| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K171351 |
09/08/2017 |
Posterior Spine Truss System (PSTS) Interbody Fusion Device |
4Web, Inc. |
Jessee Hunt |
| K162482 |
09/15/2017 |
A.B. DENTAL DEVICES Dental Implants System |
A. B. Dental Device Ltd. |
Gabi Krauss |
| K170183 |
09/27/2017 |
Cetus system, Cetus probe |
A.R.C. Laser GmbH |
Angela Thyzel |
| K171941 |
09/27/2017 |
FreeStyle Precision Neo Blood Glucose Test Strips |
Abbott Diabetes Care Inc. |
Danielle Tayor |
| K171583 |
09/01/2017 |
RhythmView Workstation |
Abbott Electrophysiology |
Dennis Pozzo |
| K172394 |
09/06/2017 |
Steerable Guide Catheter |
Abbott Vascular |
Makena Mc Gowan |
| K171687 |
09/05/2017 |
Relieva SpinPlus Nav Balloon Sinuplasty System |
Acclarent, Inc. |
James Patrick Garvey II |
| K171176 |
09/15/2017 |
M-CATH Microcatheter |
Acrostak (Schweiz) AG |
Carmen Herraez |
| K170442 |
09/07/2017 |
Cranial Drill Bits and Accessories |
Ad-Tech Medical Instrument Corporation |
Lisa Theama |
| K170505 |
09/29/2017 |
SecurePortIV Catheter Securement Adhesive |
Adhezion Biomedical, LLC |
Richard G. Jones |
| K171792 |
09/29/2017 |
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit |
Alere Scarborough, Inc. |
Angela Drysdale |
| K163699 |
09/08/2017 |
ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook |
ALN Implants Chirurgicaux |
Alain Nigon |
| K163664 |
09/18/2017 |
Health-e-Connect System with IDA |
ALR TECHNOLOGIES |
SIDNEY CHAN |
| K171876 |
09/20/2017 |
Ceramill Zolid HT+ white |
Amann Girrbach AG |
Debora Engel |
| K172479 |
09/14/2017 |
Amsel Occluder Device |
Amsel Medical |
Raanan Miller |
| K170231 |
09/15/2017 |
iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)á |
Andon health Co., Ltd |
Yi Liu |
| K172486 |
09/21/2017 |
Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chlo |
Anexa Biomedical, Inc. |
Lenny Budloo |
| K172314 |
09/20/2017 |
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) |
Art Optical Contact Lens Inc |
Mike Johnson |
| K172612 |
09/28/2017 |
FiberTak DX |
Arthex, Inc |
Ivette Galmez |
| K170547 |
09/01/2017 |
Arthrex Mesh Plate System |
Arthrex, Inc. |
Ivette Galmez |
| K171953 |
09/14/2017 |
Bard Mission Disposable Core Biopsy Instrument |
Bard Peripheral Vascular, Inc. |
Susan Sheffield |
| K172544 |
09/22/2017 |
IV Fat Emulsion Administration Sets |
Baxter Healthcare Corporation |
Jill M. Laack |
| K172506 |
09/17/2017 |
BD Cathena Safety IV Catheter |
Becton, Dickinson and Company |
Henry Boland |
| K171664 |
09/13/2017 |
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software |
Bio-Rad Laboratories, Inc. |
Sweta Patel |
| K172150 |
09/15/2017 |
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) |
bioMerieux, Inc |
Cherece L. Jones |
| K170013 |
09/21/2017 |
Eztetic BellaTek Encode Healing Abutments |
BIOMET 3I |
KRUPAL PATEL |
| K171323 |
09/01/2017 |
BIOPHOTAS CELLUMA3 |
Biophotas Inc |
PATRICK JOHNSON |
| K163627 |
09/14/2017 |
Shotel Ankle Arthrodesis Nail System |
BioPro, Inc. |
Dave Mrak |
| K172372 |
09/06/2017 |
QuadraSphere Microspheres |
Biosphere Medical, S.A. |
Alix Fonlladosa |
| K171822 |
09/20/2017 |
NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) |
