| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K180289 |
07/10/2018 |
3D Bolus Software |
3D Bolus, Inc. |
Peter Hickey |
| K180629 |
07/19/2018 |
DentiqGuide |
3D Industrial Imaging Co., Ltd |
Jin Sa Kim |
| K180874 |
07/31/2018 |
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield |
3M Health Care |
Linda Johnsen |
| K180948 |
07/20/2018 |
TruDi NAV Suction Instruments |
Acclarent, Inc. |
Leena Sorathia |
| K180407 |
07/25/2018 |
Smartinhaler |
Adherium (NZ) Ltd |
Chris Mander |
| K173947 |
07/25/2018 |
Lumbar Interbody Fusion System (OLLIF) |
Advanced Research Medical, LLC |
John D Siegel |
| K181342 |
07/19/2018 |
JGH1 Bone Graft Substitute |
AgNovos Healthcare USA, LLC |
Felipe Aguel |
| K181585 |
07/20/2018 |
JGH1 Core Deccompression Procedure Kit |
AgNovos Healthcare USA, LLC |
Felipe Aguel |
| K173444 |
07/23/2018 |
Quantitative Total Extensible Imaging (QTxI) |
AIQ Solutions, Inc. |
Dona Alberti |
| K181453 |
07/25/2018 |
ATEC ALIF Spacer System |
Alphatec Spine, Inc. |
Cynthia Adams |
| K181339 |
07/24/2018 |
Altus Spine Pedicle Screw System |
Altus Partners, LLC |
Mark Melton |
| K173359 |
07/05/2018 |
Fractional CO2 Surgical Laser System |
AMI Inc. |
Hae Youn Lee |
| K172862 |
07/24/2018 |
Portable ECG Monitor (ECG3) |
Andon Health Co., Ltd. |
Liu Yi |
| K181044 |
07/05/2018 |
400um Perforator and Accessory Vein Ablation Kit |
AngioDynamics, Inc. |
Deepa R. Godhiya |
| K173762 |
07/18/2018 |
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters |
AngioDynamics, Inc. |
Teri Juckett |
| K173656 |
07/26/2018 |
Arthrex FibuLock Nail |
Arthrex, Inc. |
Rebecca R. Homan |
| K180784 |
07/18/2018 |
ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES |
ASAHI INTECC CO., LTD. |
Yasuyuki Kawahara |
| K173277 |
07/05/2018 |
ASAHI PTCA Guide Wire ASAHI SION black |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K180725 |
07/11/2018 |
Aspire Introducer Needle |
Aspire Bariatrics, Inc. |
Monica Ferrante |
| K181139 |
07/06/2018 |
OLYMPIC Posterior Spinal Fixation System |
Astura Medical, LLC |
Parker Kelch |
| K172543 |
07/11/2018 |
High-speed Turbine Handpieces for Single Use |
Beijing Dongbo Dental Handpiece Co., Ltd. |
Chengfei Yan |
| K172616 |
07/27/2018 |
Pulse Oximeter |
Beijing Safe Heart Technology Ltd. |
Xiaoming Yang |
| K173556 |
07/13/2018 |
Injection Screw |
Biedermann Medtech, Inc. |
Michelle Montesino |
| K173973 |
07/20/2018 |
TV-100 |
Bio-Med Devices, Inc. |
Ken Close |
| K181493 |
07/05/2018 |
FilmArray Blood Culture Identification (BCID) Panel |
BioFire Diagnostics, LLC |
Kristen J. Kanack |
| K181565 |
07/13/2018 |
Aquarius 8600 Digital Radiography Sensor |
Biokinemetrics Inc. |
Steven Kraus |
| K172971 |
07/08/2018 |
BMLS16-1 |
BioMedical Life Systems, Inc. |
Gary Bussett |
| K181092 |
07/06/2018 |
CHROMID CARBA agar (CARB) |
bioMerieux SA |
Asa Karlsson |
| K180936 |
07/03/2018 |
ETEST Telavancin (TLA) (0.002-32 ug/mL) |
bioMerieux SA |
Asa Karlsson |
| K181300 |
07/16/2018 |
Embosphere Microspheres |
Biosphere Medical, S.A. |
Alix Fonlladosa |
| K181554 |
07/27/2018 |
Stowe Pedicle Screw System |
