| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K150547 |
03/03/2015 |
.decimal Astroid Dosimetry App |
.decimal, inc |
KEVIN ERHART |
| K150622 |
03/11/2015 |
3M Comply Hydrogen Peroxide Chemical Indicator 1248 |
3M Company |
Hilary B. Hovde |
| K150694 |
03/18/2015 |
3M Comply Hydrogen Peroxide Indicator Tape 1228 |
3M Company |
Hilary B. Hovde |
| K150531 |
03/02/2015 |
FreeStyle Freedom Lite Blood Glucose Monitoring System |
Abbott Laboratories |
Sai Sriharshada Tatavarty |
| K150637 |
03/11/2015 |
Aerin Medical Wand Model FG011 |
Aerin Medical, Inc. |
Scott Wolf |
| K150544 |
03/03/2015 |
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System |
AESCULAP IMPLANT SYSTEMS, LLC |
Julie Tom Wing |
| K150718 |
03/19/2015 |
Wi-3 HAL-RAR System |
AGENCY FOR MEDICAL INNOVATIONS GMBH |
Stefanie Hoellger |
| K150660 |
03/13/2015 |
Alcyone MEMS Cannula (AMC) System |
ALCYONE LIFESCIENCES, INC. |
ELSA CHI ABRUZZO |
| K150773 |
03/24/2015 |
E-CUBE 15 Diagnostic Ultrasound System |
ALPINION MEDICAL SYSTEMS CO., LTD |
DONGHWAN KIM |
| K150645 |
03/12/2015 |
AN1087 Dosimeter |
ANDERSEN STERILIZERS, INC. |
William K. Andersen |
| K150644 |
03/12/2015 |
AN85/AN86 EO Indicators |
ANDERSEN STERILIZERS, INC. |
William K. Andersen |
| K150646 |
03/12/2015 |
EOGas 4 Ethylene Oxide Gas Sterilizer |
ANDERSEN STERILIZERS, INC. |
WILLIAM K. ANDERSEN |
| K150833 |
03/30/2015 |
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System |
ANDON HEALTH CO.,LTD |
Yi Liu |
| K150612 |
03/10/2015 |
Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) |
ANHUI ANYU LATEX PRODUCTS CO., LTD |
NONE PROVIDED |
| K150609 |
03/10/2015 |
Annuy Latex Surgeon's Gloves (Powdered and Powder Free) |
ANHUI ANYU LATEX PRODUCTS CO., LTD |
NONE PROVIDED |
| K150625 |
03/11/2015 |
Morrison Steerable Needle |
APRIOMED AB |
Bruno Edling |
| K150721 |
03/19/2015 |
ARDO Calypso Pro Powered Breast Pump |
ARDO MEDICAL AG |
ROGER DUBACH |
| K150648 |
03/12/2015 |
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm |
ARTHREX, INC. |
Laura Medlin |
| K150693 |
03/18/2015 |
PHIN-FX Cannulated Lag Screw System |
ASCENT MEDICAL, LLC |
DAVID FORD |
| K150553 |
03/04/2015 |
Filbloc |
ASSUT EUROPE |
GLORIA AGGIO |
| K150800 |
03/26/2015 |
Valved Safety Centesis Catheter |
B. Braun Medical Inc |
Nancy Skocypec |
| K150787 |
03/25/2015 |
Universal Spike |
B. Braun Medical Inc. |
Tracy Maddock |
| DEN150009 |
03/04/2015 |
B.R.A.H.M.S PCT sensitive KRYPTOR |
B.R.A.H.M.S GMBH |
BERNHARD CIOMMER |
| K150621 |
03/11/2015 |
OsteoSelect PLUS Demineralized Bone Matrix Putty |
BACTERIN INTERNATIONAL INC. |
Howard L Schrayer |
| K150821 |
03/27/2015 |
MDNG-3220 (Nio 3MP LED) |
Barco |
Lieven De Wandel |
| K150709 |
03/19/2015 |
ProTrack RF Anchor Wire |
BAYLIS MEDICAL COMPANY INC. |
Meghal Khakhar |
| K150815 |
03/27/2015 |
BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit |
Becton, Dickinson and Company |
Catherine(Katie) Bessette |
| K150591 |
03/09/2015 |
Besmed Reusable Jet Nebulizer |
BESMED HEALTH BUSINESS CORP. |
WINNIE CHUNG |
| K150768 |
03/24/2015 |
JuggerKnot Soft Anchors |
BIOMET MANUFACTURING CORP. |
ADAM CARGILL |
| K150522 |
03/02/2015 |
G7 Dual Mobility System |
BIOMET, INC. |
Amy Walriven |
| K150850 |
03/31/2015 |
Refobacin Bone Cement R |
BIOMET, INC. |
CARMEN ALBANY |
| K150571 |
03/06/2015 |
3i T3 Short Implants |
