| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K150477 |
07/02/2015 |
3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization |
3M COMPANY |
MATT MORTENSEN |
| K151566 |
07/10/2015 |
Abbott ARCHITECT Total T4 Calibrators |
ABBOTT LABORATORIES |
Lisa Lukowski |
| K151317 |
07/06/2015 |
Armada 18 PTA Catheter |
ABBOTT VASCULAR |
Shu Chi Hsu |
| K151014 |
07/13/2015 |
Aura DR 43C-AG flat panel detector |
ABYZR CO., LTD |
JOHN LIM |
| K141427 |
07/24/2015 |
ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST |
ACCUMETRICS, INC. |
FRANK M LADUCA |
| K150873 |
07/01/2015 |
CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System |
ACCURAY INCORPORATED |
Shweta Kaushik |
| K150866 |
07/17/2015 |
SURGISEAL Topical Skin Adhesvie |
ADHEZION BIOMEDICAL, LLC |
TRACY LOFGREN |
| K151363 |
07/31/2015 |
Zephyr Vascular Compression Device |
ADVANCED VASCULAR DYNAMICS |
MATTHEW SEMLER |
| K143719 |
07/10/2015 |
Aeroneb USB Contoller System |
Aerogen Limited |
Martin Crehan |
| K151696 |
07/20/2015 |
Caiman Seal and Cut Technology |
AESCULAP, INC. |
Denise Adams |
| K151858 |
07/21/2015 |
Caiman Seal and Cut Technology |
Aesculap, Inc. |
Denise Adams |
| K142970 |
07/08/2015 |
SterilContainer S System |
AESCULAP, INC. |
Denise R Adams |
| K151464 |
07/28/2015 |
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit |
ALERE SCARBOROUGH, INC. |
ANGELA DRYSDALE |
| K151690 |
07/16/2015 |
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A |
ALERE SCARBOROUGH, INC. |
Angela Drysdale |
| K142651 |
07/17/2015 |
The Moses Express appliance |
ALLEN J. MOSES, DDS, LTD. |
ALLEN J. MOSES, DDS |
| K150773 |
07/23/2015 |
E-CUBE 15 Diagnostic Ultrasound System |
ALPINION MEDICAL SYSTEMS CO., LTD |
DONGHWAN KIM |
| K150924 |
07/27/2015 |
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Sut |
ANCHOR INNOVATION MEDICAL (A.I.M.) |
CARY STALNECKER |
| K151513 |
07/08/2015 |
Arrow Endurance Extended Dwell Peripheral Catheter System |
Arrow Internation, Inc. (subsidiary of Teleflex Inc.) |
Tracy Larish |
| K143102 |
07/24/2015 |
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions |
Arrow International, Inc. (Subsidiary of Teleflex Inc.) |
Debra Grodt |
| K143745 |
07/02/2015 |
Arthrex Corkscrew and SwiveLock Suture Anchors |
Arthrex, Inc. |
David L Rogers |
| K151660 |
07/16/2015 |
MultiFIX S Knotless Fixation System |
ArthroCare Corporation |
Laura Kasperowicz |
| K143082 |
07/24/2015 |
IV Administration Sets with 200(micro)m Blood Filter |
B. Braun Medical Inc. |
Angela J Caravella |
| K151505 |
07/17/2015 |
Coronis Uniti |
Barco N.V. |
Franky Dubois |
| K151698 |
07/27/2015 |
BD Angiocath IV Catheter, BD Insyte IV Catheter |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
HENRY BOLAND |
| K141725 |
07/09/2015 |
BONGOLD BONE GRAFT MATERIAL |
BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO, L |
HELEN CUI |
| K150953 |
07/16/2015 |
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC |
BIO COMPRESSION SYSTEMS, INC. |
Barbara J Whitman |
| K143103 |
07/16/2015 |
PROPENCIL Smoke Pencil |
BIO PROTECH, INC. |
Terry Kim |
| K150296 |
07/02/2015 |
Biodenta Customized Abutment-Hybrid |
BIODENTA SWISS AG |
David Elier |
| K142813 |
07/31/2015 |
Biogensis Implant System-Kisses |
BIOGENESIS CO., LTD. |
Haeyong Lee |
| K143120 |
07/24/2015 |
OrthoPulse |
BIOLUX RESEARCH LTD. |
Kevin Strange |
| K141133 |
07/09/2015 |
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II |
BIOMERIEUX |
JOHN ALBRIGHT |
| K151483 |
07/31/2015 |
Biomet Spine Fusion System |
Biomet Spine LLC. |
Ted Kuhn |
| K150850 |
07/16/2015 |
Refobacin Bone Cement R |