Black Box Medical |
Todd Stanaford |
| K180864 |
07/20/2018 |
WATCHMAN TruSeal Access System |
Boston Scientific |
Nikki M Ibis |
| K173837 |
07/25/2018 |
RHYTHMIA HDx Mapping System (with software Version 2.0) |
Boston Scientific Corporation |
Gregory Neal |
| K171414 |
07/01/2018 |
qEEG-Pro |
Brainmaster Technologies, Inc. |
Tom Collura |
| K180269 |
07/17/2018 |
Cadwell Apollo System |
Cadwell Industries, Inc. |
Alison Hull |
| K181670 |
07/25/2018 |
Alphenix, INFX-8000V/B, V8.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K181834 |
07/19/2018 |
Ultimax-i, DREX-UI80 (V1.60) |
Canon Medical Systems Corporation |
Paul Biggins |
| K173487 |
07/18/2018 |
CarboClear« Pedicle Screw System |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K181287 |
07/12/2018 |
Catalyst CSR Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K170369 |
07/19/2018 |
Disposable Electrosurgical Pencils |
Cathay Manfacturing Corp. |
Ren Ren |
| K173274 |
07/10/2018 |
Ceevra Reveal 2.0 |
Ceevra, Inc. |
Russ Yoshinaka |
| K181736 |
07/30/2018 |
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, |
Centers for Disease Control and Prevention (CDC) |
Yon Yu |
| K180526 |
07/16/2018 |
EIDON FA |
CenterVue SpA |
Roberto Gabriotti |
| K180218 |
07/24/2018 |
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV |
Cepheid |
Yi-Ping Lin |
| K172273 |
07/30/2018 |
308nm Excimer System |
Chongqing Peninsula Medical Technology Co., Ltd. |
Zhang Sudi |
| K170820 |
07/18/2018 |
Capnograph and Oximeter |
CMI Health Inc. |
Jiacheng Ren |
| K181327 |
07/06/2018 |
InPen Dose Calculator |
Companion Medical, Inc. |
Jasper Benke |
| K180763 |
07/19/2018 |
CuffLink Implant System Biocomposite |
CONMED Corporation |
Diana L. Nader-Martone |
| K181276 |
07/12/2018 |
CONOD Enteral Feeding Sets |
Conod Medical Co., Limited |
Cheng Run |
| K173675 |
07/20/2018 |
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber |
ConvaTec Limited |
Justin Lovelace |
| K171272 |
07/17/2018 |
Cook-Swartz Doppler Flow Probe |
Cook Incorporated |
Tom Kardos |
| K181431 |
07/30/2018 |
Laser Ureteral Catheter |
Cook Incorporated |
Carly Powell |
| K180552 |
07/12/2018 |
Modified Novy Cornual Cannulation Set |
Cook Incorporated |
Naomi Funkhouser |
| K181712 |
07/26/2018 |
San Antonio Stopcock |
Cook Incorporated |
James O. Ebot Rnaw |
| K173654 |
07/17/2018 |
Ureteral Dilator Sets, Ureteral Dilators |
Cook Incorporated |
Kotei Aoki |
| K180868 |
07/06/2018 |
Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set |
Cook Ireland |
Jacinta Kilmartin |
| K180556 |
07/27/2018 |
Corelink Foundation 3D Anterior Lumbar System |
Corelink, LLC |
Steven D. Mounts |
| K180752 |
07/25/2018 |
Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole |
Corinth MedTech, Inc. |
Sandeep Saboo |
| K180915 |
07/17/2018 |
Sonicision Reusable Sterilization Tray |
Covidien |
Candice Bautista-Biddle |
| K180485 |
07/27/2018 |
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender |
Covidien, llc |
Carol Ming |
| K181261 |
07/09/2018 |
Curiteva Cervical Interbody Fusion System |
Curiteva, LLC |
Eric Linder |
| K172778 |
07/05/2018 |
