| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K180289 |
02/01/2018 |
3D Bolus Software |
3D Bolus, Inc. |
Peter Hickey |
| K180404 |
02/14/2018 |
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System |
3M Health Care |
Lam Duong |
| K180352 |
02/08/2018 |
7D Surgical System |
7D Surgical Inc. |
Daniel Ziskind |
| K180504 |
02/26/2018 |
Mission Lipid Panel Monitoring System |
ACON Laboratories, Inc. |
Qiyi Xie |
| K180407 |
02/14/2018 |
Smartinhaler |
Adherium (NZ) Ltd |
Chris Mander |
| K180433 |
02/20/2018 |
ENNOVATE« |
Aesculap Implant Systems, LLC |
Melanie Burkert |
| K180321 |
02/05/2018 |
Aesculap Optilene Nonabsorbable Suture |
Aesculap, Inc. |
Kathy A. Racosky |
| K180464 |
02/21/2018 |
AEVUMED PHANTOM Suture Anchors |
Aevumed, Inc. |
Saif Khalil |
| K180398 |
02/13/2018 |
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K180296 |
02/02/2018 |
Afinion HbA1c Dx |
Alere Technologies AS |
Monica Vallestad |
| K180480 |
02/23/2018 |
ATEC Universal Spacer System |
Alphatec Spine, Inc |
Jeremy Markovich |
| K180305 |
02/02/2018 |
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) |
Aquilabs US LLC |
Juan Salcedo |
| K180427 |
02/16/2018 |
ARK Fentanyl Assay |
ARK Diagnostics, Inc. |
Cherry Mun |
| K180539 |
02/28/2018 |
Deformity Analysis and Correction Software (DACS) and Instrumentation |
Arrowhead Medical Device Technologies, LLC |
Thomas J. Twardzik |
| K180349 |
02/08/2018 |
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests |
Assure Tech (Hangzhou) Co., Ltd. |
Shisheng Ling |
| K180301 |
02/02/2018 |
AXIS 5.5 Lumbar Pedicle Screw System |
Axis Orthopaedics |
Craig Wilcox |
| K180319 |
02/05/2018 |
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution |
Bausch and Lomb Incorporated |
Melissa Thomas |
| K180438 |
02/20/2018 |
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit |
BD |
Brad Spring |
| K180493 |
02/26/2018 |
A3 Total Knee System |
Beijing AK Medical Co., Ltd. |
Aiguo Liu |
| K180417 |
02/15/2018 |
Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use |
BERPU MEDICAL TECHNOLOGY CO., LTD |
Jundong Tan |
| K180315 |
02/05/2018 |
DISKOM |
Biopsybell s.r.l. |
Tiziana Bellini |
| K180344 |
02/08/2018 |
TheraCal DC |
Bisco, Inc. |
Ryan Hobson |
| K180530 |
02/28/2018 |
Imager II Urology Torque Catheter |
Boston Scientific Corporation |
Daniel FitzDaniel |
| K180375 |
02/12/2018 |
The IQoolTM Warm System |
Brain Cool AB |
Martin Waleij |
| K180323 |
02/05/2018 |
Vitrea Software Package; VSTP-001A |
Canon Medical Systems Corporation |
Paul Biggins |
| K180475 |
02/22/2018 |
CapLOX II« / TowerLOX« MIS Pedicle Screw System |
Captiva Spine, Inc. |
Jackie Ferro |
| K180416 |
02/15/2018 |
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System |
Cardiovascular Systems Inc. |
Susan Wolf |
| K180526 |
02/27/2018 |
EIDON FA |
CenterVue SpA |
Roberto Gabriotti |
| K180293 |
02/01/2018 |
Retia 2 |
CenterVue SpA |
Roberto Gabriotti |
| K180531 |
02/28/2018 |
NovoStitch Pro Meniscal Repair System |
