| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K181643 |
11/16/2018 |
SmartBag (SmartPouch) |
11 Health Technologies Limited |
Michael Seres |
| K183159 |
11/26/2018 |
3M Clarity Aligners |
3M Company |
Yanine Garcia-Quezada |
| K181381 |
11/23/2018 |
A.B. Dental Devices Dental Implants System |
A.B Dental Device Ltd. |
Gabi Krauss |
| K182687 |
11/23/2018 |
Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System |
ACCURAY INCORPORATED |
Keith Picker |
| K172907 |
11/09/2018 |
ELAN 4 Air Motor System |
Aesculap, Inc. |
Jessica Stigliano |
| DEN170056 |
11/02/2018 |
Parathyroid Detection (Model PTeye) System |
AiBiomed, Corp. |
Al Memmolo |
| K181911 |
11/02/2018 |
Interlude 100% Cotton Tampon |
ALBAAD fem |
Shlomo Helvits |
| K181454 |
11/21/2018 |
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K182988 |
11/29/2018 |
Afinion HbA1c Dx on Afinion 2 |
Alere Technologies AS |
Monica Vallestad |
| K180207 |
11/28/2018 |
Non-contact Infrared Thermometer |
Alicn Medical (Shenzhen), Inc |
Meisong Fang |
| K182808 |
11/09/2018 |
Aspida« Anterior Lumbar Plating System |
Alphatec Spine, Inc. |
Ruby Zheng |
| K182746 |
11/27/2018 |
ATEC ALIF and LLIF Spacer System |
Alphatec Spine, Inc. |
Cynthia Adams |
| K181286 |
11/30/2018 |
Ambu aScope RLS Slim |
Ambu A/S |
Camilla Wismar |
| K182083 |
11/09/2018 |
Catalys Precision Laser System |
AMO Manufacturing USA, LLC |
James Patrick Garvey II |
| K180650 |
11/15/2018 |
Amsel Endo Occluder |
Amsel Medical Corporation |
Yoram Levy |
| K182992 |
11/28/2018 |
BGM014 Blood Glucose Monitoring System |
Apex Biotechnology Corp. |
Lisa Liu |
| K181123 |
11/21/2018 |
ApnoDent Appliance |
ApnoMed, Inc. |
Joseph Yousefian |
| K182090 |
11/16/2018 |
AposTherapy System |
APOS Medical Assets Ltd. |
Cliff Bleustein |
| K182653 |
11/14/2018 |
Voyant Maryland Fusion Device |
Applied Medical Resources Corp. |
Andrew Nguyen |
| K182815 |
11/30/2018 |
XVWeb 3D |
Apteryx, Inc. |
Mark Gniewek |
| K182779 |
11/21/2018 |
ARK EDDP Assay |
ARK Diagnostics, Inc. |
Cherry Mun |
| K182391 |
11/30/2018 |
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution |
Arlington Scientific, Inc. (ASI) |
David Binks |
| K180395 |
11/09/2018 |
EZ-IO Intraosseous Vascular Access System |
Arrow International, Inc. (Subsidiary of Teleflex, Inc.) |
Frank Pelc |
| K180430 |
11/23/2018 |
Digistat Smart Central |
ASCOM UMS srl unipersonale |
Paolo Burchietti |
| K182248 |
11/13/2018 |
Aspire Venting Tube |
Aspire Bariatrics, Inc |
Monica Ferrante |
| K181288 |
11/05/2018 |
Athelas One |
Athelas Inc. |
Tanay Tandon |
| K182418 |
11/29/2018 |
V3 Segmental Plating System |
Atlas Spine, Inc. |
Thomas Smith |
| K182565 |
11/09/2018 |
AtriCure cryoICE cryoSPHERE cryoablation probe |
AtriCure, Inc. |
Jonathan McElwee |
| K181140 |
11/16/2018 |
Axis Chena Cervical PEEK Spacer System |
Axis Orthopaedics |
Craig Wilcox |
| K182255 |
11/15/2018 |
CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) |
Aziyo Biologics, Inc. |
Wendy Perreault |
| K180801 |
11/05/2018 |
Actreen Hi-Lite Cath, Actreen Hi-Lite Set |
B. Braun Medical Inc. |
Anita J. Nemeth |
| K182249 |
11/30/2018 |
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens |
Bausch & Lomb Incorporated |
Barbara Klube-Falso |
| K182276 |
11/01/2018 |
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit |
Bayer Medical Care Inc. |
Katie Dillon |
| K182273 |
11/01/2018 |
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 |
| K181427 |
11/29/2018 |
BD MAX Enteric Viral Panel, BD MAX Instrument |
Becton, Dickinson and Company |
Laura Stewart |
| K181221 |
11/30/2018 |
BD PhaSeal Optima Closed System Transfer Device |
Becton, Dickinson and Company |
Amy Honey |
| K182600 |
