| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K153357 |
07/08/2016 |
i-STAT Alinity System with i-STAT Sodium test |
ABBOTT POINT OF CARE INC. |
MELISSA ROBINSON |
| K153674 |
07/01/2016 |
Sorbact Foam Gentle Border, Sorbact Superabsorbent |
ABIGO Medical AB |
Annica Corbe |
| K153055 |
07/11/2016 |
ACE Electrosurgical Resection and Vaporization Electrodes Series |
Ace Medical Devices Pvt. Ltd. |
Vikas Sethi |
| K152189 |
07/20/2016 |
EVOTECH ECR |
Advanced Sterilization Products (ASP) |
Nazanin Yacobi |
| K153700 |
07/08/2016 |
Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments |
AESCULAP IMPLANT SYSTEMS, LLC |
Paul Amudala |
| K152960 |
07/22/2016 |
ELAN 4 Motor System |
AESCULAP, INC. |
PETER STOLL |
| K153117 |
07/28/2016 |
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM |
AESKU. SYSTEMS GMBH & CO. KG |
TOM STECKLUM |
| K160755 |
07/27/2016 |
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap |
AHLSTROM NONWOVENS LLC |
GARY JACKSON |
| K160123 |
07/12/2016 |
Apinator |
Allen J. Moses, DDS LTD |
Allen J Moses |
| K152920 |
07/08/2016 |
Savannah-T« Pedicle Screw System |
AMENDIA, INC. |
KRISTEN ALLEN |
| K160758 |
07/11/2016 |
PeriCoach OTC |
ANALYTICA LTD. |
GEOFF DALY |
| K160399 |
07/25/2016 |
Skyn Original Polyisoprene Lubricated Male Condom |
Ansell Healthcare Products, LLC |
Robert Mahler |
| K153017 |
07/06/2016 |
Voyant Fine Fusion |
APPLIED MEDICAL RESOURCES |
JESSICA CHO |
| K152905 |
07/20/2016 |
ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer |
ARC DEVICES LIMITED |
GARY BROGAN |
| K161427 |
07/30/2016 |
Pirouette 035 |
ArraVasc Limited |
Aoife Donoghue |
| K160830 |
07/06/2016 |
Integra External Fixation System |
Ascension Orthopedics |
Jayana Kenana |
| K161044 |
07/06/2016 |
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
ASSURE TECH (HANGZHOU) CO., LTD. |
SHISHENG LING |
| DEN160003 |
07/22/2016 |
Quantidex qPCR BCR-ABL IS Kit |
ASURAGEN, INC. |
FAYYAZ MEMON |
| K160757 |
07/26/2016 |
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) |
AXIS-SHIELD DIAGNOSTICS LIMITED |
CLAIRE I. DORA |
| K161012 |
07/06/2016 |
Easy-Load Lens Delivery System |
Bausch and Lomb, Inc. |
Joyce Zhong |
| K161553 |
07/06/2016 |
BD SafeAssist |
BECTON, DICKINSON AND COMPANY |
Meriam Youssef |
| K151870 |
07/08/2016 |
BD U-500 INSULIN SYRINGE |
BECTON, DICKINSON AND COMPANY |
LUISA F. METRIO |
| K160984 |
07/20/2016 |
MultiScan G-Arm System |
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD |
SHARON FAN |
| K160747 |
07/28/2016 |
Angel Catheter |
BIO2 MEDICAL, INC. |
CHRISTOPHER E. BANAS |
| K160101 |
07/27/2016 |
SinuBand |
BIOINSPIRE TECHNOLOGIES, INCORPORATED |
DORNA HAKIMIMEHR |
| K161669 |
07/28/2016 |
Waterlase Express |
Biolase, Inc. |
Alicia Mszyca |
| K161227 |
07/20/2016 |
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) |
BIOMERIEUX, INC |
CHERECE L. JONES |
| K152622 |
07/08/2016 |
Alta ACDF System |
BIOMET SPINE |
ALEXANDRA BECK |
| K150932 |
07/22/2016 |
Sheath Introducer |
BIOTEQUE CORP. |
Simon Lin |
| K161256 |
07/29/2016 |
TheraCem |
BISCO, INC. |
Ryan Hobson |
