| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K173940 |
05/15/2018 |
Astroid Planning App |
.decimal, LLC. |
Kevin Erhart |
| K180352 |
05/02/2018 |
7D Surgical System |
7D Surgical Inc. |
Daniel Ziskind |
| K180582 |
05/31/2018 |
Sternal Cable System |
A & E Medical Corporation |
Hollie Johnson |
| K180087 |
05/18/2018 |
A.M. Surgical Intramedullary Fixation Device |
A.M. Surgical, Inc |
Gavriel Feuer |
| K173294 |
05/18/2018 |
Magnesium |
Abbott Laboratories |
Kimberly Senseman |
| K180776 |
05/11/2018 |
Cytal Wound Particulate |
ACell, Inc. |
Andrea Artman |
| K180771 |
05/18/2018 |
Acro HCG Pregnancy Rapid Test |
ACRO Biotech, Inc. |
Joseph Fan |
| K181077 |
05/24/2018 |
ActiGraph CentrePoint Insight Watch |
ActiGraph |
Brian Bell |
| K180239 |
05/16/2018 |
Additive Orthopaedics Patient Specific 3D Printed Bone Segments |
Additive Orthopaedics, LLC |
Gregory Kowalczyk |
| K180742 |
05/17/2018 |
EnsoETM |
Advanced Cooling Therapy, Inc. d/b/a Attune Medical |
Erik Kulstad |
| K180464 |
05/31/2018 |
AEVUMED PHANTOM Suture Anchors |
Aevumed, Inc. |
Saif Khalil |
| K173653 |
05/02/2018 |
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit |
Alere Scarborough, Inc. |
Danielle A. Briggeman |
| K180296 |
05/07/2018 |
Afinion HbA1c Dx |
Alere Technologies AS |
Monica Vallestad |
| DEN170086 |
05/17/2018 |
TrueTear Intranasal Tear Neurostimulator |
Allergan |
Nooshin Azizi |
| K180480 |
05/31/2018 |
ATEC Universal Spacer System |
Alphatec Spine, Inc |
Jeremy Markovich |
| K172430 |
05/18/2018 |
ArgenIS Titanium Abutments |
Argen Corporation |
Paul Cascone |
| K180662 |
05/22/2018 |
Arthrex FastThread Interference Screw |
Arthrex Inc. |
Jessica L. Singelais |
| K180848 |
05/01/2018 |
AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches |
ArthroCare Corporation |
Shruthi Bhat |
| K173862 |
05/22/2018 |
Pantheris System |
Avinger, Inc. |
Thomas Lawson |
| K172412 |
05/01/2018 |
BacterioScan 216Dx System |
BacterioScan, Inc. |
Rhonda Soest |
| K173084 |
05/11/2018 |
Spectrum IQ Infusion System, Dose IQ Safety Software |
Baxter Healthcare Corporation |
Dhiraj Bizzul |
| K173913 |
05/04/2018 |
MEDRAD« Imaging Bulk Package Transfer Set |
Bayer U.S. LLC |
Leslie S. O'Nan |
| K180174 |
05/29/2018 |
Belun Ring |
Belun Technology Company Limited |
Leung Lap Wai Lydia |
| K173956 |
05/21/2018 |
Biowy PlCC Catheter |
Biowy Corporation |
Andre von Muller |
| K181042 |
05/17/2018 |
Ultra ICE Plus û PI 9 MHz Peripheral Imaging Catheter |
Boston Scientific Corporation |
Jennifer L. Foley |
| K180375 |
05/18/2018 |
The IQoolTM Warm System |
Brain Cool AB |
Martin Waleij |
| K181179 |
05/18/2018 |
BrainScope One |
BrainScope Company Inc. |
Michael E Singer |
| K173540 |
05/03/2018 |
Brainsway Deep (DTMS) System |
Brainsway Ltd. |
Ahava Stein |
| K172209 |
05/18/2018 |
AURA ICP MONITORING SYSTEM |
Branchpoint Technologies, INC. |
Nicholas Hu |
| K172717 |
05/25/2018 |
Automatic Tissue Processing Unit |
BSL Co. |
Jun Suk Lee |
| K172614 |
05/04/2018 |
Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medic |
Caldera Medical, Inc. |
Vicki Gail |
| K180162 |
05/03/2018 |
VivaScope System |
Caliber Imaging & Diagnostics, Inc. |
Joel Radford |
| K181150 |
05/25/2018 |
ProtekDuo Mini Veno-Venous Cannula Set |
CardiacAssist Inc |
Greg Johnson |
