| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K160546 |
06/09/2016 |
3M Attest Rapid Readout Biological Indicator |
3M COMPANY |
Matt Mortensen |
| K161559 |
06/23/2016 |
Kuvia3D |
4QIMAGING, LLC DBA QMETRICS |
EDWARD SCHREYER |
| K153436 |
06/06/2016 |
LATERAL Spine Truss System |
4Web, Inc. |
Jessee Hunt |
| K153730 |
06/15/2016 |
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control |
Abbott Laboratories |
Laura Yelvigi Joglekar |
| K153456 |
06/14/2016 |
Megapulse III Shortwave Diathermy |
Accelerated Care Plus |
Patrick Parker |
| K161144 |
06/24/2016 |
iDMS Data Management System |
ACCURAY INCORPORATED |
Elizabeth Osuna |
| K161136 |
06/24/2016 |
Precision Treatment Planning System |
ACCURAY INCORPORATED |
Shweta Kaushik |
| K161146 |
06/24/2016 |
Radixact Treatment Delivery System |
ACCURAY INCORPORATED |
Keith Picker |
| K160264 |
06/01/2016 |
Additive Orthopaedics Hammertoe Correction System |
Additive Orthopaedics, LLC |
Greg Kowalczyk |
| K153552 |
06/01/2016 |
AGE Automatic Upper Arm Blood Pressure Monitor |
Ageless Health Industrial Co., Ltd |
Victor Wan |
| K161061 |
06/22/2016 |
IMPAX Volume Viewing 4.0 |
AGFA HEALTHCARE N.V. |
Koen Cobbaert |
| K160364 |
06/10/2016 |
VersaWrap Tendon Protector |
Alafair Biosciences Inc |
Ben Walthall |
| K161247 |
06/30/2016 |
Relizorb |
Alcresta Therapeutics, Inc. |
Robert Gallotto |
| K161364 |
06/17/2016 |
BinaxNOW G6PD Test |
ALERE SCARBOROUGH, INC. |
Angela Drysdale |
| K152122 |
06/24/2016 |
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) |
ALFA SCIENTIFIC DESIGNS, INC. |
MICHAEL CHANG-CHIEN |
| K152576 |
06/02/2016 |
Anker II Dental Implant System |
Alliance Global Technology Co., Ltd. |
YAYUAN CHANG |
| K161363 |
06/10/2016 |
Arsenal Spinal Fixation System |
ALPHATEC SPINE, INC |
RENEE MURPHY |
| K161342 |
06/15/2016 |
Sonic Window |
ANALOGIC CORPORATION |
MICHAEL J. DOYLE |
| K153288 |
06/01/2016 |
Voyant Open Fusion Device |
APPLIED MEDICAL RESOURCES |
JESSICA CHO |
| K153632 |
06/16/2016 |
Endoform Reconstructive Template |
Aroa Biosurgery Limited (Formerly Mesynthes Limited) |
Yasmin Rai |
| K160669 |
06/24/2016 |
ClariFix Device |
ARRINEX, INC. |
VAHID SAADAT |
| K160018 |
06/13/2016 |
Arrow Quickflash Arterial Catheterization Device |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) |
TRACY LARISH |
| K161539 |
06/30/2016 |
Arthrosurface Bone Screws |
ARTHROSURFACE, INC. |
DAWN J. WILSON |
| K161362 |
06/14/2016 |
ASAHI Corsair Armet |
Asahi Intecc Co., Ltd. |
Carroll Councilman |
| K153106 |
06/21/2016 |
ASAHI Fielder XT-A, ASAHI Fielder XT-R |
ASAHI INTECC CO., LTD. |
Yoshihiko Fukui |
| K160430 |
06/24/2016 |
Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System |
Ascensia Diabetes Care US Inc. |
Jennifer L. Gregory |
| K153165 |
06/01/2016 |
NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit |
ASTUTE MEDICAL, INC |
Karin Hughes |
| K161297 |
06/07/2016 |
Beta-2-Microglobulin |
Beckman Coulter Ireland Inc. |
Eimear Carr |
| K160578 |
06/29/2016 |
Nustat XR |
Beeken Biomedical, LLC |
DAN O'HARA |
| K152984 |
06/03/2016 |
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes |
BIO PROTECH, INC. |
DANIEL WOO |
| K160911 |
06/28/2016 |
VIDAS B.R.A.H.M.S. PCT (PCT) |
bioMerieux, Inc |
Thi My Lan Dang |
| K160071 |
06/16/2016 |
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis |
Biomet, Inc. |
Carmen Albany |
| K160204 |
06/09/2016 |
BSD4343 Digital Flat Panel X-ray Detector |
BONTECH INC. |
Kwang S. Choi |
| K160751 |
06/14/2016 |
Symphion Endoscope and Symphion Cervical Sheath |
BOSTON SCIENTIFIC |
BROOKE CUDDY |
| DEN150040 |
06/03/2016 |
WallFlex Biliary RX Fully Covered Stent System RMV |
BOSTON SCIENTIFIC |
THOMAS HIRTE |
| K161003 |
06/17/2016 |
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Fee |
BOSTON SCIENTIFIC CORPORATION |
VIRGINIA GARCIA |
| K160823 |
06/23/2016 |
NC Quantum Apex PTCA Dilatation Catheter |
BOSTON SCIENTIFIC CORPORATION |
JANE HORAN |
| K160514 |
06/22/2016 |
OptiCross 18, 30 MHz Peripheral Imaging Catheter |
BOSTON SCIENTIFIC CORPORATION |
Eric Elliott |
| K161134 |
06/20/2016 |
Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator |
BOVIE MEDICAL CORPORATION |
BRIAN KUNST |
| K161183 |
06/03/2016 |
Halo One Thin-Walled Guiding Sheath |
C.R. BARD, INC |
FIONA NI MHULLAIN |
| K153393 |
06/28/2016 |
PowerMidline Catheter |
C.R. BARD, INC |
Casey Coombs |
| K151985 |
06/14/2016 |
PowerPICC« EtOH Catheter and PowerPICC SOLO«2 EtOH Catheter |
C.R. Bard, Inc |
Bryan Stone |
| K153280 |
06/02/2016 |
PowerGlide Pro Midline Catheter |
C.R. BARD, INC. |
CASEY COOMBS |
| K161024 |
06/28/2016 |
Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape |
Canadian Technical Tape, Ltd. |
Howard Cohen |
| K153312 |
06/28/2016 |
SCATTER CORRECTION FOR CXDI SERIES |
CANON, INC |
SHINJI MORI |
| K161556 |
06/30/2016 |
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit |
Centers for Disease Control and Prevention (CDC) |
Yon Yu |
| K153181 |
06/08/2016 |
MAIA |
CENTERVUE SPA |
ROBERTO GABRIOTTI |
| K160901 |
06/29/2016 |
Xpert Carba-R |
CEPHEID |
SCOTT A. CAMPBELL |
| K160775 |
06/03/2016 |
ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
CHOICE SPINE LP |
KIM FINCH |
| K152600 |
06/23/2016 |
Collagen Dental Wound Dressings |
COLLAGEN MATRIX, INC. |
GLORIA ZUCLICH |
| K161366 |
06/14/2016 |
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) |
CONFORMIS, INC. |
AMITA SHAH |
| K151229 |
06/02/2016 |
ABC D-FLEX PROBE |
CONMED CORPORATION |
SANDY LECLAIR |
| K152863 |
06/22/2016 |
Portable ECG Monitor |
CONTEC MEDICAL SYSTEMS CO., LTD |
XUEYONG LI |
| K160891 |
06/24/2016 |
Ultrathane Endoureterotomy Stent Set |
Cook Incorporated |
Kara Kanorr |
| K152893 |
06/03/2016 |
Corin Optimized Positioning System (OPS) |
CORIN USA |
Kathy Trier |
| K160539 |
06/15/2016 |
BiZact Open Sealer/Divider |
COVIDIEN |
Sharon McDermott |
| K161045 |
06/17/2016 |
Monoject |
Covidien |
Sona Manickam |
| K153749 |
06/30/2016 |
3 Series Phototherapy Unit |
DAAVLIN DISTRIBUTING COMPANY |
MICHELE THIEL |
| K160005 |
06/07/2016 |
Contact Lens Case (multiple brand name) |
DANYANG CHANXIN GLASSES CASES FACTORY |
LEMON CHEN |
| K151987 |
06/01/2016 |
DCI Edge Dental Chair with Operative Unit |
DCI |
ROBERT BELLINGHAM |
| K152246 |
06/21/2016 |
Aquarius Stoma Measuring Device |
DEGANIA SILICONE LTD |
ZOYA LEE |
| K160926 |
06/28/2016 |
F1 MPS Modular Pedicle Screw System |
Degen Medical |
Craig Black |
| K160498 |
06/15/2016 |
Dentivera Milling Disc |
Dental Solutions, LLC |
Kendra Shoulders |
| K160213 |
06/21/2016 |
s-Clean Tapered II RBM Implant System |
Dentis Co., Ltd. |
Sun Chul Shin |
| K160232 |
06/07/2016 |
Disposable Barrier Sleeves and Covers |
