| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K171003 |
07/21/2017 |
3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader |
3M Company |
Hilary B. Hovde |
| K170563 |
07/27/2017 |
3M Comply Hydrogen Peroxide Indicator Tape |
3M Company |
Nadia Battah |
| K171908 |
07/11/2017 |
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing |
3M Company |
Melissa Forth |
| K171837 |
07/25/2017 |
TomoTherapy Treatment Delivery System with iDMS |
Accuray Incorporated |
Keith Picker |
| K163406 |
07/11/2017 |
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System |
ACON LABORATORIES INC. |
QIYI XIE |
| K170587 |
07/06/2017 |
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis |
ACON Laboratories, Inc. |
Qiyi Xie |
| K163062 |
07/25/2017 |
PHMB Antimicrobial Foam Wound Dressing |
Advanced Medical Solutions Ltd. |
Kay McGrath |
| K163598 |
07/31/2017 |
Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator |
ADVANCED STERILIZATION PRODUCTS |
NAZANIN YACOBI |
| K162815 |
07/13/2017 |
SterilContainer S System |
AESCULAP, INC |
Paul Amudala |
| K170434 |
07/03/2017 |
Enterprise Imaging XERO Viewer 8.1 |
Agfa HealthCare N.V. |
Jodi Coleman |
| K163057 |
07/12/2017 |
Relizorb |
Alcresta Therapeutics, Inc. |
Robert Gallotto |
| K171242 |
07/14/2017 |
Alma LipoFlow System |
Alma Lasers Inc. |
Rekha Anand |
| K171265 |
07/28/2017 |
Otowave 302 Portable Tympanometer |
Amplivox Ltd |
Chris Roerig |
| K171282 |
07/27/2017 |
Fully Automatic Blood Pressure Monitor |
Andon Health Co., Ltd |
Liu Yi |
| K170775 |
07/19/2017 |
Mini Stick ENVI Non-Vascular Introducer Kit |
AngioDynamics, Inc. |
Hans Kjolhede |
| K171701 |
07/20/2017 |
GelPOINT Path Transanal Access Platform |
Applied Medical Resources Corp. |
Corinne Weisheit |
| K171544 |
07/18/2017 |
Arterys Viewer |
Arterys Inc. |
Golnaz Moeini |
| K170326 |
07/20/2017 |
dynaMX Intramedullary Implant |
Arthrex, Inc. |
Howard L. Schrayer |
| K171613 |
07/01/2017 |
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip |
Asahi Intecc Co., Ltd. |
Yasuyuki Kawahara |
| K162153 |
07/14/2017 |
Integra« CAPTUREÖ Screw System & Integra« Ti6« Internal Fixation System |
ASCENSION ORTHOPEDICS |
GABRIELLA BECKER |
| K170223 |
07/21/2017 |
Progreat |
ASHITAKA FACTORY OF TERUMO CORPORATION |
LAUREN P. NITAHARA |
| K170978 |
07/19/2017 |
Embrace Neonatal MRI System |
Aspect Imaging Ltd. |
Israel Citron |
| K170407 |
07/17/2017 |
BD ChloraShield IV Dressing with CHG Antimicrobial |
Avery Dennison Belgie BVBA |
Lisa Bartakovics |
| K163025 |
07/20/2017 |
DORA Disposable A.V. Fistula Needle Sets |
Bain Medical Equipment (Guangzhou) Co., Ltd. |
Sophia Shao |
| K160337 |
07/07/2017 |
Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns |
BAM CORPORATION LIMITED |
MARY MEJAES |
| K171812 |
07/19/2017 |
Nio Color 2MP (MDNC-2123) |
Barco NV |
Helena Soenen |
| K171404 |
07/17/2017 |
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) |
BAUSCH + LOMB Incorporated |
Glenn A. Davies |
| K170974 |
07/03/2017 |
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK |
Becton, Dickinson and Company |
Li Zhou |
| K162398 |
07/06/2017 |
CO2 Laser Therapy Systems |
BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. |
XIN WANG |
| K162950 |