11/30/2018 |
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) |
Better Care Plastic Technology Co., Ltd |
Zhu Chuyan |
| K182270 |
11/02/2018 |
Cellene CO2 Laser System |
Bio-Med USA Inc. |
Young Chi |
| DEN170049 |
11/06/2018 |
Innovo |
Bio-Medical Research Ltd. |
Anne-Marie Keenan |
| K180966 |
11/09/2018 |
FilmArray Pneumonia Panel |
BioFire Diagnostics, LLC |
Kristen J. Kanack |
| K181324 |
11/15/2018 |
FilmArray Pneumonia Panel plus |
BioFire Diagnostics, LLC |
Kristen J. Kanack |
| K182764 |
11/27/2018 |
Biop Digital Colposcope |
Biop Medical Ltd. |
Ilan Landesman |
| K182030 |
11/08/2018 |
Faros Mobile |
Bittium Biosignals Ltd. |
Taneli Vaaraniemi |
| K182338 |
11/09/2018 |
Blue Sky Bio Computerized Orthodontic Bracket System |
Blue Sky Bio |
Albert Zickmann |
| K180343 |
11/16/2018 |
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer |
Bonraybio Co., Ltd. |
Clare Huang |
| K182169 |
11/27/2018 |
AdVance XP Male Sling |
Boston Scientific Corporation |
Kaitlyn Rainbow |
| K182324 |
11/26/2018 |
EkoSonic Endovascular System |
BTG International, Inc. |
Benjamin Hornsey |
| K181497 |
11/14/2018 |
HPM-6000UF |
BTL Industries, Inc. |
David Chmel |
| K182427 |
11/02/2018 |
Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
Paul Biggins |
| K181646 |
11/16/2018 |
Celesteion, PCA-9000A/3, V6.5 |
Canon Medical Systems Corporation |
Paul Biggins |
| K183013 |
11/26/2018 |
Vitrea Software Package, VSTP-001A |
Canon Medical Systems Corporation |
Paul Biggins |
| K182596 |
11/02/2018 |
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
Paul Biggins |
| K181667 |
11/29/2018 |
Thoraguard System |
Centese, Inc. |
Evan Luxon |
| K182967 |
11/23/2018 |
Visor System |
Cerebrotech Medical Systems, Inc. |
Dawnel Scott |
| K180683 |
11/07/2018 |
Certa Dose Pediatric Midazolam 5mg/mL IM Syringe |
Certa Dose, Inc. |
Caleb Hernandez |
| K182306 |
11/22/2018 |
Sunkingdom Slit Lamp |
Chongqing Sunkingdom Medical Instrument Co Ltd |
Joy Tse |
| K181292 |
11/15/2018 |
PrimeSightÖ UNITY 9000 Video Processor, PrimeSightÖ UNITY 9100 Video Processor |
Cogentix Medical, Inc. |
Christa Blaisdell |
| K181963 |
11/14/2018 |
ostaPek Interbody Fusion Cages |
coLigne, AG |
Robert Lange |
| K182757 |
11/29/2018 |
Espire Elbow Pro, Espire Elbow Hybrid |
College Park Industries, Inc. |
Deborah Mackmin |
| K180469 |
11/06/2018 |
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent |
Coloplast Corp |
Cori Ragan |
| K182134 |
11/26/2018 |
ARiX RAD Radiographic System |
Compania Mexicana De Radiologia CGR, S.A. DE C.V. |
Tonatiuh Monroy Soberon |
| K182882 |
11/14/2018 |
CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control |
Conmed Corporation |
Orjada Dervishleri |
| K182304 |
11/23/2018 |
Hyper GP (tisilfocon A) Daily Wear Contact Lens |
CONTAMAC LTD. |
Rob McGregor |
| K180792 |
11/30/2018 |
Arterial Pressure Monitoring Set/Tray |
Cook Incorporated |
Johnathan Liu |
| K181757 |
11/06/2018 |
Gⁿnther Tulip« Vena Cava Filter Retrieval Set |
Cook Incorporated |
Steven Lawrie |
| K180557 |
11/23/2018 |
Greene Renal Transplant Stent Set |
Cook Incorporated |
Yuan Zhou |
| K182980 |
11/16/2018 |
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent |
Cook Ireland Ltd |
Cathrina McHale |
| K183038 |
11/26/2018 |
Corin Optimized Positioning System (OPS) Plan |
Corin USA |
Lucinda Gerber |
| K182772 |
11/19/2018 |
Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil |
Covidien |
Jennie van Diemen |
| K182451 |
11/06/2018 |
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
Covidien, LLC |
Rebecca Clark |
| K181434 |
11/14/2018 |
SporView Rapid Read Biological Indicator SteamPlus Test Pack |
Crosstex/SPSmedical, A Division of Cantel Medical |
