| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K173519 |
04/23/2018 |
3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader |
3M Company |
Hilary B. Hovde |
| K172630 |
04/03/2018 |
Kisses Plus Implant System |
ACHIMHAI Medical Corporation |
Ji Ho Jung |
| K180096 |
04/16/2018 |
GDT-1000 System |
AcuVu Inc. |
Sam Mostafavi |
| K180433 |
04/26/2018 |
ENNOVATE« |
Aesculap Implant Systems, LLC |
Melanie Burkert |
| K180914 |
04/17/2018 |
Aesculap Slim Clip Applier |
Aesculap, Inc. |
Paul Amudala |
| K180589 |
04/05/2018 |
DR 800 with MUSICA Dynamic |
Agfa HealthCare N.V. |
Wim Govaerts |
| K171720 |
04/19/2018 |
encevis |
AIT Austrian Institute of Technology GmbH |
Tilmann Kluge |
| K180669 |
04/27/2018 |
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K180398 |
04/10/2018 |
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 |
| K173715 |
04/23/2018 |
AlertWatch:OB |
AlertWatch, Inc. |
Justin Adams |
| K180699 |
04/13/2018 |
Voyant Open Fusion Device |
Applied Medical Resources Corporation |
Patricia Villarreal |
| K180305 |
04/13/2018 |
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) |
Aquilabs US LLC |
Juan Salcedo |
| K173900 |
04/20/2018 |
Arthrex Univers Revers Modular Glenoid System |
Arthrex Inc. |
Courtney Smith |
| K173964 |
04/18/2018 |
OVOMotion Shoulder Arthroplasty System |
Arthrosurface, Inc. |
Dawn J. Wilson |
| K180566 |
04/03/2018 |
Unite Connect for Clinical Systems |
Ascom Sweden AB |
Ivan Liljegren |
| K180349 |
04/05/2018 |
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests |
Assure Tech (Hangzhou) Co., Ltd. |
Shisheng Ling |
| K172947 |
04/18/2018 |
HALF DOME Posterior Lumbar Interbody System |
Astura Medical |
Thomas Purcell |
| K172166 |
04/27/2018 |
OLYMPIC Navigated Instruments |
Astura Medical |
Troy Taylor |
| K172427 |
04/19/2018 |
AViTA Radar Thermo NT16 Series IR Thermometer |
Avita Corporation |
Steven Jhou |
| K180301 |
04/10/2018 |
AXIS 5.5 Lumbar Pedicle Screw System |
Axis Orthopaedics |
Craig Wilcox |
| K173867 |
04/05/2018 |
Axis Anterior Cervical Plate System |
Axis Orthopaedics |
Craig Wilcox |
| K173699 |
04/04/2018 |
The Pump by Babyation |
Babyation, LLC |
Jared Miller |
| K162525 |
04/25/2018 |
Oniko nail brace |
BEGUM SAGLIK HIZMETLERI TIBBI MALZEMELER DANISMANLIK LSTI |
FATMA GULRU ERDOGAN |
| K162499 |
04/13/2018 |
Best Instruminal Applicator |
BEST MEDICAL INTERNATIONAL, INC. |
MANNY SUBRAMANIAN |
| K173767 |
04/06/2018 |
A. L. P. S. Clavicle Plating System |
Biomet Inc. |
Dhaval Saraiya |
| K170901 |
04/13/2018 |
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 |
BioSystems S.A. |
Teresa Maria Cortes |
| K180344 |
04/05/2018 |
TheraCal DC |
Bisco, Inc. |
Ryan Hobson |
| K180271 |
04/06/2018 |
NAVIOÖ Surgical System (NAVIO system) |
Blue Belt Technologies, Inc. |
Corrine Herlinger |
| K172955 |
04/26/2018 |
LungVision Tool |
Body Vision Medical Ltd. |
Dorian Averbuch |
| K180102 |
04/19/2018 |
Embozene Color-Advanced Microspheres |
Boston Scientific |
Heidi Shearer |
| K180795 |
04/12/2018 |
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire |
Boston Scientific |
Nikki M. Ibis |
| K180530 |
04/10/2018 |
Imager II Urology Torque Catheter |
Boston Scientific Corporation |
Daniel FitzDaniel |
| DEN170081 |
04/20/2018 |
MALDI Biotyper CA System |
Bruker Daltonik GmbH |
Markus Kostrzewa |
| K173143 |
04/25/2018 |
Phasix ST Mesh |
C. R. Bard Inc |
Tony John |
| K172511 |