07/22/2017 |
VITEK MS |
bioMerieux, Inc. |
Nathan Hardesty |
| K171054 |
07/28/2017 |
Biomet Knee Joint Replacement Prostheses |
Biomet, Inc |
Jason Heckaman |
| K170143 |
07/06/2017 |
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, |
Bionime Corporation |
Kay Wu |
| K170600 |
07/25/2017 |
CARTO 3 EP Navigation System, Version 6.0 and Accessories |
Biosense Webster, Inc. |
Phoung Chau |
| K170997 |
07/25/2017 |
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath |
Biosense Webster, Inc. |
John Jimenez |
| K162853 |
07/14/2017 |
Bonafix TWO - Dental Implant System |
BONAFIX SURGICAL AND DENTAL IMPLANTS |
Juan Tezak |
| K162856 |
07/18/2017 |
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) |
Bonart Co., Ltd. |
Bankson Tsai |
| K171454 |
07/07/2017 |
Interject Injection Therapy Needle Catheter |
Boston Scientific Corporation |
Tara Paul |
| K170815 |
07/06/2017 |
PSA Cable |
Boston Scientific Corporation |
Melissa Klamerus |
| K171913 |
07/25/2017 |
Rubicon 14, 18 and 35 Support Catheters |
Boston Scientific Corporation |
Ka Zoua Xiong |
| K170757 |
07/14/2017 |
Aegis Transit System |
Boston-Biomedical Associates |
Lauren Baker |
| K170686 |
07/14/2017 |
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs |
Brightway Holdings Sdn. Bhd. |
G. Baskaran |
| K163536 |
07/26/2017 |
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System |
BRUKER DALTONIK GMBH |
MARKUS KOSTRZEWA |
| K171132 |
07/31/2017 |
Carefusion NeutraClear Needle-free connector |
CAIR LGL |
Delphine Molinari |
| K170550 |
07/13/2017 |
Coveris Cervical Cage System |
Camber Spine Technologies |
Ryan Gaffney |
| K171957 |
07/19/2017 |
MaxZero Extension Sets with Needless Connector |
Carefusion 303 Inc. |
Viviana Lai |
| K162858 |
07/24/2017 |
NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST |
Careplus (M) SDN BHD |
LIM KWEE SHYAN |
| K162991 |
07/24/2017 |
YELLOW 560 Fluorescence Module |
Carl Zeiss Meditec AG |
Peter Schrutka-Rechtenstamm |
| K171588 |
07/31/2017 |
NuBODY Skin Toning Device |
Carol Cole Company dba NuFACE |
Donald Ellis |
| K170870 |
07/06/2017 |
Site~Rite Halcyon Diagnostic Ultrasound System |
CHISON Medical Imaging Co., Ltd. |
Qifei Liu |
| K162609 |
07/06/2017 |
ClearPath Aligner |
ClearPath Orthodontics Ltd |
Waqas Wahab |
| K171747 |
07/14/2017 |
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and |
Codman & Shurtleff, Inc. |
Vivian Perez |
| K171653 |
07/03/2017 |
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up |
Codman & Shurtleff, Inc. |
Yoon Hee Beatty |
| K170541 |
07/07/2017 |
Anorganic Bone Mineral in Delivery Applicator |
Collagen Matrix, Inc. |
Danielle Lindner |
| K171855 |
07/21/2017 |
External Moisturizing Gel |
Combe Incorporated |
Richard Grabarz |
| K162934 |
07/10/2017 |
Biodesign Parastomal Hernia Repair Graft |
Cook Biotech Incorporated |
Perry W. Guinn |
| K163031 |
07/27/2017 |
Bunegin-Albin Air Aspiration Set |
COOK INCORPORATED |
JOHNATHAN LIU |
| K163353 |
07/11/2017 |
Needle's Eye Snare Retrieval Set - 54cm |
Cook Incorporated |
Thomas Kardos |
| K171999 |
07/31/2017 |
Performer Introducer |
Cook Incorporated |
Jennifer Allman |
| K163318 |
07/14/2017 |
Soules Intrauterine Insemination Catheter |
Cook Incorporated |
