| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K173041 |
12/20/2018 |
3DIEMME RealGUIDE |
3DIEMME Ltd. |
Alessandro Montroni |
| K181838 |
12/20/2018 |
Sinusway Dilation System |
3NT Medical Ltd. |
Ehud Bendory |
| K183128 |
12/12/2018 |
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 |
Abbott |
Cody Johnson |
| K181908 |
12/03/2018 |
Action Trackchair |
Action Manufacturing Inc. |
Alan Macht |
| K181405 |
12/10/2018 |
Hailie Sensor |
Adherium (NZ) Ltd |
Chris Mander |
| K182404 |
12/27/2018 |
STERRAD VELOCITY Biological Indicator |
Advanced Sterilization Products (ASP) |
Sun Choi |
| K182032 |
12/21/2018 |
SterilContainer S System |
Aesculap, Inc. |
Paul Amudala |
| K182664 |
12/07/2018 |
FiXcision |
Agency for Medical Innovations GmbH |
Martin Hohlrieder |
| K182902 |
12/11/2018 |
Precision1 |
Alcon Laboratories, Inc. |
Alicia Plesnarski |
| K180826 |
12/21/2018 |
Natrelle 133 Plus MICROCELL Tissue Expander |
Allergan |
Melissa Pathmajeyan |
| K182845 |
12/27/2018 |
minisono |
Alpinion Medical Systems Co., Ltd. |
Boyeon CHO |
| K180867 |
12/28/2018 |
AmCAD-UO |
AmCad BioMed Corporation |
Jack Yang |
| K173749 |
12/06/2018 |
AMRA Profiler |
AMRA Medical AB |
Janne West |
| K182593 |
12/18/2018 |
KET-1 Blood Ketone Monitoring System |
Apex Biotechnology Corp. |
Lisa Liu |
| K181756 |
12/18/2018 |
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle |
AprioMed AB |
Katrin Svensson |
| K182681 |
12/14/2018 |
AC5 Topical Gel |
Arch Therapeutics, Inc. |
Terrence W. Norchi |
| K182280 |
12/10/2018 |
ARK Tramadol Assay |
ARK Diagnostics, Inc. |
Cherry Mun |
| K181935 |
12/04/2018 |
Endoform Reconstructive Template - Non Absorbable |
Aroa Biosurgery Ltd. |
Tina O'Brien |
| K182361 |
12/18/2018 |
Arthrex Compression FT Screws |
Arthrex Inc. |
Rebecca R. Homan |
| K181555 |
12/21/2018 |
Arthrex Fracture Adapter Hemi Shoulder Prosthesis |
Arthrex Inc. |
David L. Rogers |
| K180768 |
12/14/2018 |
Arthrex SwiveLock Anchors |
Arthrex Inc. |
Jessica L. Singelais |
| K182420 |
12/20/2018 |
ASAHI Corsair Pro XS |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K182878 |
12/18/2018 |
Integra Salto Total Ankle System |
Ascension Orthopedics |
Divya Savant |
| K183065 |
12/04/2018 |
Coolrail Linear Pen |
AtriCure, Inc. |
Caitlin Wunderlin |
| K182012 |
12/21/2018 |
ADVIA Centaur Calcitonin (CALCT) assay |
Axis-Shield Diagnostics Limited |
Claire Dora |
| K182320 |
12/20/2018 |
BD Contoured Base Pen Needle |
Becton, Dickinson and Company |
Meriam Youssef |
| K181766 |
12/10/2018 |
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance |
bioMerieux, Inc |
Cherece L. Jones |
| K181412 |
12/21/2018 |
VITEK MS |
bioMerieux, Inc. |
Jennifer Jines |
| K183162 |
12/14/2018 |
Affixus Hip Fracture Nail |
Biomet Inc. |
Dhaval Saraiya |
| K183265 |
12/13/2018 |
Selectra Catheters, Selectra Accessory Kit |
Biotronik, Inc. |
Jon Brumbaugh |
| K183080 |
12/10/2018 |
Mega Plus Spine System |
BK Meditech Co., Ltd |
Meredith Lee May |
| K182065 |
12/13/2018 |
EVOLUX CAD/CAM PMMA BLOCKS |
Blue Dent Dental |
Adriana Paula T I Gomes |
| K181785 |
12/19/2018 |
Modified BrainScope One |
BrainScope Company Inc. |
Michael E Singer |
| DEN170021 |
12/20/2018 |
SEM Scanner (Model 200) |