Megan Skaar |
| K182220 |
11/07/2018 |
Curbell branded Patient Monitoring Cables |
Curbell Medical Products, Inc. |
Michael Winter |
| K180247 |
11/01/2018 |
DAEHAN Adhesive Surface Electrodes |
Daehan Medical Systems Co., Ltd. |
Da Pin Jeong |
| K180184 |
11/16/2018 |
Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System |
Dentalpoint AG |
Anja Lieberherr |
| K182288 |
11/20/2018 |
TPH Spectra ST Flowable Composite Restorative |
Dentsply Sirona |
Karl Nittinger |
| K182405 |
11/02/2018 |
Dexcom Pro Q Continuous Glucose Monitoring System |
Dexcom, Inc |
Luke Olson |
| K182467 |
11/07/2018 |
Simplexa GBS Direct, Simplexa GBS Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K182329 |
11/08/2018 |
SureCure Orthodontic Aligner System |
Digital Orthodontic Care |
Jeff Sheppard |
| K182977 |
11/21/2018 |
Isolette 8000 Plus |
Draeger Medical Systems, Inc. |
Karen Otrupchak |
| K182245 |
11/30/2018 |
EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System |
Edwards Lifesciences, LLC |
Christine Chun |
| K180881 |
11/16/2018 |
HemoSphere Advanced Monitor, HemoSphere Pressure Cable |
Edwards Lifesciences, LLC |
Chirag Shah |
| K181684 |
11/08/2018 |
VAMP Plus Venous/Arterial Blood Management Protection System |
Edwards Lifesciences, LLC |
Ye Seul Kim |
| K173744 |
11/21/2018 |
ProFuse CAD |
Eigen |
William Mandel |
| K182369 |
11/27/2018 |
gammaCore Sapphire |
Electrocore, Inc. |
Mike Romaniw |
| K182444 |
11/06/2018 |
ERBEFLO Olympus Scope Port Connector |
Erbe USA, Inc. |
John Tartal |
| K181886 |
11/14/2018 |
VivaSight-DL System |
ETView Ltd. |
Yoram Levy |
| K181880 |
11/29/2018 |
VivaSight-SL (TVT) system |
ETView Ltd. |
Yoram Levy |
| K182462 |
11/08/2018 |
Exactech Alteon Highly Polished Femoral Stem |
Exactech, Inc. |
Zach Sharrah |
| K182346 |
11/26/2018 |
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws |
Exactech, Inc. |
Meredith May |
| K172602 |
11/14/2018 |
Miracu |
Feeltech Co., Ltd. |
Keun-Sik Kim |
| K180047 |
11/08/2018 |
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System |
Fiab SpA |
Alberto Calabro |
| K173916 |
11/06/2018 |
Finapres Nova Noninvasive Hemodynamic Monitor |
Finapres Medical Systems B.V. |
Iris van Uitert |
| K182663 |
11/30/2018 |
Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System |
FineMEC Co., Ltd. |
William H. McGrail |
| K180363 |
11/01/2018 |
Clear-Tip EUS-FNA |
Finemedix Co. Ltd. |
Heon Sik Lee |
| DEN170092 |
11/02/2018 |
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System |
Fluoptics |
Odelie Allard |
| K182684 |
11/23/2018 |
HammerTechTM Fixation System |
Fusion Orthopedics, LLC |
Eli Jacobson |
| K173589 |
11/30/2018 |
Prizma |
G-Medical Innovations Ltd. |
N. Epstein |
| K180917 |
11/20/2018 |
GC Acrylic Primer |
GC America Inc. |
Mark Heiss |
| K181403 |
11/02/2018 |
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR |
GE Healthcare |
Michel Genuer |
| K181985 |
11/15/2018 |
Voluson E6, Voluson E8, Voluson E10 |
GE Healthcare |
Bryan Behn |
| K182626 |
11/16/2018 |
OEC One |
GE Hualun Medical Systems Co., Ltd. |
Lifeng Wang |
| K181934 |
11/06/2018 |
Vivid T8, Vivid T9 |
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
Tracey Ortiz |
| K182277 |
11/21/2018 |
Versana Premier |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K182838 |
11/08/2018 |
Geistlich Derma-Gide |
Geistlich Pharma AG |
Marco Steiner |
| K180840 |
11/30/2018 |
UNO Negative Pressure Wound Therapy System |
Genadyne Biotechnologies, Inc. |
Andrew Goh |
| K181846 |
11/06/2018 |
ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolu |
Globus Medical Inc. |
Lori Burns |
| K180495 |
11/30/2018 |
Tinnitus Sound Generator Module |
GN Hearing A/S |
Lars Hagander |