BIOMET, INC. |
CARMEN ALBANY |
| K142129 |
07/24/2015 |
RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET |
BIOPHOR DIAGNOSTICS, INC. |
NATAHANIEL G BUTLIN |
| K151187 |
07/27/2015 |
QuadraSphere Microspheres |
BIOSPHERE MEDICAL S.A. |
ALIX FONLLADOSA |
| K142799 |
07/09/2015 |
Model BT-220L and BT-220C |
Bistos Co., Ltd. |
Young Chi |
| K151760 |
07/27/2015 |
Barricade Embolization Coil System |
BLOCKADE MEDICAL |
REBECCA K. PINE |
| K143193 |
07/24/2015 |
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters |
BOSTON SCIENTIFIC |
Anna Deraney |
| K151177 |
07/30/2015 |
XenMatrix AB Surgical Graft |
C.R. Bard |
Tony John |
| K150699 |
07/28/2015 |
Bard LubriGuard Foley Catheter |
C.R. Bard, Inc. |
Michele Davis |
| K151054 |
07/07/2015 |
Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System |
C2 Therapeutics, Inc. |
Theresa Brandner-Allen |
| K151107 |
07/22/2015 |
CoSense ETCO Monitor |
Capnia Inc |
KRISTEN YEN |
| K151010 |
07/28/2015 |
Piccolo Composite Nailing System |
CARBOFIX ORTHOPEDICS LTD. |
YAEL RUBIN |
| K142468 |
07/11/2015 |
Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System |
CARDIAC INSIGHT, INC. |
BRAD HARLOW |
| K150990 |
07/02/2015 |
ECVUE Mapping System |
CardioInsight Technologies, Inc. |
Christina V Vacca |
| K141965 |
07/02/2015 |
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT |
CAREFUSION |
JOY GREIDANUS |
| K143275 |
07/10/2015 |
IOLMaster700 |
Carl Zeiss Meditec, Inc. |
Christine Dunbar |
| K151068 |
07/24/2015 |
SureLock W Suture Anchor |
CAYENNE MEDICAL, INC |
SHIMA HASHEMIAN |
| K143356 |
07/21/2015 |
NovoStitch Plus Meniscal Repair System |
Ceterix Orthopaedics, Inc. |
Michael Hendricksen |
| K150861 |
07/28/2015 |
QBit Series Diagnostic Ultrasound System |
CHISON MEDICAL IMAGING CO., LTD. |
QIFEI LIU |
| K150886 |
07/20/2015 |
Trojan Riviera Personal Lubricant |
CHURCH & DWIGHT CO., INC. |
LISA BURNS |
| K150661 |
07/07/2015 |
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite |
CITIEFFE s.r.l |
Stefano Pullega |
| K150555 |
07/15/2015 |
BA400 14mm Abutment |
COCHLEAR AMERICAS |
Tristan Manus |
| K150751 |
07/22/2015 |
Cordelle II Sound Processor |
COCHLEAR AMERICAS |
Laura Blair |
| K150935 |
07/02/2015 |
SpeediCath Compact Eve |
COLOPLAST A/S |
Meg Daniel |
| K151037 |
07/09/2015 |
GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle |
CONMED CORPORATION |
NYROBIA FREEMAN |
| K150590 |
07/10/2015 |
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, |
CONTAMAC LTD |
Rob McGregor |
| K150350 |
07/21/2015 |
Flexi-Seal Signal Fecal Management System |
ConvaTec Ltd. |
Clare Williamson |
| K142829 |
07/28/2015 |
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Co |
Cook Incorporated |
Sarah Reeves |
| K151676 |
07/22/2015 |
Retracta Detachable Embolization Coil |
COOK INCORPORATED |
DAVID LEHR |
| K142819 |
07/24/2015 |
Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set |
COOK INCORPORATED |
STEVEN LAWRIE |
| K143650 |
07/21/2015 |
CooperSurgical Advincula Delineator Uterine Manipulator |
Cooper Surgical Inc. |
James Keller |
| K151204 |
07/31/2015 |
HEMO-Bandage |
CORELEADER BIOTECH CO., LTD. |
Ya-Wen Kuo |
| K150084 |
07/13/2015 |
Argyle┐ Polyvinyl Chloride (PVC) and Kangaroo┐ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector |
COVIDIEN |
SONA MANICKAM |
| K150844 |
07/14/2015 |
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula |
COVIDIEN |
Danielle Mueller |
| K151548 |
07/02/2015 |
VersaOne Bladed Trocar, VersaOne Bladeless Trocar |
COVIDIEN |
Trang Huynh |
| K150251 |
07/28/2015 |
Barrx Anorectal RFA Wand |
Covidien LLC |
RACHEL SILVA |