Ceterix Orthopaedics, Inc. |
Tarhan Kayihan |
| K180519 |
02/27/2018 |
HARRIER-SAÖ Lumbar Interbody System |
Choice Spine, LP |
Kim Finch |
| K180476 |
02/22/2018 |
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Chan Yew Men |
| K180429 |
02/16/2018 |
Advincula Delineator Uterine Manipulator |
CooperSurgical, Inc. |
Roaida Johnson |
| K180517 |
02/27/2018 |
CorPath GRX System |
Corindus, Inc. |
Robert Lavado |
| K180496 |
02/26/2018 |
TruClear Elite Hysteroscope |
Covidien |
Gail Yaeker-Daunis |
| K180485 |
02/23/2018 |
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 |
| K180350 |
02/08/2018 |
Dornier Medilas H Solvo 35 Laser |
Dornier MedTech America |
John Hoffer |
| K180473 |
02/22/2018 |
ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR |
ECOTRON Co., Ltd |
Sang Bond Lee |
| K180408 |
02/14/2018 |
U60 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
Crystal Cai |
| K180538 |
02/28/2018 |
gammaCore Sapphire |
electroCore, LLC |
Mike Romaniw |
| K180406 |
02/14/2018 |
Ellipse Ydun |
Ellipse A/S |
Ole Kofod |
| K180524 |
02/27/2018 |
EEG-Now |
EncephaloDynamics, Inc. |
J. Chris Sackellares |
| K180403 |
02/14/2018 |
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 |
| K180348 |
02/08/2018 |
Field Orthopaedics Micro Screw System |
Field Orthopaedics Pty. Ltd. |
Christopher Jeffery |
| K180513 |
02/27/2018 |
CustomizedBone Service |
Fin-Ceramica Faenza S.p.A |
Marina Monticelli |
| K180341 |
02/07/2018 |
FUJIFILM 600 Series Endoscope EG-600WR v2 |
FUJIFILM Corporation |
Randy Vader |
| K180405 |
02/14/2018 |
FUJIFILM Endoscope Models EC-600HL and EC-600LS |
FUJIFILM Corporation |
Randy Vader |
| K180414 |
02/15/2018 |
EPX-4440FN Digital Video Processor with Light Source |
FUJIFILM New Development U.S.A., Inc. |
Stephen Mariano |
| K180535 |
02/28/2018 |
Voluson P6 and Voluson P8 |
GE Healthcare |
Bryan Behn |
| K180374 |
02/12/2018 |
Voluson S8/ Voluson S10/ Voluson S10 Expert |
GE Healthcare |
Bryan Behn |
| K180318 |
02/05/2018 |
PET Digital Gating |
GE Medical Systems, LLC |
Lee Bush |
| K180304 |
02/02/2018 |
Geri Embryo Incubator and Geri Dish |
Genea Biomedx Pty Ltd |
Kea Dent |
| K180518 |
02/27/2018 |
GME LinScan Lite 808 Laser System |
GME German Medical Engineering GmbH |
Stefan Schulze |
| K180287 |
02/01/2018 |
GSI Corti |
Grason-Stadler Inc. |
Amy Yanta |
| K180360 |
02/09/2018 |
OKTAGON Implant System |
Hager & Meisinger GmbH |
Adam Tomczak |
| K180505 |
02/26/2018 |
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) |
Hartalega Sdn. Bhd. |
Kuan Kam Hon |
| K180364 |
02/12/2018 |
HD LifeSciences Cervical IBFD System |
HD LifeSciences LLC |
John Sullivan |
| K180385 |
02/12/2018 |
Infrared Body Thermometer |
HeTaiDa Technology Co., Ltd. |
Tom Chen |
| K180527 |
02/28/2018 |
IS3 |
Hiossen, Inc. |
David Kim |
| K180326 |
02/06/2018 |
icobrain |
icometrix |
Dirk Smeets |
| K180522 |
02/27/2018 |
IGTFusion |
IGI Technologies |
Will Plishker |
| DEN180005 |
02/05/2018 |
OsteoDetect |