| K161722 |
07/26/2016 |
VITRUVIAN ULTIMATE ASPIRATOR |
BLACK & BLACK SURGICAL, INC. |
CYNTHIA REES |
| K152764 |
07/13/2016 |
EXACTECH GPS |
BLUE ORTHO |
ANTHONY BOYER |
| K161461 |
07/25/2016 |
BostonSight PD Prosthetic Device |
BostonSight |
Gene Guselli |
| K161558 |
07/29/2016 |
Bovie 3.3mm Disposable Bipolar Ablator 90░, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55░, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60░, Non-Aspirating |
BOVIE MEDICAL CORPORATION |
Rubiela Maldonado |
| K153473 |
07/22/2016 |
Braemar Telemetry Patch System |
Braemar Manufacturing, LLC |
Kent Sayler |
| K152113 |
07/21/2016 |
BioHPP - breCAM.BioHPP |
Bredent GmbH & Co.KG |
Stefanie Bochtler |
| K160256 |
07/29/2016 |
Polux , Minerva and Atropos PTA Balloon Dilatation Catheter |
Brosmed Medical Co., Ltd. |
Tina Yin |
| K152731 |
07/20/2016 |
XP1100 RF |
BTL INDUSTRIES, INC |
JAN ZARSKY |
| K161137 |
07/20/2016 |
Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload |
CARDICA, INC. |
Greg Watson |
| K160339 |
07/28/2016 |
Cardinal Health Isolation Gown |
Cardinal Health 200, LLC |
Caroline Miceli |
| K160875 |
07/11/2016 |
Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating |
CARDINAL HEALTH, INC. |
Megan Middaugh |
| K160411 |
07/25/2016 |
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating |
CARDINAL HEALTH, INC. |
Megan Middaugh |
| K153234 |
07/07/2016 |
AirLife Adult Heated Wire Circuit |
CAREFUSION INC |
ERIKA FERNANDEZ |
| K150208 |
07/21/2016 |
Dakin's Skin and Wound Cleanser |
CENTURY PHARMACEUTICALS, INC. |
Stephen Deardorff |
| K160988 |
07/14/2016 |
Biopor, AOC Porous Polyethylene, Cerepor |
CEREMED, INC. |
CHELSEA MITCHELL |
| K161507 |
07/29/2016 |
Cianna Medical SAVI Scout Reflector and SAVI Scout System |
CIANNA MEDICAL, INC. |
GARY MOCNIK |
| K160629 |
07/26/2016 |
InPen |
COMPANION MEDICAL, INC. |
JASPER BENKE |
| K161668 |
07/15/2016 |
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) |
CONFORMIS, INC. |
AMITA SHAH |
| K160859 |
07/13/2016 |
OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) |
CONTAMAC LTD. |
ROB MCGREGOR |
| K161048 |
07/26/2016 |
Conventus Orthopaedics Ulna Fixation System |
CONVENTUS ORTHOPAEDICS, INC. |
KENT LIND |
| K160887 |
07/26/2016 |
Cook Intraosseous Infusion Needles |
COOK INCORPORATED |
JULIA FERGUSON |
| K161801 |
07/29/2016 |
CrossCath Support Catheter |
Cook Incorporated |
Jessica Swafford |
| K161218 |
07/22/2016 |
Gianturco-Roehm BirdÆs Nest Vena Cava Filter |
COOK INCORPORATED |
Jessica Swafford |
| K161296 |
07/06/2016 |
Cool Renewal |
COOL RENEWAL, LLC |
ASHLEY RAINS |
| K160803 |
07/13/2016 |
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens |
CooperVision, Inc. |
Roya Borazjani |
| K153074 |
07/06/2016 |
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal |
COVIDIEN |
Karin Desjardins |
| K152913 |
07/21/2016 |
GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle |
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL |
ORLA HICKEY |
| K160385 |
07/27/2016 |
Precision Screw |
CRYPTYCH PTY LTD |
GREG ROGER |
| K161557 |
