Interbody System NuVasive, Incorporated Cynthia Adams
K170469 02/16/2017 NxStage System One Plus NxStage Medical, Inc Randall Covill
K173707 12/04/2017 P200TE Optos plc Geoff Fatzinger
K173894 12/21/2017 Jade PTA Balloon Dilatation Catheter OrbusNeich Medical Trading Inc. John Pazienza
K173680 12/01/2017 Sapphire II PRO OrbusNeich Medical Trading Inc. John Pazienza
K173874 12/21/2017 StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO Origami Surgical LLC John Gillespie
K173951 12/27/2017 Legend Acetabular Liners Ortho Development Corporation Drew Weaver
K173693 12/01/2017 Orbitum Bone Staple Implant, X and VI Orthovestments, LLC Robert Weinstein
K173967 12/29/2017 Remedy Acetabular Cup Osteoremedies LLC Chris Hughes
K170534 02/23/2017 PROLIXUS TOTAL KNEE SYSTEM OTIS Biotech Co., Ltd. Sanjay Lingot
K173881 12/21/2017 Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G Owen Mumford Ltd Darren Mansell
K170435 02/13/2017 NerveGuard NRFit, NerveGuard LUER PAJUNK GmbH Medizintechnologie Christian G.H. Quass
K170327 02/02/2017 Parcus SLiK Anchors Parcus Medical Paul Vagts
K173679 12/01/2017 PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes PENTAX of America, Inc. James W. Monroe
K173761 12/11/2017 Penumbra System Reperfusion Catheter JET 7 Penumbra, Inc. Michaela Mahl
K173792 12/14/2017 EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay Phadia AB Carina Magnusson
K173726 12/05/2017 ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut Phadia AB Ulf Karlberg
K173704 12/04/2017 ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip Phadia AB Carina Magnusson
K170527 02/22/2017 Phoenix Clinical ICON Phoenix Technology Group, Inc. dba Phoenix Clinical Christopher A. Henderson
K173729 12/06/2017 REVIAN RED PhotonMD, Inc William A Knape
K173807 12/15/2017 Accu O2 Oxygen Analyzer Precision Medical Inc. James Parker
K173878 12/21/2017 PreXion3D Excelsior PreXion Corporation Katsumi Hayashi
K170515 02/21/2017 Sterile Nitrile Surgical Gloves, Powder-free Primus Gloves PVT Limited Jose Paul M
K173734 12/06/2017 RocaJJ Soft Stents Promepla SAM Alexandre Bareille
K170411 02/10/2017 ER-REBOA Catheter Prytime Medical Devices, Inc Brian Young
K170331 02/02/2017 Cyber Ho quanta system spa Francesco Dell'Antonio
K173939 12/26/2017 Quantib Brain Quantib BV Floor van Leeuwen
K173691 12/01/2017 Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack Quidel Corporation Jennifer S. Rial
K170491 02/17/2017 Solana C. difficile Assay Quidel Corporation Ronald H. Lollar
K170349 02/03/2017 RA-308 Excimer Laser System, Excimer Laser Catheter Ra Medical Systems, Inc. Dean Irwin
K170355 02/06/2017 RayStation 6 RaySearch Laboratories AB (publ) David Hedfors
K170567 02/27/2017 Tempus Pro Patient Monitor Remote Diagnostic Technologies Ltd Chris Hannan
K173768 12/11/2017 Tempus Pro Patient Monitor Remote Diagnostic Technologies Ltd. James Hamlyn
K173741 12/07/2017 Reprocessed ArthoCare Ablation Wand ReNovo, Inc. Mark K. Wells
K173740 12/07/2017 Reprocessed DePuy Mitek Ablation Wand ReNovo, Inc. Mark K. Wells
K170334 02/02/2017 XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack RevMedx, Inc. Amy K. Pointer
K170373 02/07/2017 Flextra Steerable Introducer Rhythm Xience, Inc. (RXI) James Hassett