| K171007 |
05/03/2018 |
Fluorescence Mode |
Carl Zeiss Suzhou Co., Ltd. |
Huang XiaoDong |
| K180003 |
05/10/2018 |
FORE-SIGHT ELITE Module Tissue Oximeter |
CAS Medical Systems, Inc. |
Ron Jeffrey |
| K180293 |
05/30/2018 |
Retia 2 |
CenterVue SpA |
Roberto Gabriotti |
| K173347 |
05/08/2018 |
STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX |
Centinel Spine, Inc. |
Jessica Staub |
| K181080 |
05/24/2018 |
McKesson Cardiology |
Change Healthcare Israel Ltd. |
Nadia Marchant |
| K180519 |
05/16/2018 |
HARRIER-SAÖ Lumbar Interbody System |
Choice Spine, LP |
Kim Finch |
| K180799 |
05/14/2018 |
Clarius Ultrasound Scanner |
Clarius Mobile Health Corp. |
Brendan Seward |
| K180476 |
05/15/2018 |
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Chan Yew Men |
| K180906 |
05/16/2018 |
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System |
Conformis, Inc. |
Emmanuel Nyakako |
| K180028 |
05/02/2018 |
Cook 810 Set, Desilets-Hoffman Introducer Set |
Cook Incorporated |
Carly Powell |
| K173035 |
05/01/2018 |
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets |
Cook Incorporated |
Erum B. Nasir |
| K172980 |
05/03/2018 |
Micropuncture Pedal Access Set |
Cook Incorporated |
Daniel J Corbin |
| K180756 |
05/24/2018 |
Safety Wire Guide Introducer |
COOK Incorporated |
Carly Powell |
| K180034 |
05/07/2018 |
Weinmann Tracheostomy Exchange Set |
Cook Incorporated |
Paul Meyer |
| K180727 |
05/11/2018 |
LineUp |
CurveBeam, LLC |
Stuti Singh |
| K180891 |
05/04/2018 |
EVOL Spinal Interbody System, EVOS Lumbar Interbody System |
Cutting Edge Spine, LLC |
Kyle Kuntz |
| K181122 |
05/31/2018 |
CARDIOSAVE Intra-Aortic Balloon Pump |
Datascope Corp. |
Hemang Kotecha |
| K172640 |
05/14/2018 |
Dentium Implantium & SuperLine Prosthetics |
Dentium Co., Ltd. |
Sangpil Yoon |
| K181024 |
05/23/2018 |
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips |
DFI Co., Ltd. |
Bella Cho |
| K180932 |
05/09/2018 |
Diamond Orthopedic Bone Fixation Screws and Pins |
Diamond Orthopedic, LLC |
Roy Bivens |
| K171505 |
05/17/2018 |
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) |
Dimesol, Inc. |
Stephen P. Callaghan |
| K172656 |
05/01/2018 |
BiliLux |
Draeger Medical Systems, Inc. |
Gale Winarsky |
| K173861 |
05/02/2018 |
Drug Relief |
DyAnsys, Inc. |
San Mateo |
| K171577 |
05/03/2018 |
Smartcord, Smartcord X |
EASTDENT Co., Ltd |
Hyonsu Kim |
| K180862 |
05/24/2018 |
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System |
Edan Instruments, Inc |
Alice Yang |
| K180961 |
05/10/2018 |
RadiForce MX194 |
EIZO Corporation |
Hiroaki Hashimoto |
| K180524 |
05/18/2018 |
EEG-Now |
EncephaloDynamics, Inc. |
J. Chris Sackellares |
| K180197 |
05/21/2018 |
Erchonia FX-635 |
Erchonia Corporation |
Steven Shanks |
| K180031 |
05/07/2018 |
Endopath Electrosurgery Probe Plus II |
Ethicon Endo-Surgery, LLC |
Carmen Ortiz |
| K180403 |
05/23/2018 |
ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length |
Ethicon Endo-Surgery, LLC |
Sigfrido Delgado |
| K172582 |
05/24/2018 |
EUROIMMUN IFA Granulocyte MosaicÖ EUROPattern and EUROIMMUN EUROPLUS Granulocyte MosaicÖ EUROPattern |
Euroimmun US, Inc. |
Michael A. Locke |
| K181067 |
05/23/2018 |
AlignX Ankle Fusion System |
Extremity Medical, LLC |
Brian Smekal |
| K180808 |
05/22/2018 |