Naomi N. Funkhouser |
| K171602 |
07/28/2017 |
Williams Cystoscopic Injection Needle |
Cook Incorporated |
Rebecca Odulio (Li-chun Liu) |
| K171623 |
07/31/2017 |
Nasal Pancreatic Drainage Set |
Cook Ireland Ltd |
Orla Gunning |
| K170660 |
07/13/2017 |
Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula |
CooperSurgical, Inc. |
Roaida Johnson |
| K170808 |
07/13/2017 |
Unity Total Knee System |
Corin USA Limited |
Rachel King |
| K170100 |
07/18/2017 |
CreoDent Solidex Customized Abutment and Screw |
CreoDent Prosthetics, Ltd. |
Calvin Shim |
| K171087 |
07/07/2017 |
AXON IR Heat Lamp |
Crystal Medtech, LLC |
Nelson Marquina |
| K171522 |
07/14/2017 |
truFreeze Rapid AV Spray Kit |
CSA Medical, Inc. |
Sherrie Coval-Goldsmith |
| K172041 |
07/27/2017 |
truFreeze System |
CSA Medical, Inc. |
Sherrie Coval-Goldsmith |
| K171290 |
07/19/2017 |
Vela RX PTA Balloon Dilatation Catheter |
Curatia Medical |
Jessica Chiu |
| K163714 |
07/18/2017 |
OSSIX BONE |
Datum Dental Ltd |
Arie Goldlust |
| K171115 |
07/17/2017 |
3D Endo Software |
Dentsply Sirona |
Karl Nittinger |
| K163137 |
07/12/2017 |
NIRA Beauty Skin Laser |
Dermal Photonics Corporation |
David Bean |
| K170814 |
07/11/2017 |
Devon 24 |
Devon Medical Products (Jiangsu) Ltd. |
Julian Chu |
| K171301 |
07/31/2017 |
Scanmate Flex |
DGH Technology, Inc. |
David Henderson |
| K170798 |
07/14/2017 |
Dictum Health |
Dictum Health, Inc. |
Paul Landesman |
| K170871 |
07/03/2017 |
DigniCap Scalp Cooling System |
Dignitana AB |
Johan Ericsson |
| K163150 |
07/14/2017 |
ViMove2 |
DORSAVI LTD |
DAN RONCHI |
| K162951 |
07/28/2017 |
TUBETECH IV Administration Set |
Douglas Medical Products, Inc. |
Doug Johnson |
| K171539 |
07/14/2017 |
Contact Lens Case |
E-Link Plastic & Metal Industrial Co.,Ltd |
Marvis Lee |
| K170769 |
07/26/2017 |
wireless thermometer |
ECH (Changzhou) Medical Instrument Co., Ltd. |
Yuan Hu |
| K171339 |
07/07/2017 |
EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs |
ECO MEDI GLOVE SDN. BHD |
Suresh Kumar |
| K171824 |
07/18/2017 |
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System |
Edan Instruments Inc |
Alice Yang |
| K170503 |
07/11/2017 |
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages |
EIT Emerging Implant Technologies GmbH |
Barbara Wirth |
| K170637 |
07/14/2017 |
sensiFirm |
EL Global Trade Ltd |
Yael Liebes |
| K171401 |
07/11/2017 |
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 |
ELITechGroup |
Valerie Gourdon |
| K163035 |
07/07/2017 |
DilaCheck Nitrile Powder Free Examination Glove, (Sterile) |
Elm Tree Medical, Inc. |
Eva Martin |
| K170706 |
07/03/2017 |
Equashield Closed System drug Transfer Device (CSTD) |
Equashield Medical Ltd. |
Dorit Valal |
| K161349 |
07/07/2017 |
Everyway Incontinence Stimulation System |
EVERYWAY MEDICAL INSTRUMENT CO., LTD. |
ROBERT TU |
| K170729 |
07/18/2017 |
Examion X-AQS |
Examion GmbH |
Andreas Oppermann |
| K171018 |
07/13/2017 |
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System |
Extremity Medical, LLC. |
Brian Smekal |
| K170786 |
07/18/2017 |
Faxitron Bioptics Speciemen Radiography System |
Faxitron Bioptics LLC |
Douglas C. Wiegman |
| K170842 |
07/31/2017 |
WEGO-PTFE |
Foosin Medical Supplies Inc., Ltd. |
Zhipeng Yang |