K170377 02/07/2017 TipControl RF INSTRUMENT BIPO ? 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO ? 2.5MM WL 350MM Richard Wolf Medical Instruments Corporation Mike Loiterman
K173927 12/26/2017 Elecsys BRAHMS PCT Roche Diagnostics Wes Gerbig
K173887 12/21/2017 cobas CT/NG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc. Nobuko Nakajima
K170403 02/09/2017 CenterCross Ultra LV Catheter Roxwood Medical, Inc. Mehrdad Farhangnia
K170538 02/23/2017 RVS-100 Vital Signs Monitor Rudolf Riester GmbH Christof Kleiner
K170398 02/09/2017 S.I.N. Dental Implant System S.I.N. û Sistema de Implante Nacional S.A. Denis Oliveira
K170392 02/08/2017 S.I.N. Implant System S.I.N. û Sistema de Implante Nacional S.A. Denis Oliveira
K170528 02/22/2017 SterispineÖ PS SAFE ORTHOPAEDICS Pierre Dumouchel
K173828 12/18/2017 GU60A & GU60A-65 Samsung Electronics Co.,Ltd. Noh Jaesang
K170493 02/17/2017 HS50 / HS60 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Jiyeon Cho
K173713 12/04/2017 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
K170406 02/10/2017 Plato MICROCATH 27B Microcatheter Scientia Vascular LLC David Sabodski
K173882 12/21/2017 SeaSpine Mariner Pedicle Screw System SeaSpine Orthopedics Corporation Gina Flores
K170569 02/27/2017 SeaSpine Shoreline ACS - Anterior Cervical Standalone System SeaSpine Orthopedics Corporation Gina Flores
K170480 02/16/2017 Models 3543A, 4343A, 2929A and A843B Shanghai PZ Medical Technolgoy Co., Ltd. Jeff Moeller
K173953 12/27/2017 uDR 780i Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K173766 12/11/2017 PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs Shen Wei USA Inc. Cheryl Reep
K173801 12/14/2017 Transcranial Doppler Ultrasound System Shenzhen Delica Medical Equipment Co., Ltd. Zhenhua Xiao
K173869 12/20/2017 Med-link Reusable Blood Pressure Cuff Shenzhen Med-link Electronics Tech Co., Ltd Baihan Feng
K170475 02/16/2017 SICAGEÖ System Sicage LLc Kristi Vondra
K173909 12/22/2017 Dimension Hemoglobin A1c Assay Siemens Healthcare Diagnostics Inc. Alan Haley
K170315 02/01/2017 Acuson SC2000 Diagnostic Ultrasound System Siemens Medical Solutions Inc. Kevin Kong
K173957 12/28/2017 ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
K170396 02/09/2017 MAGNETOM Vida Siemens Medical Solutions USA, Inc. Cordell L. Fields, Esq.
K173897 12/22/2017 syngo.via MI Workflows Siemens Medical Solutions USA, Inc. Veronica Padharia
K173981 12/29/2017 ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Ultrasound Group Sulgue Choi
K170489 02/17/2017 Skylit Phototherapy System Skylit Medical Martyn Gross
K173779 12/12/2017 REXMONO, PDREX SM ENG CO., LTD Soon-Gu Lee
K170457 02/15/2017 EVOS Small Fragment Lower Extremity Plates Smith & Nephew, Inc. Samantha Staubach
K173912 12/22/2017 BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Trache Smiths Medical ASD, Inc. Donna M. Semlak
K173784 12/13/2017 Smylic Invisible Clear Aligners Smylio, Inc Ken Menon
K173796 12/14/2017 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) Sofradim Production Benjamin Rochette
K173759 12/11/2017 Thermage CPT System and Accessories Solta Medical Ken Nehmer
K173934 12/26/2017 Reza Band, Reflux Band Somna Therapeutics, L.L.C. James S. Miller
K173896 12/22/2017 Microcyn Antimicrobial Hydrogel Sonoma Pharmaceuticals, Inc. Brian Martin
K170460 02/15/2017 Sorin Connect Sorin Group Deutschland GmbH Luigi Vecchi