DENTSPLY International Inc. |
Helen Lewis |
| K160700 |
06/10/2016 |
ATTUNE Revision Knee System |
Depuy (Ireland) |
Jaime Weeks |
| K161526 |
06/30/2016 |
LIAISON CMV IgM Serum Control Set |
DiaSorin Inc. |
JOHN WALTER |
| K161522 |
06/30/2016 |
LIAISON EBV IgM Serum Control Set |
DiaSorin Inc. |
John Walter |
| K152667 |
06/09/2016 |
ATOVEN-Reusable Laser Fiber |
DIOTECH CO |
LEE KYUNG YONG |
| K153704 |
06/03/2016 |
Strive |
DJO, LLC |
Rand Daoud |
| K161444 |
06/21/2016 |
DBSWIN and VistaEasy Imaging Software |
Duerr Dental AG |
Oliver Lange |
| K152937 |
06/23/2016 |
EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented |
ECO MEDI GLOVE SDN. BHD. |
SURESH KUMAR |
| K151137 |
06/07/2016 |
X-VIEW, IMAGEN |
EDLEN IMAGING LLC |
NICK RADACHI |
| K160552 |
06/01/2016 |
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform |
EDWARDS LIFESCIENCES, LLC |
Tara Viviani |
| K160645 |
06/16/2016 |
PreSep Oligon Oximetry Catheter |
EDWARDS LIFESCIENCES, LLC |
Deana Boushell |
| K160668 |
06/03/2016 |
HumaPen Savvio |
Eli Lilly and Company, Inc. |
Christine A. Phliips |
| K153353 |
06/23/2016 |
SANDMAN ELITE |
EMBLA SYSTEMS |
SHANE T. SAWALL |
| K152918 |
06/02/2016 |
Gun Oil, Pink, Gun Oil H2O, Pink Water |
EMPOWERED PRODUCTS, INC. |
MATT CARR |
| K161482 |
06/27/2016 |
EndoChoice Water Bottle Cap Irrigation System |
ENDOCHOICE, INC. |
DAINEL HOEFER |
| K161147 |
06/07/2016 |
EndoCure Model EUR078A |
ENDOCURE TECHNOLOGIES, INC. |
CHARLES J. NEFF |
| K153164 |
06/03/2016 |
LunulaLaser |
ERCHONIA MEDICAL, INC. |
STEVE SHANKS |
| K160752 |
06/29/2016 |
HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length |
ETHICON ENDO-SUREGERY, LLC |
MARJORIE MEDINA |
| K153611 |
06/03/2016 |
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device |
Ethicon, LLC |
Marjorie Medina |
| K160697 |
06/28/2016 |
Gibralt« Spine System and Gibralt« Occipital Spine System |
Exactech, Inc. |
Dawn Davisson |
| K153057 |
06/23/2016 |
FitRiteÖ Total Hip Arthroplasty System |
EXCERA ORTHOPEDICS, INC. |
SCOTT COLERIDGE |
| K153372 |
06/30/2016 |
Repagyn vaginal suppositories |
FARMA-DERMA S.R.L. |
MARA CALZOLARI |
| K160573 |
06/01/2016 |
FirstSense Breast Exam |
First Sense Medical, LLC |
Paul G. Angott |
| K160540 |
06/23/2016 |
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM |
FLEXICARE MEDICAL LIMITED |
JOEL BIDDLE |
| K152737 |
06/29/2016 |
Lite Touch |
FOCUS MEDICAL LLC |
JOHN B LEE |
| K161186 |
06/29/2016 |
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
SHRADDHA MORE |
| K153136 |
06/30/2016 |
Initial LiSi Press |
GC AMERICA INC. |
MARK HEISS |
| K160131 |
06/21/2016 |
OEC Elite MiniView |
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
LIFENG WANG |
| K160618 |
06/09/2016 |
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T |
GE MEDICAL SYSTEMS, LLC |
Jason Ma |
| K153713 |
06/07/2016 |
Getinge Series Warming Cabinet |
GETINGE SOURCING, LLC |
BARB SMITH |
| K153517 |
06/24/2016 |
AnyPlus« Cervical PEEK Cage System |
GS Medical Co., Ltd. |
Milan George |
| K153388 |
06/07/2016 |
IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IM |
GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. |
BANGFU SUN |
| K161214 |
06/27/2016 |
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
Bin Chen |
| K160763 |
06/29/2016 |
ally Liquid Personal Lubricant |