| K152257 |
07/21/2017 |
Fujifilm Duodenoscope Model ED-530XT |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
AARON GE |
| K171103 |
07/28/2017 |
Lumipulse G TSH-III Immunoreaction Cartridges |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K171669 |
07/05/2017 |
g.Nautilus PRO |
g.tec medical engineering GmbH |
Christoph Guger |
| K171800 |
07/12/2017 |
OEC Elite MiniView |
GE Hualun Medical Systems Co.Ltd. |
Lifeng Wang |
| K171128 |
07/14/2017 |
SIGNA Premier |
GE Medical Systems, LLC |
Mary A. Mayka |
| K171656 |
07/13/2017 |
Genesys Spine Apache Interbody Fusion System |
Genesys Spine |
Brian J. Bergeron |
| K171838 |
07/19/2017 |
TiLock2 Spinal System |
Genesys Spine |
William W. Sowers |
| K171413 |
07/14/2017 |
HAVENÖ Laminoplasty System, CANOPY« Laminoplasty Fixation System |
Globus Medical Inc. |
Kelly J. Baker |
| K171885 |
07/25/2017 |
Radiance V4 |
GMV Soluciones Globales Internet S.A.U. |
Carlos Illana |
| K162707 |
07/14/2017 |
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload |
Golden Stapler Surgical Co., Ltd. |
Hao Chao |
| K163648 |
07/07/2017 |
Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series |
Grandway Technology (Shenzhen) Limited |
Patrick Chow |
| K163571 |
07/12/2017 |
Great Basin Stool Bacterial Pathogens Panel |
Great Basin Scientific, Inc. |
Suzette Chance |
| K170676 |
07/13/2017 |
HD Lumbar Interbody System |
HD LifeSciences LLC |
Ian Helmar |
| K170090 |
07/14/2017 |
RTHawk, HeartVista Cardiac Package |
HeartVista, Inc. |
James J Rogers |
| K163687 |
07/19/2017 |
OLINDA EXM |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K163486 |
07/24/2017 |
DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Tak· Plates, DuoTak· Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates |
HNM Total Recon, LLC |
Noah Roitman |
| K170318 |
07/12/2017 |
NeoFuse Ti3D PLIF/TLIF/Cervical Interbody |
HT Medical, LLC |
Robert Compton |
| K170812 |
07/26/2017 |
HygePLUS Alginate Impression Material |
HYGEDENT INC. |
Peng Wang |
| K163177 |
07/28/2017 |
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
| K162633 |
07/24/2017 |
Custom Bars |
IMPLANT DIRECT SYBRON MANUFACTURING, LLC |
Reina Choi |
| K163127 |
07/31/2017 |
bellavista 1000 |
IMTMEDICAL AG |
BEAT KELLER |
| K170518 |
07/14/2017 |
In2Bones Fracture and Correction System |
In2BonesUSA, LLC |
Joe Clift |
| K163560 |
07/12/2017 |
Reprocessed AcuNav Diagnostic Ultrasound Catheter |
Innovative Health, LLC. |
Rafal Chudzik |
| K170710 |
07/14/2017 |
True Spinal Fixation System |
Innovative Surgical Designs, Inc. |
Jon Rinehart |
| K171559 |
07/24/2017 |
True Spinal Fixation System |
Innovative Surgical Designs, Inc. |
Jon Rinehart |
| K171092 |
07/10/2017 |
XiniWave II Model ECS322P |
International Trade Group, Inc. |
Brent C. Reider |
| K171699 |
07/28/2017 |
da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System |
Intuitive Surgical, Inc |
Brandon Hansen |
| K170507 |
07/12/2017 |
Invacare« TDX« SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx |
Invacare Corporation |
Elijah N. Wreh |
| K170207 |
07/31/2017 |
Obturys |
Itena Clinical |
Charles Peyre |
| K170313 |
07/27/2017 |
ARIX Ankle Distal Tibia System |
Jeil Medical Corporation |
Sejin RYU |
| K171285 |
07/24/2017 |
ARIX Diaphysis System |
Jeil Medical Corporation |
Yein Han |
| K163194 |
07/14/2017 |
Neodent Implant System - GM Line |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA |
Julianne Lechechem |
| K170941 |
07/07/2017 |
RX NC Takeru PTCA Balloon Dilatation Catheter |
Kaneka Corporation |
Toshihiko Motomine |
| K162992 |
07/07/2017 |
Karl Storz UROMAT E.A.S.I. |
KARL STORZ ENDOSCOPY AMERICA, INC |
SERKAN SEZER |
| K163064 |
07/18/2017 |
Demi Ultra |
KERR CORPORATION |
Mohammad Saad Ansari |
| K162878 |
07/13/2017 |
Kitazato ET Catheters |
Kitazato Corporation |
Mari Yazaki |
| K162881 |
07/11/2017 |
Kitazato OPU Needles |
Kitazato Corporation |
Mari YAZAKI |
| K171040 |
07/31/2017 |
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range |
Koelis |
Laetitia GERVAIS |
| K170397 |
07/10/2017 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy D |
Kossan International Sdn. Bhd. |
Cho Sow Fong |
| K163352 |
07/28/2017 |
Wheelchair |
Kunshan Hi-Fortune Health Products Co.,Ltd. |
HongFa Zhi |
| K170986 |
07/13/2017 |
KATANA Zirconia Block |
Kuraray Noritake Dental Inc. |
Yasujiro Ohara |
| K171813 |
07/13/2017 |
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System |
L&K BIOMED Co., Ltd. |
Yerim An |
| K163159 |
07/19/2017 |
Dario Blood Glucose Monitoring System |
LabStyle Innovations, Ltd. |
Erez Raphael |
| K171753 |
07/21/2017 |
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 |
Leica Biosystems Newcastle Limited |
Bert Peerboom |
| K170239 |
07/05/2017 |
Leica FL560 |
LEICA MICROSYSTEMS (SCHWEIZ) AG |
GRAINNE GRIFFIN |
| K171448 |
07/07/2017 |
Hammertoe Correction System |
Life Spine Inc. |
Randy Lewis |
| K170073 |
07/25/2017 |
LightMed Dental Laser System |
LIGHTMED DENTALTECHNOLOGY CORP. |
APRIL CHENG |
| K171515 |
07/26/2017 |
NHAC 16 |
LMT Medical Systems GmbH |
Thomas Plein |
| K171441 |
07/21/2017 |
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit |
Luminex Corporation |
Wendy Ricker |
| K170841 |
07/26/2017 |
BiopSee, Mobile US |
MedCom GmbH |
Johannes Messow |
| K171333 |
07/18/2017 |
20G x 5/8 Pro-Lock CT Safety Infusion Set |
Medcomp (dba Medical Components, Inc.) |
Courtney Nix |
| K170770 |
07/25/2017 |
CT Midline |
Medical Components, Inc. (dba Medcomp) |
Courtney Nix |
| K171439 |
07/20/2017 |
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, U |
Medos International SARL |
Catherine Kilshaw |
| K171425 |
07/20/2017 |
CONCORDE LIFT |
Medos International, SARL |
Karen Sylvia |
| K171267 |
07/03/2017 |
NavLock Trackers |
Medtronic Navigation |
Nicole Zimmerman |
| K171031 |
07/06/2017 |
CRESCENTÖ Spinal System |
Medtronic Sofamor Danek |
Ankit K. Shah |
| K170532 |
07/21/2017 |
True Form Reshapable Guide Wire |
Merit Medical Systems, Inc. |
Mark Mullaney |
| K163597 |
07/27/2017 |
VacLok AT Vacuum Syringe |
Merit Medical Systems, Inc. |
Angela Brady |
| K170219 |
07/20/2017 |
Microlife Digital Infrared Ear Thermometer |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
GERHARD FRICK |
| K171255 |
07/25/2017 |
Monteris Medical NeuroBlate System |
Monteris Medical, Inc. |
David H. Mueller |
| K163136 |
07/31/2017 |
Youha electric breast pump |
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD. |