Biotest Medical Corporation |
Fred Lee |
| K171785 |
09/15/2017 |
WowGoHealth Blood Glucose Monitoring System |
Biotest Medical Corporation |
Fred Lee |
| K171648 |
09/08/2017 |
BM.IRIS |
Bluecore Co.,Ltd. |
Bill Choi |
| K171893 |
09/08/2017 |
Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) |
Bluestone Synergy |
Lisa Peterson |
| K163464 |
09/05/2017 |
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) |
BMC MEDICAL.,LTD. |
Jiang Huiqi |
| K170816 |
09/26/2017 |
Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM |
Brainlab AG |
Rainer Birkenbach |
| K171922 |
09/28/2017 |
Anatotemp Anatomic Dental Implant Healing Abutment |
Buckeye Medical Technologies LLC |
Terry B. Philibin |
| K163510 |
09/06/2017 |
Poseidon Ultrasound System |
BUTTERFLY NETWORK, INC. |
BRIAN SAWIN |
| K172571 |
09/22/2017 |
ULTRASCORE Focused Force PTA Balloon |
C.R. Bard |
Jonathan Holmes |
| K172247 |
09/20/2017 |
Magic3 Go Intermittent Urinary Catheter |
C.R. Bard, Inc. |
Nancy Underwood |
| K172397 |
09/29/2017 |
Sherlock 3CG Tip Positioning System Stylet |
C.R. Bard, Inc. |
Mona Shahrebani |
| K171117 |
09/01/2017 |
Carefusion NeutraClear Needle-free connector (EL-NC1000) |
Cair L.G.L |
Delphine Molinari |
| K172064 |
09/15/2017 |
Ti-Diagon Oblique TLIF |
Camber Spine Technologies |
Daniel Pontecorvo |
| K171986 |
09/22/2017 |
Sterling Supreme Diode Laser |
CAO Group, Inc. |
Robert K. Larsen |
| K171499 |
09/22/2017 |
Occlusion Detection Dressing Kit |
Cardinal Health |
Beth Foster |
| K171531 |
09/11/2017 |
Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle |
CareFusion |
Tamara Brey |
| K172015 |
09/26/2017 |
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) |
Careglove Global Sdn Bhd |
Lim Kwee Shyan |
| K172581 |
09/26/2017 |
CareView 1800Cw X-ray Flat Panel Detectors |
CareRay Digital Medical System Co., Ltd. |
Xu Wei |
| K171408 |
09/29/2017 |
Carbon Monoxide Breath Sensor System (COBSS) |
Carrot Sense, Inc. |
Daniel J. Balbierz |
| K171446 |
09/15/2017 |
Cefaly Acute |
CEFALY Technology |
Jean-Yves Mignolet |
| K172126 |
09/25/2017 |
Xpert Xpress Strep A |
Cepheid |
Yi-Ping Lin |
| K171442 |
09/25/2017 |
Exofin Fusion Skin Closure System |
Chemence Medical, Inc. |
Kenneth Broadley |
| K171686 |
09/15/2017 |
Choice Spine HawkeyeÖ Vertebral Body Replacement (VBR) System |
Choice Spine |
Kim Finch |
| K172385 |
09/14/2017 |
Clarius Ultrasound System |
Clarius Mobile Health Corp. |
Abhijit Ahir |
| K163439 |
09/01/2017 |
NaviENT |
ClaroNav Inc. |
Ahmad Kolahi |
| K171862 |
09/25/2017 |
GALAXY G3 Mini Microcoil Delivery System |
Codman & Shurtleff, Inc |
Yoon Hee Beatty |
| K171541 |
09/20/2017 |
Powder Free Nitrile Examination Gloves (Orange) |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Chan Yew Men |
| K171805 |
09/08/2017 |
Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml |
ConceptoMed AS |
Marit Martinsen |
| K171725 |
09/08/2017 |
CuffLink Implant System |
CONMED Corporation |
Dionne Sanders |
| K162956 |
09/22/2017 |
NOWCARDIO SYSTEM |
CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC. |
RICARDO RODRIGUEZ |
| K170323 |
09/14/2017 |
Entuit Start Initial Placement Gastrostomy Set |