Bruin Biometrics, LLC |
Ya-Chen Tonar |
| K180359 |
12/13/2018 |
BTL-FR2000 |
BTL Industries, Inc. |
David Chmel |
| K182601 |
12/14/2018 |
Vitrea Software Package, VSTP-001A |
Canon Medical Systems Corporation |
Paul Biggins |
| K181174 |
12/11/2018 |
Cardinal Health Sterilization Wrap |
Cardinal Health 200 LLC |
Jillian Connery |
| K182790 |
12/14/2018 |
Cardio-TriTest v6.5 |
Cardio-Phoenix Inc. |
Marc Bisnaire |
| K182397 |
12/13/2018 |
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series |
Cardiovascular Systems Inc. |
Kris Miller |
| K183000 |
12/29/2018 |
ViperCath XC Peripheral Exchange Catheter |
Cardiovascular Systems, Inc. |
Erika Huffman |
| K182424 |
12/18/2018 |
NuFACE FIX Skin Toning Device |
Carol Cole Company dba NuFACE |
Donald Ellis |
| K182149 |
12/19/2018 |
FFRangio System |
CathWorks Ltd |
Miriam Ivenshitz |
| K180014 |
12/21/2018 |
Creme de La Femme Feminine Lubricant |
Cewal, Inc. dba Premiere Enterprises |
Jerome Vozoff |
| K181344 |
12/14/2018 |
C.T.M Mobility Scooter |
CHIEN TI ENTERPRISE CO., LTD. |
Vivian Lo |
| K182339 |
12/12/2018 |
LEUCADIA AUTOLOKÖ Pedicle Screw System |
ClearView Orthopedic Development, LLC |
Hartmut Loch |
| K182116 |
12/19/2018 |
BA310 Abutment, BIA310 Implant/Abutment |
Cochlear Americas |
Beth Murray |
| K182831 |
12/10/2018 |
SabreLine and SabreGuard Laser Fibers |
Coloplast Corp |
Cori Ragan |
| K181120 |
12/21/2018 |
2.8 mm/3.3 mm PopLok Suture Anchors |
ConMed Corporation |
Diana L. Nader-Martone |
| K182446 |
12/19/2018 |
TruShot with Y-Knot All-Suture Anchor |
ConMed Corporation |
Diana L. Nader-Martone |
| K181529 |
12/06/2018 |
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection |
Contego Medical, LLC |
Elizabeth Saylors |
| K181463 |
12/13/2018 |
DuraSheath Introducer Sheath System |
Contract Medical International GmbH |
Jan Kloboucnik |
| K180846 |
12/19/2018 |
Arterial Pressure Monitoring Set/Tray |
Cook Incorporated |
Johnathan Liu |
| K183036 |
12/20/2018 |
Dilator Sets |
Cook Incorporated |
David Lehr |
| K182709 |
12/26/2018 |
One-Step Suprapubic Introducer |
Cook Incorporated |
Carly Powell |
| DEN170055 |
12/12/2018 |
Retrograde Intubation Set |
Cook Incorporated |
Hui Ouyang |
| K180830 |
12/20/2018 |
Reuter Tip Deflecting Wire Guide |
Cook Incorporated |
Jennifer L. Allman |
| K181920 |
12/11/2018 |
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker |
CooperVision, Inc. |
Marie Dutton |
| K183239 |
12/19/2018 |
CoreLink F3DÖ Lateral System |
Corelink, LLC |
Steven Mounts |
| K183369 |
12/28/2018 |
COR12 ECG |
Corscience GmbH & Co. |
Karlheinz Trost |
| K182008 |
12/14/2018 |
Phasix ST Mesh with Echo 2 Positioning System |
CR Bard Inc. |
Shirin Mate |
| K180820 |
12/14/2018 |
Tono Vue Non-Contact Tonometer |
Crystalvue Medical Corporation |
Oliver Lin |
| K180797 |
12/14/2018 |
Xcess Guiding Catheter |
Curatia Medical Co. |
Jessica Chiu |
| K181589 |
12/20/2018 |
Curiteva Lumbar Interbody Fusion System |
Curiteva, LLC |
Eric Linder |
| K182997 |
12/12/2018 |
enlighten III Laser System |
Cutera, Inc. |
Julia Brown |
| DEN170070 |
12/21/2018 |
MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /M |
Cytocell Ltd |
Xavier Baker |
| K180859 |
12/13/2018 |