04/20/2018 |
Hickman TriFusion Catheter |
C.R. Bard, Inc |
Mona Shahrebani |
| K180548 |
04/26/2018 |
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology |
C.R. Bard, Inc (Bard has joined BD) |
Bryan Stone |
| K180069 |
04/27/2018 |
HDR MRI Lumen Marker |
C4 Imaging LLC |
Andrew Bright |
| DEN170028 |
04/26/2018 |
Cala ONE |
Cala Health, Inc. |
Scott A. Wilson |
| K173432 |
04/18/2018 |
ENZA-A Titanium ALIF |
Camber Spine Technologies |
Damian Heinz |
| K180416 |
04/17/2018 |
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System |
Cardiovascular Systems Inc. |
Susan Wolf |
| K180667 |
04/13/2018 |
SmartGrid |
Carestream Health, Inc. |
Diane Koetter |
| K173371 |
04/13/2018 |
VisuMax Femtosecond Laser |
Carl Zeiss Meditec, Inc. |
Todd Otani |
| K180121 |
04/11/2018 |
Rafugen DBM |
Cellumed Co., Ltd. |
JooWoong (Albert) Jang |
| K173398 |
04/26/2018 |
Xpert Xpress Strep A |
Cepheid |
Yi-Ping Lin |
| K172151 |
04/09/2018 |
Hysteroscopy System |
Chongquin Jinshan Science & Technology (Group) Co., Ltd. |
Qing Xu |
| K172258 |
04/27/2018 |
Novasight Hybrid System |
Conavi Medical Inc. |
Sam Mostafavi |
| K180616 |
04/25/2018 |
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens |
Contamac Ltd. |
Rob McGregor |
| K172588 |
04/19/2018 |
Balloon Catheter and Balloon Ureteral Dilator Set |
Cook Incorporated |
Carly Powell |
| K171603 |
04/16/2018 |
Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set |
Cook Incorporated |
Erum B. Nasir |
| K171917 |
04/23/2018 |
Frova Intubating Introducer |
Cook Incorporated |
Kotei Aoki |
| K173686 |
04/11/2018 |
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF« Transfer Catheter |
Cook Incorporated |
Naomi Funkhouser |
| K172635 |
04/03/2018 |
High-Flo Silver Polyethylene Catheter |
Cook Incorporated |
Jessica Swafford |
| K173103 |
04/13/2018 |
Pivet and Soft-Pass Embryo Transfer Catheter Sets |
Cook Incorporated |
Naomi Funkhouser |
| K180081 |
04/18/2018 |
RAILWAY Sheathless Access System |
Cordis Corporation |
Michelle Ragozzino Rodgers |
| K171847 |
04/05/2018 |
Corin Optimized Positioning System (OPSÖ) Plan |
Corin USA Limited |
Kathy Trier |
| K173880 |
04/11/2018 |
Corin TriFit CF Hip Stem |
Corin USA Limited |
Rachel King |
| K172206 |
04/10/2018 |
NAJAÖ Ligament Correction System |
Cousin Biotech S.A.S. |
Mathilde Collet |
| K180037 |
04/26/2018 |
Beacon EUS Access System |
Covidien llc |
Rachel Silva |
| K180007 |
04/19/2018 |
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter |
Creagh Medical, Ltd. |
Shane Costello |
| K180252 |
04/24/2018 |
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank |
Crown Porcelain Dental Technology Co., Ltd. |
Chu Lien Fan |
| DEN170047 |
04/03/2018 |
Curetis Unyvero LRT Application |
Curetis GmbH |
Gail E. Radcliffe |
| K180561 |
04/04/2018 |
MobileX Portable X-ray System |
Denterprise International, Inc. |
Claude Berthoin |
| K172239 |
04/04/2018 |
SIMPLANT 18 |
Dentsply Sirona |
Karl Nittinger |
| K170339 |
04/26/2018 |
Summit Hip System |
DePuy Orthopaedics, Inc. |
Carol S. Ming |
| K173072 |
04/04/2018 |
Algidex Ag Silver Alginate Wound Dressing |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K172154 |
04/19/2018 |
Isolette 8000 plus |
Draeger Medical Sytems, Inc. |
Gale Winarsky |
| K171562 |
04/13/2018 |
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono |
Dreve Dentamid GmbH |
Reiner Altmann |
| K162408 |
04/05/2018 |