Omni Foot Plating System |
Extremity Medical, LLC |
Brian Smekal |
| K173309 |
05/09/2018 |
Faxitron VisionCT |
Faxitron Bioptics Llc |
Douglas C. Wiegman |
| K172661 |
05/08/2018 |
Fetzer Medical Gynecological Forceps |
Fetzer Medical GmbH & Co. KG |
Harald Jung |
| K180513 |
05/15/2018 |
CustomizedBone Service |
Fin-Ceramica Faenza S.p.A |
Marina Monticelli |
| K181059 |
05/23/2018 |
geko T-3 Neuromuscular Stimulator |
Firstkind Limited |
Neil Buckley |
| K170663 |
05/11/2018 |
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer |
Foremount Enterprise Co., Ltd. |
John Yang |
| K172570 |
05/11/2018 |
ALGS6 Ag Alginate Wound Dressing |
Foshan United Medical Technologies, Ltd. |
Una Chen |
| K173972 |
05/10/2018 |
2008T BlueStar Hemodialysis Machine |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K181108 |
05/24/2018 |
Fresenius Liberty Select Cycler |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K173718 |
05/01/2018 |
Liberty Cycler Set |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K173593 |
05/21/2018 |
stayòsafe catheter extension set with Safe-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 6 inch, stayòsafe catheter extension set with Luer-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 18 inch, stayòsafe to Luer-Lock a |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K180711 |
05/25/2018 |
FUJIFILM Endoscopic CO2 Regulator GW-100 |
FUJIFILM Corporation |
Randy Vader |
| K180414 |
05/24/2018 |
EPX-4440FN Digital Video Processor with Light Source |
FUJIFILM New Development U.S.A., Inc. |
Stephen Mariano |
| K173684 |
05/04/2018 |
g.Estim PRO |
g.tec medical engineering GmbH |
Christoph Guger |
| K181153 |
05/15/2018 |
ICEfx Cryoablation System |
Galil Medical Inc. |
Rachel Owens |
| K180641 |
05/04/2018 |
Invenia ABUS Viewer |
GE Healthcare |
Bryan Behn |
| K173576 |
05/14/2018 |
Pristina Serena |
GE Healthcare |
Gregory Pessato |
| K180599 |
05/02/2018 |
Venue |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Tracey Ortiz |
| K173395 |
05/21/2018 |
MECALL CLISIS SYSTEMS, Discovery RF180 |
General Medical Merate S.P.A |
Luca Bianchessi |
| K180817 |
05/21/2018 |
AERIALÖ Interspinous Fixation |
Globus Medical Inc. |
Kelly J. Baker |
| K173722 |
05/23/2018 |
PATRIOT COLONIAL Spacer, SUSTAIN Spacer |
Globus Medical Inc. |
Kelly Baker |
| K172867 |
05/10/2018 |
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange |
GMP MEDICARE SDN BHD (F25) |
Noraini Raus |
| K180264 |
05/02/2018 |
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit |
Gold Standard Diagnostics |
Napoleon Monce |
| K173157 |
05/29/2018 |
Dr's Light2 |
Good Doctors Co.,Ltd. |
Sungro Joo |
| K180287 |
05/11/2018 |
GSI Corti |
Grason-Stadler Inc. |
Amy Yanta |
| K180545 |
05/21/2018 |
VACUETTE SAFELINK Holder with male luer lock |
Greiner Bio-One NA Inc. |
Manfred Abel |
| K180360 |
05/10/2018 |
OKTAGON Implant System |
Hager & Meisinger GmbH |
Adam Tomczak |
| K172871 |
05/29/2018 |
SpineKure Kyphoplasty System |
Hanchang Co., Ltd. |
An Kwon Ho |
| K172729 |
05/21/2018 |
Polypectomy Snare |
Hangzhou AGS MedTech CO., Ltd |
Chunqi Han |
| K172719 |
05/11/2018 |
HealthBeacon HB2 Sharps Bin |
HealthBeacon Ltd |
Joyce Power |
| K180385 |
05/11/2018 |
Infrared Body Thermometer |
HeTaiDa Technology Co., Ltd. |
Tom Chen |
| K180079 |