PYRAMIDION Dental Implants and Prostheses |
DenTack Implants Ltd |
Tali Hazan |
| K180657 |
12/07/2018 |
Resin for Temporary Crown & Bridge |
Dentis Co., Ltd. |
Dong-Hun Jang |
| K182422 |
12/18/2018 |
Lucitone Denture Base Materials |
Dentsply Sirona |
Karl Nittinger |
| K182783 |
12/26/2018 |
DePuy Synthes Trauma Orthopedic Nail Implants |
DePuy Synthes |
Elizabeth Jacobs |
| K181231 |
12/06/2018 |
DePuy Synthes T-PAL Spacer System |
DePuy Synthes Spine |
Heta Shah |
| K182150 |
12/18/2018 |
Devon 52 Sequential Compression Device |
Devon Medical Products (Jiangsu) Ltd |
Neil Cheng |
| K182698 |
12/26/2018 |
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device |
DiaSorin Inc. |
John C. Walter |
| K183223 |
12/19/2018 |
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K181037 |
12/21/2018 |
DIO CAD/CAM Abutment |
DIO Corporation |
Jiae Park |
| K182194 |
12/14/2018 |
UV Active Implant System |
DIO Corporation |
Park Jiae |
| K173048 |
12/06/2018 |
No-contact Forehead Thermometer |
Dongguan SIMZO Electronic Technology Co.Ltd. |
Mei Mei |
| K180380 |
12/21/2018 |
vital signs monitor |
Edan Instruments, Inc. |
Alice Yang |
| K181498 |
12/10/2018 |
X-ray Imaging System for the McLaren Proton Treatment System |
EhmetDx, LLC |
Daniel Schoettlin |
| K182076 |
12/04/2018 |
Elekta Unity |
Elekta Limited |
Nicholas Power |
| K183037 |
12/04/2018 |
Monaco RTP System |
Elekta, Inc |
Kathryn Stinson |
| K183034 |
12/04/2018 |
MOSAIQ Oncology Information System |
Elekta, Inc |
Faiza Ahmed |
| K183012 |
12/21/2018 |
vascuCAP |
Elucid Bioimaging Inc. |
Andrew Buckler |
| K173783 |
12/14/2018 |
SCIg60 Infusion System |
EMED Technologies Corporation |
Peter Kollings |
| K181861 |
12/20/2018 |
Embrace |
Empatica Srl |
Simone Tognetti |
| K183191 |
12/04/2018 |
6420 Ultrasound System |
Esaote, S.p.A. |
Massimo Polignano |
| K182680 |
12/06/2018 |
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing |
Exciton Technologies, Inc. |
Melanie Ussyk |
| K183123 |
12/20/2018 |
microTargeting Guideline 4000 5.0 System |
FHC, Inc. |
Kelly Moeykens |
| K181690 |
12/21/2018 |
Clear-Jet Injection Catheter |
Finemedix Co. Ltd. |
Hee Kyung Kwon |
| K162553 |
12/20/2018 |
AirSpiral Heated Breathing Tube |
FISHER & PAYKEL HEALTHCARE |
STEPHANIE ELVIN |
| K181583 |
12/07/2018 |
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Si |
Flexicare Medical Limited |
Joel Biddle |
| K183307 |
12/11/2018 |
Magma Spark Pro (Magma Spark Plus, Alpha) |
Formatk Systems Ltd. |
Amit Goren |
| K183059 |
12/21/2018 |
3nethra neo |
Forus Health Pvt. Ltd. |
Shruti Kashinath |
| K180831 |
12/10/2018 |
CATSmart |
Fresenius Kabi AG |
Barry G. Hicks |
| K180615 |
12/04/2018 |
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter |
Fresenius Kabi USA LLC |
Kim Forch |
| K182419 |
12/14/2018 |
Centricity Universal Viewer |
GE Healthcare |
Renee Webb |
| K183116 |
12/06/2018 |
Unity Network ID |
GE Healthcare |
Brandon O'Shea |
| K182750 |
12/21/2018 |
4D View |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K181727 |
12/06/2018 |
Vivid iq |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K181663 |
12/20/2018 |
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel |
GenMark Diagnostics, Incorporated |
Alan Maderazo |
| K182690 |
12/21/2018 |
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel |
GenMark Diagnostics, Incorporated |
Beth Stofka |
| K180679 |
12/07/2018 |
CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Conc |
Global Scientific Technologies, LLC |
William J. Griswold, Jr. |
| K181357 |
12/06/2018 |
PATRIOT« Lumbar Spacers, SUSTAIN« Spacers |
Globus Medical Inc. |
Kelly Baker |
| K180909 |
12/18/2018 |
REVEL Spacers |
Globus Medical Inc. |
Kelly J. Baker |
| K182701 |
12/03/2018 |
Wondfo T-Cup Multi-Drug Urine Test Cup |
Guangzhou Wondfo Biotech Co., Ltd. |
Bin Chen |
| K181087 |
12/18/2018 |
Apex Locator, DPEX III |
Guilin Woodpecker Medical Instrument Co., Ltd. |
Xunxian Wu |
| K183068 |
12/21/2018 |
Nitrile Glove Powder Free White |
Haining Medical Products Co., Ltd. |
Zhiming Yao |
| K182068 |
12/13/2018 |
Erran Dental Zirconia |
Hangzhou Erran Technology Co., Ltd. |
Tingkai Li |
| K180578 |
12/12/2018 |
Harvest Dental Polymer Blocks |
Harvest Dental Products, LLC |
Sasha Der Avanessian |
| K182035 |
12/06/2018 |
FFRct |
HeartFlow, Inc |
Windi Hary |
| K183253 |
12/18/2018 |
ValPro 2 Plus, VaPro 2 Plus Pocket |
Hollister Incorporated |
Michelle Schiltz-Taing |
| K182006 |
12/06/2018 |
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths |
Hologic, Inc |
Rachelle D. Fitzgerald |
| K181294 |
12/14/2018 |
Honda Walking Assist Device |
Honda Motor Company, Ltd. |
Kazushi Hamaya |
| K182479 |
12/04/2018 |
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus |
Hycor Biomedical |
Tara Viviani |
| K182373 |
12/06/2018 |
PowerLook Tomo Detection V2 Software |
iCAD Inc. |
John DeLucia |
| K182167 |
12/21/2018 |
The ICHOR Panacea Vascular Embolectomy Catheter System |
ICHOR Vascular, Inc. |
Jeff Blair |
| K180670 |
12/07/2018 |
ICONN Campbell Interference Screw |
ICONN Orthopedics, LLC |
Whitt Israel |
| K183145 |
12/13/2018 |
IlluminOss Photodynamic Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K173083 |
12/03/2018 |
IMPLANTER DENTAL PLANNING SOFTWARE |
Implanter LLC |
Jorge Millan |
| K183198 |
12/17/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
Eben Gordan |
| K181703 |
12/28/2018 |
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments |
Institut Straumann AG |
Viviana Horhoiu |
| K182809 |
12/07/2018 |
CUSA Clarity Ultrasonic Surgical Aspirator System |
Integra LifeSciences Corporation |
MaryBeth Carson |
| K183107 |
12/11/2018 |
Intuitive Surgical Vessel Sealer Extend |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K182946 |
12/11/2018 |
Invacare TDX SP2-HD with Captain's Seat |
Invacare Corporation |
Elijah Wreh |
| K182900 |
12/14/2018 |
3880 MRI Patient Monitoring System |
Iradimed Corporation |
Francis X. Casey |
| K182130 |
12/27/2018 |
iSchemaView RAPID |
iSchemaView, Inc. |
Jim Rosa |
| K181374 |
12/14/2018 |
NRFit Syringe |
Jiangsu Caina Medical Co., Ltd |
Jun Lu |
| K181331 |
12/21/2018 |
JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White |
Juvora, Ltd. |
Tim Leyva |
| K182473 |
12/12/2018 |
PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems |
K2M Inc. |
Nancy Giezen |
| K182688 |
12/18/2018 |
SKR 3000 |
KONICA MINOLTA, INC. |
Tsutomu Fukui |
| K181958 |