CheckMyHeart Plus |
DailyCare Biomedical, Inc |
Ming Da Lee |
| K172991 |
07/10/2018 |
Advanced Dental Applicance |
DaSoft Partners |
Dante Togliatti |
| K181189 |
07/18/2018 |
ATLANTIS Conus Structure |
Dentsply Sirona |
Karl Nittinger |
| K181156 |
07/27/2018 |
Panther Fusion GBS Assay |
Diagenode |
Geraldine Poncin |
| K181398 |
07/23/2018 |
DV-300 Aspirator |
Ding Hwa Co., Ltd. |
Eric Han |
| K172440 |
07/13/2018 |
Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 |
Dongguan Prestige Sporting Goods., Ltd. |
Zhang Zhao |
| K181579 |
07/26/2018 |
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K |
E&E Optics Inc. |
Bonnie Wan |
| K181574 |
07/10/2018 |
Uscan |
EchoNous, Inc. |
Trish Liau |
| K181547 |
07/09/2018 |
FibroScan« Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) |
Echosens |
Karine Bonenfant |
| K181095 |
07/24/2018 |
RF-Relief |
EL Global Trade Ltd |
Martin Gurovich |
| K180627 |
07/27/2018 |
Macroduct Advanced Model 3710 |
ELITechGroup Inc. |
Stacey Pahulu |
| K180930 |
07/09/2018 |
EMPOWR VVC TIBIAL INSERT |
Encore Medical, L.P. |
Teffany Hutto |
| K181720 |
07/30/2018 |
Epiphany Cardio Server Mobile |
Epiphany Healthcare, LLC |
Pat White |
| K180910 |
07/02/2018 |
ULTRAPRO Mesh and ULTRAPRO ADVANCED |
Ethicon Inc |
Melina Escobar |
| K173019 |
07/06/2018 |
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar |
Ethicon Inc. |
Melina Escobar |
| K181268 |
07/26/2018 |
PROLENE (Polypropylene) 3D Patch |
Ethicon, Inc. |
Melina Escobar |
| K180755 |
07/06/2018 |
Vail ALIF Buttress Plate System |
Evolution Spine, LLC |
Douglas Davis |
| K180632 |
07/25/2018 |
Exactech Equinoxe Small Reverse Shoulder System |
Exactech Inc. |
Zach Sharrah |
| K180695 |
07/12/2018 |
FBC 921 (ALIF) |
FBC Device ApS |
Finn Bjarke Christensen |
| K180348 |
07/17/2018 |
Field Orthopaedics Micro Screw System |
Field Orthopaedics Pty. Ltd. |
Christopher Jeffery |
| K172952 |
07/03/2018 |
Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit |
Figaro Crowns, Inc. |
Kyle Rose |
| K173929 |
07/24/2018 |
CipherOx CRI M1 |
Flashback Technologies, Inc. |
Gregory Z. Grudic |
| K181763 |
07/27/2018 |
FUJIFILM Ultrasonic Endoscope |
FUJIFILM Corporation |
Randy Vader |
| K181741 |
07/30/2018 |
IceSphere 1.5 CX Cryoablation Needle |
Galil Medical Ltd. |
Stacey Backlund |
| K173645 |
07/23/2018 |
JASPER Spinal Fixation System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K181011 |
07/12/2018 |
AIM2 |
GC America Inc. |
Mark Heiss |
| K172987 |
07/13/2018 |
Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) |
GMAX Industries, Inc. |
Julia Huang |
| K180518 |
07/23/2018 |
GME LinScan Lite 808 Laser System |
GME German Medical Engineering GmbH |
Stefan Schulze |
| K181586 |
07/13/2018 |
Tinnitus Sound Generator Module |
GN Hearing A/S |
Lars Hagander |
| K181855 |
07/26/2018 |
RadialSeal Introducer Kit |
Greatbatch Medical |
Phyllis Piet-Hughes |
| K181019 |
07/16/2018 |
Diode Laser System |
Guangzhou Huafei Tongda Technology Co., Ltd. |
Liu Pengqi |
| K181790 |
07/26/2018 |
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup |
Hangzhou Clongene Biotech Co.,Ltd. |