05/07/2018 |
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation |
Hill-Rom Inc. |
Sarah Marie Fitzgerald |
| K180527 |
05/16/2018 |
IS3 |
Hiossen, Inc. |
David Kim |
| K180901 |
05/16/2018 |
Low Dose CT Lung Cancer Screening Option |
Hitachi Healthcare Americas |
Doug Thistlethwaite |
| K173901 |
05/08/2018 |
MyoSure MANUAL Tissue Removal Device |
Hologic, Inc. |
Anne-Marie Keefe |
| K180279 |
05/09/2018 |
Silk'n MODEL H5003 device |
Home Skinovations Ltd. |
Amit Goren |
| K172554 |
05/01/2018 |
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing |
Huizhou Foryou Medical Devices Co., Ltd. |
Huida Huang |
| K172480 |
05/17/2018 |
icotec Interbody Cage System |
icotec ag |
Valeria Consiero |
| K172690 |
05/31/2018 |
ToFscan |
Idmed |
FrΘdΘric BERNERT |
| DEN180005 |
05/24/2018 |
OsteoDetect |
Imagen Technologies, Inc. |
Alex Dresner |
| K180466 |
05/17/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical, Inc. |
Eben Gordon |
| K173906 |
05/31/2018 |
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories |
Intuitive Surgical, Inc. |
Elaine Lee |
| K173415 |
05/31/2018 |
EndoWrist 5mm Thoracic Grasper |
Intuitive Surgical, Inc. |
Gayle Perry |
| K173005 |
05/25/2018 |
SURECELL Gelling Fiber Wound Dressing |
Jiangsu Newvalue Medical Producst Co.,Ltd |
Julie Chen |
| K180259 |
05/18/2018 |
Sterile Hypodermic Needle for Single Use |
Jiangsu Shenli Medical Production Co., Ltd |
Tina Cai |
| K181188 |
05/30/2018 |
EVEREST Spinal System |
K2M Inc. |
Nancy Giezen |
| K173269 |
05/30/2018 |
KATOR Suture Anchor |
KATOR LLC |
Robert Hoy |
| K173572 |
05/09/2018 |
DSM Biomedical Calcium Phosphate Cement with Microspheres |
Kensey Nash Corporation dba DSM Biomedical |
Susan Pileggi |
| K180445 |
05/15/2018 |
reVive Light Therapy LED Ultrasonic Wrinkle System |
LED Technologies, Inc. |
Lloyd Nelson |
| K180071 |
05/03/2018 |
STYLO Interbody Fusion Device |
Legend Spine Technologies |
Gwendolyn DeBoer |
| K180642 |
05/10/2018 |
Pro-Link« Ti Stand-Alone Cervical Spacer System |
Life Spine Inc. |
Randy Lewis |
| K172271 |
05/04/2018 |
Trackit T4 EEG Amplifier |
Lifelines Ltd. |
Michael Hulin |
| K180886 |
05/18/2018 |
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K180663 |
05/18/2018 |
LaVid FMTS DIAGNOSTIC X-RAY SYSTEM |
LIVERMORETECH Inc. |
Jae Hong Kim |
| K173405 |
05/22/2018 |
DiLumen Endolumenal Interventional Scissors (DiLumen Is) |
Lumendi, LLC |
Dennis Daniels |
| K180313 |
05/04/2018 |
Apollo TMS Therapy System |
Mag & More GmbH |
Kerstin Haringer |
| K180270 |
05/22/2018 |
Cellvizio 100 Series Systems with Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K172864 |
05/02/2018 |
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
Maxter Glove Manufacturing Sdn Bhd |
Yap Peak Geeh |
| K173510 |
05/08/2018 |
BioStamp nPoint |
MC10 Inc. |
Rakesh Lal |
| K172145 |
05/09/2018 |
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion û 120 days, Invia Motion û 60 days, Invia Motion û 30 days, Invia Motion û 15 days, Invia Motion û 7 days), Invia Liberty Negati |
Medela AG |
Georges Hakim |
| K173667 |
05/17/2018 |
15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodia |
Medical Components, Inc. (Dba Medcomp) |
Courtney Nix |
| K173360 |
05/17/2018 |
Athena 190 |
Medical Rehab Products, LLC |
Brad Evans |
| K180101 |
05/10/2018 |
HEALIX ADVANCE KNOTLESS BR Anchor |
Medos International SARL |
Ashley Goncalo |
| K181132 |
05/29/2018 |
Tri-Ad 2.0 Adams Tricuspid Band |
Medtronic |
Tracy Gray |
| K181001 |
05/03/2018 |
Medtronic Confida Brecker Guidewire |
Medtronic Core Valve, LLC. |
Gerardine Drummond |
| K180700 |
05/18/2018 |
KYPHON HV-R Bone Cement |
Medtronic Sofamor Danek USA, Inc. |
Laveeda Leflore |
| K181111 |
05/17/2018 |
Navigated INFINITY Instruments |
Medtronic Sofamor Danek USA, Inc. |
Tejas Patel |
| K180819 |
05/16/2018 |
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens |
Menicon Co., Ltd. |
Kenichi Tanaka |
| K181023 |
05/17/2018 |
Mozec û Rx PTCA Balloon Dilatation Catheter, Mozec NC û Rx PTCA Balloon Dilatation Catheter |
Meril Life Sciences Private Limited |
Utpal Thakor |
| K171449 |
05/15/2018 |
Metacem |
Meta Biomed Co., Ltd |
Suk Song Oh |
| K172813 |
05/18/2018 |
Esophageal Stent System |
Micro-Tech (Nanjing) Co.,Ltd. |
Becky Li |
| K180317 |
05/04/2018 |
EVOLUTION« Knee Systems û MR Labeling, EVOLUTION« BIOFOAM« Tibial System, EVOLUTION« Revision Tibial System, EVOLUTION« Revision CCK System |
MicroPort Orthopedics, Inc. |
Grace Johnson-Bann |
| K173931 |
05/17/2018 |
MindMotion(TM) GO |
MindMaze SA |
Sylvian Bourriquet |
| K170703 |
05/31/2018 |
Single Use Arthroscopic Electrode (with Pencil) |
Modern Medical Equipment Manufacturing Limited |
Jerry Cheung |
| K173279 |
05/14/2018 |
RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder |
MYCO Medical Supplies, Inc. |
Sanjiv Kumar |
| K173938 |
05/24/2018 |
IS-III HActive Fixture |
Neobiotech Co., Ltd. |
Young-Ko Heo |
| K180455 |
05/22/2018 |
NeuralBot |
Neural Analytics, Inc. |
Javad Seyedzadeh |
| K173452 |
05/09/2018 |
EmboTrap ll Revascularization Device |
Neuravi Ltd. |
Mairsil Claffey |
| K180908 |
05/18/2018 |
Irrigation Tubing Bipolar Cord Set |
New Deantronics Taiwan Ltd |
Jane Liu |
| K172625 |
05/11/2018 |
Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor |
Nonin Medical Inc. |
Kim E. Aves |
| K173892 |
05/04/2018 |
NuVasive« XLX Interbody System |
NuVasive, Incorporated |
Cynthia Adams |
| K172555 |
05/01/2018 |
SAPPHIRE, ELEVARE SAPPHIRE |
Omm Imports, Inc. d/b/a Zero Gravity |
Zivan Habibi |
| K171828 |
05/31/2018 |
ETCO2 Sensor |
Orantech Inc. |
Yunxi Xiong |
| K173874 |
05/04/2018 |
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO |
Origami Surgical LLC |
John Gillespie |
| K180740 |
05/04/2018 |
VitriGuard |
ORIGIO a/s |
Roaida Johnson |
| K173951 |
05/30/2018 |
Legend Acetabular Liners |
Ortho Development Corporation |
Drew Weaver |
| K180624 |
05/15/2018 |
Guided Growth Plate System Plus |
Orthofix Srl |
Gianluca Ricadona |
| K172583 |
05/10/2018 |
OrthoPediatrics PediNail Intramedullary Platform |
OrthoPediatrics, Inc. |
Adam Cargill |
| K173391 |
05/10/2018 |
OsteoMed QuickFix Hybrid MMF Sterilization Tray |
OsteoMed LLC |
Jessica M. Ruperto |
| K172777 |
05/03/2018 |
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 |
PAJUNK GmbH Medizintechnologie |
Christian G. H. Quass |
| K173012 |
05/10/2018 |
ANGIO-PRESS LITE DVT Compression Device |
Pegasus Medical Supply, Inc. |
Pao-Ming Shih |
| K180939 |
05/03/2018 |
Indigo Aspiration System - Modified 110 Aspiration Tubing |
Penumbra, Inc. |
Richard Kimura |
| K180412 |
05/15/2018 |
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister |
Penumbra, Inc. |
Richard Kimura |
| K172959 |
05/01/2018 |
PeraServer and PeraTrend |
PeraHealth, Inc. |
Joseph Beals |
| K181177 |
05/31/2018 |
Interventional Workspot |
Philips Medical Systems Nederland BV |
Chandrika Srinivasan |
| K180019 |
05/03/2018 |
CAAS Workstation |
Pie Medical Imaging BV |
Annemiek Bouts |
| K180976 |
05/24/2018 |
PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels |
Pixxgen Corporation |
John Ross |
| K180167 |
05/30/2018 |
Playtex Stella Tampons |
Playtex Manufacturing, Inc. |
Ludjane Fiorillo |
| K172568 |
05/04/2018 |
Cervage |
PRECIFIT MEDICAL LTD |
Zhen Yu (Eric) Wu |
| K173807 |
05/02/2018 |
Accu O2 Oxygen Analyzer |
Precision Medical Inc. |
James Parker |
| K180876 |
05/18/2018 |
DTRAX Spinal System |
Providence Medical Technology, Inc. |
Edward Liou |
| K180111 |
05/25/2018 |
ClearGuard HD Antimicrobial Barrier Cap |
Pursuit Vascular, Inc. |
Douglas Killion |
| K180157 |
05/04/2018 |
QT ECG |
QT Medical, Inc. |
Ruey-Kang Chang |
| K180922 |
05/08/2018 |
Empower H100, Cyber Ho 100, Litho 100 |
quanta system spa |
Francesco Dell'Antonio |
| K180687 |
05/15/2018 |
Reliance Lumber IBF System |
Reliance Medical Systems |
Bret M Berry |
| K180051 |
05/18/2018 |
XSTAT 30, 1-Pack |
RevMedx, Inc. |
Amy K. Pointer |
| K180625 |
05/10/2018 |
Rondek PGA Suture (Beige or Violet) |
RK Manufacturing Corporation |
Joshua Hubbard |
| K180609 |
05/23/2018 |
Rodo Smilekey |
Rodo Medical, Inc. |
Michael Parsons |
| K180201 |
05/23/2018 |
Route 92 Medical Access System |
Route 92 Medical, Inc. |
Kirsten Valley |
| K180543 |
05/24/2018 |
GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 |
Samsung Electronics Co.,Ltd. |
Jaesang Noh |
| K180409 |
05/11/2018 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co, Ltd. |
Ji Yea Lee |
| K180883 |
05/15/2018 |
5D Viewer |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K172137 |
05/03/2018 |
PIEZOTOME CUBE |
Satelec - Acteon Group |
Philippe Girard |
| K180356 |
05/25/2018 |
inui In-Home Urine Analysis Test System |
Scanadu, Inc. |
Daya Ranamukhaarachchi |
| K180508 |
05/18/2018 |
JOULE SYSTEM |
Sciton, Inc. |
Jay M/ Patel |
| K180686 |
05/14/2018 |
SeaSpine Daytona Small Stature Spinal System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K172517 |
05/11/2018 |
SeaSpine Navigation System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K173108 |
05/18/2018 |
Smoklean |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K173202 |
05/09/2018 |
CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set |
Sekisui Medical Co., Ltd. |
Kazunori Saito |
| K180773 |
05/22/2018 |
Reusable and Self-Adhesive Electrodes |
Shaoxing DongZhi Electrical Technology Co., Ltd. |
Haze XU |
| K180383 |
05/11/2018 |
Light based hair removal device |
Shenzhen GSD Tech Co., Ltd |
Ziyi Gui |
| K172894 |
05/17/2018 |
Infrared Thermometer |
Shenzhen Jiacom Technology Co ., Ltd |
Luo Tianfeng |
| K172889 |
05/25/2018 |
Infrared Thermometer |
Shenzhen Pacom Medical Instruments Co., Ltd. |
Liangzhou Zhong |
| K180461 |
05/09/2018 |
Navi e/Navi s/Navi X Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co., Ltd. |
Jiang Xiaosan |
| K172242 |
05/25/2018 |
DripAssist Plus |
Shift Labs, Inc. |
Beth Kolko |