12/06/2018 |
MagnetOs Putty |
Kuros Biosciences B.V. |
Yvonne P. Bovell |
| K183168 |
12/11/2018 |
OpenLoc-L Spinal Fixation System |
L&K Biomed Co., Ltd. |
Jihyeon Seo |
| K183348 |
12/17/2018 |
Reusable Silicone Cover CPRmeter 2 |
Laerdal Medical AS |
Mari Kaada |
| K182045 |
12/27/2018 |
Lotus III Multi-Pulsed Er: Yag Laser System |
Laseroptek Co., Ltd. |
Hong Chu |
| K183102 |
12/07/2018 |
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody |
Leica Biosystems Newcastle Limited |
Jeremy Allen |
| K183100 |
12/07/2018 |
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra |
Leica Biosystems Newcastle Limited |
Jeremy Allen |
| K182795 |
12/21/2018 |
LENSAR Laser System - fs 3D (LLS-fs 3D) |
Lensar, Inc. |
Keith Peck |
| K183286 |
12/07/2018 |
17HK701G-W |
LG Electronics Inc. |
Jinhwan Jun |
| K181625 |
12/11/2018 |
Life Spine ResoluteÖ Threaded Cage System |
Life Spine Inc. |
Angela Batke |
| K182099 |
12/26/2018 |
Delta TT Pro |
Limacorporate S.p.A. |
Roberto Gabetta |
| K181159 |
12/03/2018 |
LZI Fentanyl Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Bernice Lin |
| K182354 |
12/14/2018 |
SafeAir Telescopic Smoke Pencil |
LiNA Medical ApS |
Natalia Szychulska |
| K183115 |
12/20/2018 |
MTS Levofloxacin 0.002 - 32 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K182922 |
12/14/2018 |
MTS Omadacycline 0.002-32 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K180945 |
12/10/2018 |
LUTRONIC GENIUS Radiofrequency System |
Lutronic Corporation |
Jhung Won Vojir |
| K182434 |
12/13/2018 |
LaparoGuard |
Mariner Endosurgery Inc. |
Mitch Wilson |
| K181826 |
12/10/2018 |
Glenoid Polyaxial Non-locking Screws |
Medacta International SA |
Stefano Baj |
| K181970 |
12/04/2018 |
MectaLIF Posterior Extension |
Medacta International SA |
Stefano Baj |
| K182812 |
12/12/2018 |
Medline Cautery Electrode (SILICONE) |
Medline Industries, Inc. |
Matt Clausen |
| K182610 |
12/19/2018 |
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device |
Medtronic |
Kari Christianson |
| K182242 |
12/26/2018 |
VO200 û NeurOs Cerebral Oximetry System |
Mespere LifeSciences Inc. |
Rebecca S. Li |
| K180772 |
12/17/2018 |
Met One Czar Anterior Cervical Plate System |
Met One Technologies |
Evan Carbonell |
| K182810 |
12/10/2018 |
Distal Radius Plating System |
Miami Device Solutions, LLC |
Michelle Montesino |
| K183185 |
12/18/2018 |
Riptide Aspiration System (Riptide Large Bore Aspiration System) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Nancy Drew |
| K182556 |
12/14/2018 |
SureClip Repositionable Hemostasis Clip |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K182125 |
12/06/2018 |
EVOLUTION Stemmed CS Femur |
MicroPort Orthopedics Inc. |
Hunter Ethan Williams |
| K182624 |
12/18/2018 |
MIM - MRT Dosimetry |
MIM Software Inc. |
Lynn Hanigan |
| K182207 |
12/14/2018 |
TR90BH |
MinXray, Inc |
Keith Kretchmer |
| K182016 |
12/06/2018 |
Simplicit90Y |
Mirada Medical Ltd. |
Sarah Bond |
| DEN180007 |
12/21/2018 |
Miris Human Milk Analyzer |
Miris AB |
Elin Hallen |
| K182989 |
12/18/2018 |
AURORAÖ Screw System |
MiRus, LLC |
Jordan Bauman |
| K180828 |
12/20/2018 |
Natureplex Warm Touch Warming Jelly |
Natureplex, LLC |
Pamela Hopkins |
| K182178 |