K173706 12/04/2017 Piccolo Implants and Accessories Southern Implants (Pty) Ltd. Lauranda Breytenbach
K173844 12/19/2017 Titan Ag 200 Specialty Fibres and Materials Ltd Lindie Marx
K173834 12/18/2017 Quantum Pump Console Spectrum Medical Ltd Mark Drain
K173702 12/04/2017 Juliet Ti LL SPINEART Franck Pennesi
K170372 02/07/2017 SpiralTech Dental Implant System SpiralTech Superior Dental Implants, Inc. Daniel Rosenthal
K170379 02/07/2017 Disposable Standard Clamp Standard Bariatrics Alison Sathe
K173875 12/21/2017 GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert StelKast, Inc. Dave Stumpo
K173692 12/01/2017 D-Actor 200 Vibration Massage System Storz Medical AG Pavel Novak
K170338 02/02/2017 A-View Stroke2Prevent B.V. Maarten Nibbelke
K173841 12/18/2017 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm Stryker Angelica Beckmann
K173866 12/20/2017 Stryker AIM Light Source and SafeLight cable Stryker Jay Nayar
K170496 02/17/2017 Xia« 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory Stryker Corporation Meriam Gabera
K173946 12/27/2017 ADAPT for Gamma3 Stryker GmbH Nesli Karakaya
K173849 12/19/2017 Triathlon Total Knee System Stryker Orthopaedics Margaret Crowe Klippel
K170456 02/15/2017 Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Stryker Sustainability Solutions Chelsea Cullen
K170418 02/13/2017 Stryker SonicPin System Stryker Trauma Gmbh Heike Gustke
K173823 12/18/2017 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
K170388 02/08/2017 ANCHORMAN Tibial Ligament Fixation Device Summit Medical Ltd. Sam Drew
K170572 02/27/2017 Summit Spine Yellowstone Lumbar Interbody Fusion System Summit Spine Eric Buescher
K170307 02/01/2017 SunCHECK SUN NUCLEAR CORPORATION RENE HARDEE
K170488 02/17/2017 Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr Surge Cardiovascular Rick Shorey
K170582 02/28/2017 Saf-T-Vac Smoke and Fluid Evacuator Surgical Technology Laboratories, Inc Mathew Fairfax
K170597 02/28/2017 PicoWay Laser System Syneron Candela Corporation Ruthie Amir
K170370 02/06/2017 ULTRASHAPE POWER SYSTEM Syneron Medical Ltd. Ruthie Amir
K170482 02/16/2017 Spider Frame External Fixation System TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S Sumru Alperen
K170588 02/28/2017 DESS Dental Smart Solutions Terrats Medical SL Roger Terrats
K173908 12/22/2017 DESS Dental Smart Solutions Terrats Medical SL Roger Terrats
K170417 02/10/2017 Glidewire GT Terumo Corporation Monika McDole-Russell
K173799 12/14/2017 NaviCross 0.018 Terumo Corporation Yuko Watanabe
K173831 12/18/2017 Glidesheath Slender Terumo Medical Corporation Liang Lu
K173732 12/06/2017 Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit The Binding Site Group Ltd Christopher Bradshaw
K173915 12/22/2017 Test of Variables of Attention (T.O.V.A.) The TOVA Company Chris Holder
K170430 02/13/2017 TSolution One Surgical System Model 210 THINK Surgical Inc. In K. Mun
K173821 12/18/2017 LungQ Software Thirona Corporation Eva van Rikxoort
K170399 02/09/2017 Endoskeleton TO Interbody Fusion Device (IBD) Titan Spine, LLC Jane Rodd
K170549 02/24/2017 TOKUYAMA CUREGRACE Tokuyama Dental Corporation Fumio Takahashi
K170409 02/10/2017 PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System Topcon Medical Laser Systems, Inc. (TMLS) Sweta Srivastava
K170490 02/17/2017 Celesteion, PCA-9000A/3 Toshiba Medical Systems Corporation Paul Biggins