Nano Varnish, Plaquit, Lightpaint on Surface |
DREVE DENTAMID GMBH |
REINER ALTMANN |
| K170776 |
04/10/2018 |
DTI-1 SLA IMPLANT SYSTEM |
DTI Implant Sistemleri Sanayi Ticaret Anonim Sirketi |
Fatih Ormeci |
| K180408 |
04/13/2018 |
U60 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
Crystal Cai |
| K173586 |
04/05/2018 |
VAMP Venous/Arterial Blood Management Protection System |
Edwards Lifesciences, LLC |
Ye Seul Kim |
| K172173 |
04/06/2018 |
DiaSpect Tm, DiaSpect Tm Cuvettes |
EKF-diagnostic GmbH |
Mick Fenton |
| K172244 |
04/20/2018 |
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern |
Euroimmun US, Inc. |
Daniel Castellanos |
| K172252 |
04/20/2018 |
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern |
Euroimmun US, Inc. |
Daniel Castellanos |
| K172919 |
04/19/2018 |
EV-804 OTC Pain Relief TENS |
Everyway Medical Instruments Co., Ltd. |
Paul Hung |
| K180636 |
04/30/2018 |
ExactVu High Resolution Micro-Ultrasound System |
Exact Imaging Inc. |
Randy AuCoin |
| K173775 |
04/06/2018 |
Clench Compression Staple |
F & A Foundation LLC d.b.a. Reign Medical |
Daniel Lanois |
| K180208 |
04/09/2018 |
Disposable Endoscopic Trocar |
Fengh Medical Co., Ltd. |
Jun Zhou |
| K180704 |
04/13/2018 |
SonoSite iViz Ultrasound System |
FUJIFILM SonoSite, Inc. |
Sudipta Chakrabarti |
| K173226 |
04/16/2018 |
CardiMax Electrocardiograph |
Fukuda Denshi USA, Inc. |
Doug Blakely |
| K172382 |
04/02/2018 |
GC Fuji Direct |
GC America Inc. |
Mark Heiss |
| K173816 |
04/17/2018 |
NM/CT 850, NM/CT 860 |
GE Healthcare |
George Mashour |
| K180666 |
04/12/2018 |
48CH Head Coil |
GE Healthcare Coils (USA Instruments, Inc.) |
Veronica A. Meridith |
| K180225 |
04/24/2018 |
GSI Viewer with GSI Fat Option |
GE Medical Systems SCS |
Peter Uhlir |
| K180782 |
04/20/2018 |
Aria |
GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC |
Nicole Landreville |
| K180318 |
04/11/2018 |
PET Digital Gating |
GE Medical Systems, LLC |
Lee Bush |
| K180304 |
04/20/2018 |
Geri Embryo Incubator and Geri Dish |
Genea Biomedx Pty Ltd |
Kea Dent |
| K173885 |
04/03/2018 |
Genesys Spine Binary Lumbar Plate System |
Genesys Spine |
Brian J. Bergeron |
| K180836 |
04/18/2018 |
Genistrong |
Genicon, Inc |
Katlyn Kachman |
| K180210 |
04/02/2018 |
CREO« Stabilization System |
Globus Medical Inc. |
Kelly J. Baker |
| K171379 |
04/10/2018 |
Digital Automatic Wrist Blood Pressure Monitor MD4300 |
Grandway Technology (Shenzhen) Limited |
Patrick Chow |
| K173757 |
04/19/2018 |
VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set |
Greiner Bio-One NA Inc |
Manfred Abel |
| K172887 |
04/19/2018 |
XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K172368 |
04/05/2018 |
Bipolar Micro-Coagulation Forceps |
Gunter Bissinger Medizintechnik GmbH |
Matthias Bissinger |
| K172727 |
04/16/2018 |
Hemoclip |
Hangzhou AGS MedTech CO., Ltd |
Chunqi Han |
| K171821 |
04/26/2018 |
2 Face / Face Evolution |
Heat In A Click |
Guy Levi |
| K180233 |
04/10/2018 |
Eviva Stereotactic Guided Breast Biopsy System |
Hologic, Inc |
Brenda M Geary |
| K173201 |
04/26/2018 |
UNITY Sacroiliac Joint Fixation System |
Huvexel Co., Ltd |
Sung Hee-Lee |
| K170463 |
04/13/2018 |
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K180125 |
04/05/2018 |
PowerLook Density Assessment Software |
iCAD, Inc |
John DeLucia |
| K172306 |
04/19/2018 |
SuperSlyde Personal Lubricant |
ICM Pharma Pte Ltd |
Dennis Fortich |
| DEN180001 |
04/11/2018 |