12/13/2018 |
neoBLUE blanket LED Phototherapy System |
Natus Medical Incorporated |
Judy Buckham |
| K182776 |
12/21/2018 |
Neocis Guidance System |
Neocis Inc. |
Thomas E. Claiborne |
| K181695 |
12/07/2018 |
Nihon Kohden NKV-550 Series Ventilator System |
Nihon Kohden OrangeMed, Inc. |
Sheryl Higgins |
| K183069 |
12/04/2018 |
NobelZygoma 0░ |
Nobel Biocare AB |
Charlemagne Chua |
| K181869 |
12/12/2018 |
On1 Universal Abutment |
Nobel Biocare AB |
Charlemagne Chua |
| K183169 |
12/27/2018 |
Pulse 2.0, Pulse Pro 2.0 |
NormaTec Industries, LP |
Albert G. Sanford |
| K183328 |
12/21/2018 |
Pulse Rx 2.0, Pulse Pro Rx 2.0 |
NormaTec Industries, LP |
Albert G. Sanford |
| K173036 |
12/21/2018 |
North-vision Multi-parameter Patient Monitor |
North-vision Tech. Inc. |
Albert Huang |
| K182549 |
12/13/2018 |
StatStrip Xpress 2 Glucose Hospital Meter System |
Nova Biomedical Corporation |
Khushboo Surendran |
| K182552 |
12/13/2018 |
StatStrip Xpress Glucose Hospital Meter System |
Nova Biomedical Corporation |
Khushboo Surendran |
| K182387 |
12/17/2018 |
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) |
Novo Nordisk Inc. |
Elizabeth D'Amato |
| K182949 |
12/04/2018 |
HealixÖ Compression Screw System |
Nvision Biomedical Technologies, LLC |
Diana Langham |
| K182454 |
12/20/2018 |
O2 Concepts Oxlife Independence Model 301-0001 |
O2 Concepts LLC |
Kathryn G. Forgione |
| DEN170091 |
12/28/2018 |
EyeBOX |
Oculogica, Inc. |
Rosina Samadani |
| K183267 |
12/20/2018 |
DyeVertÖ NG Contrast Reduction System, DyeVertÖ PLUS EZ Contrast Reduction System, DyeTectÖ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVertÖ PLUS EZ Contrast Reduction System |
Osprey Medical, Inc. |
Melanie Hess |
| K182296 |
12/14/2018 |
HyperFil-LV |
Parkell, Inc. |
David Mott |
| K173681 |
12/10/2018 |
reSET-O |
Pear Therapeutics, Inc. |
Yuri Maricich |
| K182747 |
12/18/2018 |
EliA RF IgM Immunoassay |
Phadia AB |
Carina Magnusson |
| K183007 |
12/24/2018 |
EliA SmDP Immunoassay |
Phadia AB |
Carina Magnusson |
| K182926 |
12/06/2018 |
IntelliSpace Radiology |
Philips Healthcare Informatics, Inc. |
Paige Gridack |
| K183101 |
12/31/2018 |
Zenition 50 |
Philips Medical Systems Nederland BV |
Sumit Kumar |
| K183040 |
12/06/2018 |
Zenition 70 |
Philips Medical Systems Nederland BV |
Sumit Kumar |
| K181825 |
12/04/2018 |
CAAS MR Solutions |
Pie Medical Imaging B.V. |
Annemiek Bouts |
| K182781 |
12/21/2018 |
PTS Professional Chemistry Kit |
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
Samuel Engelman |
| K182670 |
12/20/2018 |
FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute |
Prosidyan, Inc |
Charanpreet S. Bagga |
| K183111 |
12/07/2018 |
Contour 24 |
Quality Electrodynamics, LLC |
Eric Yeh |
| K182564 |
12/27/2018 |
Quantib ND |
Quantib BV |
Floor van Leeuwen |
| K163601 |
12/06/2018 |
RII Smart IR Thermometer |
RADIANT INNOVATION INC. |
Monica Chung |
| K182668 |
12/14/2018 |
Rapid Reboot Compression Therapy System |
Rapid Reboot Recovery Products, LLC |
David Johnson |
| K182805 |
12/14/2018 |
RCT800 |
RAY Co., Ltd |
Changhwan Lee |
| K182007 |
12/07/2018 |
Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System |
Renovis Surgical Technologies |