07/26/2016 |
truFreeze System |
CSA MEDICAL, INC. |
SHERRIE COVAL-GOLDSMITH |
| K160088 |
07/07/2016 |
Cydar EV |
Cydar Ltd. |
John Clarke |
| K160470 |
07/21/2016 |
SculpSure |
CYNOSURE, INC. |
Aastha Kohli |
| K153328 |
07/20/2016 |
SUNCO Mechanical Wheelchair, model SKW-9003 |
DANYANG SUNCO MACHINERY CO., LTD |
JEN KE-MIN |
| K152385 |
07/27/2016 |
Zeramex P6 Dental Implant System |
DENTALPOINT AG |
Viktor Lienhard |
| K153268 |
07/20/2016 |
NR Line Implant System |
DENTIUM CO., LTD. |
YOUNJUNG YUK |
| K161118 |
07/28/2016 |
SIMPLANT Online Case Review and SIMPLANT Editor |
DENTSPLY SIRONA |
HELEN LEWIS |
| K160907 |
07/19/2016 |
DePuy Actis DuoFix Hip Prosthesis |
DEPUY (IRELAND) |
Jaime Weeks |
| K161382 |
07/28/2016 |
LVivo Software Application |
DIACARDIO, LTD. |
Michal Yaacobi |
| K161139 |
07/22/2016 |
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set |
DIASORIN, INC. |
JOHN WALTER |
| K160704 |
07/15/2016 |
myPatch-s |
DMS-SERVICE LLC |
LYNDA COLE |
| K161771 |
07/28/2016 |
Medilas H Laser Fibers |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K160996 |
07/06/2016 |
Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm |
Dunamis LLC |
Prithvi Raj Chavan |
| K151978 |
07/15/2016 |
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control |
EDAN INSTRUMENTS, INC. |
TRACY YUE |
| K161302 |
07/01/2016 |
PC ECG |
EDAN INSTRUMENTS, INC. |
ERICO LI |
| K161443 |
07/19/2016 |
EksoÖ (version 1.1) and Ekso GTÖ (version 1.2) |
EKSO BIONICS, INC. |
Thomas Looby |
| K161089 |
07/08/2016 |
sensiLight Mini |
EL GLOBAL TRADE LTD |
YAEL LIEBES-PEER |
| K161305 |
07/07/2016 |
Habib EUS RFA |
EMCISION LTD. |
FRANCOIS POULIN |
| DEN150004 |
07/15/2016 |
EPIC ClearView System |
EPIC RESEARCH & DIAGNOSTICS, INC. |
NANCY RIZZO |
| K161359 |
07/19/2016 |
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System |
Esaote S.p.A |
Massimo Polignano |
| K161238 |
07/08/2016 |
S-scan |
Esaote S.p.A. |
Donatella Ragghianti |
| K161726 |
07/12/2016 |
E-Pack Procedure Kit |
ETHICON, INC. |
ENZA DESERIO |
| K160722 |
07/07/2016 |
CorticaLINK Spinal Fusion Platform |
FACETLINK DBA LINKSPINE |
MASSIMO CALAFIORE |
| K161314 |
07/06/2016 |
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE |
FLEXICARE MEDICAL LIMITED |
JOEL BIDDLE |
| K160308 |
07/15/2016 |
Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) |
Fudakang Industrial Co., Ltd |
Bob Yu |
| K161055 |
07/12/2016 |
Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji û 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 |
Fuji Dynamics Ltd |
Kam Tim Ng |
| K153145 |
07/05/2016 |
Lumipulse G TP-N Immunoreaction Cartridge Set |
Fujirebio Diagnostics, Inc. |
Diana Dickson |
| K153533 |
07/05/2016 |
Tearaway Introducer Sheath, MicroSlide Tearaway Introducer |
GALT MEDICAL CORP. |
DAVID DERRICK |
| K153325 |
07/12/2016 |
Gradia Plus |
GC America Inc. |
Mark Heiss |
| K153231 |
07/06/2016 |
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer |
GC AMERICA, INC. |
Mark Heiss |
| K161631 |
07/28/2016 |
MAMMI |
GENERAL EQUIPMENT FOR MEDICAL IMAGING |
JOSE MONTES |
| K152099 |