| K180463 |
11/14/2018 |
Apoller Flow Light Cure Flowable Composite |
Greenway YW LLC |
Scott Yin |
| K181696 |
11/30/2018 |
ChitoZolve |
Gyrus ACMI, Inc |
Dolan Mills |
| K182528 |
11/15/2018 |
Nitrile Glove Powder Free Black |
Haining Medical Products Co., Ltd. |
Zhiming Yao |
| K180645 |
11/16/2018 |
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) |
Hartalega Sdn Bhd |
Mr. Kuan Kam Hon |
| K180786 |
11/02/2018 |
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff |
HARTALEGA SDN. BHD. |
Kuan Kam Hon |
| K181297 |
11/21/2018 |
DENTIOIII series (DENTIOIII, DENTIOIII-S) |
HDX WILL CORP. |
Lee Myoung-Joon |
| K183009 |
11/26/2018 |
HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES |
Hemostatix Medical Technologies, LLC |
Jeff Cobb |
| K181604 |
11/28/2018 |
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite |
HRS Co., Ltd. |
Seunghwan Go |
| K181273 |
11/01/2018 |
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K181939 |
11/06/2018 |
icobrain |
icometrix NV |
Jan Verheyden |
| K182298 |
11/16/2018 |
hemochroma PLUS System |
Immunostics, Inc. |
Junghee Kim |
| K173701 |
11/29/2018 |
Implant-One System |
Implant Logistics, Inc. |
Thomas Arendt |
| K181897 |
11/15/2018 |
Reprocessed Marinr Diagnostic EP Catheter |
Innovative Health, LLC. |
Amanda Babcock |
| K182265 |
11/20/2018 |
CodMan Certas Plus Programmable Valve |
Integra LifeSciences Corp. |
Nancy MacDonald |
| K182801 |
11/27/2018 |
Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable |
Integra LifeSciences Corporation |
Jennifer Siu |
| K181639 |
11/02/2018 |
Panta 2 Arthrodesis Nail System |
Integra Lifesciences Corporation |
Blesson Abraham |
| K180732 |
11/08/2018 |
MiroCam Capsule Endoscope System |
IntroMedic Co., Ltd. |
Jinyoung Lee |
| K181090 |
11/14/2018 |
Invacare« Solara« 3G and Solara« 3G Spree Manual Wheelchairs |
Invacare Corporation |
Elijah N. Wreh |
| K181806 |
11/20/2018 |
ARIX Sternal System |
Jeil Medical Corporation |
Ahhyeon Woo |
| K180546 |
11/21/2018 |
Jet Power Injectable PICC |
Jet Medical, Inc. |
Courtney Nix |
| K182649 |
11/09/2018 |
Enteral Feeding Syringes with Enfit Connectors |
Jiangsu Kangbao Medical Equipment Co., Ltd |
Qian Li |
| K182498 |
11/30/2018 |
Advanced Skin Renewing Device |
Jiangsu Unimed Laser Technology Co., Ltd. |
Simon Wang |
| K181890 |
11/09/2018 |
Brainlab Compatible K2M Navigation Instruments |
K2M |
Nancy Giezen |
| K182182 |
11/15/2018 |
YUKON OCT Spinal System |
K2M |
Nancy Giezen |
| K180665 |
11/28/2018 |
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System |
K2M, LLC. |
Nancy Giezen |
| K182652 |
11/20/2018 |
COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 |
Kangfu Medical Equipment Factory |
Zelong Cao |
| K182696 |
11/20/2018 |
Telepack X LED |
KARL STORZ Endoscopy-America, Inc |
Winkie Wong |
| K182162 |
11/07/2018 |
OptiBond eXTRa Universal |
Kerr Corporation |
Mohammad Saad Ansari |
| K181469 |
11/09/2018 |
Cryotop«US-flash and Cryotop«US-scoop |
Kitazato Corporation |
Futoshi Inoue |
| K182431 |
11/26/2018 |
Konicaminolta DI-X1 |
Konica Minolta, Inc. |
Tsutomu Fukui |
| K181750 |
11/15/2018 |
SITZMARKS |
Konsyl Pharmaceuticals |
Frank Gunsallus III |
| K181857 |
11/20/2018 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Kossan International Sdn. Bhd. |
Cho Sow Fong |
| K182699 |
11/26/2018 |
Selethru PTCA Balloon Dilatation Catheter |
Kossel Medtech (Suzhou) Co., Ltd. |
Zane Wang |
| K180607 |
11/23/2018 |
Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit |
KRONUS, Inc. |
Brian Deis |
| K183117 |
11/15/2018 |
PathLoc-L MIS Spinal System |
L&K Biomed Co., Ltd. |
Jihyeon Seo |
| K182674 |
11/13/2018 |
Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia |
Largan Medical Co., Ltd |
Amy Tien |
| K182523 |
11/01/2018 |
Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens |
Largan Medical Co., Ltd. |
Amy Tien |
| K182916 |
11/16/2018 |
Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr |
LeMaitre Vascular |
John N. Bradsher |
| K182380 |
11/28/2018 |
AEON Endoscopic Stapler |
Lexington Medical, Inc. |
Douglas MacBride |
| K182470 |
11/26/2018 |
Plateau Spacer System |
Life Spine |
Angela Batker |
| K182557 |
11/02/2018 |
MTS Eravacycline 0.002 - 32 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K183023 |
11/30/2018 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K183030 |
11/30/2018 |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
Luminex Molecular Diagnostics, Inc. |
Tina Ip |
| K180180 |
11/02/2018 |
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) |
M.I. Tech Co., Ltd. |
Inae Kim |
| K181559 |
11/09/2018 |
Neurosign V4 Intraoperative Nerve Monitor |
Magstim Company Ltd. |
Tom Campbell |
| K182077 |
11/02/2018 |
Mazor X System (Mazor X Stealth Edition) |
Mazor Robotics Ltd. |
Marina Hefetz |
| K181693 |
11/28/2018 |
SMS Femoral Stem |
Medacta International SA |
Stefano Baj |
| K180643 |
11/23/2018 |
MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) |
MedCu Technologies, Ltd. |
Gadi Borkow |
| K180415 |
11/02/2018 |
Invia White Foam NPWT |
Medela AG |
Georges Hakim |
| K182352 |
11/21/2018 |
SP-LINKÖ System |
Medical Designs LLC |
Kristi Vondra |
| K181820 |
11/01/2018 |
Medline Unite Mini Plates and Screws |
Medline Industries, Inc. |
Jennifer Mason |
| K181781 |
11/05/2018 |
DynaClipTM Bone Staple |
MedShape, Inc. |
Jack Griffis |
| K183174 |
11/26/2018 |
FlexCath Advance Steerable Sheath and Dilator |
Medtronic CryoCath LP |
Natalie Sadeghi |
| K182104 |
11/02/2018 |
NavLock Trackers, Robotic Reference Frame |
Medtronic Navigation |
Jainam Shah |
| K182121 |
11/02/2018 |
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition |
Medtronic Sofamor Danek USA, Inc. |
Erikka Edwardsen |
| K182957 |
11/21/2018 |
Heli-FX EndoAnchor System |
Medtronic Vascular, Inc. |
Janelle Wong Keller |
| K181918 |
11/08/2018 |
CardioInsight Cardiac Mapping System |
Medtronic, Inc. |
Janell Colley |
| DEN180040 |
11/30/2018 |
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit |
Meridian Bioscience, Inc. |
Jack Rogers |
| K182559 |
11/05/2018 |
PREMIER Platinum HpSA PLUS |
Meridian Bioscience, Inc. |
Jack Rogers |
| K182216 |
11/06/2018 |
Merit Syringe |
Merit Medical Systems, Inc |
John Skousen |
| K182279 |
11/06/2018 |
Merit Syringe |
Merit Medical Systems, Inc. |
John Skousen |
| K181443 |
11/23/2018 |
Accula RSV Test |
Mesa Biotech, Inc. |
Barbara Stevens |
| K181689 |
11/15/2018 |
Nexcomp |
Meta Biomed Co., Ltd. |
Suk Song Oh |
| K182097 |
11/14/2018 |
React 71 Catheter |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K182101 |
11/14/2018 |
Riptide Aspiration System (React 71 Catheter) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K181819 |
11/06/2018 |
SMARTRELEASE Endoscopic Soft Tissue Release System |
MicroAire Surgical Instruments LLC |
Glenn Gerstenfeld |
| K182472 |
11/08/2018 |
Cepheid Xpert GBS LB Control Panel |
Microbiologics, Inc. |
Tina Sobania |
| DEN180030 |
11/19/2018 |
QMS Plazomicin Immunoassay |
Microgenics Corporation |
Minoti Patel |
| K181195 |
11/02/2018 |
ClearPoint System |
MRI Interventions, Inc. |
Pete Piferi |
| K181731 |
11/20/2018 |
MR Compatible Aspiration Kit |
MRI Interventions, Inc. |
Pete Piferi |
| K181137 |
11/16/2018 |
IT-III active System |
Neobiotech Co., Ltd. |
Young-Ku Heo |
| K182958 |
11/16/2018 |
1.5T 16ch Breast Coil |
NeoCoil, LLC |
Katie Gonzalez |
| K173917 |
11/08/2018 |
neoClose PDS |