Imagen Technologies, Inc. |
Alex Dresner |
| K180377 |
02/12/2018 |
Fracture and Correction System |
In2Bones USA, LLC |
Rebecca Wahl |
| K180329 |
02/06/2018 |
ClotTriever Thrombectomy System |
Inari Medical |
Eben Gordon |
| K180466 |
02/21/2018 |
FlowTriever Catheter, 6-10 mm; FlowTreiver Catheter, 11-14 mm; FlowTreiver Catheter, 15-18 mm; Aspiration Guide Catheter; Retraction Aspirator |
Inari Medical |
Eben Gordon |
| K180486 |
02/23/2018 |
HemosIL Factor XII Deficient Plasma |
Instrumentation Laboratory Co. |
Carol Marble |
| K180351 |
02/08/2018 |
EndoWrist Mercury Bipolar Grasper |
Intuitive Surgical, Inc. |
Vishal Kanani |
| K180515 |
02/27/2018 |
GammaTile |
Isoray Medical Inc. |
Bill Joy |
| K180536 |
02/28/2018 |
Neodent Implant System û GM Line |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Julianne de Oliveira Capucho Lechechem |
| K180299 |
02/02/2018 |
ACUVUE OASYS (senofilcon A) with Photochromic Additive |
Johnson & Johnson Vision Care, Inc. |
Victoria Brennand |
| K180376 |
02/12/2018 |
K2M Patient Specific Rods |
K2M, Inc. |
Nancy Giezen |
| K180401 |
02/14/2018 |
TiWAVE-CÖ Porous Titanium Cervical Cage |
Kalitec Direct, LLC |
Scott Winn |
| K180320 |
02/05/2018 |
dpl IIa Panel |
LED Technologies, Inc. |
Lloyd Nelson |
| K180447 |
02/20/2018 |
reVive Light Therapy LED Cleansing System |
LED Technologies, Inc. |
Lloyd Nelson |
| K180445 |
02/20/2018 |
reVive Light Therapy LED Ultrasonic Wrinkle System |
LED Technologies, Inc. |
Lloyd Nelson |
| K180332 |
02/06/2018 |
17HK700G-W |
LG Electronics |
Jinhwan Jun |
| K180339 |
02/07/2018 |
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 ?g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K180330 |
02/06/2018 |
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K180313 |
02/05/2018 |
Apollo TMS Therapy System |
Mag & More GmbH |
Kerstin Haringer |
| K180307 |
02/02/2018 |
Mazor X |
Mazor Robotics Ltd. |
Shiran Conforti |
| K180308 |
02/02/2018 |
Prelude |
MedCom GmbH |
Johannes Messow |
| K180453 |
02/20/2018 |
Bio-Medicus Adult Cannulae and Introducer |
Medtronic Inc |
Huda Yusuf |
| K180456 |
02/20/2018 |
Bio-Medicus Adult Cannulae Kit |
Medtronic Inc. |
Huda Yusuf |
| K180450 |
02/20/2018 |
Corvocet Biopsy System |
Merit Medical Systems, Inc. |
Angela Brady |
| K180325 |
02/05/2018 |
Single Use MultiClip Device |
Micro-Tech (Nanjing) CO., Ltd |
Becky Li |
| K180317 |
02/05/2018 |
EVOLUTION« Knee Systems û MR Labeling, EVOLUTION« BIOFOAM« Tibial System, EVOLUTION« Revision Tibial System, EVOLUTION« Revision CCK System |
MicroPort Orthopedics, Inc. |
Grace Johnson-Bann |
| K180396 |
02/13/2018 |
miraDry System |
Miramar Labs, Inc. |
Cynthia Kada |
| K180393 |
02/13/2018 |
AIRO Computed Tomography (CT) X-ray System |
Mobius Imaging, LLC |
Norma LeMay |
| DEN180008 |
02/16/2018 |
MolecuLight i:X |
MolecuLight Inc. |
Jeffrey K. Shapiro |
| K180290 |
02/01/2018 |
Natus Brain Monitor Amplifier |
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