Anthony DeBenedictis |
| K181372 |
12/13/2018 |
Argos |
Retia Medical, LLC |
Marc Zemel |
| K180999 |
12/11/2018 |
Mygen V-1000 RF System |
RF Medical Co., Ltd |
Kwang S. Choi |
| K181269 |
12/14/2018 |
iCertainty |
Rfpi |
Jeffery Basham |
| K181131 |
12/13/2018 |
Accu-Chek Guide Me Blood Glucose Monitoring System |
Roche Diabetes Care |
Ginger Emrich |
| K182512 |
12/10/2018 |
Route 92 Medical Delivery Catheter |
Route 92 Medical Inc. |
Kathy Tansey |
| K182183 |
12/07/2018 |
GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A |
Samsung Electronics Co., LTD. |
Jaesang Noh |
| K182595 |
12/18/2018 |
HERA W10 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K181336 |
12/04/2018 |
HS50 / HS60 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K182905 |
12/14/2018 |
UniPulse |
Seaward Group |
Jim Wallace |
| K180762 |
12/14/2018 |
CAPI 3 HEMOGLOBIN(E) |
SEBIA |
Karen Anderson |
| K182001 |
12/17/2018 |
Acucy Influenza A&B Test with the Acucy System |
Sekisui Diagnostics, LLC |
Shelly Harris |
| K181744 |
12/11/2018 |
BI-MENTUM dual mobility system |
Serf |
Jean-Lus Aurelle |
| K182938 |
12/18/2018 |
Emission Computed Tomography System |
Shanghai United Imaging Healthcare Co., Ltd. |
Shumei Wang |
| K180878 |
12/17/2018 |
BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Tes |
Shanghai Venture Bio-Tech CO., Ltd. |
Longli Long |
| K180879 |
12/14/2018 |
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use |
SHANGHAI VENTURE BIO-TECH CO., LTD. |
Longli Long |
| K182190 |
12/19/2018 |
Fetal Doppler |
Shenzhen AOJ Medical Technology Co., Ltd. |
Qihuan Zhao |
| K182755 |
12/21/2018 |
Disposable Temperature Probe |
Shenzhen Caremed Medical Technology Co., Ltd. |
Alan Xie |
| K182433 |
12/17/2018 |
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff |
Shenzhen Caremed Medical Technology Co., Ltd. |
Alan Xie |
| K181967 |
12/10/2018 |
Disposable Temperature Probe |
Shenzhen Launch Electrical Co., LTD |
Jiaan Huang |
| K182075 |
12/10/2018 |
BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K172897 |
12/07/2018 |
Neck Care Therapy, Model: SYK 509B |
Shenzhen OSTO Technology Co., Ltd. |
Li Yang |
| K182165 |
12/20/2018 |
Color Doppler Ultrasound System; Model: mEye1 and mEye2 |
Shenzhen Well.D Medical Electronics Co., LTD. |
Ning Bai |
| K181496 |
12/18/2018 |
VINTAGE PRO |
Shofu Dental Corporation |
Mauro Malzyner |
| K180754 |
12/07/2018 |
C-Zero Pedicle Screw System, Freedom Pedicle Screw System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K181899 |
12/13/2018 |
ROCCIA« PLIF |
Silony Medical GmbH |
Bircan Tasdelen |
| K173747 |
12/21/2018 |
REXLENE |
SM ENG CO., LTD |
Soon-Gu Lee |
| K182146 |
12/03/2018 |
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set |
Sol-Millennium Medical, Inc. |
James Barley |
| K180653 |
12/04/2018 |
Spartan eCoil System |
Spartan Micro, Inc |
Mark Dias |
| K182584 |
12/10/2018 |
Lucent« XP |
Spinal Elements Inc |
Cheryl Allen |
| K182954 |
12/12/2018 |
SalvoÖ Spine System |
Spine Wave, Inc. |
Amy Noccioli |
| K181865 |
12/14/2018 |
Acu-sInQ Complete Endoscope Cleaning Aid System |
STERIS Corporation |
Gregory Land |
| K182724 |
12/10/2018 |
CelerityTM 10 STEAM Chemical Indicator |
STERIS Corporation |