| K151659 |
07/17/2015 |
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks |
Covidien LLC |
Mary Mellows |
| K150484 |
07/09/2015 |
Penguin In-Line Warmer |
Creche Innovations |
REBECCA P PINE |
| K151568 |
07/31/2015 |
Arthrex OrthoVis Preoperative Plan |
Custom Orthopaedic Solutions, Inc. |
Peter O'Neill |
| K143143 |
07/22/2015 |
PATHWAY ELIF |
CUSTOM SPINE, INC. |
Mahmoud Abdelgany |
| K150321 |
07/13/2015 |
EVOS Lumbar Interbody System |
Cutting Edge Spine, LLC |
John Souza |
| K150724 |
07/01/2015 |
SculpSure |
CYNOSURE, INC. |
KEVIN O'CONNELL |
| K150587 |
07/21/2015 |
Cortex Laser System |
Cynosure, Inc. dba Ellman |
Allison Sathe |
| K151854 |
07/28/2015 |
3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display |
D-VIEW DISPLAY TECHNOLOGY CO., LTD. |
JIANFEI SUN |
| K151254 |
07/02/2015 |
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump |
DATASCOPE CORP. |
Helder A Sousa |
| K150759 |
07/28/2015 |
Hyper-C Anterior Cervical Plate System |
Degen Medical |
Craig Black |
| K150347 |
07/24/2015 |
Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ |
DELTEX MEDICAL LIMITED |
Paul Dwane |
| K143033 |
07/21/2015 |
DENTCA DENTURE BASE |
DENTCA, INC. |
Jason Lee |
| K150344 |
07/24/2015 |
Dentis Dental Implant System |
DENTIS CO., LTD. |
JINJU LEE |
| K142962 |
07/23/2015 |
PROTOCOL Incision Dressing |
DEROYAL INDUSTRIES |
Elizabeth Wheeler |
| K141970 |
07/31/2015 |
DIGITEK TITANIUM ABUTMENT |
DIGITEK DENTAL SOLUTIONS LIMITED |
ALWIN NGAI |
| K150371 |
07/30/2015 |
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH |
DIROS TECHNOLOGY, INC. |
GEORGE DARMOS |
| K151298 |
07/30/2015 |
Gemini XXP-HP |
Dornier MedTech America |
John Hoffer |
| K151038 |
07/24/2015 |
EPX-Series Mobile X-ray System |
ECOTRON CO.,LTD |
SANG BONG LEE |
| K150901 |
07/01/2015 |
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express |
EDAN INSTRUMENTS, INC. |
Queena Chen |
| K150906 |
07/24/2015 |
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh |
EHICON INC. |
SUSAN LIN |
| K151883 |
07/30/2015 |
5MP Monochrome LCD Monitor, RadiForce GX540 |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
| K151113 |
07/22/2015 |
ELITech Clinical Systems CALCIUM ARSENAZO |
ELITechGroup |
Valerie Gourdon |
| K151552 |
07/08/2015 |
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II |
ELITechGroup |
Valerie Gourdon |
| K142398 |
07/14/2015 |
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow |
Ellex Medical Pty. Ltd. |
KEVIN HOWARD |
| K150907 |
07/07/2015 |
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra |
Ellipse A/S |
Ole Kofod |
| K151340 |
07/10/2015 |
HARMONIC Focus Long Shears + Adaptive Tissue Technology |
ETHICON ENDO-SURGERY, LLC |
MARJORIE MEDINA |
| K150670 |
07/02/2015 |
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device |
ETHICON, INC. |
DONNA MARSHALL |
| K150066 |
07/20/2015 |
Exactech Alteon Monobloc Revision Stem |
EXACTECH, INC. |
Patrick Hughes |
| K143732 |
07/06/2015 |
FUJIFILM Endoscope Models EC-600HL and EC-600LS |
FUJIFILM Medical Systems U.S.A., Inc. |
Mary Moore |
| K150349 |
07/14/2015 |
Rapid Hair Removal Pads |
FULL POWER AED |
Jahn Power |
| K150128 |
07/16/2015 |
GC Ortho Connect, GC Ortho Etching Gel |
GC Orthodontics America Inc. |
Mark Heiss |
| K143676 |
07/31/2015 |
B40i Patient Monitor |
GE HEALTHCARE FINLAND OY |
JOEL KENT |
| K150245 |
07/17/2015 |
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX |
GE HEALTHCARE FINLAND OY |
Mari Salmenkaita |
| K143345 |
07/10/2015 |
SIGNA Pioneer |
GE HEALTHCARE JAPAN CORPORATION |
Toru Shimizu |
| K143368 |
07/29/2015 |
GenIQ |