Zheng Shujian |
| K181700 |
07/10/2018 |
HardyDisk AST Plazomicin 30ug (PLZ30) |
Hardy Diagnostics |
Anna Klavins |
| K173327 |
07/18/2018 |
DIP/U.S. Urine Analysis Test System |
Healthy.io Ltd |
Ron Zohar |
| K171888 |
07/23/2018 |
Non-contact infrared body thermometer |
Hetaida Technology Co., Ltd |
ZhenGuang Chen |
| K181376 |
07/18/2018 |
ARIETTA 65 |
Hitachi Healthcare Americas Corporation |
Doug Thistlethwaite |
| K173474 |
07/27/2018 |
RetiCapture |
Ilooda Co., Ltd. |
Yun-Jung Ha |
| K180263 |
07/20/2018 |
EcoFit Vit E Acetabular System |
implantcast Gmbh |
Juliane Hoeppner |
| K172389 |
07/18/2018 |
ePTFE-Coated Auricular Implant |
Implantech Associates Inc. |
Craig Arthur |
| K181694 |
07/27/2018 |
FlowTriever Retrieval/Aspiration System |
Inari Medical |
Eben Gordon |
| K181201 |
07/10/2018 |
Synermed ISE Reagents |
Infrared Laboratory Systems, LLC (dba Synermed) |
Julie Paschal |
| K181115 |
07/16/2018 |
CxHA PEEK Cervical IBF System |
Innovasis, Inc. |
Marshall McCarty |
| K181063 |
07/13/2018 |
KestrelÖ Buttress Plate System |
Innovasis, Inc. |
Marshall McCarty |
| K173562 |
07/09/2018 |
Straumann Jason Membrane |
Institut Straumann AG |
Christopher Klaczyk |
| K173968 |
07/17/2018 |
Straumann Variobase for Bridge/Bar Cylindrical |
Institut Straumann AG |
Gordon Dodds |
| K173721 |
07/05/2018 |
SureForm 60 and SureForm 60 Reloads |
Intuitive Surgical |
Nadine Nasr |
| K173585 |
07/19/2018 |
da Vinci Xi Surgical System, da Vinci X Surgical System |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K181395 |
07/27/2018 |
Universal Cannula Seal (5-12 mm) |
Intuitive Surgical, Inc. |
Cheryl Wu |
| K171880 |
07/13/2018 |
IRRAflow CNS System |
IRRAS Inc. |
Dessi Lyakov |
| K180515 |
07/06/2018 |
GammaTile |
Isoray Medical Inc. |
Bill Joy |
| K173808 |
07/27/2018 |
VoutiaÖ |
Jeffrey Ward Cash, DDS |
Jeffrey Ward Cash |
| K173340 |
07/13/2018 |
Yikang Latex Foley Catheter |
Jiangxi Yikang Medical Instrument Group Co., LTD. |
Nicholas Su |
| K180977 |
07/18/2018 |
KARL STORZ New Generation Trocars |
KARL STORZ Endoscopy-America, Inc. |
AnnaLisa Smullin |
| K181015 |
07/18/2018 |
Braun BFH175 Infrared Forehead Thermometer |
Kaz USA, Inc., A Helen of Troy Company |
Matt J. Baun |
| K181242 |
07/23/2018 |
Braun BNT400 No Touch + Forehead Thermometer |
Kaz USA, Inc., A Helen of Troy Company |
Matt J. Baun |
| K180970 |
07/10/2018 |
Disposable guides KDNG00 |
Koelis |
Pauline Nicole |
| K181600 |
07/16/2018 |
PathLoc-SI Joint Fusion System |
L&K BIOMED Co., Ltd. |
Jihyeon Seo |
| K180967 |
07/11/2018 |
Dental Diode Laser System |
Lazon Medical Laser Co., Ltd. |
Gen Cheng |
| K181708 |
07/31/2018 |
MTS Plazomicin 0.016-256 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K173970 |
07/06/2018 |
Materialise PKA Guide System |
Materialise NV |
Oliver Clemens |
| K173039 |
07/10/2018 |
TruMatch CMF Titanium 3D Printed Implant |
Materialise NV |
Lina Ramirez |
| K180151 |
07/16/2018 |
MC3 Jugular Dual Lumen Catheter |
MC3 Incorporated |
Adam Viitala |
| DEN170009 |
07/20/2018 |
Bonebridge |
MED-EL Elektromedizinische Geraete GmbH |