GUY & O'NEILL, INC. |
THOMAS MISGEN |
| K160717 |
06/14/2016 |
ally Warming Liquid Personal Lubricant |
GUY & O'NEILL, INC. |
THOMAS MISGEN |
| K152744 |
06/10/2016 |
DIEGO ELITE DRILL |
GYRUS ACMI, INC |
DOLAN MILLS |
| K161156 |
06/14/2016 |
Full Automatic (NIBP) Blood Pressure Monitor |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K153740 |
06/30/2016 |
RTHawk, HeartVista Cardiac Package |
HeartVista, Inc. |
James J Rogers |
| K152251 |
06/10/2016 |
Endobronchial Tube |
HENAN TUOREN MEDICAL DEVICE CO., LTD |
MEIZI ZHANG |
| K161188 |
06/09/2016 |
HEPATIQ 1.1 |
HEPATIQ LLC |
DIPU GHOSH |
| K153056 |
06/01/2016 |
Hermes Medical Imaging Suite v5.6 |
HERMES MEDICAL SOLUTIONS, AB |
JOAKIM ARWIDSON |
| K153719 |
06/03/2016 |
LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream |
HONEYWELL HOMMED, LLC |
Greg Lillegard |
| K160870 |
06/01/2016 |
Hospira Administration Sets |
HOSPIRA, INC. |
DAVID BLONSKI |
| K160265 |
06/17/2016 |
Image Navigator by Immuno Concepts |
Immuno Concepts, NA, Ltd. |
Eric S. Hoy |
| K160995 |
06/10/2016 |
NEOVIEW Plating System |
In2Bones SAS |
Morgane Grenier |
| K153692 |
06/24/2016 |
Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer |
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) |
JULIE PASCHAL |
| K160496 |
06/10/2016 |
Reprocessed Inquiry Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
Rafal Chudzik |
| K152635 |
06/01/2016 |
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls |
INOVA DIAGNOSTICS, INC. |
Gabriella Lakos |
| K160468 |
06/23/2016 |
Synthetic Vinyl Examination Gloves, Powder-Free, Yellow |
INPRO TECHNOLOGY DEVICE FACTORY |
WANG YANMEI |
| K160238 |
06/14/2016 |
Airborne Phototherapy Light |
INTERNATIONAL BIOMEDICAL |
Amy Pieper |
| K153472 |
06/23/2016 |
Quiver Laparoscopic Extendable |
ITL Corporation PTY LTD |
Emily Rossiter |
| K152606 |
06/28/2016 |
Jeesung Safety Syringe and Single Use Needles |
JEESUNG MEDICAL CO LTD |
Choi Yong Hyun |
| K161421 |
06/24/2016 |
Single Use Surgical Suction Irrigator |
JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD. |
Vivian Sun |
| K160602 |
06/23/2016 |
JustRight Surgical Vessel Sealing System |
JustRight Surgical |
Jenifer Kennedy |
| K160451 |
06/20/2016 |
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
MELANIE AVILA |
| K160474 |
06/07/2016 |
DSM Biomedical Porcine Pericardium Dental Membrane |
Kensey Nash Corporation dba DSM Biomedical |
Brianna Schehr |
| K160334 |
06/21/2016 |
Advanced Medical Imaging Software Suite (KSWVWR) |
KEOSYS SAS |
Laurence BOY-MACHEFER |
| K160441 |
06/30/2016 |
Identic and KromaFaze Alginate Dental Impression Materials |
KERR CORPORATION |
Mohammad Saad Ansari |
| K152856 |
06/02/2016 |
Helios III |
LASEROPTEK CO. LTD. |
HONG CHU |
| K161101 |
06/22/2016 |
PolypVac Microdebrider (3.3mm and 4.0mm) |
LAURIMED LLC |
BRIAN R DUBOIS |
| K160644 |
06/30/2016 |
Lelo Hex Natural Rubber Latex Condom |
LELO Inc. |
Pavle Sedic |
| DEN150007 |
06/13/2016 |
Magnetic Surgical System |
Levita Magnetics International Corp. |
Cindy Domecus |
| K160169 |
06/23/2016 |
The Life Spine Subtalar Implant System |
Life Spine |
Randy Lewis |
| K160130 |
06/29/2016 |
BloodSTOP iX Battle Matrix |
LifeSciencePLUS Inc. |
Audrey Vitale |
| K152843 |
06/24/2016 |
Liger Medical HTU-110 |
LIGER MEDICAL, LLC |
STEVE SMITH |
| K160878 |