IDx-DR |
IDx, LLC |
Michael D. Abramoff |
| K162314 |
04/24/2018 |
IMACTIS CT-Navigation system |
IMACTIS, SAS |
MADY BATAILH |
| K180126 |
04/16/2018 |
SOZO |
ImpediMed Limited |
Catherine Kingsford |
| K180329 |
04/09/2018 |
ClotTriever Thrombectomy System |
Inari Medical, Inc. |
Eben Gordon |
| K172416 |
04/19/2018 |
Synermed Opiate Enzyme Immunoassay |
Infrared Laboratory Systems, LLC (dba Synermed) |
Julie Paschal |
| K172167 |
04/19/2018 |
Zenith Flex System |
InNeuroCo, Inc. |
Marc Litzenberg |
| K180140 |
04/20/2018 |
ProFlex Laser Fibers |
InnovaQuartz LLC |
Stephen E Griffin |
| K180078 |
04/17/2018 |
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System |
Innovasis, Inc. |
Marshall McCarty |
| K173935 |
04/16/2018 |
Mediant Anterior Cervical Plating System |
Intelligent Implant Systems, LLC |
Michael Nutt |
| K180033 |
04/06/2018 |
8mm Monopolar Curved Scissors |
Intuitive Surgical, Inc |
Gayle Perry |
| K173842 |
04/23/2018 |
da Vinci Xi Surgical System, da Vinci X Surgical System |
Intuitive Surgical, Inc |
Brandon Hansen |
| K173337 |
04/26/2018 |
Intuitive Surgical EndoWrist Vessel Sealer Extend |
Intuitive Surgical, Inc. |
Crystal Ong |
| K172329 |
04/23/2018 |
Patient Status Engine |
Isansys Lifecare Ltd |
Julian Jones |
| K172477 |
04/19/2018 |
iSchemaView RAPID |
iSchemaView, Inc. |
Jim Rosa |
| K172598 |
04/19/2018 |
Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE |
ITW Contamination Control Electronics |
Steve Cook |
| K173902 |
04/20/2018 |
Neodent Implant System û GM Line |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Julianne de Oliveira Capucho Lechechem |
| K171713 |
04/05/2018 |
Neodent Instrument Kits |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Julianne de Oliveira Capucho Lechechem |
| K180299 |
04/10/2018 |
ACUVUE OASYS (senofilcon A) with Photochromic Additive |
Johnson & Johnson Vision Care, Inc. |
Victoria Brennand |
| K180376 |
04/05/2018 |
K2M Patient Specific Rods |
K2M, Inc. |
Nancy Giezen |
| K180146 |
04/17/2018 |
KARL STORZ ICG Imaging System |
KARL STORZ Endoscopy America, Inc. |
Winkie Wong |
| K173362 |
04/03/2018 |
DSM Biomedical Calcium Phosphate Cement |
Kensey Nash Corporation dba DSM Biomedical |
Susan Pileggi |
| K173669 |
04/02/2018 |
K-D Balance |
King-Devick Technologies, Inc. |
Lori Grover |
| K180320 |
04/03/2018 |
dpl IIa Panel |
LED Technologies, Inc. |
Lloyd Nelson |
| K170761 |
04/13/2018 |
LIGHTSonic BUBM |
Lightmed USA, Inc. |
Katrina Hsu |
| DEN170010 |
04/20/2018 |
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Chris Wang |
| K180339 |
04/04/2018 |
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K180576 |
04/19/2018 |
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) |
LPI, Inc. |
Christopher Steadman |
| K173304 |
04/30/2018 |
Finessis Intense Polyisoprene Surgical Glove |
Lucenxia Prescience Ag |
Robert Hill |
| K173386 |
04/09/2018 |
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs |
Lucenxia Prescience AG |
Robert Hill |
| K173317 |
04/17/2018 |
DiLumen C2; DiLumen Tool Mount |
Lumendi, LLC |
Dennis Daniels |
| K180597 |
04/03/2018 |
AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO |
Lumenis Ltd. |
Amaya De Levie |
| K172963 |
04/04/2018 |
Master-Frank N95 Particulate Respirator |
Master & Frank Enterprise Co., Ltd |
Shuge Zhao |
| K180307 |
04/30/2018 |
Mazor X |
Mazor Robotics Ltd. |
Shiran Conforti |
| K171326 |
04/13/2018 |