GE MEDICAL SYSTEMS, LLC. |
Jenny Wong |
| K150752 |
07/31/2015 |
GME ExSys 308 |
GME (GERMAN MEDICAL ENGINEERING) GMBH |
STEFAN SCHULZE |
| K142726 |
07/24/2015 |
O Glide Personal Lubricant |
Grafenberg Labs |
Manny Frankl |
| K143735 |
07/23/2015 |
Digital Automatic Blood Pressure Monitor MD2300 |
Grandway Technology (Shenzhen) Limited |
Patrick Chow |
| K151478 |
07/01/2015 |
Wondfo CR3 Keyless Split Sample Cup |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
BEN CHEN |
| K143656 |
07/09/2015 |
StarCeram« Z-Nature, StarCeram« Z-Smile |
H.C. Starck Ceramics GmbH |
Alexandra Krausch |
| K143219 |
07/31/2015 |
NIRO-200NX |
Hamamatsu Photonics K.K. |
SUSUMU SUZUKI |
| K142764 |
07/09/2015 |
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port |
HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD. |
Lydia HE |
| K151730 |
07/23/2015 |
Magellan Robotic System |
HANSEN MEDICAL, INC. |
TODD MILHOLLAND |
| K143227 |
07/01/2015 |
Magellan Robotic System, Magellan Robotic Catheter 10Fr |
HANSEN MEDICAL, INC. |
TODD MILHOLLAND |
| K150933 |
07/07/2015 |
iBond Universal & iBond Ceramic Primer |
Heraeus Kulzer LLC, Mitsui Chemicals Group |
Jamie Cleveland |
| K150756 |
07/20/2015 |
Micro well group culture dish, 9-well; Micro well group culture dish, 16-well |
HERTART |
MICHAEL TRINKLE |
| K151015 |
07/29/2015 |
ECHELON Oval V 5.0 MRI System |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K143737 |
07/27/2015 |
EM25 - glute toning device |
HIVOX BIOTEK, INC. |
CLYTIE CHIOU |
| K151395 |
07/24/2015 |
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets |
Immunalysis Corporation |
Joseph Ginete |
| K151233 |
07/07/2015 |
Monaco |
IMPAC MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K143011 |
07/16/2015 |
2014 InterActive/SwishActive System |
Implant Direct Sybron Manufacturing LLC |
Debleena Sinha |
| K151146 |
07/24/2015 |
N-Force Fixation System |
INNOVISION, INC. |
KEITH RUSSELL |
| K143213 |
07/10/2015 |
INOmax DSIR Plus MRI |
INO Therapeutics/Ikaria |
Robert Bovy |
| K150365 |
07/21/2015 |
Cloud9 System |
inSleep Technologies, LLC |
Marty Kerber |
| K151534 |
07/06/2015 |
HemosIL D-Dimer HS |
INSTRUMENTATION LABORATORY CO. |
NIKITA MALLADI |
| K151616 |
07/15/2015 |
AT235 |
INTERACOUSTICS A/S |
ERIK NIELSEN |
| K150486 |
07/24/2015 |
Halo |
J & J Solutions, Inc. d/b/a/Corvida Medical |
Dana Schramm |
| K140762 |
07/02/2015 |
AUTOMATIC BLOOD PRESSURE MONITOR |
JAWON MEDICAL CO., LTD. |
WOO PARK |
| K150248 |
07/23/2015 |
ORL Video NasoPharyngo-Larngoscope |
JEDMED INSTRUMENT COMPANY |
CRAIG PARKS |
| K143070 |
07/07/2015 |
Disposable Safety Self-destructive Syringes, 5 ML |
Jiangsu Yile Medical Article Co.,Ltd. |
Feng Xingyuan |
| K141777 |
07/20/2015 |
NEODENT IMPLANT SYSTEM |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
KEVIN A THOMAS |
| K150367 |
07/13/2015 |
Neodent Implant System |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
Jacson Cambruzzi |
| K151143 |
07/09/2015 |
EndoLIF On-Cage |
JOIMAX GMBH |
Eulodie Tila |
| K150983 |
07/14/2015 |
Pyrenees Cervical Plate System |
K2M |
Nancy Giezen |
| K143271 |
07/01/2015 |
CastleLoc-P Anterior Cervical Plate System |
L&K BIOMED Co., Ltd |
Ki-Hyang Kim |
| K143278 |
07/29/2015 |
LnK Posterior Cervical Fixation System |
L&K BIOMED Co., Ltd. |
An Yerim |
| K151677 |
07/15/2015 |
LnK Cervical Interbody Fusion Cage System |
L&K BIOMED Co.,Ltd. |
Yerim An |
| K143152 |
07/22/2015 |
TM-ABI system |
LD TECHNOLOGY LLC |
Albert Maarek |
| K151196 |
07/14/2015 |
Nautilus Spinal System |
LIFE SPINE, INC |
RANDY LEWIS |
| K150712 |
07/02/2015 |
LTM-Perforated Surgical Mesh |