06/29/2016 |
OPTIS Metallic Stent Optimization E.4 SW |
LIGHTLAB IMAGING, INC. |
PADMINI SURAVARAM |
| K152688 |
06/15/2016 |
LightLas Multi-Wavelength Medical Laser System |
LIGHTMED CORPORATION |
Mollie Li |
| K161476 |
06/24/2016 |
SMR Shoulder System |
Limacorporate S.p.A. |
Sara Viel |
| K153569 |
06/22/2016 |
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml |
LIOFILCHEM S.R.L |
Fabio Brocco |
| K161495 |
06/30/2016 |
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) |
LUMINEX CORPORATION |
CHRISTIE HUGHES |
| K152961 |
06/03/2016 |
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit |
MAINE STANDARDS COMPANY LLC |
JAMES CHAMPLIN |
| K160526 |
06/09/2016 |
Masimo O3 Regional Oximeter System |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K153225 |
06/21/2016 |
Masimo Root Monitoring System and Accessories |
Masimo Corporation |
Marguerite Thomlinson |
| K153659 |
06/10/2016 |
MaxO2ME |
MAXTEC, LLC |
JERALD WILSON |
| K153273 |
06/29/2016 |
MySpine Pedicle Screw Placement Guides - LP |
Medacta International SA |
Michael G Loiterman |
| K152585 |
06/24/2016 |
Resmon PRO FULL |
MEDICAL GRAPHICS CORP. |
JIM PURDIE |
| K152519 |
06/02/2016 |
MTR550 (Tentative) Antimicrobial Silver Wound Gel |
MEDICAL TECHNOLOGY RESEARCH INC. |
Bhalchandra M. Karandikar |
| K152458 |
06/01/2016 |
Gemini Bonded Sterilization Wrap |
MEDLINE INDUSTRIES, INC. |
Jennifier Mason |
| K161035 |
06/13/2016 |
Medline Singe Patient Use Blood Pressure Cuff |
MEDLINE INDUSTRIES, INC. |
Matt Clausen |
| K161001 |
06/09/2016 |
MILAGRO ADVANCE PEEK Interference Screw |
MEDOS INTERNATIONAL SARL |
Kristine Christo |
| K160829 |
06/13/2016 |
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 |
MERIDIAN BIOSCIENCE, INC. |
MICHELLE L. SMITH |
| K160625 |
06/14/2016 |
Disposable Hot Biopsy Forceps |
MICRO-TECH (NANJING) CO., LTD. |
BECKY LI |
| K153739 |
06/28/2016 |
MRI Patient Monitor TeslaDUO |
MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN |
HANS SCHWAIGER |
| K160400 |
06/08/2016 |
Miromatrix Biological Mesh |
MIROMATRIX MEDICAL INC. |
JEFF ROSS |
| K153078 |
06/28/2016 |
LED Curing Light GT-2000 |
MONITEX INDUSTRIAL CO., LTD. |
Shu-Lung Wang |
| K160427 |
06/03/2016 |
dynaMX(TM) Nitinol Compression Screw |
MX ORTHOPEDICS CORP. |
HOWARD L. SCHRAYER |
| K160874 |
06/28/2016 |
Nanovis Intervertebral Body Fusion System and FortiCore« |
NANOVIS LLC |
Matthew Hedrick |
| K160209 |
06/21/2016 |
Gold Anchor |
NASLUND MEDICAL AB |
Tomas Naslund |
| K152301 |
06/03/2016 |
Background Pattern Classification [BPc(TM)] |
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
Sanjay Mehta |
| K151239 |
06/06/2016 |
NMI DUAL PORT II |
NAVILYST MEDICAL, INC. |
ROBIN FULLER |
| K160511 |
06/24/2016 |
Naya Breast Pump System |
NAYA HEALTH INC. |
Janica B. Alvarez |
| K160350 |
06/16/2016 |
ECG CT Gating Device |
NEOCOIL, LLC |
MICHAEL LEIGH |
| K161039 |
06/17/2016 |
NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) |
NeoMed, Inc. |
Tony Lair |
| K160739 |
06/12/2016 |
Cranial COVER |
Neos Surgery S.L. |
Eduard Garcia |
| K160703 |
06/10/2016 |
NeuroStar TMS Therapy System |
NEURONETICS, INC. |
Judy P. Ways |
| K152501 |
06/29/2016 |
Spinal Jaxx Interbody Fusion Device |
NEUROPRO SPINAL JAXX, INC. |
BENJAMIN J. REMINGTON |
| K161285 |
06/29/2016 |
Ablation Confirmation |
NEUWAVE MEDICAL, INC. |