Huang Yun Jun |
| K171754 |
07/28/2017 |
NovaPACS |
Novarad Corporation |
Doug Merrill |
| K163005 |
07/27/2017 |
TIGR Matrix Surgical Mesh |
NOVUS SCIENTIFIC AB |
MATS NORBERG |
| K170768 |
07/10/2017 |
Mini Needle |
OcuJect, LLC |
Rebecca K. Pine |
| K171734 |
07/25/2017 |
HP PRO Positioning Device |
Orfit Industries NV |
Eddy Marivoet |
| K171844 |
07/18/2017 |
Inspire ICE aka Inspire ICE Clear Brackets |
Ormco Corporation |
Tara Bonny |
| K171780 |
07/11/2017 |
OrthAlign Plus System |
OrthAlign, Inc. |
David Vancelette |
| K160712 |
07/14/2017 |
VITROS Chemistry Products hsCRP Reagent |
Ortho Clinical Diagnostics |
Marlene Hanna |
| K163048 |
07/28/2017 |
Smart Stitching Software System, Image Processing, Radiological |
OSKO, INC. |
Richard Jeon |
| K171698 |
07/07/2017 |
Smart Syringe |
Osprey Medical, Inc. |
Melanie Hess |
| K170844 |
07/03/2017 |
Gemini-C Hybrid Cervical Interbody System |
Osseus Fusion Systems, LLC |
Robert Pace |
| K171316 |
07/11/2017 |
O2Vent W |
Oventus Manufacturing Pty Ltd |
Hemangi Malde |
| K170867 |
07/25/2017 |
FTRD System Set |
Ovesco Endoscopy AG |
Marc O. Schurr |
| K170435 |
07/12/2017 |
NerveGuard NRFit, NerveGuard LUER |
PAJUNK GmbH Medizintechnologie |
Christian G.H. Quass |
| K170305 |
07/25/2017 |
Spinal Manometer NRFit; Spinal Manometer LUER |
PAJUNK GmbH Medizintechnologie |
Christian G.H. Quass |
| K170923 |
07/24/2017 |
JAWS(TM) Nitinol Staple System |
Paragon 28 |
Frank S. Bono |
| K170852 |
07/19/2017 |
POD Packing Coil |
Penumbra, Inc. |
Aditi Kolla |
| K171055 |
07/06/2017 |
Philips BlueControl |
Philips Electronics Nederland B.V. |
Gaozhen Hang |
| K163584 |
07/07/2017 |
M3290B Philips IntelliVue Information Center iX |
Philips Medical Systems |
Theresa Poole |
| K171461 |
07/07/2017 |
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K171630 |
07/25/2017 |
LumFuse-TP |
Precifit Medical Ltd |
ZhenYu (Eric) Wu |
| K171133 |
07/11/2017 |
Qfix« Abdominal/Thoracic Motion Control System,Qfix« SBRT Solution and Accessories |
Qfix |
Alexandra Nicole Low |
| K171945 |
07/28/2017 |
Discovery Pico, Discovery Pico Plus |
Quanta System S.p.A. |
Francesco Dell'Antonio |
| K171711 |
07/07/2017 |
Thunder, Thunder VT, Thunder HR |
Quanta System S.p.A. |
Francesco Dell'Antonio |
| K172025 |
07/31/2017 |
Litho 60 |
quanta system spa |
Francesco Dell' Antonio |
| K170067 |
07/25/2017 |
Easyret |
Quantel Medical |
Bruno Pages |
| DEN170022 |
07/19/2017 |
QuantX |
Quantitative Insights, Inc |
Robert Tomek |
| K171398 |
07/06/2017 |
Dermal Cooling System |
R2 Dermatology ,Inc |
Kristine Tatsutani |
| K163295 |
07/24/2017 |
Infant Transport Mattress Warmer with Disc |
RAPID AID CORP. |
Laureta Prifti |
| K171666 |
07/06/2017 |
MPR2 logO DATALOGGER |
Raumedic AG |
Reiner Thiem |
| K170567 |
07/06/2017 |
Tempus Pro Patient Monitor |
Remote Diagnostic Technologies Ltd |
Chris Hannan |
| K162470 |
07/11/2017 |
RT300 FES cycle ergometer |
Restorative Therapies, Inc. |
Andrew Barriskill |
| K163633 |
07/28/2017 |
cobas HbA1c Test, cobas b 101 system |
Roche Diagnostics Operations |
Patty Bates |
| DEN150053 |
07/27/2017 |
FETAL PILLOW |
SAFE OBSTETRIC SYSTEMS LTD |
RAJIV VARMA |
| K171093 |
07/19/2017 |
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE |
Sanrea Healthcare Products Pvt Ltd |
JOSE PAUL M. |
| K170182 |
07/19/2017 |
CARDIOVIT FT-1 |
SCHILLER AG |
ZHENRONG YU |
| K171046 |
07/07/2017 |
SeaSpine Cambria System |
SeaSpine Orthopedics Corporation |
Gina Flores |
| K162816 |
07/27/2017 |
SML-OSA2 Appliances |
SELANE PRODUCTS, INC. |
JOHN CHRISTIAN |
| K171615 |
07/31/2017 |
Xingyu Nitrile Powder Free Patient Examination Gloves, White color |
Shandong Xingyu Gloves Co., Ltd |
Xu Qiang |
| K171616 |
07/20/2017 |
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color |
Shandong Xingyu Gloves Co., Ltd |
Xu Qiang |
| K170480 |
07/07/2017 |
Models 3543A, 4343A, 2929A and A843B |
Shanghai PZ Medical Technolgoy Co., Ltd. |
Jeff Moeller |
| K162312 |
07/25/2017 |
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color |
SHEN WEI USA INC. |
CHERYL BAILEY-KROLL |
| K171034 |
07/10/2017 |
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Ma Chao |
| K162698 |
07/14/2017 |
MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer |
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD |
Jie Rao |
| K161845 |
07/31/2017 |
Electronic Blood Pressure Monitor |
Shenzhen Pango Electronic Co.,Ltd. |
Xiaoyun Yang |
| K162867 |
07/26/2017 |
MagDen Dental Implant System |
SHINHUNG MST Co., Ltd. |
Lee Sunbyung |
| K171766 |
07/12/2017 |
Acuson SC2000 Diagnostic Ultrasound System |
Siemens Medical Solutions Inc. |
Kevin Kong |
| K171905 |
07/27/2017 |
VISCO 360 Viscosurgical System |
Sight Sciences, Inc. |
Anne-Marie Ripley |
| K163589 |
07/20/2017 |
SIGN IM Nail |
SIGN FRACTURE CARE INTERNATIONAL |
Robert Schmitt |
| K170613 |
07/17/2017 |
Genius Total Knee System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K162219 |
07/20/2017 |
CADD« Infusion Disposables Portfolio with NRFitÖ connectors |
Smiths Medical ASD, Inc. |
Wendy J. Kivens |
| K170607 |
07/17/2017 |
!M1 |
Solutions For Tomorrow AB |
Martin Yngvesson |
| K171727 |
07/26/2017 |
Hydrocleanse Antimicrobial Skin and Wound Care Solution |
Sonoma Pharmaceuticals |
Brian W. Martin |
| K170999 |
07/12/2017 |
P50 Series Digital Color Doppler Ultrasound System |
SONOSCAPE MEDICAL CORP. |
Toki Wu |
| K171000 |
07/11/2017 |
P60 Series Digital Color Doppler Ultrasound System |
SONOSCAPE MEDICAL CORP. |
Toki Wu |
| K171724 |
07/24/2017 |
Rampart L Lumbar Interbody Fusion Device |
Spineology Inc. |
Jacqueline A. Hauge |
| K161394 |
07/06/2017 |
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux |
Sportarredo Group S.C. |
STEFANO IRIDIO |
| K170379 |
07/19/2017 |
Disposable Standard Clamp |
Standard Bariatrics |
Alison Sathe |
| K171645 |
07/25/2017 |
CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle |
Strukmyer Medical |
Pamela Liberto |
| K171364 |
07/24/2017 |
MP LeFort I Plates |
Stryker |
Gregory Gohl |
| K171807 |
07/18/2017 |
ES2 Neuromonitoring Accessory Instruments |
Stryker Corporation |
Nikin Desai |
| K171149 |
07/18/2017 |
Altrix Temperature Management Wraps |
Stryker Medical |
Brian Orwat |
| K163259 |
07/28/2017 |
AXS Offset Delivery Assist Catheter |
STRYKER NEUROVASCULAR |
Shazia Hakim |
| K170388 |
07/25/2017 |
ANCHORMAN Tibial Ligament Fixation Device |
Summit Medical Ltd. |
Sam Drew |
| K171105 |
07/11/2017 |