Cook Incorporated |
Erum B. Nasir |
| K170020 |
09/28/2017 |
Peel-Away Introducer Set |
Cook Incorporated |
Colin Jacob |
| K171685 |
09/29/2017 |
Med4 Elite |
Cool Systems, Inc. (dba Game Ready) |
Natalie Kennel |
| K170981 |
09/07/2017 |
NeuroQuant |
CorTechs Labs, Inc |
Kora Marinkovic |
| K163556 |
09/14/2017 |
MediClear PreOp |
COVALON TECHNOLOGIES, INC. |
KIM CROOKS |
| K171358 |
09/01/2017 |
Emprint SX Ablation Platform and Accessories |
Coviden llc |
Patti Arndt |
| K170166 |
09/29/2017 |
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture |
CPT Sutures Co., Ltd. |
Khoa Do |
| K171251 |
09/08/2017 |
014 Hydrophilic Coated PTA Balloon Dilatation Catheter |
Creagh Medical |
Shane Costello |
| K170810 |
09/27/2017 |
CRYOFOS |
CRYOFOS Medical Gmbh |
Gerlinde Hornung-Stehling |
| K171992 |
09/26/2017 |
SculpSure |
Cynosure, Inc |
Amy Tannenbaum |
| K171262 |
09/22/2017 |
TempSure |
Cynosure, Inc |
Amy Tannenbaum |
| K171027 |
09/06/2017 |
Dentis Dental Implant System |
Dentis Co.,Ltd. |
Sun Chul Shin |
| K171126 |
09/07/2017 |
Implantium II |
Dentium Co., Ltd. |
Yoon Spyoon |
| K170487 |
09/11/2017 |
Navina Classic System |
Dentsply Sirona |
Karl Nittinger |
| K171161 |
09/25/2017 |
Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) |
Dimensional Bioceramics LLC |
David Delaney |
| K172481 |
09/14/2017 |
IntelliCart System |
Dornoch Medical Systems |
Larry Smith |
| K171189 |
09/11/2017 |
AIR-FLOW PLUS Prophylaxis powder |
E.M.S. Electro Medical Systems S.A. |
Suzanne Fassio-Hardy |
| K172142 |
09/13/2017 |
FibroScan 430 Mini+ |
Echosens |
Karine Bonenfant |
| K172196 |
09/19/2017 |
ECOMÖ Cardiac Output Monitoring System |
ECOM Medical, Inc |
Guy Lowery |
| K172380 |
09/29/2017 |
U2 Diagnostic Ultrasound System |
Edan Instruments Inc |
Alice Yang |
| K171178 |
09/06/2017 |
Central Monitoring System |
Edan Instruments, Inc. |
Alice Yang |
| K171943 |
09/25/2017 |
Electrocardiograph |
Edan Instruments, Inc. |
Alice Yang |
| K171123 |
09/15/2017 |
Leksell Vantage Stereotactic System |
Elekta Instrument AB |
Matilda Forsberg |
| K170970 |
09/01/2017 |
Epilaser |
Epilady 2000 LLC |
Joseph Miller |
| K171519 |
09/15/2017 |
FLXfitÖ |
Expanding Orthopedics, Inc. |
Ofer Bokobza |
| K171558 |
09/01/2017 |
ExsoMed ITN Cannulated Screw System |
Exsomed Holdings Company, LLC |
Richard Kovach |
| K163209 |
09/14/2017 |
Fiagon Navigation System |
FIAGON GMBH |
Dirk Mucha |
| K171507 |
09/01/2017 |
CustomizedBone Service |
Fin-ceramica faenza spa |
Marina Monticelli |
| K163710 |
09/08/2017 |
BePOD« EZ Weil Screws |
Fournitures Hospitalieres Industrie |
Patricia Donnard |
| K163148 |
09/14/2017 |
BePOD« Foot Screws |
Fournitures Hospitalieres Industrie |
Patricia Donnard |
| K171652 |
09/15/2017 |
Fresenius Liberty Select Cycler |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K171463 |
09/29/2017 |
ASPIRE Bellus II |
FUJIFILM Medical Systems U.S.A., Inc. |
Jyh-Shyan Lin |
| K170032 |
09/08/2017 |
QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP |
Fysicon BV |
C.W.A (Eric) Van Antwerpen |
| K170181 |
09/01/2017 |
Prizma |
G-Medical Innovations Ltd. |
N. Epstein |
| K163302 |
09/01/2017 |
Senographe Pristina |