Elizabeth Gfoeller |
| K172095 |
07/24/2018 |
Autokeeper |
MedExel Co.,Ltd. |
Cha Dong Ik |
| K181175 |
07/05/2018 |
12F Tri-Flow Triple Lumen Catheter |
Medical Components Inc. (Dba Medcomp) |
Courtney Nix |
| K173969 |
07/11/2018 |
Medicalgorithmics Unified Cardiac Rehabilitation System |
Medicalgorithmics S.A. |
Marek Dziubinski |
| K173911 |
07/19/2018 |
Medline Burn and Wound Dressing |
Medline Industries, Inc. |
Bethany Benoit-DiMaria |
| K173276 |
07/02/2018 |
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP |
Medline Industries, Inc. |
Claire Pigman |
| K180816 |
07/11/2018 |
Ziehm RFD 3D Tracker |
Medtronic Navigation |
Nicole Zimmerman |
| K180022 |
07/20/2018 |
Athena Cervical Plate System |
Medyssey USA, Inc. |
Shawn Kim |
| K172857 |
07/19/2018 |
Latitud Hip Replacement System |
Meril Healthcare Pvt. Ltd. |
Bhavik Gondaliya |
| K181062 |
07/18/2018 |
Ultra Facial Toning System |
Micro Current Technology, Inc. |
David Suzuki |
| K180715 |
07/04/2018 |
React 68 Catheter |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K180705 |
07/04/2018 |
Riptide Aspiration System React 68 Catheter |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K180018 |
07/05/2018 |
Disposable Hot Biopsy Forceps |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K181499 |
07/06/2018 |
DRI Cocaine Metabolite Assay |
Microgenics Corporation |
Emily Chien |
| K173943 |
07/24/2018 |
Dental High-speed Handpiece and Accessories |
MicroP Technology (Taiwan), Inc. |
Ina Lin |
| K173776 |
07/06/2018 |
BIOLOX delta Option and Extra-long Heads |
MicroPort Orthopedics Inc. |
Allen Mamaril |
| K180798 |
07/09/2018 |
Prime Acetabular Cup System |
MicroPort Orthopedics Inc. |
Sarah Evonne Stroupe |
| K181399 |
07/24/2018 |
FIREFLY« Pedicle Screw Navigation Guide |
Mighty Oak Medical Inc. |
Mark A. Wylie |
| K181572 |
07/10/2018 |
Workflow Box |
Mirada Medical Ltd. |
Gwilym Owen |
| K181623 |
07/19/2018 |
Clarifi Imaging System |
Modulated Imaging, Inc. |
David Cuccia |
| DEN180008 |
07/31/2018 |
MolecuLight i:X |
MolecuLight Inc. |
Jeffrey K. Shapiro |
| K181017 |
07/20/2018 |
Free Testosterone AccuBind ELISA Test System |
Monobind Inc. |
Anthony Shatola |
| K161085 |
07/05/2018 |
Nitrile Patient Examination Powder Free Glove, Textured, Black |
MULTISAFE SDN. BHD. |
THUM TECK LAM |
| K173486 |
07/11/2018 |
NTU-USB Ultrasound USB Box |
National Taiwan University |
Pai-Chi Li |
| K173366 |
07/20/2018 |
NicoletOne |
Natus Neurology Incorporated |
Shane T. Sawall |
| K181178 |
07/24/2018 |
S-mini active Fixture |
Neobiotech Co., Ltd. |
Young-Ku Heo |
| K181025 |
07/24/2018 |
I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System |
Neuro Kinetics, Inc. |
Robin C. Ashmore |
| K173868 |
07/02/2018 |
Serenity Body Position Sensor, Serenity RIP Sensors |
Neurotronics, Inc. |
David Pezet |
| K181345 |
07/19/2018 |
Image Filing Software NAVIS-EX |
Nidek Co., Ltd |
Yoneji Mizuno |
| K173797 |
07/17/2018 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Adam Heroux |
| K181043 |
07/12/2018 |
StatStrip Glucose Hospital Meter System |
Nova Biomedical Corporation |