BIOMET3I |
CHRIS MCKEE |
| K150722 |
03/20/2015 |
EnFocus 2300, EnFocus 4400 |
BIOPTIGEN, INC. |
Tammy B Carrea |
| K150781 |
03/25/2015 |
Tissue Removal Pouch |
BOEHRINGER LABORATORIES, LLC |
Chris Radl |
| K150692 |
03/18/2015 |
AXIOS Stent with Electrocautery Enhanced Delivery System |
BOSTON SCIENTIFIC CORP. |
Carole Sykes |
| K150679 |
03/17/2015 |
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector |
BOSTON SCIENTIFIC CORP. |
Virginia Garcia |
| K150720 |
03/19/2015 |
XP3000 |
BTL Industries, Inc. |
Jan Zarsky |
| K150569 |
03/06/2015 |
LaparoVue |
Buffalo Filter, LLC |
Pamela Netzel |
| K150529 |
03/02/2015 |
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System |
C.R. Bard, Inc |
Reily Inman |
| K150699 |
03/18/2015 |
Bard LubriGuard Foley Catheter |
C.R. Bard, Inc. |
Michele Davis |
| K150667 |
03/16/2015 |
True Dilatation Balloon Valvuloplasty Catheter |
C.R. Bard, Inc. |
Aaron Conovaloff |
| K150585 |
03/09/2015 |
Ascent 3D |
CAO GROUP, INC. |
Robert K Larsen |
| K150578 |
03/09/2015 |
Capillus 272 Office Pro |
Capillus, LLC |
Patricia Schnoor |
| K150579 |
03/09/2015 |
Cardinal Health External Fixation System |
CARDINAL HEALTH |
TATYANA BOGDAN |
| K150769 |
03/24/2015 |
Cardinal Health Trochanteric IM Nail System |
Cardinal Health |
Tatyana Bogdan |
| K150732 |
03/20/2015 |
Diamondback 360 Peripheral Orbital Atherectomy System |
CARDIOVASCULAR SYSTEMS, INC. |
Blair Buth |
| K150523 |
03/02/2015 |
AVAmax Vertebral Balloon |
CAREFUSION |
JOY GREIDANUS |
| K150810 |
03/26/2015 |
Vyntus / SentrySuite Product Line |
CareFusion Germany 234 GmbH |
Elmar Niedermeyer |
| K150766 |
03/24/2015 |
Carestream DRX-1 System |
Carestream Health, Inc. |
Carolyn L Wagner |
| K150620 |
03/10/2015 |
740 SELECT |
CAS MEDICAL SYSTEMS, INC. |
Ron Jeffrey |
| K150643 |
03/12/2015 |
Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti |
CENTINEL SPINE, INC. |
MR. JOHN PARRY |
| K150684 |
03/17/2015 |
WASTON General Spinal System |
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
Jack Lu |
| K150661 |
03/13/2015 |
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite |
CITIEFFE s.r.l |
Stefano Pullega |
| K150573 |
03/06/2015 |
ebb Complete Tamponade System |
CLINICAL INNOVATIONS, LLC |
Tom Haueter |
| K150555 |
03/04/2015 |
BA400 14mm Abutment |
COCHLEAR AMERICAS |
Tristan Manus |
| K150751 |
03/23/2015 |
Cordelle II Sound Processor |
COCHLEAR AMERICAS |
Laura Blair |
| K150798 |
03/26/2015 |
Codent Low Speed Dental Handpieces and Accessories |
CODENT TECHNICAL INDUSTRY CO., LTD. |
Chin-Ting Wen |
| K150825 |
03/27/2015 |
Collagen Dural Regeneration Matrix |
COLLAGEN MATRIX, INC. |
GLORIA ZUCLICH |
| K150615 |
03/10/2015 |
Vaginal Moisturizing Gel |
COMBE INCORPORATED |
Pushpa Rao |
| K150616 |
03/10/2015 |
Trevo XP ProVue Retriever (4x30mm) |
Concentric Medical, Inc. |
Rhoda M. Santos |
| K150590 |
03/09/2015 |
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 |
| K150668 |
03/16/2015 |
Biodesign Enterocutaneous Fistula Plug |
COOK BIOTECH INCORPRATED |
Perry W Guinn |
| K150594 |
03/09/2015 |
Biodesign Otologic Repair Graft |
COOK BIOTECH INCORPRATED |
PERRY W. GUINN |
| K150748 |
03/23/2015 |
Flexipet Denuding Pipette, Flexipet Manipulation Pipette |
COOK INCORPORATED |
NAOMI FUNKHOUSER |
| K150802 |
03/26/2015 |
Heavy Double Flexible Tipped Wire Guide |