| K181082 |
05/25/2018 |
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) |
Siemens Healthcare Diagnostics, Inc. |
Kathleen Dray-Lyons |
| K181098 |
05/31/2018 |
ACUSON SC2000 Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc |
Christine Dunbar |
| K180811 |
05/23/2018 |
Biograph Vision |
Siemens Medical Solutions USA, Inc. |
Alaine Medio |
| K172147 |
05/25/2018 |
STAR 65 |
Skanray Technologies Pvt Ltd |
Mahadevan J |
| K180361 |
05/30/2018 |
MICRORAPTOR REGENESORB Suture Anchor |
Smith and Nephew, Inc |
Katherine Marcaccio |
| K173912 |
05/08/2018 |
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 |
| K172592 |
05/17/2018 |
CADD Yellow High Volume Administration Set with NRFit connector |
Smiths Medical ASD, Inc. |
Michael R. Johnson |
| K180606 |
05/31/2018 |
SOMAVAC Device |
SOMAVAC Medical Solutions, Inc. |
Esra Roan |
| K173834 |
05/25/2018 |
Quantum Pump Console |
Spectrum Medical Ltd |
Mark Drain |
| K180220 |
05/21/2018 |
SAGICO OSI Spinal System by Osimplant |
Spinal Analytics & Geometrical Implant Co, LLC |
James J Gibson Jr. |
| K172484 |
05/08/2018 |
A-CIFT SoloFuse |
SpineFrontier, Inc. |
Vito Lore |
| K180796 |
05/02/2018 |
Spineology Navigation Instruments |
Spineology Inc. |
Jacqueline A. Hauge |
| K180807 |
05/24/2018 |
Celling Aspiration Needle |
SpineSmith Holdings, LLC |
Clifton (Chris) Naivar |
| K180437 |
05/04/2018 |
Hexanium« TLIF |
SpineVision, SAS |
Anaella Gallego |
| K180553 |
05/29/2018 |
VERIFY Spore Test Strip for S40 Sterilant |
Steris Corporation |
Marcia L. Benedict |
| K173946 |
05/02/2018 |
ADAPT for Gamma3 |
Stryker GmbH |
Nesli Karakaya |
| K173004 |
05/08/2018 |
SB Soft Hood - Straight type, SB Soft Hood - Undercut type |
Sumitomo Bakelite Co., Ltd |
Shiro Agehama |
| K173110 |
05/18/2018 |
GRAFTSITE |
Summit Medical Ltd. |
Robyn Cochrane |
| K180572 |
05/29/2018 |
AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 |
Supersonic Imagine |
Laurence Hermitte |
| K180937 |
05/10/2018 |
Graftgun Universal Graft Delivery System |
Surgentec, LLC |
Boca Raton |
| K170697 |
05/24/2018 |
GBR system |
SURGIDENT |
Duck-su Hur |
| K171019 |
05/30/2018 |
ScioCardio ECG Transmitter |
Synergen Technology Labs LLC |
Sunil Konda |
| K172708 |
05/24/2018 |
T2Bacteria Panel |
T2 Biosystems, Inc. |
Tom Lowery |
| K173345 |
05/04/2018 |
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System |
TaiDoc Technology Corporation |
Sheena Song |
| K162021 |
05/04/2018 |
3.0 Dynamic TiBase |
TALLADIUM ESPANA, SL |
ESTEBAN XAM-MAR |
| K180585 |
05/11/2018 |
Collagentex Rx-6 |
Tanses Technologies inc. |
Kirk Kiremitci |
| K173831 |
05/08/2018 |
Glidesheath Slender |
Terumo Medical Corporation |
Liang Lu |
| K180460 |
05/18/2018 |
Theradome LH40 |
Theradome, Inc. |
Tamim Hamid |
| K180402 |
05/25/2018 |
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar |
Topcon Medical Laser Systems, Inc. |
Sweta Srivastava |
| K180929 |
05/09/2018 |
Klassic HD« Hip System |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K180163 |
05/25/2018 |
TransEnterix Senhance Surgical System |
TransEnterix, Inc. |
Stephanie Fitts |
| K171690 |
05/08/2018 |
Trident Extremity Fixation System |
Trident Orthopedics |
Al Austin |
| K181136 |
05/24/2018 |
CS 9600 |
Trophy |
Marie-Pierre Labat-Camy |
| K172100 |
05/04/2018 |