Sanjay Mehta |
| K180421 |
02/16/2018 |
Natus NeuroWorks |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Shane Sawall |
| K180455 |
02/20/2018 |
NeuralBot |
Neural Analytics, Inc. |
Javad Seyedzadeh |
| K180431 |
02/16/2018 |
Cortina [MAX] Lumbar Cage System |
NeuroStructures, Inc. |
Kathleen Wong |
| K180306 |
02/02/2018 |
Nexy |
Next Sight srl |
Arianna Dalla Ba |
| K180428 |
02/16/2018 |
Stat Profile Prime Plus Analyzer System |
Nova Biomedical Corporation |
Adam Heroux |
| K180503 |
02/26/2018 |
PRECICE STRYDE System |
NuVasive Specialized Orthopedics, Inc. |
Lance Justice |
| K180458 |
02/20/2018 |
FOCUS Pedicle Screw System |
Nvision Biomedical Technologies, LLC |
Diana Langham |
| K180449 |
02/20/2018 |
Single Use Aspiration Needle NA-U200H |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K180378 |
02/12/2018 |
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module |
Optomed Oy |
Jyri Leskela |
| K180459 |
02/20/2018 |
VERASENSE for Zimmer Biomet Persona |
OrthoSensor, Inc. |
Deborah Johnson |
| K180412 |
02/15/2018 |
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump Canister |
Penumbra, Inc. |
Richard Kimura |
| K180534 |
02/28/2018 |
Philips IntelliVue GuardianSoftware |
Philips Medizin Systeme Boeblingen GmbH |
Michael Asmalsky |
| K180426 |
02/16/2018 |
Empower H35 |
Quanta System Spa |
Francesco Dell'Antonio |
| K180423 |
02/16/2018 |
Empower H65 |
quanta system spa |
Francesco Dell'Antonio |
| K180288 |
02/01/2018 |
QuickVue Influenza A+B |
Quidel Corporation |
Jennifer S. Rial |
| K180379 |
02/12/2018 |
RayStation 7 |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K180372 |
02/12/2018 |
Aurora Evacuator |
Rebound Therapeutics |
Jeffrey J. Valko |
| K180502 |
02/26/2018 |
S128 Anterior Lumbar Interbody Fusion (ALIF) System |
Renovis Surgical Technologies Inc. |
Anthony DeBenedictis |
| K180497 |
02/26/2018 |
Scone Mask |
ResMed Ltd |
Kim Kuan LEE |
| K180452 |
02/20/2018 |
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim |
Riverstone Resources SDN BHD |
Suresh Kumar |
| K180481 |
02/23/2018 |
Servator B SALF Solution |
S.A.L.F. spa |
Carmelo Gagliano |
| K180409 |
02/14/2018 |
HS40 Diagnostic Ultrasound System |
Samsung Medison Co, Ltd. |
Ji Yea Lee |
| K180356 |
02/08/2018 |
inui In-Home Urine Analysis Test System |
Scanadu, Inc. |
Daya Ranamukhaarachchi |
| K180508 |
02/26/2018 |
JOULE SYSTEM |
Sciton, Inc. |
Jay M/ Patel |
| K180367 |
02/12/2018 |
Ureterorenoscope System |
Shanghai AnQing Medical Instrument CO., Ltd. |
Lina FEI |
| K180335 |
02/06/2018 |
Accutension Smartphone Auscultatory Blood |
Shanghai Hulu Devices Co., Ltd |
Junfeng Zhao |
| K180331 |
02/06/2018 |
Wireless Pain Relieve Device |
Shenzhen Dongdixin Technology Co.,Ltd. |
Siping Yuan |
| K180383 |
02/12/2018 |
Light based hair removal device |
Shenzhen GSD Tech Co., Ltd |
Ziyi Gui |
| K180419 |
02/15/2018 |
Ultrasonic Doppler (Model YM-2T8) |
Shenzhen IMDK Medical Technology Co., Ltd. |
Yuan Xia |
| K180461 |