Piezosurgery White |
Mectron S.p.a |
Franco Zunino |
| K172460 |
04/27/2018 |
ADHEAR System |
MED-EL Elektromedizinische Geraete GmbH |
Elizabeth Gfoeller |
| K180089 |
04/05/2018 |
Medacta Shoulder System Short Humeral Diaphysis |
Medacta International SA |
Stefano Baj |
| K173472 |
04/19/2018 |
MySpine Pedicle Screw Placement Guides û MC and Drill Pilot Instruments |
Medacta International SA |
Stefano Baj |
| K172956 |
04/06/2018 |
Medicant Mucosal Atomizer |
Medica Holdings, LLC |
George Reed |
| K180567 |
04/12/2018 |
C3 Wave System |
Medical Components, Inc. (dba Medcomp) |
Courtney Nix |
| K173506 |
04/03/2018 |
LigaPASS |
Medicrea International S.A. |
David Ryan |
| K173782 |
04/25/2018 |
UNiD Patient Specific 3D printed cage |
Medicrea International S.A. |
David Ryan |
| K180090 |
04/23/2018 |
CureÖ Lumbar Plate System |
Meditech Spine, LLC |
Bruce Dunaway |
| K173889 |
04/09/2018 |
Medline Cautery Electrode (PTFE) |
Medline Industries, Inc. |
Matt Clausen |
| K180696 |
04/30/2018 |
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) |
Medline Industries, Inc. |
Pauline Maralit |
| K173859 |
04/11/2018 |
HEALIX ADVANCE Anchor with DYNACORD Suture |
Medos International SARL |
Tatyana Tatyana Korsunsky |
| K173526 |
04/05/2018 |
SENTIO MMG Gen 2 |
Medos International, SARL |
Karen Sylvia |
| K180222 |
04/24/2018 |
Reaxon Plus |
Medovent GmbH |
Peter Meier |
| K180851 |
04/18/2018 |
VERTEXÖ Reconstruction System |
Medtronic Sofamor Danek USA, Inc |
Ankit K Shah |
| K173515 |
04/12/2018 |
Admiral Xtreme |
Medtronic Vascular |
Maddalena Pinsi |
| K173855 |
04/20/2018 |
Sharpsite AC Rigid Endsocope |
Medtronic Xomed Inc. |
Shravan Chawla |
| K180873 |
04/19/2018 |
Medtronic Model 53401 External Pulse Generator (EPG) |
Medtronic, Inc. |
Brenna Loufek |
| K180030 |
04/24/2018 |
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) |
Medtronic, Inc. |
Nancy Cameron |
| K172866 |
04/27/2018 |
NeuroCap |
Memory MD INC |
Abdus-Salaam Muwwakkil |
| K172930 |
04/13/2018 |
mCare Powder-free Blue Nitrile Examination Gloves |
Mercator Medical (Thailand) LTD. |
Dariusz Jan Krezymon |
| K180723 |
04/17/2018 |
PreludeSYNC DISTAL Radial Compression System |
Merit Medical Systems, Inc |
Susan Christensen |
| K172014 |
04/05/2018 |
Wedge Microcatheter |
Micro Vention, Inc. |
Chet Jones |
| K172880 |
04/18/2018 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K172464 |
04/24/2018 |
XD880A Ultrasonic Osteotomy Surgical System |
Morley Research Consortium |
Suzan Davis |
| K172764 |
04/27/2018 |
Keymill |
Mycone Dental Supply Company, Inc. (aka Keystone Industries) |
Priscilla Herpai |
| K173865 |
04/24/2018 |
trophon2 |
Nanosonics Limited |
Ruth Cremin |
| K180257 |
04/25/2018 |
InCore« Lapidus System |
Nextremity Solutions, Inc. |
Greg Denham |
| K180503 |
04/03/2018 |
PRECICE STRYDE System |
NuVasive Specialized Orthopedics, Inc. |
Lance Justice |
| K180458 |
04/17/2018 |
FOCUS Pedicle Screw System |
Nvision Biomedical Technologies, LLC |
Diana Langham |
| K172726 |
04/30/2018 |
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K172610 |
04/17/2018 |
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K180200 |
04/26/2018 |
ESG-300, APU-300, Pressure Reducer, MAPC Probes |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K171692 |
04/02/2018 |
Instrument basket, for EndoEYE |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K180630 |
04/06/2018 |
PTFE SURGICAL SUTURE |
OMNIA SPA |
Roberto Cerioli |
| K173390 |
04/27/2018 |
hipEOS |
oneFIT Medical |
Camille Vernay |
| K180378 |
04/05/2018 |
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module |
Optomed Oy |
Jyri Leskela |
| K172699 |
04/23/2018 |
Agile Nail |
Orthofix Srl |
Gianluca Ricadona |
| K173525 |
04/06/2018 |
NovoGro |
OsteoNovus, Inc. |
Brian M. Schlossberg |
| K173615 |
04/18/2018 |
Stryker Universal Select Sterilization Tray System |
Paragon Medical |
Rebecca Walker |
| K180651 |
04/12/2018 |
Uroview FD II |
Pausch Medical GmbH |
Christian Stoian |
| K171872 |
04/26/2018 |
P50 Series Dental Operative Unit and Accessories |
Pelton & Crane |
Frank Ray |
| K172156 |
04/05/2018 |
PENTAX Medical EPK-3000 Video Imaging System |
Pentax Medical |
William Goeller |
| K173614 |
04/17/2018 |
Penumbra Coil 400, Ruby Coil System, POD System |
Penumbra, Inc. |
Aditi Kolla |
| K173726 |
04/16/2018 |
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut |
Phadia AB |
Ulf Karlberg |
| K173079 |
04/04/2018 |
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 |
Philips Medical Systems Nederland B.V. |
Jan van de Kerkhot |
| K172365 |
04/19/2018 |
Panoramic Oxygen Mask (POM) |
Pom Medical, LLC |
Jeff Voss |
| K172495 |
04/11/2018 |
Reform« POCT System |
Precision Spine, Inc. |
Michael C. Dawson |
| K180080 |
04/06/2018 |
FIBERGRAFT BG Matrix Bone Graft Substitute |
Prosidyan, Inc |
Charanpreet S Bagga |
| K172636 |
04/30/2018 |
VitaMESH Macroporous PP Surgical Mesh |
Proxy Biomedical Ltd. |
Adrienne Tierney |
| K173258 |
04/20/2018 |
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy |
Pt. Medisafe Technologies |
Deepak Bang |
| K180154 |
04/27/2018 |
QiF Blood and Fluid Warmer |
Quality In Flow Ltd. |
Neta Sherman |
| K180595 |
04/04/2018 |
SciMoCa |
Radialogica LLC |
Debra Vigil |
| K180379 |
04/25/2018 |
RayStation 7 |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K180372 |
04/09/2018 |
Aurora Evacuator |
Rebound Therapeutics |
Jeffrey J. Valko |
| K173661 |
04/18/2018 |
Wingman 35 Crossing Catheter |
ReFlow Medical, Inc. |
Rebecca K Pine |
| K180206 |
04/24/2018 |
neuromate Gen III |
Renishaw Mayfield Sarl |
Stephane Vinot |
| K180637 |
04/04/2018 |
leva Pelvic Floor Trainer |
Renovia Inc. |
Gina Prochillo-Cawston |
| K172875 |
04/26/2018 |
Astral 100/150 |
ResMed Ltd |
Peter Jennings |
| K171409 |
04/09/2018 |
OT EQUATOR |
Rhein'83 SRL |
Claudia Nardi |
| K180684 |
04/19/2018 |
CoaguChek XS Plus System |
Roche Diagnostics |
Bin Sun |
| K180693 |
04/19/2018 |
CoaguChek XS Pro System |
Roche Diagnostics |
Angie Clements |
| K180753 |
04/20/2018 |
SafetyFix EasyOut System |
SafetyFix Medical Technologies, Inc. |
Michael Horwitz |
| K172047 |
04/11/2018 |
Riva Star |
SDI Limited |
Ray Cahill |
| K173606 |
04/13/2018 |
SeaSpine Vu aòPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aòPOD Prime Intervertebral Body Fusion Device |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K172141 |
04/04/2018 |
Pulse Oximeter |
Shanghai Berry Electronic Tech Co., Ltd |
Xuezhi Yin |
| K172143 |
04/13/2018 |
uMI 780 PET/CT System |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K172998 |
04/05/2018 |
uWS-MI |
Shanghai United Imaging Healthcare Co.,Ltd. |
Shumei Wang |
| K173207 |
04/05/2018 |
SIC invent Dental Implant Systems |
SIC invent AG |
Cretia Arlene McNett |
| K172201 |
04/12/2018 |
Atellica IM Folate Assay |
Siemens Healthcare Diagnostics Inc. |
Darius Daruwala |
| K180563 |
04/25/2018 |
syngo.plaza |
Siemens Healthcare GmbH |
Vijay Ramadas |
| K173597 |
04/04/2018 |
Scenium VE20 Software |
Siemens Medical Solutions USA, Inc. |
Veronica Padharia |
| K173632 |
04/13/2018 |
SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K180336 |
04/19/2018 |
syngo.MR Applications |
Siemens Medical Solutions USA, Inc. |
Cordell L Fields |
| K173897 |
04/05/2018 |
syngo.via MI Workflows |
Siemens Medical Solutions USA, Inc. |
Veronica Padharia |
| K173639 |
04/02/2018 |
Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax |
Siemens Medical Solutions, Inc |
Denise Adams |
| K180750 |
04/20/2018 |
World Knee System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K180744 |
04/11/2018 |
Stablyx CMC Arthroplasty Implant System |
Skeletal Dynamics, LLC |
Ana M. Escagedo |
| K180614 |
04/06/2018 |
PICO Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Lavinia Tompkins |
| K180618 |
04/20/2018 |
PICO Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Lavinia Tompkins |
| K180277 |
04/24/2018 |
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter |
Smith & Nephew, Inc. |
Allison Chan |
| K173384 |
04/10/2018 |
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube |
Smiths Medical ADS, Inc. |
Donna M. Semlak |
| K173934 |
04/13/2018 |
Reza Band, Reflux Band |
Somna Therapeutics, L.L.C. |
James S. Miller |
| K173896 |
04/02/2018 |
Microcyn Antimicrobial Hydrogel |
Sonoma Pharmaceuticals, Inc. |
Brian Martin |
| K180694 |
04/05/2018 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
Spectranetics, Inc. |
Travis Pittman |
| K180514 |
04/25/2018 |
VERITON NM |
Spectrum Dynamics Medical Ltd. |
Igor Naroditsky |
| K172967 |
04/10/2018 |
Mercury« Spinal System |
Spinal Elements Inc. |
Julie Lamothe |
| K171151 |
04/27/2018 |
ACRONÖ TLIF System |
SpineMED Ges.m.b.H |
Andreas Bernegger |
| K180002 |
04/25/2018 |
Rampart One Lumbar Interbody Fusion Device |
Spineology Inc. |
Jacqueline A. Hauge |
| K172396 |
04/23/2018 |
EnSite Velocity Cardiac Mapping System v5.2 |
St. Jude Medical |
Melissa Frank |
| K172393 |
04/23/2018 |
Advisor HD Grid Mapping Catheter, Sensor Enabled |
St. Jude Medical, Inc. |
Jennifer Ruether |
| K172155 |
04/12/2018 |
StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing |
StatGuard, LLC |
Gary Mills |
| K180689 |
04/12/2018 |
Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device |
STERIS Corporation |
Tony Piotrkowski |
| K180342 |
04/04/2018 |
SYSTEM 1E Liquid Chemical Sterilant Processing System |
Steris Corporations |
Jennifer Nalepka |
| K173692 |
04/13/2018 |
D-Actor 200 Vibration Massage System |
Storz Medical AG |
Pavel Novak |
| K172315 |
04/12/2018 |
Straub Endovascular System |
Straub Medical AG |
Amy Ehlenfeldt |
| K173074 |
04/04/2018 |
ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor |
Stryker |
Jacob Scheenstra |
| K180451 |
04/20/2018 |
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider |
Stryker Sustainability Solutions |
Scott English |
| K180499 |
04/23/2018 |
Reprocessed LigaSure Maryland Jaw Sealer/Divider |
Stryker Sustainability Solutions |
Scott English |
| K180677 |
04/03/2018 |
Surefire Spark Infusion System |
Surefire Medical, Inc. |
Lynne Aronson |
| K172187 |
04/11/2018 |
Inno-Hydrowire |
Suzhou Innomed Medical Device Co.,Ltd |
Jimmy Li |
| K171883 |
04/23/2018 |
Sysmex UF-5000 Fully Automated Urine Particle Analyzer |