GE Healthcare |
Camille Vidal |
| K172342 |
09/29/2017 |
Voluson E6, Voluson E8, Voluson E10 |
GE Healthcare |
Bryan Behn |
| K170498 |
09/28/2017 |
Gems Oocyte Retrieval Buffer ORB-20, ORB-50 |
Genea Biomedx Pty Ltd |
Kea Dent |
| K170596 |
09/11/2017 |
TN-Brush |
GENOSS Co. Ltd. |
Hyeyoung Moon |
| K170210 |
09/01/2017 |
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 |
Given Imaging Ltd. |
Hilla Debby |
| K170157 |
09/25/2017 |
INDEPENDENCE« Spacers |
Globus Medical Inc. |
Kelly J. Baker |
| K163611 |
09/19/2017 |
Pain Therapy Device |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K171440 |
09/29/2017 |
Berkeley VC-10 Vacuum Curettage System |
Gyrus ACMI |
Christina Flores |
| K163283 |
09/20/2017 |
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 |
HAMILTON MEDICAL AG |
Steffen Boden |
| K171599 |
09/22/2017 |
WiTouch Pro, WiTouch, Neubac |
Hollywog LLC |
Michael Treas |
| K172566 |
09/20/2017 |
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices |
Hologic, Inc. |
Catherine Sanford |
| K171963 |
09/26/2017 |
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes |
Hologic, Inc. |
Ron Domingo |
| K163465 |
09/08/2017 |
hemochroma PLUS System |
IMMUNOSTICS, INC. |
ANTOINETTE PRUSIK |
| K163577 |
09/25/2017 |
Ecofit« Hip System |
Implantcast GmbH |
Juliane Hoeppner |
| K163525 |
09/05/2017 |
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls |
Inova Diagnostics, Inc. |
Peter Martis |
| K163538 |
09/06/2017 |
QUANTA Flash« LKM-1 Reagents, QUANTA Flash« LKM-1 Calibrators, QUANTA Flash« LKM-1 Controls |
INOVA DIAGNOSTICS, INC. |
ROGER ALBESA |
| K162848 |
09/22/2017 |
Straumann CARES Golden Ti/TiN Abutments |
INSTITUT STRAUMANN AG |
Christopher Klaczyk |
| K170854 |
09/08/2017 |
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls |
Instrumentation Laboratory Co. |
Carol Marble |
| K172595 |
09/28/2017 |
CUSA Excel+ Ultrasonic Surgical Aspirator System |
Integra LifeSciences Corporation |
Alexandra Wells |
| K163326 |
09/29/2017 |
SmartEP |
INTELLIGENT HEARING SYSTEMS |
Edward Miskiel |
| K171632 |
09/19/2017 |
da Vinci Xi Surgical System |
Intuitive Surgical, Inc |
Brandon Hansen |
| K170641 |
09/21/2017 |
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K170644 |
09/11/2017 |
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K170875 |
09/12/2017 |
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories |
Intuitive Surgical, Inc. |
Manjunath Bisalehalli |
| K170645 |
09/11/2017 |
da Vinci Xi EndoWrist Instruments and Accessories |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K170640 |
09/17/2017 |
Endoscope Sterilization Tray |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K170879 |
09/21/2017 |
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories |
Intuitive Surgical, Inc. |
Kunal Gunjal |
| K163270 |
09/25/2017 |
ISEN-Goggles with Data Viewer |
ISENT TECH & TRADING COMPANY,LTD. |
MARTIN LIU |
| K170275 |
09/11/2017 |
Tri Auto ZX2 |
J. MORITA USA, INC. |
KEISUKE MORI |
| K170705 |
09/21/2017 |
ARIX Wrist System |
Jeil Medical Corporation |
Ji won SONG |
| K170368 |
09/11/2017 |
Sterile NS System |
Jeil Medical Corporation |
Seungyong Lee |
| K172513 |
09/14/2017 |