DAN KOSEDNAR |
| K160617 |
06/03/2016 |
Large Screws Range |
NEWCLIP TECHNICS |
Gaelle LUSSORI |
| K160820 |
06/28/2016 |
PressON Pro Spinal Fixation System |
Nexus Spine, LLC |
Jared Crocker |
| K152729 |
06/06/2016 |
MICROPERIMETER MP-3 |
NIDEK CO., LTD. |
YONEJI MIZUNO |
| K152350 |
06/28/2016 |
Regular and Special Umbilical Cord Clamp and Cutter |
NINGBO FEITE MEDICAL DEVICE CO., LTD |
CHARLES SHEN |
| K153036 |
06/02/2016 |
NobelDesign Software |
NOBEL BIOCARE AB |
CHARLEMAGNE CHUA |
| K153534 |
06/06/2016 |
NobelProcera HT ML Full Contour Zirconia Crown |
NOBEL BIOCARE AB |
Charlemagne Chua |
| K160119 |
06/02/2016 |
NobelSpeedy Groovy |
NOBEL BIOCARE AB |
Charlemagne Chua |
| K161062 |
06/13/2016 |
NR Recorder |
Norav Medical GmbH |
David Seal |
| K161346 |
06/15/2016 |
NormaTec PCD-T and PCD-B |
NormaTec Industries, LP |
Peter Novello |
| K160156 |
06/23/2016 |
StatStrip Xpress Blood Glucose Monitoring System |
NOVA BIOMEDICAL CORPORATION |
Eliza Wang |
| K160598 |
06/20/2016 |
REBOA Balloon Catheter |
NUMED, INC. |
NICHELLE LAFLESH |
| K160916 |
06/28/2016 |
CoRoent« Ti-C System |
NUVASIVE, INCORPORATED |
Michelle Cheung |
| K160989 |
06/09/2016 |
NuVasive« Reline« System |
NuVasive, Incorporated |
Olga Lewis |
| K160510 |
06/09/2016 |
MAKO 7 |
nVision Medical Corporation |
Surbhi Sarna |
| K161180 |
06/09/2016 |
Oak Ridge Products Sharps Containers |
OAK RIDGE PRODUCTS, LLC |
Tibor Kovari |
| K151976 |
06/27/2016 |
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode |
OMNITECH SYSTEMS, INC. |
JON D. BARRETT |
| K160115 |
06/03/2016 |
Heat Pain Pro |
OMRON HEALTHCARE, INC. |
RENEE Thornborough |
| K161479 |
06/28/2016 |
hipEOS |
ONEFIT MEDICAL |
Julien SIMON |
| K153374 |
06/17/2016 |
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System |
ORTHOCARE |
RAJEEV CHHABRA |
| K161280 |
06/17/2016 |
Cervical Stand Alone System |
Orthofix Inc. |
Natalia Volosen |
| K152339 |
06/24/2016 |
Unifine Pentips/ Unifine Pentips Plus |
OWEN MUMFORD LTD |
Patty Cronan |
| K153434 |
06/10/2016 |
Pall-Aquasafe Water Filter |
PALL INTERNATIONAL, SARL |
KAREN D PETERSON-DOYLE |
| K161064 |
06/12/2016 |
Penumbra System ACE 68 Reperfusion Catheter |
Penumbra, Inc. |
Charles DeNault |
| K161164 |
06/24/2016 |
CareEvent inclusive of the CareEvent Mobile Application accessory |
PHILIPS MEDICAL SYSTEMS |
Theresa Poole |
| K153702 |
06/13/2016 |
M3290B Philips IntelliVue Information Center iX |
PHILIPS MEDICAL SYSTEMS |
THERESA POOLE |
| K153518 |
06/03/2016 |
Medipure Oxygen-LC System |
PRAXAIR DISTRIBUTION, INCORPORATED. |
Michael Skrjanc |
| K160012 |
06/02/2016 |
O-pel Laser and families of probe delivery devices |
PRECISE LIGHT SURGICAL |
KEN ARNOLD |
| K152884 |
06/20/2016 |
DermaTherapy Bed Linens |
PRECISION FABRICS GROUP, INC. |
Terry Montgomery |
| K152561 |
06/03/2016 |
Communicator Surgical Facemask with Clear Window |
Prestige Ameritech, Ltd |
Rex Reese |
| K160627 |
06/14/2016 |
Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution |
QFIX |
Nadia Sookdeo Harhen |
| K161193 |
06/02/2016 |
16ch Tx/Rx Knee SPEEDER |
Quality Electrodynamics, LLC |
Kathleen Aras |
| K150404 |
06/23/2016 |
QiF Blood and Fluid Warmer |
Quality in Flow Ltd. |
Neta Sherman |
| K153351 |
06/17/2016 |
Quantib Brain 1 |
QUANTIB BV |
FLOOR VAN LEEUWEN |
| K160458 |
06/20/2016 |