K170412 02/10/2017 Vantage Titan 1.5T, MRT-1510, M-Power GX Toshiba Medical Systems Corporation Paul Biggins
K173962 12/28/2017 Viamo c100 TUS-VC100 Diagnostic Ultrasound System Toshiba Medical Systems Corporation Paul Biggins
K173736 12/06/2017 TrackX TrackX Technology, LLC Calley Herzog
K173930 12/26/2017 PYTHON Plate Trial Instruments Treace Medical Concepts, Inc. Rachel Osbeck
K173825 12/18/2017 MC 300R* Nebulizer Trudell Medical International Marianne Tanton
K173918 12/22/2017 VersaPAP Positive Airway Pressure (PAP) Device Trudell Medical International Marianne Tanton
K170578 02/27/2017 True Function Adjustable Herbst Appliances True Function Laboratory, Inc. Frank Madrigal
K170545 02/24/2017 Automatic Wrist Bluetooth Blood Pressure Monitor Truly Instrument Ltd. Yang Jian-Hao
K173694 12/01/2017 STERIZONE VP4 Sterilizer TSO3, Inc. Alexandre Jokci
K170571 02/27/2017 Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw Tyber Medical, LLC Mark F. Schenk
K170555 02/24/2017 U Deliver Bolink ENFit Enteral Feeding Sets U Deliver Medical, LLC Brian Johnson
K173879 12/21/2017 MiniMed Mio Advance infusion set Unomedical A/S Heidi Bjerre Lovkvist
K170335 02/02/2017 Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens Valley Contax, Inc. Josh Adams
K173864 12/20/2017 Peekplus« Interbody Fusion Device Vallum Corporation Stephen Blinn
K170570 02/27/2017 Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung Varian Medical Systems Inc Lisa Levine
K173838 12/18/2017 ARIA Radiation Therapy Management Varian Medical Systems, Inc. Peter J. Coronado
K173891 12/21/2017 Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume Vascular Solutions, Inc. Lisa Gallatin
K170544 02/24/2017 Langston dual lumen catheter Vascular Solutions, Inc. Jake Schultz
K173952 12/27/2017 Universal SmartECG VectraCor, Inc. Andrew Schreck
K173810 12/15/2017 Ventripoint Medical System Plus (VMS+) Ventripoint Diagnostics, Ltd. Desmond Hirson
K173958 12/28/2017 OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens Visco Vision Inc Evan Huang
K170385 02/08/2017 CORE M2 Vascular System Volcano Corporation Courtney Moore
K173860 12/20/2017 s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System Volcano Corporation Nora York
K173914 12/22/2017 VORTRAN Cuff Inflator (VCI) VORTRAN Medical Technology 1, Inc. James Lee
K170378 02/07/2017 AirLife Adult Heated Wire BiPAP/NIV Circuit Vyaire Medical Sharon Nichols
K173711 12/04/2017 Wallaby Avenir Coil System Wallaby Medical, Inc. Rebecca K. Pine
K173829 12/18/2017 NeoLSD MSMS kit Wallac Oy, a subsidiary of PerkinElmer Kay A Taylor
K170530 02/22/2017 Butrex Lumbar Buttress Plating System X-Spine Systems, Inc. Kriss Anderson
K173832 12/18/2017 InTiceÖ-C Porous Ti Cervical Interbody System X-Spine Systems, Inc. Charlene Brumbaugh
K173752 12/08/2017 SI Screw System Zavation Medical Products, LLC James M. Phillips
DEN170090 12/21/2017 MATRx plus Zephyr Sleep Technologies Sabrina Bruehlmann
K173758 12/11/2017 Disposable Biopsy Valve Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long
K170393 02/08/2017 Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) Zibo Chengxun Automatic Device Co., Ltd Ding Wei
K170533 02/23/2017 Model 330 Multifunction Aspirator ZOLL Medical Corporation Pooja Dalvi


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact