| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K173940 |
12/26/2017 |
Astroid Planning App |
.decimal, LLC. |
Kevin Erhart |
| K173795 |
12/14/2017 |
HI-TORQUE TurnTrac Guide Wire Family |
Abbott Vascular |
Aniket Khakhadiya |
| K173947 |
12/27/2017 |
Lumbar Interbody Fusion System (OLLIF) |
Advanced Research Medical, LLC |
John D Siegel |
| 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 |
| 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 |
| K173749 |
12/08/2017 |
AMRA Profiler |
AMRA Medical AB |
Janne West |
| K173762 |
12/11/2017 |
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters |
AngioDynamics, Inc. |
Teri Juckett |
| K173788 |
12/14/2017 |
Arthrex Corkscrew FT |
Arthrex Inc. |
David L Rogers |
| K173845 |
12/19/2017 |
Arthrex SwiveLock |
Arthrex Inc. |
David L Rogers |
| K173900 |
12/22/2017 |
Arthrex Univers Revers Modular Glenoid System |
Arthrex Inc. |
Courtney Smith |
| K173964 |
12/29/2017 |
OVOMotion Shoulder Arthroplasty System |
Arthrosurface, Inc. |
Dawn J. Wilson |
| K173760 |
12/11/2017 |
Monarch Endoscopy Platform (Monarch Platform) |
Auris Surgical Robotics, Inc. |
Joy Sacmar |
| K173862 |
12/20/2017 |
Pantheris System |
Avinger, Inc. |
Thomas Lawson |
| K173867 |
12/20/2017 |
Axis Anterior Cervical Plate System |
Axis Orthopaedics |
Craig Wilcox |
| K173803 |
12/15/2017 |
Omnican fine |
B. Braun Medical Inc. |
Kimberly Smith |
| K173699 |
12/04/2017 |
The Pump by Babyation |
Babyation, LLC |
Jared Miller |
| 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 |
| 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 |
| K173973 |
12/29/2017 |
TV-100 |
Bio-Med Devices, Inc. |
Ken Close |
| 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 |
| 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 |
| K173910 |
12/22/2017 |
Impress SFS System |
Cable Fix Medical LLC |
Carey Bryant |
| K173800 |
12/14/2017 |
Camber Spine Technologies SPIRA - VÖ Open Matrix Corpectomy Cage |
Camber Spine Technologies |
Michael Black |
| 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 |
| 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 |
| 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 |
| K173848 |
12/19/2017 |
Model WP-3840 and WP-3040 |
CNMC Co., Inc. |
Thomas Kraus |
| K173893 |
12/21/2017 |
Trabis |
coLigne, AG |
Robert Lange |
| K173822 |
12/18/2017 |
Anchor Tissue Retrieval System by CONMED |
Conmed Corporation |
Rachelle D Fitzgerald |
| 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 |
| 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 |
| K173884 |
12/21/2017 |
Unity Total Knee System |
Corin USA Limited |
Lorraine Mander |
| K173806 |
12/15/2017 |
CorPath GRX System |
Corindus, Inc. |
Robert Lavado |
| 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 |
| K173960 |
12/28/2017 |
DePuy Corail AMT Hip Prosthesis |
DePuy France S.A.S. |
David Holzwarth |
| 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 |
| K173861 |
12/20/2017 |
Drug Relief |
DyAnsys, Inc. |
San Mateo |
| K173843 |
12/18/2017 |
illumiflow 148 Laser Cap |
EGlobal, LLC |
Wayne De Stefano |
| K173744 |
12/07/2017 |
ProFuse CAD |
Eigen |
William Mandel |
| 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 |
| K173793 |
12/14/2017 |
XactTrace Single Use Respiratory Effort Belt System |
Embla Systems |
Sanjay Mehta |
| K173783 |
12/13/2017 |
SCIg60 Infusion System |
EMED Technologies Corporation |
Peter Kollings |
| K173723 |
12/05/2017 |
EMPOWR Universal Tibial Baseplate |
Encore Medical, L.P. |
Teffany Hutto |
| K173937 |
12/26/2017 |
SpiroSphere |
eResearchTechnology GmbH |
Johannes Thalhammer |
| K173923 |
12/26/2017 |
Temporary Cardiac Pacing Wire |
Ethicon, Inc. |
Joice Pappan |
| 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 |
| K173916 |
12/22/2017 |
Finapres Nova Noninvasive Hemodynamic Monitor |
Finapres Medical Systems B.V. |
Iris van Uitert |
| K173770 |
12/11/2017 |
OJR215 Pressure Relief Manifold |
Fisher & Paykel Healthcare Limited |
Adele Bindon |
| K173929 |
12/26/2017 |
CipherOx CRI M1 |
Flashback Technologies, Inc. |
Gregory Z. Grudic |
| DEN170092 |
12/22/2017 |
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System |
Fluoptics |
Odelie Allard |
| 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 |
| K173684 |
12/01/2017 |
g.Estim PRO |
g.tec medical engineering GmbH |
Christoph Guger |
| K173816 |
12/15/2017 |
NM/CT 850, NM/CT 860 |
GE Healthcare |
George Mashour |
| K173830 |
12/18/2017 |
MAC VU360 Resting ECG Analysis System |
GE Medical Systems Information Technologies, Inc. |
Marcella Entwisle |
| K173885 |
12/21/2017 |
Genesys Spine Binary Lumbar Plate System |
Genesys Spine |
Brian J. Bergeron |
| K173982 |
12/29/2017 |
FORTIFY Corpectomy Spacers |
Globus Medical Inc. |
Lori Burns |
| 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 |
| 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 |
| 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 |
| K173919 |
12/22/2017 |
HX Device |
Human Extension Ltd. |
Dalit Doron |
| K173895 |
12/21/2017 |
Tel-O-Graph |
I.E.M. Industrielle Entwicklung and Medizintechnik |
Hella Witt |
| K173701 |
12/04/2017 |
Implant-One System |
Implant Logistics, Inc. |
Thomas Arendt |
| K173811 |
12/15/2017 |
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System |
In2Bones SAS |
Morgane Grenier |
| K173709 |
12/04/2017 |
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm |
InNeuroCo, Inc |
Marc Litzenberg |
| K173961 |
12/28/2017 |
Straumann BLX Implant System |
Institut Straumann AG |
Viviana Horhoiu |
| K173945 |
12/26/2017 |
Straumann SC Variobase Abutments |
Institut Straumann AG |
Christopher Klaczyk |
| K173968 |
12/29/2017 |
Straumann Variobase for Bridge/Bar Cylindrical |
Institut Straumann AG |
Gordon Dodds |
| 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 |
| K173965 |
12/29/2017 |
Implant Planning Software |
Inteware Co. Ltd. |
Wayne Tsai |
| 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 |
| K173920 |
12/22/2017 |
LS OIL |
J. Mortia USA, Inc. |
Keith A. Barritt |
| K173808 |
12/15/2017 |
VoutiaÖ |
Jeffrey Ward Cash, DDS |
Jeffrey Ward Cash |
| K173902 |
12/22/2017 |
Neodent Implant System û GM Line |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Julianne de Oliveira Capucho Lechechem |
| K173730 |
12/06/2017 |
Kinsa QuickCare Thermometer |
KINSA, Inc. |
David Gal |
| K173886 |
12/21/2017 |
CPRmeter 2 CPR Feedback Device |
Laerdal Medical AS |
Mari Kaada |
| K173926 |
12/26/2017 |
DORADOnova MR3T |
LAP GmbH Laser Applikationen |
Martin Pfabel |
| K173696 |
12/01/2017 |
TBL-ABI System |
LD Technology LLC |
Albert Maarek |
| K173883 |
12/21/2017 |
External Fixation System |
Life Spine Inc. |
Randy Lewis |
| K173827 |
12/18/2017 |
LightScalpel |
LightScalpel LLC |
David Walters |
| K173817 |
12/15/2017 |
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 ?g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K173700 |
12/04/2017 |
PICOPLUS Laser System |
Lutronic Corporation |
Jhung Won Vojir |
| 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 |
| K173976 |
12/29/2017 |
Masimo Acoustic Respiration Sensors, infant and neonate |
Masimo Corporation |
Karina Simpson |
| K173970 |
12/29/2017 |
Materialise PKA Guide System |
Materialise NV |
Oliver Clemens |
| 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 |
| 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 |
| 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 |
| 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 |
| K173855 |
12/20/2017 |
Sharpsite AC Rigid Endsocope |
Medtronic Xomed Inc. |
Shravan Chawla |
| K173750 |
12/08/2017 |
Prelude IDeal Hydrophilic Sheath Introducer |
Merit Medical Systems, Inc. |
David Thomas |
| K173963 |
12/28/2017 |
DRI Benzodiazepine Assay |
Microgenics Corporation |
Minoti Patel |
| K173943 |
12/26/2017 |
Dental High-speed Handpiece and Accessories |
MicroP Technology (Taiwan), Inc. |
Ina Lin |
| K173776 |
12/12/2017 |
BIOLOX delta Option and Extra-long Heads |
MicroPort Orthopedics Inc. |
Allen Mamaril |
| K173898 |
12/22/2017 |
MicroPort Orthopedics Total Hip Systems MR Labeling |
MicroPort Orthopedics Inc. (MPO) |
Usman Rashid |
| K173931 |
12/26/2017 |
MindMotion(TM) GO |
MindMaze SA |
Sylvian Bourriquet |
| K173765 |
12/11/2017 |
Surveyor Patient Monitor |
Mortara Instrument, Inc. |
Manisha Gokuli |
| K173856 |
12/20/2017 |
Express 4 Sleep appliance/CPAP Sidekick appliance |
Moses Appliances LLC |
Allen J. Moses |
| 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 |
| K173917 |
12/22/2017 |
neoClose PDS |
neoSurgical Ltd |
Orla Brennan |
| 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 |
| K173756 |
12/11/2017 |
Certus 140 2.45GHz Ablation System |
NeuWave Medical, Inc. |
Dan Kosednar |
| K173746 |
12/08/2017 |
Activmotion 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 |
| K173892 |
12/21/2017 |
NuVasive« XLX Interbody System |
NuVasive, Incorporated |
Cynthia Adams |
| DEN170091 |
12/22/2017 |
EyeBOX |
Oculogica, Inc. |
Rosina Samadani |
| 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 |
| K173881 |
12/21/2017 |
Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G |
Owen Mumford Ltd |
Darren Mansell |
| K173681 |
12/01/2017 |
reSET-O |
Pear Therapeutics, Inc. |
Yuri Maricich |
| 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 |
| K173944 |
12/26/2017 |
Endocular Viewing Lenses and Silicone Ring |
Phakos |
J. D. Webb |
| K173941 |
12/26/2017 |
IntelliSpace Perinatal Rev.K.00 |
Philips Medizin Systeme Boeblingen GmbH |
Christoph Krause |
| 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 |
| K173734 |
12/06/2017 |
RocaJJ Soft Stents |
Promepla SAM |
Alexandre Bareille |
| K173872 |
12/20/2017 |
FibriCheck |
Qompium nv |
Jo Van der Auwera |
| K173939 |
12/26/2017 |
Quantib Brain |
Quantib BV |
Floor van Leeuwen |
| K173716 |
12/05/2017 |
MPS2 Myocardial Protection System Console |
Quest Medical, Inc. |
Jan Hodges |
| K173691 |
12/01/2017 |
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack |
Quidel Corporation |
Jennifer S. Rial |
| 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 |
| K173974 |
12/29/2017 |
DROWZLE |
Resonea, Inc. |
Ruchir Sehra |
| K173927 |
12/26/2017 |
Elecsys BRAHMS PCT |
Roche Diagnostics |
Wes Gerbig |
| K173857 |