3D Echo |
JointVue LLC |
Mohamed R. Mahfouz |
| K163518 |
09/19/2017 |
Digital Thermometer |
JOYTECH HEALTHCARE CO., LTD |
Ren Yunhua |
| K170262 |
09/28/2017 |
Digital Thermometer |
K-Jump Health Co., Ltd. |
JM Lin |
| K171832 |
09/14/2017 |
Range/Denali/Mesa Spinal System |
K2M, Inc. |
Nancy Giezen |
| K172086 |
09/22/2017 |
MatiraÖ Anterior Cervical System |
Kalitec Direct, LLC |
Keith Cannan |
| K171035 |
09/06/2017 |
Katalyst Mark 1 Muscle Stimulation System |
Katalyst Inc. |
Amish Patel |
| K170286 |
09/18/2017 |
Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA |
Largan Medical Co. Ltd. |
Amy Tien |
| K161434 |
09/28/2017 |
Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) |
LI-TEK ELECTRONICS TECHNOLOGIES |
BARRY YUAN |
| K172109 |
09/27/2017 |
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 ╡g/mL |
Liofilchem s. r. l. |
Fabio Brocco |
| K170179 |
09/18/2017 |
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity |
Lumenis Ltd. |
Amaya De Levie |
| K172659 |
09/28/2017 |
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(gly |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K171051 |
09/13/2017 |
HORIZON Therapy System |
Magstim Company Ltd. |
Tom Campbell |
| K172219 |
09/21/2017 |
Mako Total Knee Application |
MAKO Surgical Corp. |
Karen Ariemma |
| K170168 |
09/14/2017 |
Masimo Rad-97 and Accessories |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K172522 |
09/15/2017 |
Mazor X |
Mazor Robotics Ltd. |
Shiran Conforti |
| K172587 |
09/18/2017 |
Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers |
Medacta International SA |
Stefano Baj |
| K172170 |
09/08/2017 |
APTUS(R) Wrist 2.5 System |
Medartis AG |
Andrea Schweizer |
| K171144 |
09/12/2017 |
Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel |
Medbio LLC. |
Jatin Rajani |
| K170838 |
09/15/2017 |
Medentika CAD/CAM TiBases |
Medentika GmbH |
Gerhard Polzer |
| K170002 |
09/19/2017 |
Medline Blood Collection Set |
Medline Industries, Inc. |
Matt Clausen |
| K170415 |
09/08/2017 |
Medline Hemo-Force DVT Compression Sleeve |
Medline Industries, Inc. |
Matt Clausen |
| K170937 |
09/14/2017 |
VIPER PRIME navigated inserter |
Medos International, SARL |
Karen Sylvia |
| K170381 |
09/07/2017 |
Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini |
Medtronic Advanced Energy |
Heather Valley |
| K172199 |
09/19/2017 |
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium |
Medtronic Sofamor Danek |
Justin O'Connor |
| K171107 |
09/26/2017 |
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Julie Bassett |
| K172117 |
09/11/2017 |
Prelude Pursuit Splittable Sheath Introducer |
Merit Medical Systems, Inc. |
Jacquelyn Huyghue |
| K172309 |
09/29/2017 |
Endoscopic Ultrasound Aspiration Needle |
Micro-Tech (Nanjing) CO.,Ltd. |
Becky Li |
| K163442 |
09/28/2017 |
Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) |
Modern Medical Equipment Manufacturing Limited |
Thomas Tsz Fung Chan |
| K171964 |
09/19/2017 |
LigaMetrics Suture Anchors |
Mortise Medical LLC |
Robert Hoy |
| K171330 |
09/08/2017 |
Nanova Sealant |
Nanova Biomaterials Inc |
Andrew C. Ritts |
| K163674 |
09/22/2017 |
Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry |
NEO COSMETIQUE |
NATHALIE VERNIN |
| K171582 |
09/12/2017 |
NEO Pedicle Screw SystemÖ |
Neo Medical S.A. |
Jonas Larsson |
| K171201 |
09/13/2017 |
NeuViz Prime Multi-slice CT Scanner System |
Neusoft Medical Systems Co., Ltd. |
Shao Xiancheng |
| K171510 |
09/08/2017 |
Footmotion Plating System |
Newclip Technics |
Gaelle Lussori |
| K172433 |
09/07/2017 |
NICO BrainPath |
NICO Corporation |
Sean Spence |
| K171730 |
09/07/2017 |
FuckWater |
Non-Friction Products Inc. |
Marc Barrette |
| K172628 |
09/25/2017 |
PRECICE System |
NuVasive Specialized Orthopedics, Inc. |
Cora Sim |
| K171633 |
09/28/2017 |
NuVasive TLX Interbody System |
NuVasive, Incorporated |
Cynthia Adams |
| K171894 |
09/28/2017 |
NuVasive« PreceptÖ Spinal System |
NuVasive, Incorporated |
Marysa Loustalot |
| K171232 |
09/21/2017 |
PeriView FLEX |
Olympus Surgical Technologies America |
Mary Anne Patella |
| K171965 |
09/28/2017 |
Resection Electrodes with HF cable |
Olympus Winter & Ibe GmbH |
Jan-Oliver Upmeier |
| K163338 |
09/01/2017 |
OMNIBotics Knee System |
OMNllife Science Inc. |
Daniel Decruppe |
| K170822 |
09/11/2017 |
Electronic Caries Detector |
Ortek Therapeutics, Inc. |
Mitchell Goldberg |
| K163433 |
09/18/2017 |
VITROS Chemistry Products GLU Slides |
Ortho Clinical Diagnostics |
Darlene J. Phillips |
| K171211 |
09/27/2017 |
OIC External Fixation System |
Orthopaedic Implant Company |
Douglas Fulton |
| K171334 |
09/08/2017 |
Indego |
Parker Hannifin Corporation |
Achilleas Dorotheou |
| DEN160018 |
09/14/2017 |
reSet |
PEAR THERAPEUTICS, INC. |
NANDINI MURTHY |
| K171936 |
09/27/2017 |
Peerbridge Cor(TM) System |
Peerbridge Health INc. |
Arthur A. Bertolero |
| K170704 |
09/08/2017 |
The Locking Pediatric Osteotomy Plate (LolliPOP) System |
Pega Medical Inc. |
Ariel R. Dujovne |
| K163614 |
09/20/2017 |
PENTAX Medical ED34-i10T, Video Duodenoscope |
PENTAX Medical |
Kanchana Iyer |
| K171184 |
09/21/2017 |
Persyst Mobile App |
Persyst Development Corporation |
Dari Darabbeigi |
| K170527 |
09/15/2017 |
Phoenix Clinical ICON |
Phoenix Technology Group, Inc. dba Phoenix Clinical |
Christopher A. Henderson |
| K171359 |
09/13/2017 |
Pollogen Legend+ System |
Pollogen Ltd. |
Ilana Dessow Lironne |
| K171667 |
09/08/2017 |
Powder Free Nitrile Examination Glove |
Professional Latex Sdn Bhd |
Yoon Lim Kok |
| K172279 |
09/20/2017 |
PMT Posterior Fixation System |
Providence Medical Technology, Inc. |
Edward Liou |
| K163590 |
09/15/2017 |
Psychemedics Microplate EIA for Benzodiazepines in Hair |
Psychemedics Corporation |
Virginia Hill |
| K171215 |
09/27/2017 |
QiF Blood and Fluid Warmer |
Quality In Flow Ltd. |
Neta Sherman |
| K163462 |
09/21/2017 |
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX |
Radiometer Medical ApS |
Per Pape Thomsen |
| K172489 |
09/07/2017 |
Reliance Cervical IBF System |
Reliance Medical Systems, LLC |
Bret M. Berry |
| K163666 |
09/15/2017 |
neuro inspire |
Rensihaw plc |
Roberto Liddi |
| K171212 |
09/28/2017 |
AirFit N20 |
ResMed Ltd |
Kim Kuan LEE |
| K171770 |
09/12/2017 |
cobas Cdiff Nucleic acid test for use on the cobas Liat System |
Roche Molecular Systems, Inc. |