BI IMAGE-X EVOLUTION |
RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V. |
Marcelo Mojica |
| K160525 |
06/20/2016 |
RCT700 |
RAY CO.,LTD |
Changhwan Lee |
| DEN130051 |
06/08/2016 |
PEDIATRIC VISION SCANNER |
REBISCAN, INC. |
JUSTIN G SHAKA |
| K160655 |
06/03/2016 |
OrthoButton CL |
RIVERPOINT MEDICAL |
EDWIN ANDERSON |
| K160795 |
06/16/2016 |
United Urologics Intermittent Catheter |
ROBLING MEDICAL |
Diane Peper |
| K160729 |
06/13/2016 |
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 |
Roche Diagnostics |
Adam Clark |
| K153607 |
06/15/2016 |
ROMA Calculation Tool Using Elecsys Assays |
ROCHE DIAGNOSTICS |
Angelo Pereira |
| K160681 |
06/17/2016 |
CenterCross Ultra Catheter |
ROXWOOD MEDICAL, INC |
Grace Li |
| K153201 |
06/24/2016 |
SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System |
SD BIOSENSOR |
Yeon Park |
| K153545 |
06/22/2016 |
Portable Slit Lamp |
SHANGHAI BOLAN OPTICAL-ELECTRIC CO.,LTD. |
Johnny Hu |
| K160853 |
06/27/2016 |
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System |
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD (SIUI) |
Flower Cai |
| K160370 |
06/09/2016 |
BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
Zeng Zhe |
| K152244 |
06/20/2016 |
RADspeed Pro |
SHIMADZU CORPORATION |
Toshio Kadowaki |
| K152877 |
06/07/2016 |
SureFine Pen Needle |
SHINA MED CORPORATION |
SUNG-SOON PARK |
| K160652 |
06/03/2016 |
iFUSE Implant System |
SI-BONE, INC. |
ROXANNE DUBOIS |
| K151986 |
06/29/2016 |
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
MATTHEW GEE |
| K153360 |
06/29/2016 |
ADMIRE |
SIEMENS MEDICAL SOLUTIONS, INC. |
JOHN URTZ |
| K153131 |
06/03/2016 |
Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20░ Hooded Acetabular Liner |
SIGNATURE ORTHOPAEDICS PTY LTD. |
DECLAN BRAZIL |
| K160095 |
06/10/2016 |
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz |
Simple Science, LLC |
Eoin Croke |
| K160770 |
06/29/2016 |
Vent-Os Sinus Dilation family |
SINUSYS CORPORATION |
Lloyd H. Griese |
| K160099 |
06/02/2016 |
CEREC SpeedGlaze |
Sirona Dental Systems GmbH |
Thomas Diesch |
| K153606 |
06/02/2016 |
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application |
SMITH & NEPHEW |
JANICE HASELTON |
| K160738 |
06/15/2016 |
ZUK Select Knee System |
SMITH & NEPHEW, INC. |
BRAD SHEALS |
| K160235 |
06/30/2016 |
ViaValve Safety I.V. Catheter |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
| K153537 |
06/17/2016 |
Sol-M Insulin Syringe, Sol-M TB Syringe |
SOL-MILLENNIUM MEDICAL, INC. |
Jim Barley |
| K160905 |
06/03/2016 |
Sonendo GentleWave System |
SONENDO, INC. |
DAN W. MILLER |
| K161122 |
06/08/2016 |
Sony IP Converter NU-IP40S |
SONY ELECTRONICS INC. |
AMARJIT 'ANDY' JOWANDHA |
| K153391 |
06/16/2016 |
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration |
SOPHONO INC. |
Rozanne Paciej |
| K153367 |
06/17/2016 |
S698 Symbioz flow |
SOPRO - ACTEON GROUP |
Philippe BOYER |
| K152276 |
06/03/2016 |
Wing Smart FEVI and Peak Flow Meter |
Sparo Inc. |
Mona Dean |
| K152011 |
06/09/2016 |
Lucent Intervertebral Body Fusion Device |
Spinal Elements Inc. |
Julie Lamothe |
| K152747 |
06/10/2016 |
DSG Threaded Drill System |
SPINEGUARD, S.A. |
STEPHANE BETTE |
| K161191 |
06/23/2016 |
Latera Absorbable Nasal Implant |
SPIROX, INC. |
Mike Rosenthal |
| K152342 |
06/09/2016 |