12/20/2017 |
Elecsys Tacrolimus |
Roche Diagnostics |
Khoa Tran |
| K173887 |
12/21/2017 |
cobas CT/NG for use on cobas 6800/8800 systems |
Roche Molecular Systems, Inc. |
Nobuko Nakajima |
| K173828 |
12/18/2017 |
GU60A & GU60A-65 |
Samsung Electronics Co.,Ltd. |
Noh Jaesang |
| K173713 |
12/04/2017 |
HS70A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K173743 |
12/07/2017 |
Greenmedi Safety Filter Syringe |
Sang-A Frontec Co., Ltd |
Park Sung-soon |
| K173882 |
12/21/2017 |
SeaSpine Mariner Pedicle Screw System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K173833 |
12/18/2017 |
CRP Vario |
SENTINEL CH. SpA |
Patricia Dupe |
| 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 |
| K173813 |
12/15/2017 |
IPL Hair Removal Device Joy Version |
Shen Zhen CosBeauty Co., Ltd |
Nicole Hu |
| 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 |
| K173824 |
12/18/2017 |
Humeral Short Stem System |
Shoulder Innovations Inc |
Don Running |
| K173909 |
12/22/2017 |
Dimension Hemoglobin A1c Assay |
Siemens Healthcare Diagnostics Inc. |
Alan Haley |
| K173957 |
12/28/2017 |
ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Sulgue Choi |
| 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 |
| K173747 |
12/08/2017 |
REXLENE |
SM ENG CO., LTD |
Soon-Gu Lee |
| K173779 |
12/12/2017 |
REXMONO, PDREX |
SM ENG CO., LTD |
Soon-Gu Lee |
| 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 |
| K173921 |
12/26/2017 |
HD-500 Video Endoscope System |
Sonoscape Medical Corp. |
Toki Wu |
| 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 |
| 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 |
| 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 |
| K173946 |
12/27/2017 |
ADAPT for Gamma3 |
Stryker GmbH |
Nesli Karakaya |
| K173849 |
12/19/2017 |
Triathlon Total Knee System |
Stryker Orthopaedics |
Margaret Crowe Klippel |
| 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 |
| K173871 |
12/20/2017 |
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres |
Suzhou Hengrui Callisyn Biomedical Co., Ltd. |
Xiao Chen |
| K173908 |
12/22/2017 |
DESS Dental Smart Solutions |
Terrats Medical SL |
Roger Terrats |
| 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 |
| K173821 |
12/18/2017 |
LungQ Software |
Thirona Corporation |
Eva van Rikxoort |
| 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 |
| K173694 |
12/01/2017 |
STERIZONE VP4 Sterilizer |
TSO3, Inc. |
Alexandre Jokci |
| K173879 |
12/21/2017 |
MiniMed Mio Advance infusion set |
Unomedical A/S |
Heidi Bjerre Lovkvist |
| K173864 |
12/20/2017 |
Peekplus« Interbody Fusion Device |
Vallum Corporation |
Stephen Blinn |
| 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 |
| 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 |
| 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 |
| 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 |
| K173832 |
12/18/2017 |
InTiceÖ-C Porous Ti Cervical Interbody System |
X-Spine Systems, Inc. |
Charlene Brumbaugh |
| K173933 |
12/26/2017 |
Sorrento Bioglass Bone Graft Substitute |
Xenco Medical, LLC |
gustavo Prado |
| K173847 |
12/19/2017 |
Disposable Ultra Reinforced Surgical Gown |
Xiantao Rayxin Medical Products Co., ltd. |
Liang Zhang |
| K173971 |
12/29/2017 |
K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent |
Yeti Dentalprodukte Gmbh |
Thomas Biskupski |
| 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 |