neoSurgical Ltd |
Orla Brennan |
| K182195 |
11/09/2018 |
ArcoÖ-SA Lumbar Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K181590 |
11/08/2018 |
Neurostructures Cavetto« [MAX] Cervical Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K181709 |
11/16/2018 |
Serenity Piezo Sensor, Serenity Thermocouple Sensor |
Neurotronics, Inc. |
David Pezet |
| K181501 |
11/02/2018 |
Afina |
NeuroVision Imaging, LLC |
Pepe Davis |
| K182201 |
11/16/2018 |
StratumÖ Foot Plating System |
Nextremity Solutions, Inc. |
Adam Finley |
| K182508 |
11/13/2018 |
SaxxonyÖ Posterior Cervical Thoracic System |
Nexxt Spine LLC |
Andy Elsbury |
| K182616 |
11/02/2018 |
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System |
NinePoint Medical, Inc. |
Eman Namati |
| K182606 |
11/21/2018 |
PINPOINT Endoscopic Fluorescence Imaging System |
Novadaq Technologies ULC (now a part of Stryker) |
Agatha Szeliga |
| K181266 |
11/01/2018 |
Implantswiss Dental Implant System, Implantswiss Dental Abutment System |
Novodent SA |
Cem Kocer |
| K180550 |
11/20/2018 |
NuVasive Monolith Cervical Corpectomy System |
NuVasive, Incorporated |
Martin Yahiro |
| K180498 |
11/28/2018 |
NuVasive Reline Fenestrated Screws, High V+ Bone Cement |
NuVasive, Incorporated |
Martin Yahiro |
| K180668 |
11/15/2018 |
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K173495 |
11/30/2018 |
Single Use Hot Biopsy Forceps FD-231 |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K182587 |
11/29/2018 |
Device Electrosurgical Generator ESG-150 |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K181992 |
11/09/2018 |
Heat Pain Pro |
Omron Healthcare, Inc. |
Renee Thornborough |
| K182481 |
11/09/2018 |
HEM-6410T-ZM Wrist Blood Pressure Monitor |
Omron Healthcare, Inc. |
Renee Thornborough |
| K182166 |
11/08/2018 |
Wrist Blood Pressure Monitor Model BP4350 |
Omron Healthcare, Inc. |
Renee Thornborough |
| K182127 |
11/02/2018 |
Wrist Blood Pressure Monitor Model BP6100 |
Omron Healthcare, Inc. |
Renee Thornborough |
| K182274 |
11/20/2018 |
Orbit Subretinal Delivery System |
Orbit Biomedical, Inc. |
Michael Keane |
| K182360 |
11/09/2018 |
Teleport Microcatheter |
OrbusNeich Medical Trading Inc. |
John Pazienza |
| K181112 |
11/26/2018 |
Orchestrate 3D |
Orchestrate 3D |
Todd Ehrler |
| K182096 |
11/02/2018 |
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs |
Owens & Minor Halyard, Inc. |
Angela L. Bunn |
| K181396 |
11/16/2018 |
Oral Device OA, Oral Device S |
Passion for Life Healthcare (UK) Limited |
Paul Earps |
| K182181 |
11/29/2018 |
Persyst 14 EEG Review and Analysis Software |
Persyst Development Corporation |
Dari Darabbeigi |
| K182353 |
11/27/2018 |
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay |
Phadia AB |
Carina Magnusson |
| K181831 |
11/15/2018 |
IntelliVue Multi-Measurement Module MMX |
Philips Medizin Systeme Boeblingen GmbH |
Stefan Breuer |
| K182857 |
11/09/2018 |
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
Kym Rupp |
| K180918 |
11/30/2018 |
Planmed Verity |
Planmed Oy |
Lars Moring |
| K182581 |
11/21/2018 |
PlayMakar Sport Muscle Stimulator, Model PRO-500 |
PlayMakar Inc. |
Mike Williams |
| K182598 |
11/13/2018 |
VersaLinkÖ Fixation System |
Premia Spine Ltd. |
Ron Sacher |
| K181816 |
11/29/2018 |
Ceramic Denture Zirconia Ceramics Block |
Qinhuangdao Silide Ceramic Technology Co., Ltd |
Lou ChunHua |
| K180478 |
11/13/2018 |
RectalPro 75 Endorectal Balloon |
QLRAD International Ltd. |
Arjen Winkel |
| K182442 |
11/06/2018 |
MiniGuard Arterial Safety Valve |
Quest Medical, Inc. |
Tosan Onosode |
| K181948 |
11/16/2018 |
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil |
RAPID Biomedical GmbH |
Christian Zimmermann |