COOK INCORPORATED |
JULIA FERGUSON |
| K150733 |
03/20/2015 |
Vital-Port Vascular Access System Power Injectable Port |
COOK INCORPORATED |
STEVEN LAWRIE |
| K150836 |
03/30/2015 |
OUTBACK Elite Re-Entry Catheter |
CORDIS CORPORATION, A JOHNSON & JOHNSON CO. |
MICHELLE RAGOZZINO RODGERS |
| K150847 |
03/31/2015 |
Foundation Interbody Devices |
CORELINK LLC |
Sharon Gregory |
| K150778 |
03/25/2015 |
Various Brands of Ultraviolet Lamps |
COSMEDICO LIGHT, INC. |
Steven Schlitt |
| K150852 |
03/31/2015 |
SIC 8000 |
COSMO TECHNOLOGIES, LTD. |
RICHARD JONES |
| K150550 |
03/03/2015 |
SilverCoat Silicone Foley Catheter |
COVALON TECHNOLOGIES, INC. |
Kim Crooks |
| K150735 |
03/20/2015 |
Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot |
COVIDIEN |
NANCY SAUER |
| K150835 |
03/30/2015 |
LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip |
COVIDIEN |
Nancy Sauer |
| K150711 |
03/19/2015 |
Salem Sump Dual Lumen Stomach Tube with Multi-functional Port |
COVIDIEN |
Jim Welsh |
| K150844 |
03/30/2015 |
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula |
COVIDIEN |
Danielle Mueller |
| K150724 |
03/20/2015 |
SculpSure |
CYNOSURE, INC. |
KEVIN O'CONNELL |
| K150587 |
03/09/2015 |
Cortex Laser System |
Cynosure, Inc. dba Ellman |
Allison Sathe |
| K150759 |
03/23/2015 |
Hyper-C Anterior Cervical Plate System |
Degen Medical |
Craig Black |
| K150535 |
03/03/2015 |
Cavitron Touch Ultrasonic Scaling System |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K150696 |
03/18/2015 |
Jade 37% Phosphoric Acid Etchant Gel |
Dharma Research, Inc. |
Ricardo Carles |
| DEN150010 |
03/06/2015 |
Dignitana AB DigniCap System |
DIGNITANA AB |
JAN RICHARDSSON |
| K150518 |
03/02/2015 |
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm |
DUPACO INC. |
AN VU |
| K150672 |
03/16/2015 |
VistaCam iX Proof |
Durr Dental AG |
Oliver Lange |
| K150823 |
03/27/2015 |
EDLENi Intra-Oral Sensor |
EDLEN IMAGING LLC |
Nick Radachi |
| K150516 |
03/02/2015 |
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS |
EL.EN ELECTRONIC ENGINEERING SPA |
PAOLO PERUZZI |
| K150656 |
03/13/2015 |
PRECICE Intramedullary Limb Lengthening System |
Ellipse Technologies, Incorporated |
Rebecca Shelburne |
| K150840 |
03/30/2015 |
Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier |
ETHICON ENDO-SURGERY, LLC |
Marjorie Medina |
| K150670 |
03/16/2015 |
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device |
ETHICON, INC. |
DONNA MARSHALL |
| K150761 |
03/23/2015 |
Ez3D-i/E3 |
EWOO SOFT CO., LTD |
Young Seok Kim |
| K150568 |
03/06/2015 |
ARROW Humeral stems size 6 and 16 |
FOURNITURES HOSPITALIERES INDUSTRIE |
Patricia Donnard |
| K150708 |
03/19/2015 |
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
DENISE OPPERMANN |
| K150681 |
03/17/2015 |
GEMORE OTC TENS |
GEMORE TECHNOLOGY CO., LTD. |
Boden S.P Lai |
| K150649 |
03/12/2015 |
G3 Active Plate Large Fragment System |
GENESIS FRACTURE CARE, INC. |
MICHAEL BOTTLANG, |
| K150812 |
03/26/2015 |
Genesys Spine Apache Cervical Interbody Fusion System |
Genesys Spine |
Dave Lamb |
| K150782 |
03/25/2015 |
AbStats Gateway |
GI Logic Inc |
James Beeton |
| K150552 |
03/04/2015 |
ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS |
GLOBUS MEDICAL INC. |
Kelly J. Baker |
| K150752 |
03/23/2015 |
GME ExSys 308 |
GME (GERMAN MEDICAL ENGINEERING) GMBH |