Sysmex America, Inc. |
Sharita Brooks |
| K180588 |
04/17/2018 |
FAST1Ö Intraosseous Infusion System; FASTResponderÖ Sternal Intraosseous Device |
Teleflex Medical |
Ying Zhao |
| K173321 |
04/25/2018 |
StimuQuik 21G x 9cm (3.5ö) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5ö) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6ö) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6ö) Peripheral Nerve Block Needle, StimuQuik 21G x |
Teleflex Medical |
Kristen Bisanz |
| K180765 |
04/20/2018 |
Televere Podiatry X-Ray System HF |
Televere Systems, Inc. |
Randell Quaal |
| K172923 |
04/26/2018 |
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue |
Top Glove Sdn. Bhd. |
Noor Akilah Binti Saidin |
| K173962 |
04/20/2018 |
Viamo c100 TUS-VC100 Diagnostic Ultrasound System |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K172720 |
04/27/2018 |
TRACOE silcosoft Tracheostomy Tube |
TRACOE medical GmbH |
Eva Schaeffer |
| K180219 |
04/20/2018 |
JO H2O Flavored Personal Lubricants |
United Consortium |
Stephanie Morris |
| K180083 |
04/09/2018 |
Silicone Personal Lubricant, ALL-IN-ONE |
United Consortium |
Stephanie Morris |
| K180731 |
04/19/2018 |
Ultramatrix EUS Balloon |
United States Endoscopy Group, Inc. (US Endoscopy) |
Coletta Cohara |
| K180324 |
04/06/2018 |
Patriot Spinal Fixation System |
Valorus Spine |
Leah Fero |
| DEN170001 |
04/10/2018 |
Precision Flow« HVNI |
VAPOTHERM, INC. |
SOM KOVVURI |
| K170570 |
04/06/2018 |
Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung |
Varian Medical Systems Inc |
Lisa Levine |
| K180586 |
04/02/2018 |
Varian Head Frame |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K180088 |
04/04/2018 |
TrapLiner catheter |
Vascular Solutions, Inc. |
Beka Vite |
| K172747 |
04/27/2018 |
HYALURONIC ACID TOPICAL WOUND CREAM |
VIRCHOW BIOTECH PVT LTD |
Bruce Gibbins |
| K173958 |
04/03/2018 |
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 |
| K180322 |
04/20/2018 |
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens |
Visco Vision Inc. |
Evan Huang |
| K180584 |
04/06/2018 |
Viveve RF System, Secure |
Viveve Inc. |
Suzon Lommel |
| K180161 |
04/20/2018 |
Viz CTP |
Viz.ai, Inc. |
Gregory Ramina |
| K173860 |
04/11/2018 |
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 |
| K171678 |
04/30/2018 |
Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m |
Vyaire Medical, Inc. |
Leo Sohlberg |
| K171443 |
04/20/2018 |
Etherea MX |
Vydence Medical Industria E Comercio Ltda |
Kathy Maynor |
| K173333 |
04/05/2018 |
GORE ENFORM Biomaterial |
W.L. Gore & Associates, Inc. |
Barbara L Smith |
| K172478 |
04/19/2018 |
TENS device-EmeTerm, CinvStop |
WAT Medical Technology (Ningbo) Co., Ltd |
Joe Xu |
| K172288 |
04/17/2018 |
Fusion OMNI Sphincterotome |
Wilson-Cook Medical, Inc./ Cook Endoscopy |
Sierra Lowe |
| K172633 |
04/26/2018 |
INFINITY Total Ankle System |
Wright Medical Technology, Inc. |
Tara Conrad |
| K180571 |
04/04/2018 |
GammaPod |
Xcision Medical Systems, LLC |
Daniel R. Plonski |
| K180243 |
04/03/2018 |
Infinity-Lock Button System |
Xiros Ltd |
Stephen Seed |
| K180549 |
04/12/2018 |
ZED Link |
Zed Technologies |
Ronald Li |
| K172735 |
04/17/2018 |
WR19 System |
Zeto, Inc. |
Aswin Gunasekar |
| K172768 |
04/24/2018 |
ZOOM |
Zetta Medical Technologies, LLC. |
Main M. Ghazal |
| K180353 |
04/17/2018 |
Diode laser hair removal device |
Zhengzhou PZ Laser Slim Technology Co., Ltd |
Zhou Hongwei |