| K182218 |
11/30/2018 |
FerriSmart Analysis System |
Resonance Health Analysis Services Pty Ltd |
Celine Royet |
| K180573 |
11/23/2018 |
Responsive Arthroscopy Interference Screw System |
Responsive Arthroscopy LLC |
Doug Kohrs |
| K180949 |
11/08/2018 |
Steribite |
RJR Surgical, Inc. |
John Redmond |
| K173857 |
11/06/2018 |
Elecsys Tacrolimus |
Roche Diagnostics |
Khoa Tran |
| K182095 |
11/05/2018 |
Tina-quant Transferrin ver.2 (urine application) |
Roche Diagnostics Operations (RDO) |
Lindsay Jones |
| K182654 |
11/19/2018 |
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card |
Safecare Biotech (Hangzhou) Co., Ltd. |
Alex Qiu |
| K180838 |
11/06/2018 |
SaliPen |
Saliwell Ltd. |
Ben Z. Beiski |
| K181998 |
11/15/2018 |
CardioBand ECG Event Recorder |
Samsung Strategy and Innovation Center (SSIC) |
Bhupinder Singh |
| K181704 |
11/21/2018 |
Transpara |
ScreenPoint Medical BV |
Nico Karssemeijer |
| K173001 |
11/07/2018 |
uWS-CT |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K172999 |
11/07/2018 |
uWS-MR |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K180381 |
11/07/2018 |
Powder Free Vinyl Patient Examination Gloves |
Shanxi Hongjin Plastic Technology Co., Ltd |
Wu Zhigang |
| K182133 |
11/20/2018 |
Infrared Thermometer |
Shenzhen AOJ Medical Technology Co., Ltd. |
Qihuan Zhao |
| K182291 |
11/20/2018 |
6MP Color LCD Monitor (C61W+) |
Shenzhen Beacon Display Technology Co., Ltd. |
Fu Ailing |
| K182530 |
11/09/2018 |
BIOEASY Multi-Drug Test Cup |
Shenzhen Bioeasy Biotechnology Co.,Ltd. |
Wenhau Yan |
| K180432 |
11/19/2018 |
AI-ECG Platform |
Shenzhen Carewell Electronics., Ltd |
Chang Liu |
| K172792 |
11/13/2018 |
Handheld Pulse Oximeter, Model SP-20 |
Shenzhen Creative Industry Co., Ltd. |
Jia Wang |
| K182603 |
11/14/2018 |
Z6 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., LTD |
Jiang Xiaoyong |
| K172837 |
11/26/2018 |
Low-frequency Multi-function physiotherapy instrument |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K182715 |
11/20/2018 |
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co., Ltd. |
Jiang Xiaosan |
| K182983 |
11/27/2018 |
iFuse Implant System« |
SI-BONE, Inc. |
Roxanne Dubois |
| K182098 |
11/01/2018 |
N Latex FLC kappa assay, N Latex FLC lambda assay |
Siemens Healthcare Diagnostics Products GmbH |
Christine Perkins |
| K181613 |
11/06/2018 |
MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K182179 |
11/16/2018 |
AdvantageRib Anterior System |
SIG Medical Corp. |
Andrew Davison |
| K181759 |
11/09/2018 |
PowerDot PD-01MT |
Smartmissimo Technologies Pte Ltd |
Alexey Pisarev |
| K182535 |
11/19/2018 |
R3 Anteverted Liners |
Smith & Nephew, Inc. |
Meenakshi Gupta |
| K182109 |
11/16/2018 |
REDAPT Modular Acetabular Shell |
Smith & Nephew, Inc. |
Meenakshi Gupta |
| K183010 |
11/28/2018 |
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks |
Smith & Nephew, Inc. |
Brad Sheals |
| K182543 |
11/14/2018 |
Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package |
snap40 Ltd |
Edwin Lindsay |
| K180631 |
11/08/2018 |
Silk Voice |
Sofregen Medical, Inc. |
Anh Hoang |
| K180388 |
11/30/2018 |
Transcend 365 miniCPAP System |
Somnetics International, Inc. |
Eric Becker |
| K180979 |
11/16/2018 |
PureFlex Arterial Cannulae |
Sorin Group Italia S.r.l |
Luigi Vecchi |
| K181850 |
11/14/2018 |
Inversa Implants |
Southern Implants (Pty) Ltd |
Lauranda Breytenbach |
| K182484 |
11/09/2018 |
VERITON CT whole body SPECT/CT system |
Spectrum Dynamics Medical Ltd |
Igor Naroditsky |
| K181837 |
11/02/2018 |
Spinal Elements Ti-Bond coated devices |
Spinal Elements Inc. |
Julie Lamothe |
| K182604 |
11/14/2018 |
New Era |
Step Up Skin Laser, LLC |
Michelle Hokama |