John Mchale |
| K173631 |
07/11/2018 |
Intelli-C |
NRT X-ray A/S |
Jan Malling |
| K180575 |
07/12/2018 |
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K181193 |
07/03/2018 |
PeriView FLEX |
Olympus Surgical Technologies America |
Mary Anne Patella |
| K181375 |
07/17/2018 |
Apex Femoral Nailing System |
OrthoXel |
Aisling O'Sullivan |
| K173881 |
07/11/2018 |
Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G |
Owen Mumford Ltd |
Darren Mansell |
| K180064 |
07/27/2018 |
OsteoFab Patient Specific Cranial Device |
Oxford Performance Materials, Inc. |
M. Beth Pashko |
| K180226 |
07/25/2018 |
TREND II Spinal Fixation System- STEP Series |
Paonan Biotech Co., Ltd. |
Vivi Tsai |
| K171011 |
07/18/2018 |
PENTAX Medical VIVIDEO ENT Videoscope Solution |
Pentax Medical |
James W. Monroe |
| K181522 |
07/09/2018 |
PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope |
PENTAX of America, Inc. |
William Goeller |
| K173679 |
07/03/2018 |
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes |
PENTAX of America, Inc. |
James W. Monroe |
| K180923 |
07/09/2018 |
Personal Lubricating Jelly |
Perrigo New York, Inc. |
Karen Dombrowski |
| K181556 |
07/13/2018 |
EliA M2 Immunoassay |
Phadia AB |
Carina Magnusson |
| K180017 |
07/24/2018 |
MX40 Release C.01 |
Philips Medical Systems |
Theresa Poole |
| K180534 |
07/16/2018 |
Philips IntelliVue GuardianSoftware |
Philips Medizin Systeme Boeblingen GmbH |
Michael Asmalsky |
| K181485 |
07/27/2018 |
EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
Kym Rupp |
| K181659 |
07/26/2018 |
Avologi ENEO |
Premier North America Inc. |
Yaniv Applicant |
| K180655 |
07/13/2018 |
Viking Lumbar Polyaxial Screw System |
Presidio Surgical |
Meredith Lee May |
| K180011 |
07/13/2018 |
Pulmonx Chartis Tablet Console |
Pulmonx Corporation |
Sherry Kim |
| K173188 |
07/20/2018 |
The Graft Natural Bone Substitute |
Purgo Biologics Inc. |
Hana Jung |
| K181697 |
07/11/2018 |
16ch Foot/ Ankle SPEEDER |
Quality Electrodynamics, LLC |
Eric Yeh |
| K181029 |
07/15/2018 |
Solana Bordetella Complete Assay |
Quidel Corporation |
Ronald H. Lollar |
| K180027 |
07/18/2018 |
ACCUSYTE 3D Fiducial Marker |
Radiation Products LLC |
John D Corbitt |
| K181452 |
07/27/2018 |
RCT800 |
Ray Co., Ltd. |
Changhwan Lee |
| K181706 |
07/26/2018 |
neuromate Gen III |
Renishaw Mayfield Sarl |
Stephane Vinot |
| K181495 |
07/25/2018 |
Republic Spine Dark Star Spinal System |
Republic Spine, L.L.C. |
James Doulgeris |
| K180272 |
07/26/2018 |
Saniclave 250 |
REVOLUTIONARY SCIENCE |
Isaac Erickson |
| K173927 |
07/06/2018 |
Elecsys BRAHMS PCT |
Roche Diagnostics |
Wes Gerbig |
| K180654 |
07/13/2018 |
PINXEL-RF system |
Rohrer Aesthetics, LLC |
Mark Rohrer |
| K180697 |
07/10/2018 |
Pseudo-Patient |
RTsafe, Inc. |
Dimitris Makris |
| K181030 |
07/17/2018 |
Rubicon Lumbar Interbody Fusion System |
Rubicon Spine, LLC |
Mike Boyer |
| K181401 |
07/26/2018 |
RxSight Insertion Device |
RxSight, Inc. |
Maureen O'Connell |
| K180960 |
07/25/2018 |
FIXIT / ComposiTCP Threaded Anchor System |
S.B.M. SAS Sciences for Bio Materials |
Anne Cospin-Latapie |