Clare Santulli |
| K161719 |
09/21/2017 |
Salter Labs Bubble Humidifier |
SALTER LABS |
MARA CALER |
| K163215 |
09/13/2017 |
AnemoCheck |
SANGUINA, LLC |
ERIKA TYBURSKI |
| K171661 |
09/27/2017 |
Scopis Extended Instrument Set EM |
Scopis GmbH |
Christopher ╓zbek |
| K171537 |
09/12/2017 |
CAPI 3 Hb A1c |
Sebia |
Karen Aderson |
| K171726 |
09/25/2017 |
LapBag |
Sejong Medical Co., Ltd. |
Yoojung Choi |
| K171378 |
09/14/2017 |
Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs |
SEMPERIT INVESTMENTS ASIA PTE. LTD. |
Clemens Eichler |
| K171317 |
09/11/2017 |
Clear Vinyl Powder-free Patient Examination Gloves |
Shandong Zhi Hong Medical Products, Co. Ltd. |
Jennifer Guo |
| K171460 |
09/24/2017 |
Powder-free Clear Vinyl Patient Examination Gloves |
Shandong Zhiwei Medical Products, Co. Ltd. |
Carrie Wu |
| K163422 |
09/18/2017 |
Shanghai Sanyou PEEK Cage System |
SHANGHAI SANYOU MEDICAL CO, LTD |
David Fan |
| K170047 |
09/09/2017 |
All-in-One Health Monitor, PC-303 |
Shenzhen Creative Industry Co., Ltd. |
Jia Wang |
| K163135 |
09/19/2017 |
Finger Pulse Oximeter |
SHENZHEN FITFAITH TECHNOLOGY CO.,LTD |
Yuan Junfeng |
| K161586 |
09/06/2017 |
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) |
SHENZHEN HOMED MEDICAL DEVICE CO., LTD |
Shengming Shi |
| K171891 |
09/21/2017 |
ZS3 Ultrasound System, z.one pro Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Zhai Pei |
| K171233 |
09/12/2017 |
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd |
Zhai Pei |
| K170855 |
09/07/2017 |
T-Rex Standalone ALIF |
SIATS, LLC |
Robert Compton |
| K172521 |
09/20/2017 |
PICO Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Samantha Neilson |
| K172519 |
09/15/2017 |
PICO Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Samantha Neilson |
| K172545 |
09/22/2017 |
SERI Contour |
Sofregen Medical, Inc. |
Anh Hoang |
| K170758 |
09/22/2017 |
Thermage FLX System and Accessories |
Solta Medical |
Melissa Thomas |
| K172082 |
09/21/2017 |
S60 Series Digital Color Doppler Ultrasound System |
Sonoscape Medical Corp. |
Toki Wu |
| K163292 |
09/08/2017 |
Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford |
SPECTRA MEDICAL DEVICES |
SCOTT HENDERSON |
| K172101 |
09/26/2017 |
ROMEO« 2 Posterior Osteosynthesis System |
Spineart |
Franck Pennesi |
| K172065 |
09/29/2017 |
SCARLET AC-T |
SPINEART |
Franck PENNESI |
| K163407 |
09/29/2017 |
Confirm Rx Insertable Cardiac Monitor (ICM) System |
St. Jude Medical, Inc. |
Jennifer Dunham |
| K172375 |
09/06/2017 |
MicroSTAAR Injector System Cartridges |
STAAR Surgical Company |
Kate Ueda |
| K170956 |
09/22/2017 |
SYSTEM 1E Liquid Chemical Sterilant Processing System |
STERIS Corporation |
Tricia Cregger |
| K171728 |
09/28/2017 |
MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm |
Sterngold Dental, LLC |
Maria Rao |
| K171840 |
09/15/2017 |
Stryker Consolidated Operating Room Equipment (CORE) 2 Console |
Stryker Corporation |
Nicholas Werner |
| K171496 |
09/06/2017 |
Tritanium C Anterior Cervical Cage |
STRYKER SPINE |
Deborah Cynamon |
| K162171 |
09/07/2017 |
S4 Screw SystemÖ |
SUBCHONDRAL SOLUTIONS |
SHERYL MCCOY |
| K163448 |
09/01/2017 |
GrindCare System |