AIXPLORER« & AIXPLORER« Ultimate Ultrasound Systems |
Supersonic Imagine |
Laurence HERMITTE |
| K170675 |
07/19/2017 |
Graftgun Universal Graft Delivery System |
Surgentec, LLC |
Travis Greenhalgh |
| K170955 |
07/03/2017 |
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector |
Surgical Instrument Service and Savings Inc (dba Medline ReN |
Brandi Panteleon |
| K162778 |
07/21/2017 |
Portable Slit Lamp Microscope |
SUZHOU KANGJIE MEDICAL INC |
Hong Zhu |
| K171078 |
07/10/2017 |
TRI-COMBO PARASITE SCREEN |
Techlab, Inc. |
Donna T. Link |
| K161527 |
07/21/2017 |
Teco Creatinine Enzymatic Reagent Kit |
TECO DIAGNOSTICS, INC. |
XIAOYAN HU |
| K170399 |
07/06/2017 |
Endoskeleton TO Interbody Fusion Device (IBD) |
Titan Spine, LLC |
Jane Rodd |
| K170549 |
07/05/2017 |
TOKUYAMA CUREGRACE |
Tokuyama Dental Corporation |
Fumio Takahashi |
| K171967 |
07/25/2017 |
MagVita TMS Therapy System |
Tonica Elektronik A/S |
Lise Terkelsen |
| K170832 |
07/21/2017 |
Ultimax-i, DREX-UI80 V1.60 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K171597 |
07/21/2017 |
Vantage Elan 1.5T, V4.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K171962 |
07/24/2017 |
Klassic HD« Hip System |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K171749 |
07/13/2017 |
Velofix(tm) Interbody Fusion System |
U&i Corporation |
Jee Ae Bang |
| K162510 |
07/18/2017 |
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue |
UG GLOBAL RESOURCES SDN. BHD. |
WONG SEE KEONG |
| K171021 |
07/18/2017 |
JO AgapΘ Personal Lubricant |
United Consortium |
Stephanie Morris |
| K162957 |
07/17/2017 |
U2 Femoral Head |
UNITED ORTHOPEDIC CORPORATION |
GIMPEL CHIEN |
| K170187 |
07/28/2017 |
Photodynamic Therapy Device |
UVBIOTEK, LLC |
Dave Oberhelman |
| K170969 |
07/05/2017 |
Eclipse Treatment Planning System |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K171733 |
07/12/2017 |
TrueBeam, TrueBeam STx, Edge |
Varian Medical Systems, Inc. |
Sara Muddell |
| K172013 |
07/28/2017 |
VitalBeam |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K162803 |
07/14/2017 |
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts |
VASCUTEK LTD. |
NEIL MCLACHLAN |
| K162190 |
07/06/2017 |
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) |
VILLA SISTEMI MEDICALI S.P.A. |
PAOLO CASAGRANDE SANTIN |
| K163504 |
07/12/2017 |
Borrelia B31 ViraChip IgG Test Kit |
VIRAMED BIOTECH AG |
MARTIN KINTRUP+ |
| K171029 |
07/14/2017 |
eCareCoordinator |
Visicu Inc. |
Daniel R. Plonski |
| K163232 |
07/21/2017 |
Vitrea View |
Vital Images, Inc |
Fei Li |
| K171607 |
07/31/2017 |
Bronchi and Gastrointestinal Cytology Brush |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
Doris A. Hawks |
| K170224 |
07/06/2017 |
Spider Cervical Plating System |
X-SPINE SYSTEMS, INC. |
KRISS ANDERSON |
| K171423 |
07/27/2017 |
Nasal Alar SpO2 Sensor |
Xhale, Inc |
Jeffrey Hoebelheinrich |
| K163388 |
07/19/2017 |
XPress BCD Breast Compression Device |
XPress BCD, LLC |
Peter Kremers |
| K163400 |
07/26/2017 |
Orbit Inserter |
YPSOMED AG |
STEPHAN AFFOLTER |
| K171069 |
07/07/2017 |
ZELTIQ CoolSculpting System |
ZELTIQ Aesthetics, Inc. |
Shruti Jayakumar |
| K171907 |
07/14/2017 |
Vitality« Spinal Fixation System |
Zimmer Biomet Spine, Inc. |
Kelly Stratton |