07/28/2016 |
Genesys Spine Apache« Anchored Cervical Interbody Fusion System |
GENESYS SPINE |
BEN KELLER |
| K161404 |
07/21/2016 |
Genesys Spine Apache« Lateral Lumbar Interbody Fusion System |
Genesys Spine |
Dave Lamb |
| K160144 |
07/21/2016 |
rainbow LS Block |
GENOSS CO., LTD. |
HAN YEIN |
| K161223 |
07/15/2016 |
TransContinental« M Spacers and InterContinental« Plate-Spacers |
GLOBUS MEDICAL INC. |
KELLY J. BAKER |
| K161008 |
07/28/2016 |
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE |
HARTALEGA SDN. BHD. |
KUAN KAM HON |
| K160102 |
07/14/2016 |
Amber Mill Series and Amber Press Series |
HASS CORP. |
YONGSU KIM |
| K160557 |
07/06/2016 |
Full Automatic (NIBP) Blood Pressure Monitor |
HEALTH & LIFE CO.,LTD. |
SARAH SU |
| K160448 |
07/12/2016 |
ARTLINE |
HEALTH LINE INTERNATIONAL CORPORATION |
JOEL FAULKNER |
| K151626 |
07/21/2016 |
ET III Bio-SA Fixture System |
HiOSSEN Inc. |
David Kim |
| K161163 |
07/13/2016 |
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory |
HITACHI, LTD. |
Naoya Nishimura |
| K152087 |
07/29/2016 |
HeatLux Pro II |
HOME SKINOVATIONS LTD. |
Ahava Stein |
| K153557 |
07/19/2016 |
ABPM 7100, Hypertension Management Software |
I.E.M. GMBH |
Hella Witt |
| K153296 |
07/29/2016 |
MEDINAUT Kyphoplasty System |
IMEDICOM Co., Ltd. |
Bonggu Ha |
| K153568 |
07/12/2016 |
InMode Plus System |
InMode MD Ltd. |
Ahava Stein |
| K153137 |
07/08/2016 |
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls |
INSTRUMENTATION LABORATORY CO. |
Carol Marble |
| K153484 |
07/27/2016 |
Dillard Airway Dilatation System |
INTUIT MEDICAL PRODUCTS, LLC |
JACK GRIFFIS |
| K161271 |
07/11/2016 |
da Vinci Xi Surgical System |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K153544 |
07/25/2016 |
cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System |
IQuum, Inc. |
Lingjun Chen |
| K153070 |
07/26/2016 |
Watch-PAT200U |
ITAMAR MEDICAL, LTD. |
KOBY SHEFFY |
| K153087 |
07/14/2016 |
IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved |
Ivy Sports Medicine, LLC |
John Dichiara |
| K160077 |
07/12/2016 |
RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set |
JBW7 Innovations, LLC |
Jason B Wynberg |
| K152166 |
07/11/2016 |
JSM Insulin Pen Needle |
JEESUNG MEDICAL CO LTD |
CHOI YONG HYUN |
| K153727 |
07/21/2016 |
INTRAcel Premium Fractional RF Micro Needle (FRM) System |
JEISYS MEDICAL, INC. |
HYOSEOK LEE |
| K161028 |
07/22/2016 |
K2M Growing Spine System |
K2M, Inc. |
Nancy Giezen |
| K161369 |
07/21/2016 |
EVEREST Spinal System |
K2M, Incorporated |
NANCY GIEZEN |
| K160631 |
07/15/2016 |
Keos Lumbar IBFD |
KEOS |
MARK F. SCHENK |
| K160863 |
07/28/2016 |
PBS(-), Phosphate Buffered Saline |
KITAZATO BIOPHARMA CO., LTD. |
FUTOSHI INOUE |
| K161951 |
07/22/2016 |
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay |
KRONUS, INC. |
Brian Deis |
| K153439 |
07/21/2016 |
PathLoc-C Posterior Cervical Fixation System |
L&K BIOMED CO., LTD. |
Yerim An |
| K160956 |
07/06/2016 |
LD-Oxi system |
LD TECHNOLOGY LLC |
Albert MAAREK |
| K153399 |
07/05/2016 |
LightStim Professional LED Bed |