LifeCell Corporation |
Linda Scamardella |
| K150214 |
07/31/2015 |
OneTouch Verio Flex Blood Glucose Monitoring System |
LIFESCAN EUROPE |
Alison Wilson |
| K143277 |
07/29/2015 |
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), |
Lifestyle Safety Products (Hui Zhou) Co., Ltd. |
Lee Hong Chong |
| K150878 |
07/15/2015 |
ILUMIEN OPTIS |
LIGHTLAB IMAGING,INC. |
ERDIE DE PERALTA |
| K150903 |
07/15/2015 |
EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural |
MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD. |
Viva Gu |
| K142705 |
07/07/2015 |
LeadCare Plus Blood Lead Testing System |
Magellan Diagnostics |
Reba Daoust |
| K151199 |
07/30/2015 |
SmartDrive Wheelchair Power Assist |
MAX MOBILITY, LLC |
Ben Hemkens |
| K151377 |
07/16/2015 |
ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare |
MEDICAL COMPRESSION SYSTEM (DBN) LTD. |
EYAL SANDACH |
| K143688 |
07/01/2015 |
ASFORA ANTERIOR CERVICAL PLATE SYSTEM |
MEDICAL DESIGNS, LLC |
KRISTI VONDRA |
| K151628 |
07/24/2015 |
Medline ENFit Connectors |
MEDLINE INDUSTRIES, INC. |
STEPHANIE BLAIR |
| K143322 |
07/20/2015 |
Medline Natural Lubricating Liquid |
MEDLINE INDUSTRIES, INC. |
JENNIFER MASON |
| K150776 |
07/17/2015 |
Medrobotics Flex System |
MEDROBOTICS CORPORATION |
JOHN D BONASERA |
| K150611 |
07/15/2015 |
MedSource ClearSafe Safety IV Catheter |
MedSource International |
Laura Riggen |
| K143031 |
07/07/2015 |
mcompass Biofeedback Anorectal Manometry System |
MEDSPIRA, LLC |
JIM QUACKENBUSH |
| K151067 |
07/22/2015 |
Ventilation (Tympanostomy) Tubes |
Medtronic Xomed, Inc. |
Michelle Hughes |
| K151532 |
07/23/2015 |
KYPHON ELEMENT Inflatable Bone Tamp |
MEDTRONIC, INC. |
PAMELA EDWARDS |
| K151523 |
07/16/2015 |
Uncoated Tubing and Connector Components |
MEDTRONIC, INC. |
JACQUELINE A. HAUGE |
| K150537 |
07/21/2015 |
MiNi Internal Implant System |
MEGAGEN IMPLANT CO., LTD |
Dong Guk Ha |
| K151046 |
07/17/2015 |
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 |
MERIDIAN BIOSCIENCE, INC. |
STEFANIE JOHNS |
| K151497 |
07/01/2015 |
EN Snare Endovascular Snare System |
MERIT MEDICAL SYSTEMS INC |
MARK MULLANEY |
| K150107 |
07/29/2015 |
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter |
MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR |
Phuong Chau |
| K151447 |
07/28/2015 |
Axium Detachable Coil System |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
PATRICIA CASING |
| K150316 |
07/30/2015 |
Polypectomy Snare |
MICRO- TECH (NANJING) CO., LTD. |
BECKY LI |
| K151330 |
07/14/2015 |
Microlife Wrist Watch Blood Pressure Monitor |
MICROLIFE INTELLECTUAL PROPERTY GmbH, SWITZERLAND |
GERHARD FRICK |
| K151543 |
07/07/2015 |
Graft Delivery Device with Integrated Stylet |
Micromedics Inc. (d/b/a Nordson Medical) |
Amy L Peterson |
| K151536 |
07/08/2015 |
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm |
MRI INTERVENTIONS, INC. |
E F WADDELL |
| K151557 |
07/16/2015 |
EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine |
NANTONG EGENS BIOTECH CO., LTD. |
BEN CHEN |
| K150912 |
07/10/2015 |
Houva-NET Control System |
National Biological Corporation |
Lynn Keller |
| K143607 |
07/08/2015 |
I-Portal NOTC, VNG and VOG |
NEURO KINETICS, INC. |
J. Howison Schroeder |
| K150313 |
07/09/2015 |
Ablation Confirmation |
NEUWAVE MEDICAL INC. |
DAN KOSEDNAR |
| K142040 |
07/31/2015 |
OCS-B COLLAGEN |
NIBEC CO LTD |
DANIEL NAM |
| K150742 |
07/23/2015 |
Muscle Stimulation System 110 |
NIVEUS MEDICAL, INC. |
Brian Fahey |
| K151654 |
07/17/2015 |
PROW FUSION |
NLT SPINE LTD |
Eti Zinger |
| K150874 |
07/31/2015 |