| K181626 |
07/20/2018 |
Digital Diagnostic Mobile X-ray System |
Samsung Electronics Co., Ltd. |
Chang Soeun |
| K181629 |
07/20/2018 |
GC85A |
Samsung Electronics Co., Ltd. |
Noh Jaesang |
| K181631 |
07/20/2018 |
GR40CW |
Samsung Electronics Co., Ltd. |
Noh Jaesang |
| K171550 |
07/13/2018 |
Sterile Latex Surgical Gloves, Powder Free |
Sanrea Healthcare Products Pvt Ltd |
Jose Paul M |
| K181079 |
07/18/2018 |
SeaSpine Regatta Lateral System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K173206 |
07/12/2018 |
SEKURE HbA1c Assay |
Sekisui Diagnostics PEI Inc. |
Penny White |
| K180367 |
07/03/2018 |
Ureterorenoscope System |
Shanghai AnQing Medical Instrument CO., Ltd. |
Lina FEI |
| K173766 |
07/08/2018 |
PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs |
Shen Wei USA Inc. |
Cheryl Reep |
| K172694 |
07/06/2018 |
Sterile Disposable Syringes |
Shenyang MasTech Medical Device Co., Ltd. |
Liu Han |
| K173801 |
07/11/2018 |
Transcranial Doppler Ultrasound System |
Shenzhen Delica Medical Equipment Co., Ltd. |
Zhenhua Xiao |
| K180419 |
07/19/2018 |
Ultrasonic Doppler (Model YM-2T8) |
Shenzhen IMDK Medical Technology Co., Ltd. |
Yuan Xia |
| K172874 |
07/12/2018 |
Infrared Thermometer |
Shenzhen Jiacom Technology Co., Ltd |
Luo Tianfeng |
| K180912 |
07/30/2018 |
TE7/TE5 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Yang Zhaohui |
| K180958 |
07/26/2018 |
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable |
Shockwave Medical, Inc. |
Cindy Morrow |
| K171274 |
07/12/2018 |
ADVIA Centaur High-Sensitivity Troponin I (TNIH) |
Siemens Healthcare Diagnostics Inc. |
Matthew Gee |
| K181002 |
07/16/2018 |
Atellica IM BRAHMS Procalcitonin (PCT) |
Siemens Healthcare Diagnostics Inc. |
Fatima Pacheco |
| K171566 |
07/19/2018 |
Atellica IM High-Sensitivity Troponin I (TNIH) |
Siemens Healthcare Diagnostics Inc. |
Matthew Gee |
| K173909 |
07/13/2018 |
Dimension Hemoglobin A1c Assay |
Siemens Healthcare Diagnostics Inc. |
Alan Haley |
| K181213 |
07/30/2018 |
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control |
Siemens Healthcare Diagnostics, Inc. |
Kira Gordon |
| K180963 |
07/11/2018 |
ROCCIA ALIF, ROCCIA TLIF |
Silony Medical GmbH |
Bircan Tasdelen |
| K181509 |
07/06/2018 |
Endorate Valve Sets |
Smartdata Suzhou Co., Ltd |
Cindy Ye |
| K181699 |
07/26/2018 |
Level 1 Convective Warmer |
Smiths Medical ASD, Inc. |
Donna M. Semlak |
| K181636 |
07/20/2018 |
Aurora |
Sodium Systems, LLC |
Brandon Bachler |
| K181440 |
07/30/2018 |
Proficient« Posterior Cervical Spine System |
Spine Wave, Inc. |
Amy Noccioli |
| K181350 |
07/06/2018 |
ASTRA-OCT Spine System |
SpineCraft LLC |
Ami Akallal-Asaad |
| K181422 |
07/31/2018 |
SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit |
SPR Therapeutics, Inc. |
Kathryn Stager |
| K181382 |
07/20/2018 |
GuardianTM Burr Hole Cover System |
St Jude Medical |
Rebecca Brunson |
| K181686 |
07/24/2018 |
CELERITY 20 Steam Biological Indicator |
STERIS Corporation |
Tony Piotrkowski |
| K181083 |
07/23/2018 |
Stryker All-PEEK Knotless Anchor System |
Stryker |
Katie Farraro |
| K181014 |
07/18/2018 |