LED Intellectual Properties LLC |
Steve Marchese |
| K160518 |
07/14/2016 |
LEONI ORION System |
LEONI CIA CABLE SYSTEM |
AURELIE GENHO |
| K161659 |
07/15/2016 |
FlexSeal Introducer Sheath with Hydrophilic Coating |
LIBRA MEDICAL INC. |
SEW-WAH TAY |
| K161175 |
07/12/2016 |
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL |
LIOFILCHEM S.R.L. |
FABIO BRACCO |
| K160477 |
07/29/2016 |
The Luco Hybrid OSA Appliance |
LUCO HYBRID OSA APPLIANCE INC. |
Ken Luco |
| K160893 |
07/27/2016 |
HANAROCare ReJu |
M.I.TECH CO.,LTD |
HWANG MI-SUNG |
| K160605 |
07/21/2016 |
MectaLIF Anterior Stand-Alone |
MEDACTA INTERNATIONAL |
MICHAEL G. LOITERMAN |
| K160431 |
07/13/2016 |
ActiveCare Home |
MEDICAL COMPRESSION SYSTEMS (DBN) LTD. |
YAKI BARAK |
| K152461 |
07/08/2016 |
The Time Machine Series Lasers |
MEDICAL LASERS MANUFACTURER INC. |
BRUCE SCHOENGOOD |
| K161149 |
07/11/2016 |
PASS OCT Spinal System |
MEDICREA INTERNATIONAL S.A |
David Ryan |
| K161627 |
07/29/2016 |
PASS LP Spinal System |
MEDICREA INTERNATIONAL S.A. |
DAVID RYAN |
| K160604 |
07/01/2016 |
CureÖ Anterior Cervical Plate (ACP) System |
MEDITECH SPINE, LLC |
BRUCE DUNAWAY |
| K160846 |
07/14/2016 |
AmplifEYE |
MEDIVATORS, INC. |
Jeff Kasoff |
| K153124 |
07/26/2016 |
DuraLazeTM HoLEP Laser Fiber |
MedKey, LLC |
Jeff Zerfas |
| K152564 |
07/07/2016 |
Gemini Sterilization Wrap |
MEDLINE INDUSTRIES, INC. |
Jennifer Mason |
| K160904 |
07/01/2016 |
Expedium Spine System, VIPER and VIPER 2 Systems |
MEDOS INTERNATIONAL SARL |
Karen Sylvia |
| K160804 |
07/19/2016 |
INTRAFIX(TM) Advance Tibial Fastener System |
MEDOS INTERNATIONAL SARL |
KRISTINE CHRISTO |
| K152703 |
07/08/2016 |
PlasmaBlade TnA Tonsil and Adenoid Dissection Device |
MEDTRONIC ADVANCED ENERGY |
LYDIA SAKAKEENY |
| K160961 |
07/30/2016 |
Mozec NC-Rx PTCA Baloon Dilatation Catheter |
MERIL LIFE SCIENCES PRIVATE LIMITED |
Utpal Thakor |
| K160107 |
07/29/2016 |
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe |
Merit Medical Systems, Inc. |
Dan W Lindsay |
| K161058 |
07/29/2016 |
Cannulated Screw |
MIAMI DEVICE SOLUTIONS, LLC |
MARKKU BIEDERMANN |
| DEN150029 |
07/27/2016 |
Permaseal |
MICRO INTERVENTIONAL DEVICES, INC. |
LINDA MORGAN |
| K153097 |
07/15/2016 |
BelvedereÖ Lateral Plating System |
NEUROSTRUCTURES, INC. |
Moti Altarac |
| K161499 |
07/29/2016 |
VertiForm Posterior Fixation System |
NEXT ORTHOSURGICAL |
ELLEN YARNALL |
| K160367 |
07/27/2016 |
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
Nissin-Metec China Co., Ltd. |
Xiwei Shen |
| K153786 |
07/11/2016 |
PROW FUSION-V |
NLT SPINE LTD |
Eti Zinger |
| K160158 |
07/25/2016 |
NobelProcera HT ML FCZ Implant Bridge and Framework |
Nobel Biocare AB |
Charlemagne Chua |
| K161337 |
07/12/2016 |
CryoDose H or Similar |
NUANCE MEDICAL, LLC |
MARC LIEBERMAN |
| K153105 |
07/11/2016 |
MLXÖ - Medial Lateral Expandable Lumbar Interbody System |
NuVasive, Incorporated |
Olga Lewis |
| K161265 |
07/15/2016 |
NuVasive« VersaTie System |
NUVASIVE, INCORPORATED |
CYNTHIA ADAMS |
| K152599 |
07/20/2016 |
PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System |