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) |
NOVO NORDISK INC. |
Poonam Tuliani |
| K150370 |
07/22/2015 |
Nutra Light Advanced |
NUTRA LUXE MD, LLC |
GLORIA AVENDANO |
| K142855 |
07/28/2015 |
Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) |
Omega Laboratories, Inc. |
William Corl |
| K151207 |
07/28/2015 |
Proton Immobilization Solution |
ORFIT INDUSTRIES NV |
EDDY MARIVOET |
| K150272 |
07/17/2015 |
Capnostream 35 Portable Respiratory Monitor |
ORIDION MEDICAL 1987 LTD. |
Dalia Givony |
| K151488 |
07/07/2015 |
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System |
Orthofix, Inc. |
Jacki Geren |
| K151147 |
07/01/2015 |
STARband, STARlight |
ORTHOMERICA PRODUCTS, INC. |
DAVID C. KERR |
| K150655 |
07/09/2015 |
OIC Intramedullary Nail System |
ORTHOPAEDIC IMPLANT COMPANY |
Douglas Fulton |
| K151021 |
07/15/2015 |
OsteoMed Cannulated Screw System |
OSTEOMED CORP. |
Blesson Abraham |
| K142005 |
07/10/2015 |
SpineFab Vertebral Body Replacement (VBR) System |
OXFORD PERFORMANCE MATERIALS |
LEIGH AYRES |
| K151150 |
07/28/2015 |
Elements |
PAC-DENT INTERNATIONAL, INC. |
WENYING ZHU |
| K151418 |
07/15/2015 |
Monster Screw System |
PARAGON 28 |
FRANK S. BONO |
| K143355 |
07/10/2015 |
The Simple Locking IntraMedullary (SLIM) System |
PEGA MEDICAL INC. |
Ariel R Dujovne |
| K143202 |
07/07/2015 |
ANGIO-PRESS DVT Compression Device Model Name: IPCS |
Pegasus Medical Supply, Inc. |
PAO-MING SHIH |
| K151572 |
07/10/2015 |
Penumbra Smart Coil |
PENUMBRA, INC. |
CHARLES DENAULT |
| K151033 |
07/28/2015 |
Philips Self-Adhesive Electrodes |
PHILIPS CONSUMER LIFESTYLE |
MARTA WALKER |
| K151035 |
07/21/2015 |
PulseRelief |
PHILIPS CONSUMER LIFESTYLE |
Marta Walker |
| K151681 |
07/17/2015 |
IntelliVue Patient Monitor |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
JOHANNES SCHMID |
| K150088 |
07/20/2015 |
Evacore Fully Disposable Vacuum Assist Biopsy Device |
Pin-Point Care Corp. |
Jeff M Hathaway |
| K151184 |
07/14/2015 |
InFill Interbody Fusion Devices |
PINNACLE SPINE GROUP, LLC |
REBECCA K PINE |
| K151314 |
07/23/2015 |
CinchLock Flex Knotless Suture Anchor |
Pivot Medical |
Kelly Kucharczyk |
| K151530 |
07/07/2015 |
CardioChek Plus Test System |
POLYMER TECHNOLOGY SYSTEMS, INC. |
Megan Burns |
| K150856 |
07/07/2015 |
Reform Pedicle Screw System |
PRECISION SPINE, INC. |
Michael Dawson |
| K150380 |
07/17/2015 |
ProMIS Fixation System |
Premia Spine Ltd. |
Ron Sacher |
| K150601 |
07/22/2015 |
Zeramic Adhesive Resin Cement |
Premier Dental Company Products |
VINCENT D'ALESSANDRO |
| K143383 |
07/23/2015 |
Q6 Edge EM |
Pride Mobility Product Corporation |
Kimberly Elmes |
| K150872 |
07/02/2015 |
BruxZir Anterior Milling Blanks |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
| K150423 |
07/08/2015 |
EXPAZEN |
PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP) |
GENEVIEVE DE VILLEDON |
| K142190 |
07/14/2015 |
Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs |
PT MEDISAFE TECHNOLOGIES |
Anil Taneja |
| K151709 |
07/17/2015 |
Hi-Light Diagnostic Ultrasound Systems |
Qingdao Hisense Medical Equipment Co., Ltd. |
Wang Wei |
| K151829 |
07/29/2015 |
Atlas SPEEDER Header/Neck |
Quality Electrodynamics, LLC |
KATHLEEN ARAS |
| K151707 |
07/19/2015 |
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i |
RAYENCE CO., LTD |
KEVIN KIM |
| K151438 |
07/07/2015 |
Dentrix Ascend Imaging |
REALCLOUD IMAGING INC. |
DOUGLAS A. GOLAY |
| K143532 |
07/31/2015 |
Durex Silicone |
Reckitt Benckiser LLC |
Elizabeth Torre |
| K143418 |
07/31/2015 |
STRONG Dental Handpieces |
Saeshin Precision Co., Ltd. |
Choi Sae Kwan |