Eileen McCafferty |
| K182359 |
12/13/2018 |
HipCheck |
Stryker Corp. |
Cara Mellits |
| K181752 |
12/21/2018 |
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) |
Stryker Corporation |
Kristi Ashton |
| K182438 |
12/06/2018 |
Synthetic Polyisoprene Lubricated Male Condom - 5 senses |
Sxwell Usa LLC |
Robert Mahler |
| K180821 |
12/21/2018 |
TruMatch Graft Cage - Long Bone |
Synthes (USA) LLC |
Christopher J. Medberry |
| K181675 |
12/10/2018 |
FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System |
TaiDoc Technology Corporation |
Yvette Chang |
| K180863 |
12/19/2018 |
FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator |
TaiDoc Technology Corporation |
Sylvia Liu |
| K182491 |
12/10/2018 |
Applanation tonometer AT-2 |
Takagi Seiko Co., Ltd. |
Shinya Kitamura |
| K182506 |
12/10/2018 |
LipiScan Dynamic Meibomian Imager |
TearScience, Inc. |
Christy Coleman |
| K182736 |
12/28/2018 |
OIC Suture Anchor System |
The Orthopaedic Implant Company |
Douglas Fulton |
| DEN170072 |
12/20/2018 |
Enlight 1810 |
Timpel Inc. |
Rafael Holzhacker |
| K182682 |
12/21/2018 |
OrthoGold 100 |
Tissue Regeneration Technologies |
John Warlick |
| K182461 |
12/27/2018 |
LATITUDE EV Total Elbow Arthroplasty |
Tornier Inc. |
Renee Stoffel |
| K180889 |
12/07/2018 |
Tractus Crossing Support Catheter |
Tractus Vascular LLC |
Janet Burpee |
| K183098 |
12/06/2018 |
Senhance Surgical System |
TransEnterix, Inc. |
Michele Jans |
| K181612 |
12/17/2018 |
Tyto Stethoscope (OTC) |
Tyto Care Ltd. |
Stella Raizelman Perry |
| K183383 |
12/12/2018 |
ANAXÖ OCT Spinal System |
U & I Corporation |
Young Eun Lee |
| K181824 |
12/13/2018 |
CBT Screw Fixation System |
U&i Corporation |
Jee-Ae Bang |
| K183212 |
12/07/2018 |
Nexus DR Digital X-ray Imaging System with stitching |
Varex Imaging Corporation |
Michael Van Ryn |
| K180175 |
12/07/2018 |
SignalMark Lung Biopsy Site Marker |
ViewPoint Medical, Inc. |
Thomas Kane |
| K172965 |
12/17/2018 |
Handheld VitalSigns Monitoring System |
Visiomed Technology Co.,Ltd |
Chen XiaoFeng |
| K180204 |
12/28/2018 |
CranioMaxillofacial Fixation (CMF) System - CMF Visionare |
Visionare LLC |
Mariane de Oliveira Quinzani |
| K173140 |
12/19/2018 |
VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitorin |
VivaChek Laboratories, Inc. |
Julie Zhou |
| K181877 |
12/17/2018 |
Phoenix 2.4mm Atherectomy Plus System |
Volcano AtheroMed Inc. |
Jean Chang |
| K182972 |
12/20/2018 |
Phoenix Atherectomy System |
Volcano AtheroMed Inc. |
Jean Chang |
| K180533 |
12/10/2018 |
Procellera Composite Antibacterial Wound Dressing |
Vomaris Wound Care, Inc. |
Charmaine Sutton |
| K182038 |
12/10/2018 |
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer |
YD Diagnostics Corporation |
Hyuckjoo Lee |
| K181641 |
12/24/2018 |
QuikClot Radial |
Z-Medica, LLC |
Sheila K. Wallin |
| K181107 |
12/06/2018 |
Elevo« Kit Snoring Intervention Device |
Zelegent, Inc. |
David C. Humbert |
| K181827 |
12/14/2018 |
Affixus Natural Nail System Humeral Nail |
Zimmer GmbH |
Robert Tommasini |
| K182048 |
12/07/2018 |
Avenir Complete Hip System |
Zimmer, Inc |
Rebecca D Noftz |
| K181761 |
12/26/2018 |
Zimmer Biomet Select Ceramic Heads |
Zimmer, Inc |
Carol Vierling |