OK BIOTECH CO., LTD. |
KE-MIN JEN |
| K160038 |
07/29/2016 |
UniStrip1 Generic Blood Glucose Test Strips |
OK BIOTECH CO., LTD. |
KE-MIN JEN |
| K153267 |
07/22/2016 |
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash |
ORIGIO A/S |
Tove Kjaer |
| K153048 |
07/08/2016 |
AcceleDent Aura |
ORTHOACCEL TECHNOLOGIES, INC. |
Zaffer Syed |
| K161138 |
07/20/2016 |
St. Louis Band |
ORTHOMERICA PRODUCTS, INC. |
DAVID C. KERR |
| K161052 |
07/20/2016 |
OsteoFab Patient Specific Facial Device |
OXFORD PERFORMANCE MATERIALS, INC. |
Leigh Ayres |
| K160577 |
07/25/2016 |
PacEndo Chlorhexidine |
PAC-DENT INTERNATIONAL, INC. |
Wenying Zhu |
| K152952 |
07/13/2016 |
E-Cath |
PAJUNK GmbH Medizintechnologie |
Christian G.H. Quass |
| K153422 |
07/14/2016 |
Panpac Disposable Pessary Fitting Set |
Panpac Medical Corporation |
YEN-MING PAN |
| K161523 |
07/01/2016 |
INDIGO Aspiration System |
Penumbra, Inc. |
Aditi Kolla |
| K161640 |
07/12/2016 |
Penumbra System ACE 68 Reperfusion Catheter |
Penumbra, Inc. |
Charles DeNault |
| K161899 |
07/28/2016 |
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve C |
PHADIA AB |
Ulf Karlberg |
| K161839 |
07/29/2016 |
2D Quantitative Analysis |
PHILIPS MEDICAL SYSTEMS NEDERLAND BV |
JEANETTE BECKER |
| K161563 |
07/29/2016 |
Allura Xper FD series and Allura Xper OR Table series |
Philips Medical Systems Nederland BV |
Jeanette Becker |
| K161531 |
07/01/2016 |
IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600 |
Philips Medizin Systeme Boeblingen GmbH |
Markus Stacha |
| K151790 |
07/14/2016 |
PMT Platinum Depthalon Depth Electrode |
PMT CORPORATION |
KIM SCHMELZER |
| K160977 |
07/13/2016 |
PolyDev Soft Contact Lenses |
Polydev Ltd. |
John Mulvihill |
| K160569 |
07/06/2016 |
NeuGuide |
POP Medical Solutions |
Guy Ohad |
| K161920 |
07/15/2016 |
Comfort Cover |
PRECISION DYNAMICS CORPORATION |
SWARNA MUKUND |
| K160425 |
07/15/2016 |
CAD/CAMouflage Milling Bock |
Prismatik Dentalcraft, Inc. |
ARMIN ZEHTABCHI |
| K152511 |
07/11/2016 |
Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula |
PROSURG, INC |
ASHVIN DESAI |
| K160082 |
07/29/2016 |
Puritan Opti-Tranz Cary-Blair Collection and Transport System |
PURITAN MEDICAL PRODUCTS LLC |
MEHDI KARAMCHI |
| K153732 |
07/29/2016 |
Powder Free Blue Nitrile Examination Glove |
QUBE MEDICAL PRODUCT SDN BHD |
TEO SIONG YAM |
| K160848 |
07/14/2016 |
Wingman 18 Crossing Catheter |
ReFlow Medical, Inc. |
Rebecca K Pine |
| K153272 |
07/09/2016 |
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set |
RELIEVANT MEDSYSTEMS |
ADAM SAVAKUS |
| K160504 |
07/18/2016 |
RI Witness Embryology Heated Plate |
RESEARCH INSTRUMENTS LIMITED |
Wendy Hassan |
| K161020 |
07/28/2016 |
XSTAT-12, 3-Pack, XSTAT-12, 1-Pack |
REVMEDX, INC. |
AMY K. POINTER |
| K160987 |
07/22/2016 |
ReWalk(TM) |
REWALK ROBOTICS INC. |
JOHN HAMILTON |
| K160192 |
07/28/2016 |
Atteris Antimicrobial Skin & Wound Cleanser |
ROCHAL INDUSTRIES LLC |
WILLIAM J. COULSTON |
| K160684 |
07/26/2016 |
Atteris No-Sting Skin Protectant |
ROCHAL INDUSTRIES LLC |