02/20/2018 |
Navi e/Navi s/Navi X Diagnostic Ultrasound System |
Shenzhen Wisonic Medical Technology Co., Ltd. |
Jiang Xiaosan |
| K180454 |
02/20/2018 |
Shockwave Medical Intravascular Lithotripsy (IVL) System |
Shockwave Medical, Inc. |
Plessy Paul |
| K180336 |
02/07/2018 |
syngo.MR Applications |
Siemens Medical Solutions USA, Inc. |
Cordell L Fields |
| K180334 |
02/06/2018 |
LEGION Knee System |
Smith & Nephew, Inc. |
Michael Scott |
| K180361 |
02/09/2018 |
MICRORAPTOR REGENESORB Suture Anchor |
Smith and Nephew, Inc |
Katherine Marcaccio |
| K180443 |
02/20/2018 |
Tumark Vision |
SOMATEX Medical Technologies GmbH |
Burkhard Jakob |
| K180448 |
02/13/2018 |
INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter |
Sorin Group Italia S.r.l |
Luigi Vecchi |
| K180411 |
02/15/2018 |
MEMO 4D |
Sorin Group Italia S.r.l. |
Mauro Ercolani |
| K180472 |
02/22/2018 |
ViSi Mobile Monitoring System |
Sotera Wireless, Inc. |
Lan Herrington |
| K180514 |
02/27/2018 |
VERITON NM |
Spectrum Dynamics Medical Ltd. |
Igor Naroditsky |
| K180437 |
02/20/2018 |
Hexanium« TLIF |
SpineVision, SAS |
Anaella Gallego |
| K180342 |
02/07/2018 |
SYSTEM 1E Liquid Chemical Sterilant Processing System |
Steris Corporations |
Jennifer Nalepka |
| K180327 |
02/06/2018 |
Stryker iVAS 13g Bone Biopsy Kit |
Stryker Corporation |
Kristi Ashton |
| K180500 |
02/26/2018 |
VariAx 2 System |
Stryker GmbH |
Paul Nelson |
| K180451 |
02/20/2018 |
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider |
Stryker Sustainability Solutions |
Scott English |
| K180499 |
02/26/2018 |
Reprocessed LigaSure Maryland Jaw Sealer/Divider |
Stryker Sustainability Solutions |
Scott English |
| K180436 |
02/20/2018 |
T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System |
Stryker Trauma GmbH |
Heike Gustke |
| K180389 |
02/13/2018 |
Venera 508 Deep Vein Thrombosis (DVT) Prevention System |
Suzhou Minhua Medical Apparatus Supplies Co. Ltd. |
Michael Ying |
| K180394 |
02/13/2018 |
BrightMatter Plan 1.6.0 |
Synaptive Medical Inc. |
Maham Ansari |
| K180460 |
02/20/2018 |
Theradome LH40 |
Theradome, Inc. |
Tamim Hamid |
| K180402 |
02/14/2018 |
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar |
Topcon Medical Laser Systems, Inc. |
Sweta Srivastava |
| K180324 |
02/05/2018 |
Patriot Spinal Fixation System |
Valorus Spine |
Leah Fero |
| K180322 |
02/05/2018 |
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens |
Visco Vision Inc. |
Evan Huang |
| K180386 |
02/12/2018 |
Meron Plus QM |
Voco GmbH |
M. Th. Plaumann |
| K180373 |
02/12/2018 |
CancelleX Porous Titanium Lumbar Interbody Device |
Xenco Medical, LLC. |
Gustavo R. Prado |
| K180314 |
02/05/2018 |
Infrared Thermometer |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
Xuecheng Zhao |
| K180537 |
02/28/2018 |
Zavation Buttress Plate System |
Zavation Medical Products LLC |
Matt Jones |
| K180353 |
02/08/2018 |
Diode laser hair removal device |
Zhengzhou PZ Laser Slim Technology Co., Ltd |
Zhou Hongwei |