Tritanium PL Cage |
Stryker Spine |
Travis Catania |
| K181134 |
07/13/2018 |
GòUòM HYDRAL Dry Mouth Oral Gel, GòUòM HYDRAL Dry Mouth Oral Rinse, GòUòM HYDRAL Dry Mouth Oral Spray |
Sunstar Americas Inc |
Liz Bastian |
| K180580 |
07/27/2018 |
Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices |
Surgical Instrument Service and Savings Inc |
Stephanie Boyle Mays |
| K173627 |
07/12/2018 |
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector |
Surgical Instrument Service and Savings Inc |
Stephanie Boyle Mays |
| K181523 |
07/11/2018 |
Syneron CO2RE System |
Syneron-Candela Corp |
Sharon Timberlake |
| K180544 |
07/24/2018 |
DePuy Synthes Static Staples |
Synthes (USA) Products, LLC |
Suchitra Basu |
| K173511 |
07/12/2018 |
ActiveCare TD-4121 Blood Glucose Monitoring System |
TaiDoc Technology Corporation |
Sheena Song |
| K180115 |
07/24/2018 |
TWBM Pump |
Taiwan Biomaterial Co., Ltd. |
Monoj Mon Kalita |
| K181184 |
07/27/2018 |
OIC Intramedullary Nail System |
The Orthopaedic Implant Company |
Douglas Fulton |
| K180613 |
07/12/2018 |
Estelite Universal Flow |
Tokuyama Dental Corporation |
Keith A. Barritt |
| K180590 |
07/06/2018 |
Tyber Medical PT Interbody Spacer System |
Tyber Medical, LLC |
Mark F Schenk |
| K180900 |
07/10/2018 |
LED Light Therapy Device |
Uvbiotek, LLC |
Dave Oberhelman |
| K173864 |
07/02/2018 |
Peekplus« Interbody Fusion Device |
Vallum Corporation |
Stephen Blinn |
| K181526 |
07/03/2018 |
XRpad2 4343 HWC-M Flat Panel Detector |
Varex Imaging Corporation |
Paul Sawicki |
| K181647 |
07/20/2018 |
Bandit guidewire |
Vascular Solutions, Inc. |
Becky Astrup |
| K173107 |
07/26/2018 |
Vios Central Station Monitor Software, Vios Central Server Software |
Vios Medical, Inc. |
Amit Patel |
| K180854 |
07/23/2018 |
Voyager Trajectory Array Guide (V-TAG) |
Voyager Therapeutics, Inc. |
Lynn E Bayless |
| K173829 |
07/18/2018 |
NeoLSD MSMS kit |
Wallac Oy, a subsidiary of PerkinElmer |
Kay A Taylor |
| K181016 |
07/16/2018 |
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System |
Welch Allyn, Inc. |
Megan Pellenz |
| K173659 |
07/06/2018 |
Howell D.A.S.H Extraction Balloon with Multiple Sizing |
Wilson-Cook Medical, Inc |
Tiffanny A. Thomas |
| K181272 |
07/31/2018 |
Picocare Family |
WON TECH Co., Ltd. |
Hyunsik Yoon |
| K180730 |
07/11/2018 |
INVISION Total Ankle Revision System |
Wright Medical Technology, Inc. |
Alayne Melancon |
| K180024 |
07/11/2018 |
SALVATION Midfoot Nail |
Wright Medical Technology, Inc. |
Alayne Melancon |
| K180314 |
07/11/2018 |
Infrared Thermometer |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
Xuecheng Zhao |
| K180673 |
07/13/2018 |
Normandy VBR System |
Zavation Medical Products LLC |
Frankie Cummins |
| K181244 |
07/10/2018 |
Zavation Cervical Plate System |
Zavation Medical Products LLC |
Matt Jones |
| K181246 |
07/10/2018 |
Zavation IBF System |
Zavation Medical Products LLC |
Matt Jones |
| K180076 |
07/27/2018 |
Ti 3Z Interbody System |
Zavation Medical Products, LLc |
Katie Motley |
| K172653 |
07/18/2018 |
Power Infuser |
ZOLL Medical Corporation |
Pooja Dalvi |