| K151685 |
07/17/2015 |
GUA60A, GU60A-65 |
SAMSUNG ELECTRONICS CO., LTD. |
Chulsin Kim |
| K151808 |
07/29/2015 |
3D/5D Viewer |
SAMSUNG MEDISON CO., LTD |
KIM JIYOUNG |
| K150014 |
07/27/2015 |
Serenity |
SANUTHERA, INC. |
JEFFERY DIGIOVANNI |
| K143268 |
07/21/2015 |
TENS AND POWERED MUSCLE STIMULATOR |
SHENZHEN AS-TEC TECHNOLOGY CO., LTD |
CONNIE LI |
| K150995 |
07/06/2015 |
Electronic Pulse Stimulator |
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD |
PU JIANG |
| K150632 |
07/06/2015 |
Hypervisor IX Monitoring System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANHONG BAI |
| K150875 |
07/22/2015 |
iFuse Implant System |
SI-BONE, Inc. |
Roxanne Dubois |
| K150039 |
07/02/2015 |
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) |
Siemens Healthcare Diagnostics Inc. |
Shanon Popson |
| K143687 |
07/17/2015 |
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Fatima Pacheco |
| K151486 |
07/17/2015 |
Biograph mCT and mCT Flow PET/CT Scanners |
Siemens Medical Solutions USA, Inc. |
ALAINE MEDIO |
| K150750 |
07/02/2015 |
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray |
Sirona Dental Systems GMBH |
Thomas Diesch |
| K150909 |
07/17/2015 |
INTEGO Family and Accesories |
Sirona Dental Systems GMBH |
Thomas Diesch |
| K151045 |
07/24/2015 |
TENEO Dental Treatment Unit and Accessories |
SIRONA DENTAL SYSTEMS GMBH |
THOMAS DIESCH |
| K151118 |
07/28/2015 |
Smith and Nephew Legion Hinge Knee System |
SMITH & NEPHEW |
ALLISON CHAN |
| K143133 |
07/23/2015 |
RENASYS┐ EZ MAX Negative Pressure Wound Therapy Device, RENASYS┐ AB Abdominal Dressing Kit with Soft Port Device |
SMITH & NEPHEW, INC. |
LAURA REYNOLDS |
| K151326 |
07/16/2015 |
RENASYS┐ EZ PLUS Negative Pressure Wound Therapy Device |
Smith & Nephew, Inc. |
Laura Reynolds |
| K151105 |
07/28/2015 |
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteorap |
Smith & Nephew, Inc. |
Katherine Marcaccio |
| K143115 |
07/15/2015 |
The VersaJet II Hydrosurgery System |
SMITH & NEPHEW, INC. |
Laura Reynolds |
| K150377 |
07/29/2015 |
Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor |
SONY ELECTRONICS, INC. |
Amarjit Andy Singh Jowandha |
| K151053 |
07/31/2015 |
PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner |
SOPRO - ACTEON GROUP |
PHILIPPE BOYER |
| K142827 |
07/20/2015 |
Visi Mobile Monitoring System, Visi Mobile Chest Sensor |
Sotera Wireless, Inc. |
Eben Gordon |
| K151581 |
07/09/2015 |
Leva Spacer System |
SPINE WAVE, INC. |
GAIL YAEKER-DAUNIS |
| K151813 |
07/31/2015 |
Sniper Spine System |
SPINE WAVE, INC. |
Ronald K Smith |
| K151198 |
07/17/2015 |
A-CIFT SoloFuse |
SPINEFRONTIER, INC. |
MANTHAN J DAMANI |
| K151020 |
07/22/2015 |
Rampart-T Interbody Fusion System |
Spineology, Inc. |
Tim Crabtree |
| K151101 |
07/17/2015 |
Lotus Series 4 Ultrasonic Surgical System & Accessories |
SRA DEVELOPMENTS, LTD. |
Alan Chivers |
| K151622 |
07/15/2015 |
St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electroph |
St. Jude Medical |
Maria Obreztchikova |
| K150968 |
07/24/2015 |
TRU Dental Implant System |
Sterngold Dental, LLC |
Maria Rao |
| K150938 |
07/24/2015 |
Straumann« Dental Implant System ┐ Roxolid« SLA Implants |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
| K150700 |
07/15/2015 |
ACP 1 Anterior Cervical Plating System |
STRYKER CORPORATION |
Tina Mornak |
| K151755 |
07/09/2015 |
OASYS(r) System |
Stryker Corporation |
Garry T Hayeck |
| K150301 |
07/08/2015 |
NavSuite3 Kit |
Stryker Leibinger GmbH & Co. KG - Navigation |
Robin L Rowe |
| K141289 |
07/24/2015 |
TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS |
TECO DIAGNOSTICS |
AQUIL MERCHANT |
| K142790 |
07/30/2015 |
OneTouch Lubricant Gel |
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
Pisut Chanwatarungkull |
| K150919 |
07/13/2015 |
ArgenZ Esthetic Plus |
THE ARGEN CORPORATION |
CRAIG JOLICOEUR |
| K143236 |
07/02/2015 |
Theranos Herpes Simplex Virus-1 IgG Assay |
THERANOS, INC. |
Brad Arington |
| K150236 |
07/27/2015 |
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) |
THERMO FISHER SCIENTIFIC |
CYNTHIA KNAPP |
| K150641 |
07/31/2015 |
MagVita TMS Therapy System |
TONICA ELEKTRONIK A/S |
Lise Terkelsen |
| K150715 |
07/28/2015 |
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors |
TORNIER, INC. |
Kaitlyn Rainbow |
| K151170 |
07/02/2015 |
Tosama 100% Organic Cotton Menstrual Tampon |
TOSAMA D.O.O. |
MARJETKA KRALJ KUNCIC |
| K151451 |
07/09/2015 |
Aplio 500/400/300 Diagnostic Ultrasound System V6.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K151091 |
07/13/2015 |
Vitrea Software Toshiba Package, VSTP-001A |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K143075 |
07/02/2015 |
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set |
TOSOH BIOSCIENCE, INC. |
ROBERT L WICK |
| K150613 |
07/22/2015 |
LaserCap LC Pro and LC Elite |
TRANSDERMAL CAP, INC. |
MICHAEL RABIN |
| K140740 |
07/23/2015 |
TRANSONIC TISSUE PERFUSION MONITOR |
TRANSONIC SYSTEMS, INC. |
DAVID KLEMENTOWSKI |
| K150394 |
07/28/2015 |
Tyber Medical Wedge System |
TYBER MEDICAL LLC |
JEFF TYBER |
| K150505 |
07/29/2015 |
Cellfina System |
ULTHERA, INC. |
Suzon Lommel |
| K151094 |
07/21/2015 |
Mosaic Universal Composite |
ULTRADENT PRODUCTS, INC. |
KAREN KAKUNES |
| K143176 |
07/17/2015 |
UltraLinq |
ULTRALINQ HEALTHCARE SOLUTIONS, INC. |
Stephen Farber |
| K150068 |
07/31/2015 |
Unimicro Veress Needle |
Unimicro Medical Systems (ShenZhen) Co.,Ltd. |
Weizhong Chen |
| K150480 |
07/08/2015 |
JO H20 Water Based Personal Lubricant |
UNITED CONSORTIUM INC. |
Joe Mendoza |
| K141720 |
07/23/2015 |
iuStar300 Medical Ultrasound Diagnostic System |
UNITED IMAGING SYSTEMS (BEIJING) CO., LTD. |
JUN PENG |
| K151889 |
07/30/2015 |
Infinity ERCP Sampling Device |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL MARTIN |
| K151197 |
07/06/2015 |
Lariat snare |
UNITED STATES ENDOSCOPY GROUP, INC. |
SAGAR PIMPALWAR |
| K150839 |
07/17/2015 |
3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J. CORONADO |
| K142965 |
07/16/2015 |
Virtuoso System for IHC PR (1E2) using iScan HT |
Ventana Medical Systems, Inc. |
Morteza Minaee |
| K150784 |
07/02/2015 |
Admira Fusion |
VOCO GMBH |
M TH PLAUMANN |
| K151904 |
07/31/2015 |
SyncVision System |
VOLCANO CORPORATION |
ELAINE ALAN |
| K142845 |
07/01/2015 |
SILKPRO laser hair removal system |
Wuhan Lotuxs Technology Co., Ltd |
Wu Na |
| K150834 |
07/10/2015 |
Atrax Anterior Cervical Plating System |
X-Spine Systems, Inc |
David Kirschman |
| K151963 |
07/31/2015 |
SmartSite Vented Vial Access Device |
YUKON MEDICAL, LLC |
CARL DUPPER |
| K150021 |
07/31/2015 |
Z5m(t) |
Z-Systems AG |
Thomas Hug |
| K150295 |
07/24/2015 |
LOCATOR RTx |
ZEST ANCHORS, INC. |
Annie Wrigth |
| K143346 |
07/22/2015 |
Powder-Free White Vinyl Patient Examination Gloves |
Zibo Changda Plastic Products Company, Limited |
Coco Kou |
| K143340 |
07/09/2015 |
Powder Free Vinyl Patient Examination Gloves, Yellow Color |
Zibo Ling Yun Medical Products Co, Ltd |
Eric Wang |
| K143347 |
07/24/2015 |
Powder-Free Yellow Vinyl Patient Examination Gloves |
Zibo Zhouheng Plastic Products Co. Ltd |
Cherry Xu |
| K150889 |
07/01/2015 |
Suture Wires and Wire Loops |
ZIMMER, INC. |
PATRICK MCCULLAGH |