SUNSTAR SUISSE S.A. |
Olivier Ducamp |
| K163455 |
09/28/2017 |
SurgiCube |
SURGICUBE INTERNATIONAL B.V. |
GER VIJFVINKEL |
| K170802 |
09/28/2017 |
TRAUMACEMÖ V+ Injectable Bone Cement |
Synthes (USA) Products, LLC |
Christopher J. Medberry |
| K171309 |
09/29/2017 |
BR-FHUS Navigation 1.0 |
TaiHao Medical Inc. |
Hsin Hung Lai |
| K170482 |
09/27/2017 |
Spider Frame External Fixation System |
TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S |
Sumru Alperen |
| K170118 |
09/21/2017 |
Scanostics UTI Check Application Test System |
Teco Diagnostics |
Ling Koh |
| K170417 |
09/15/2017 |
Glidewire GT |
Terumo Corporation |
Monika McDole-Russell |
| K172501 |
09/21/2017 |
iNSitu Total Hip System |
Theken Companies, LLC |
Dale Davison |
| K171829 |
09/21/2017 |
EndoNaut |
Therenva SAS |
Matthis HAMY |
| K172048 |
09/05/2017 |
FluidSmart |
THERMEDX, LLC |
Homer Gregory |
| K171795 |
09/29/2017 |
Thommen Implant System |
Thommen Medical AG |
Daniel Snetivy |
| K170185 |
09/12/2017 |
tremoFlo C-100 Airwave Oscillometry System |
THORASYS Thoracic Medical Systems, Inc. |
Sebastien Jutras |
| K172299 |
09/19/2017 |
Accordion Piccolo Stone Management Device |
THS International, Inc. d/b/a Accordion Medical |
David Quigley |
| K170985 |
09/25/2017 |
Urbanek Device |
TMJ Services, LLC |
Anthony Urbanek |
| K170409 |
09/12/2017 |
PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System |
Topcon Medical Laser Systems, Inc. (TMLS) |
Sweta Srivastava |
| K171303 |
09/22/2017 |
Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 |
University of Texas Medical School at Houston, Texas |
K. Lance Gould |
| K172356 |
09/15/2017 |
BladderScan Prime PLUS System |
Verathon Incorporated |
Swapna Chirala |
| K170162 |
09/26/2017 |
Vesco Medical Nasoenteric Feeding Tubes |
Vesco Medical, LLC |
Chris O'Keefe |
| K170378 |
09/14/2017 |
AirLife Adult Heated Wire BiPAP/NIV Circuit |
Vyaire Medical |
Sharon Nichols |
| K172420 |
09/29/2017 |
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim |
Wear Safe (Malaysia) Sdn. Bhd. |
Cho Sow Fong |
| K172120 |
09/14/2017 |
Veress Needle |
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. |
Haobin Li |
| K170292 |
09/20/2017 |
Tri-Ex Extraction Balloon With Multiple Sizing |
WILSON-COOK MEDICAL, INC |
TIFFANNY A. THOMAS |
| K162828 |
09/18/2017 |
Winback Back 3SE |
WINBACK USA CORP |
CHEICK KONGO |
| K171852 |
09/21/2017 |
DARCO Locking Bone Plate System |
Wright Medical Technology, Inc. |
Val Myles |
| K171067 |
09/11/2017 |
INVISION Total Ankle Revision System |
Wright Medical Technology, Inc. |
Val Myles |
| K170119 |
09/29/2017 |
Calix Lumbar Spinal Implant System |
X-Spine Systems, Inc. |
Charlene Brumbaugh |
| K170041 |
09/07/2017 |
XableCath Support Catheter |
XABLECATH, INC. |
RICK GAYKOWSKI |
| K172080 |
09/29/2017 |
Photoelectric Therapy System |
Xstrahl Ltd. |
Andrew Mullen |
| K172631 |
09/29/2017 |
Arisure Dry Spike |
Yukon Medical |
Todd Korogi |
| K171804 |
09/21/2017 |
Zap-X Radiosurgery System |
Zap Surgical Systems |
Radhika Mohan Bodduluri |
| K172275 |
09/27/2017 |
Vitality« Spinal Fixation System, Vitality«+ Power Instrument System |
Zimmer Biomet Spine, Inc. |
Kelly Stratton |