WILLIAM J. COULSTON |
| K160910 |
07/28/2016 |
Elecsys Syphilis |
ROCHE DIAGNOSTICS |
ANGELO PEREIRA |
| K161817 |
07/27/2016 |
Tina-quant Cystatin C Gen.2 |
Roche Diagnostics Operations (RDO) |
Patrick Stimart |
| K160997 |
07/06/2016 |
GC85A |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K160271 |
07/15/2016 |
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 |
SAN-M PACKAGE CO., LTD. |
Shogo Nagao |
| K161345 |
07/06/2016 |
RadPRO« Mobile 40kW; RadPRO« Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR |
SEDECAL SA |
Ma Luisa Gomez de Aguero |
| K161805 |
07/19/2016 |
EnCor MRI Introducer Set, EnCor Probe Introducer |
SENORX, INC. |
SARAH MCCARTNEY |
| K161525 |
07/13/2016 |
TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Wu Zicui |
| K160935 |
07/28/2016 |
8ch Foot Ankle Coil |
Shenzhen RF Tech Co., Ltd. |
Ke Xi |
| K152294 |
07/15/2016 |
FDR Visionary Suite |
SHIMADZU CORPORATION |
TOSHIO KADOWAKI |
| K160596 |
07/27/2016 |
BEAUTIFIL II LS |
SHOFU DENTAL CORPORATION |
Mauro Malzyner |
| K160086 |
07/21/2016 |
SHOFU Enamel Conditioner |
SHOFU DENTAL CORPORATION |
MAURO MALZYNER |
| K161685 |
07/11/2016 |
syngo«.via protoNeo (Version VA10A) |
SIEMENS HEALTHCARE GMBH |
LAUREN BENTLEY |
| K161787 |
07/28/2016 |
ACUSON NX2 Diagnostic Ultrasound Systems |
Siemens Medical Solutions USA, Inc. |
Shelly Pearce |
| K161155 |
07/19/2016 |
Origin Coxa Vara Hip Stem |
SIGNATURE ORTHOPAEDICS PTY LTD. |
Declan Brazil |
| K160613 |
07/14/2016 |
Soberlink Cellular Device and Sober Sky Web Portal |
SOBERLINK HEALTHCARE LLC |
JENNA COSTA |
| K161395 |
07/06/2016 |
SPEC Model M13 |
Source Production and Equipment Co.,Inc. |
Kelley Richardt |
| K161333 |
07/08/2016 |
TightRail Sub-C Rotating Dilator Sheath |
Spectranetics, Inc. |
Stephanie Byrum |
| K160465 |
07/28/2016 |
Spinal Elements' Spinous Process Plate System |
Spinal Elements Inc. |
Julie Lamothe |
| K153621 |
07/15/2016 |
Juliet« Ti |
SPINEART |
FRANCK PENNESI |
| K160906 |
07/14/2016 |
Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device |
SPINEOLOGY INC. |
JACQUELINE A HAUGE |
| K161694 |
07/15/2016 |
ThresholdÖ Pedicular Fixation System |
Spineology Inc. |
JACQUELINE A. HAUGE |
| K161154 |
07/23/2016 |
Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs |
SPR THERAPEUTICS, LLC |
Kathryn Stager |
| K160433 |
07/06/2016 |
V-PRO« 1 Plus and V-PRO« maX Low Temperature |
STERIS CORPORATION |
BILL BRODBECK |
| K160908 |
07/22/2016 |
Vis-U-All Low Temperature Sterilization Pouch/Tubing |
STERIS CORPORATION |
ANTHONY PIOTRKOWSKI |
| K160016 |
07/15/2016 |
Steth IO |
STRATOSCIENTIFIC, INC. |
SUMAN MULUMUDI |
| K160955 |
07/21/2016 |
Tritanium« PL Cage |
STRYKER |
Deirdre Jayko |
| K153240 |
07/07/2016 |
Styrker OrthoMap Express Knee System |
STRYKER CORPORATE |
Becky Ditty |
| K160715 |
07/08/2016 |
AccuLIF TL and PL Cage |
STRYKER CORPORATION |
AAKASH JAIN |
| K160978 |
07/08/2016 |
LITe BIO Delivery System |
STRYKER CORPORATION |
Meriam Gabera |
| K160813 |
07/26/2016 |
EasyStep |
STRYKER GMBH |
Garry T. Hayeck |
| K161407 |
07/15/2016 |
Ascential IBD PEEKc Spacer |