URIS OMNI System |
TruAbutment Inc. |
Brandon Kim |
| K173825 |
05/02/2018 |
MC 300R* Nebulizer |
Trudell Medical International |
Marianne Tanton |
| K172191 |
05/09/2018 |
STERIZONE VP4 Sterilizer |
TSO3 Inc |
Alexandre Jokic |
| K172409 |
05/02/2018 |
Lite |
Tzora Active Systems Ltd. |
Adi Shemer |
| K172882 |
05/10/2018 |
UINCARE HOME |
UINCARE Corp. |
Youngbean You |
| K180623 |
05/04/2018 |
Ulthera System |
Ulthera, Inc |
Jessica Newhard |
| K180214 |
05/03/2018 |
Repris Bladder Injection System |
URO-1, Inc. |
Thomas Lawson |
| K181032 |
05/09/2018 |
Halcyon |
Varian Medical Systems Inc. |
Peter J. Coronado |
| K181145 |
05/18/2018 |
Eclipse Treatment Planning System |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K172675 |
05/16/2018 |
Varian Cervical Sleeves |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K180913 |
05/09/2018 |
VSI Micro-Introducer Kit |
Vascular Solutions, Inc. |
Jake Schultz |
| K172471 |
05/08/2018 |
VENTANA CD30 (Ber-H2) RxDx Assay |
Ventana Medical Systems, Inc. |
Jeffrey Catania |
| K173810 |
05/14/2018 |
Ventripoint Medical System Plus (VMS+) |
Ventripoint Diagnostics, Ltd. |
Desmond Hirson |
| K180217 |
05/18/2018 |
VESTEX Apparel |
Vestagen Protective Technologies, Inc. |
Scott Pease |
| K173300 |
05/01/2018 |
ViaTherm BOOST |
ViaTherm Therapeutics, Llc. |
Michael J. Thomas |
| K181003 |
05/15/2018 |
VIVIX-S 1717V |
Vieworks Co., Ltd. |
Jordin Kim |
| K173264 |
05/11/2018 |
EmbryoScope+ |
Vitrolife A/S |
Belinda Dueholm |
| K180386 |
05/08/2018 |
Meron Plus QM |
Voco GmbH |
M. Th. Plaumann |
| K173914 |
05/25/2018 |
VORTRAN Cuff Inflator (VCI) |
VORTRAN Medical Technology 1, Inc. |
James Lee |
| K173311 |
05/09/2018 |
ARTHRO-Pump PA304 |
W.O.M. World of Medicine GmbH |
Soeren Markworth |
| K172825 |
05/30/2018 |
MN-111 |
W&H Sterilization s.r.l. |
Marco Parolini |
| K173711 |
05/04/2018 |
Wallaby Avenir Coil System |
Wallaby Medical, Inc. |
Rebecca K. Pine |
| K173246 |
05/30/2018 |
ANEROID SPHYGMOMANOMETER |
Wenzhou Bokang Instruments Co., Ltd |
Youhua Xiang |
| K173431 |
05/18/2018 |
Towako Transmyometrial Embryo Transfer Set |
William A. Cook Australia PTY LTD |
Gordana Pozvek |
| DEN170015 |
05/07/2018 |
Hemospray Endoscopic Hemostat |
Wilson-Cook Medical, Inc |
Marge Walls-Walker |
| K172665 |
05/24/2018 |
Classic Cotton Cannulatome«, CannulaTome II« Double Lumen Sphincterotome, Cotton CannulaTome II« PC, UTS« Ultra Taper Sphincterotome, Tri-Tome pc« Triple Lumen Sphincterotome, Howell D.A.S.H.« Sphincterotome with DomeTip«, Billroth II Sphincterotome, Soeh |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
Theresa de Prat |
| K173832 |
05/17/2018 |
InTiceÖ-C Porous Ti Cervical Interbody System |
X-Spine Systems, Inc. |
Charlene Brumbaugh |
| K180986 |
05/15/2018 |
XableCath Support Catheter Product Family |
XableCath, Inc. |
Rick Gaykowski |
| K173483 |
05/30/2018 |
Pure Flow External Counter-Pulsation Device |
Xtreem Pulse, LLC |
Andrew Barile |
| K173758 |
05/14/2018 |
Disposable Biopsy Valve |
Zhejiang Chuangxiang Medical Technology Co., LTD. |
Lucius Long |
| K172524 |
05/17/2018 |
Zimmer Persona Personalized Knee System |
Zimmer, Inc. |
Nicole Meredith |
| K172510 |
05/11/2018 |
╡Cor Heart Failure and Arrhythmia Management System |
ZOLL Manufacturing Corporation |
Dawn Chang |