| K182931 |
11/20/2018 |
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 Corporations |
Jennifer Nalepka |
| K182160 |
11/05/2018 |
1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM |
Stryker |
April Malmborg |
| K181258 |
11/05/2018 |
ConnectedOR Hub with Device and Voice Control |
Stryker |
April Malmborg |
| K182425 |
11/06/2018 |
Universal Mesh - Sterile |
Stryker Leibinger GmbH & Co. KG |
Gregory Gohl |
| K182336 |
11/30/2018 |
SubtlePET |
Subtle Medical, Inc. |
Enhao Gong |
| K180528 |
11/16/2018 |
InstruSafe(R) Sterilization Container |
Summit Medical Inc. |
Nicole Dove |
| K180310 |
11/01/2018 |
DePuy Synthes Trauma Orthopedic Plates and Screws |
Synthes (USA) Products LLC/DePuy Orthopaedics Inc |
Jeffrey Krawiec |
| K180541 |
11/21/2018 |
DePuy Synthes 2.0 mm Quick Insertion Screws |
Synthes USA Products, LLC |
Nicholas Fountoulakis |
| K181588 |
11/30/2018 |
POPS! one Blood Glucose Monitoring System |
TaiDoc Technology Corporation |
Anne Kuo |
| K172668 |
11/06/2018 |
W Zirconia Implants |
TAV Medical Ltd. |
Revital Shabtai |
| K180253 |
11/02/2018 |
Sheridan Endobronchial Tubes |
Teleflex Medical |
Lori Pfohl |
| K181049 |
11/01/2018 |
Spectra Optia Apheresis System |
Terumo BCT, Inc. |
Nicholas Wong |
| K182110 |
11/02/2018 |
CDI Blood Parameter Monitoring System 550 |
Terumo Cardiovascular Systems Corporation |
Bryan K. Hann |
| K181369 |
11/13/2018 |
Immucise Intradermal Injection System |
Terumo Corporation |
Yuko Watanabe |
| K182797 |
11/30/2018 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 ╡g/mL |
Thermo Fisher Scientific |
Cynthia Knapp |
| K182027 |
11/21/2018 |
Wet Organics Personal Lubricant |
Trigg Laboratories DBA Wet International |
Simone Buntin |
| K182046 |
11/30/2018 |
Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System |
Tyson Bioresearch, Inc. |
Vance Chang |
| K182047 |
11/29/2018 |
Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System |
Tyson Bioresearch, Inc. |
Vance Chang |
| K181829 |
11/14/2018 |
Velofix TLIF Cage |
U&I Corporation |
Jee-Ae Bang |
| K181921 |
11/16/2018 |
Solidity Vertebral Body Replacement |
ulrich medical USA |
Hans Stover |
| K182105 |
11/14/2018 |
JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant |
United Consortium |
Stephanie Morris |
| K182909 |
11/21/2018 |
Roth Net Retriever Product Line |
United States Endoscopy Group, Inc. |
Carroll Martin |
| K181784 |
11/30/2018 |
Spectra S3 Plus |
Uzinmedicare Co. |
Nathan Ahn |
| K173373 |
11/16/2018 |
SafeT T-Piece Resuscitator |
Ventlab, LLC |
Rob Yamashita |
| K180601 |
11/02/2018 |
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) |
Villa Sistemi Medicali S.p.A. |
Paolo Casagrande Santin |
| K181247 |
11/20/2018 |
Vitrea CT Brain Perfusion |
Vital Images, Inc. |
Susan Atwood |
| K181524 |
11/30/2018 |
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART |
Vyaire Medical, Inc. |
Elmar Niedermeyer |
| K181208 |
11/02/2018 |
Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter |
Vygon USA |
Jillian Mikovich |
| K180298 |
11/30/2018 |
welloStationX |
Wello, Inc |
Alan Camerik(Rik) Heller |
| K182562 |
11/16/2018 |
Hair Boom 69 |
WonTech |
Gyuri (Erin) Park |
| K182823 |
11/02/2018 |
PRODENSE Bone Graft Substitute |
Wright Medical Technology, Inc. |
Alayne Melancon |
| K180685 |
11/29/2018 |
AS-3XX Series Fingertip Pulse Oximeter |
Xiamen Acurio Instruments Co., Ltd |
Angel Liu |
| K173971 |
11/15/2018 |
K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent |
Yeti Dentalprodukte Gmbh |
Thomas Biskupski |
| K181996 |
11/21/2018 |
MATRx Plus |
Zephyr Sleep Technologies |
Sabina Bruehlmann |
| K180482 |
11/30/2018 |
ZOLL Propaq M |
ZOLL Medical Corporation |
Pooja Dalvi |