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover |
ST. JUDE MEDICAL |
PARITA MEHTA |
| K152597 |
06/08/2016 |
ProteXsure Safety Capsule System |
StarCap Medical LLC ( DBA Prism Medical & Design) |
Les Capella |
| K142130 |
06/06/2016 |
ORAL BOND |
STEINER LABORATORIES |
GREGORY G STEINER |
| K153006 |
06/23/2016 |
Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter |
STERILMED, INC. |
PATRICIA F KAUFMAN |
| K160485 |
06/01/2016 |
VERIFY VH2O2 Indicator Tape |
STERIS CORPORATION |
Anthony Piotrkowski |
| K161325 |
06/22/2016 |
CliniCloud Non-contact Thermometer, Model SPL1024 |
STETHOCLOUD PTY. LTD (CLINICLOUD) |
ANDREW LIN |
| K161429 |
06/22/2016 |
Target Detachable Coils |
Stryker Neurovascular |
Kate Taylor |
| K152771 |
06/17/2016 |
SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long |
SUMITOMO BAKELITE CO., LTD. |
SHIRO AGEHAMA |
| K160584 |
06/28/2016 |
Surgical Navigation Advanced Platform (SNAP) |
SURGICAL THEATER, LLC |
Kevin Murrock |
| K153033 |
06/24/2016 |
Digital Blood Pressure Monitor |
SUZHOU SUNSPIRI CO., LTD. |
JING ZHANG |
| K160523 |
06/24/2016 |
BrightMatter Guide with BrightMatter Pointer |
SYNAPTIVE MEDICAL INC. |
Cameron Piron |
| K152786 |
06/07/2016 |
A Plus Internal Fixture System |
T-PLUS IMPLANT TECH. CO., LTD. |
DANA CHENG |
| K153652 |
06/21/2016 |
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set |
TELEFLEX INC. |
CHET JONES |
| K153076 |
06/16/2016 |
silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL |
Teleflex Medical, Inc. |
Natalie Hichak |
| K160819 |
06/16/2016 |
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit |
THE BINDING SITE GROUP LTD. |
JON LAUDER |
| K152521 |
06/03/2016 |
Seal Rite Non-Rebreathing Valve |
The Lifeguard Store, Inc. |
Amy Hilten |
| K160244 |
06/02/2016 |
VARIOunite |
Thommen Medical AG |
Daniel Snetivy |
| K151250 |
06/07/2016 |
Smart Set |
TOPSPINS, INC. |
FREDERICK PRINCE |
| K160555 |
06/10/2016 |
BLUEPRINT Patient Specific Instrumentation |
TORNIER SAS |
AYMEN AZAIEZ |
| K160975 |
06/10/2016 |
Aequalis PerFORM+ Shoulder System |
TORNIER, INC. |
Loucinda Bjorklund |
| K160587 |
06/09/2016 |
Aquilion ONE (TSX-305A/3) V7.3 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K152967 |
06/22/2016 |
NERBRIDGE |
TOYOBO CO., LTD. |
YUTA KAWAKATSU |
| K160821 |
06/15/2016 |
Tria Sapphire |
TRIA BEAUTY, INC. |
Heather Tanner |
| K153682 |
06/23/2016 |
Chocolate XD PTCA Balloon Catheter |
TriReme Medical, LLC |
Shiva Ardakani |
| K153689 |
06/30/2016 |
STERIZONE Sterilizer |
TSO3 INC |
NATHALIE RACETTE |
| K153645 |
06/30/2016 |
VITA ENAMIC Implant Solutions (IS) |
VITA ZAHNFABRIK H. RAUTER GMBH CO. |
BERND WALKER |
| K152734 |
06/18/2016 |
Kerrison Rongeurs |
VITALITEC MEDIZINTECHNIK GMBH |
LYNETTE HOWARD |
| K153177 |
06/30/2016 |
Admira Fusion Flow |
VOCO GMBH |
MANFRED THOMAS PLAUMANN |
| K153018 |
06/23/2016 |
CELALUX 3 |
VOCO GMBH |
M TH. PLAUMANN |
| K160805 |
06/23/2016 |
NIO-P |
WAISMED LTD. |
Einat Swisa |
| K160170 |
06/20/2016 |
Lehman Manometry Catheter |
Wilson-Cook Medical, Inc. |
Doris A. Hawks |
| K160544 |
06/17/2016 |
Withings Thermo (Model SCT01) |
WITHINGS |
Xavier Debreuil |
| K153496 |
06/15/2016 |
Disposable Surgical Face Mask |
XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD. |
Liang Zhang |
| K160691 |
06/21/2016 |
Acne Light Therapy Wand |
ZUKO, INC. |
Jay Tapper |