Stryker Spine |
Tina Mornak |
| K152803 |
07/12/2016 |
SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE |
SUNG SHIM MEDICARE CO., LTD. |
KIM YOUNG KWAN |
| K160031 |
07/14/2016 |
Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) |
SUNRISE MEDICAL (US) LLC |
LAURIE H ROBERTS |
| K160439 |
07/06/2016 |
SunTech CT40 Spot-check Vital Signs Device |
SUNTECH MEDICAL |
CHUCK SETZER |
| K160333 |
07/20/2016 |
Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider |
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC |
BRANDI J. PANTELEON |
| K160744 |
07/13/2016 |
LOOK PTFE Suture |
Surgical Specialties Corporation |
Karen Sanchez |
| K153067 |
07/27/2016 |
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress |
SYBRON DENTAL SPECIALTIES |
Courtney Clark |
| K160607 |
07/05/2016 |
PicoWay Laser System |
SYNERON CANDELA CORPORATION |
Ruthie Amir |
| K160896 |
07/08/2016 |
ULTRASHAPE POWER SYSTEM |
SYNERON MEDICAL LTD |
Ruthie Amir |
| K152787 |
07/22/2016 |
ST Internal Fixture System |
T-PLUS IMPLANT TECH. CO., LTD. |
DANA CHENG |
| K161849 |
07/29/2016 |
Bright |
Tanda Beauty Canada Inc. |
Bobae Kim |
| K160056 |
07/25/2016 |
t:slim Insulin Delivery System |
Tandem Diabetes Care, Inc. |
Michael Sarrasin |
| K160482 |
07/13/2016 |
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater |
Tandem Diabetes Care, Inc. |
Michael Sarrasin |
| K160372 |
07/22/2016 |
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM |
TECO DIAGNOSTICS, INC. |
AQUIL MERCHANT |
| K153010 |
07/26/2016 |
Hudson RCI AquaPak Sterile Prefilled Nebulizers |
Teleflex Medical, Inc. |
Brian Gall |
| K153230 |
07/14/2016 |
ShefaBone SCPC Resorbable Bone Graft |
THE IMPLANTECH INC./SHEFABONE |
AHMED EL-GHANNAM |
| K151424 |
07/27/2016 |
The Progressive Orthopaedic Total Hip System |
The Progressive Orthopaedic Company, LLC |
Scott Keiser |
| K152671 |
07/11/2016 |
Pulse Aloe-ahh |
TOASTER LABS, INC |
AMY C. BUCKALTER |
| K152628 |
07/11/2016 |
Pulse H20h! |
TOASTER LABS, INC |
AMY C. BUCKALTER |
| K161509 |
07/28/2016 |
3D OCT-1 Maestro |
Topcon Corporation |
Charles Reisman |
| K161009 |
07/22/2016 |
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K153498 |
07/20/2016 |
Operio |
TOUL MEDITECH AB |
Tomas Hansson |
| K153363 |
07/26/2016 |
Red2Green Reusable Sharps Container |
TRIUMVIRATE ENVIRONMENTAL, INC. |
STEVE TODISCO |
| K160551 |
07/13/2016 |
VALO Grand |
ULTRADENT PRODUCTS, INC. |
Marie Hess |
| K160947 |
07/05/2016 |
LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System |
USA LASER BIOTECH INC. |
NELSON MARQUINA |
| K161198 |
07/26/2016 |
Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 |
USA LASER BIOTECH INC. |
NELSON MARQUINA |
| K161419 |
07/13/2016 |
Multi Modality Viewer |
VITAL IMAGES, INC. |
KATIE RYAN |
| K153493 |
07/29/2016 |
Clip Flow |
VOCO GmbH |
M. Th. Plaumann |
| K161072 |
07/14/2016 |
Powder Free Grey Vinyl Examination Gloves |
ZIBO FLOURISH TRADING CO., LTD. |
KOU LINGLING |
| K161192 |
07/08/2016 |
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis« System |
ZIMMER GMBH |
ROBERTO TOMMASINI |