STEFAN SCHULZE |
| K150702 |
03/18/2015 |
Exceed Tx |
GREAT LAKES ORTHODONTICS, LTD. |
DAVE GRAVER |
| K150767 |
03/24/2015 |
EDOSE |
GUANGZHOU RAYDOSE SOFTWARE TECHNOLOGY., LLC |
DENNIS DONG |
| K150602 |
03/10/2015 |
CR3 Keyless Split Sample Cup Morphine - Methamphetamine |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
BEN CHEN |
| K150519 |
03/02/2015 |
ManipulatOR PRO, ManipulatOR |
GYNETECH PTY. LTD. |
Brett Telford |
| K150857 |
03/31/2015 |
Banana Gold |
HANKOOK LATEX GONGUP CO., LTD. |
KWON DUKEE |
| K150593 |
03/09/2015 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K150791 |
03/25/2015 |
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
JIANQIU FANG |
| K150756 |
03/23/2015 |
Micro well group culture dish, 9-well; Micro well group culture dish, 16-well |
HERTART |
MICHAEL TRINKLE |
| K150595 |
03/09/2015 |
SCENARIA Phase 3 Whole-body X-ray CT System |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
Doug Thistlethwaite |
| K150565 |
03/06/2015 |
Supria Whole-body X-ray CT System |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
Doug Thistlethwaite |
| K150695 |
03/18/2015 |
Modpod |
HOLLYWOG, LLC |
MICHAEL TREAS |
| K150528 |
03/02/2015 |
Cortisol Saliva Luminescence Immunoassay |
IBL INTERNATIONAL GMBH |
NICOLA KAISER |
| K150789 |
03/25/2015 |
SPINAUT-E, SPINAUT-I |
IMEDICOM CO., LTD. |
Bonngu Ha |
| K150799 |
03/26/2015 |
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula |
INNOVACYN, INC. |
Victor Torcat Mallen |
| K150813 |
03/27/2015 |
iTClamp50 |
INNOVATIVE TRAUMA CARE INC |
Ian Atkinson |
| K150682 |
03/17/2015 |
CUSA Excel+ |
INTEGRA LIFESCIENCES CORP. |
JENNIFER SIEGEL |
| K150707 |
03/19/2015 |
IntelePACS |
INTELERAD MEDICAL SYSTEMS INCORPORATED |
Ms. Luce Caron |
| K150837 |
03/30/2015 |
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps |
INTUITIVE SURGICAL, INC. |
SARAH RIZK |
| K150758 |
03/23/2015 |
Safety Disposable Insulin Syringe |
JIANGYIN CAINA TECHNOLOGY CO., LTD |
JUN LU |
| K150743 |
03/23/2015 |
Water Based Personal Lubricant with Flavours |
KAREX INDUSTRIES SDN. BHD. |
MS. MARY GOH YIN |
| K150525 |
03/02/2015 |
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE S. CHEN |
| K150532 |
03/02/2015 |
Universal Light Handle Cover, Light Handle Cover |
Key Surgical, Inc. |
Amy Yanta |
| K150771 |
03/24/2015 |
RxG Distraction System |
KLS MARTIN L.P. |
JENNIFER DAMATO |
| K150703 |
03/18/2015 |
CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
| K150704 |
03/18/2015 |
PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Pa |
KURARAY NORITAKE DENTAL, INC. |
MICHIO TAKIGAWA |
| K150817 |
03/27/2015 |
Dario Blood Glucose Monitoring System |
LabStyle Innovations Ltd. |
TRACEY WIELINSKI |
| K150841 |
03/30/2015 |
Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant |
LACLEDE, INC. |
Michael Pellico |
| K150765 |
03/24/2015 |
LDR Spine ROI-C Cervical Cage System |
LDR SPINE USA |
Brad Strasser |
| K150712 |
03/19/2015 |
LTM-Perforated Surgical Mesh |
LifeCell Corporation |
Linda Scamardella |
| K150855 |
03/31/2015 |
H-MAX S Femoral Hip System |
Limacorporate S.P.A. |
Sara Viel |
| K150747 |
03/23/2015 |
EzDent-i /E2/Prora View |
LK Consulting Group USA, Inc. |
Priscilla Chung |
| K150691 |
03/18/2015 |
Datalys Multi-Parameter Patient Monitor |
Lutech Industries, Inc. |
RONALD VACHULA |
| K150717 |
03/19/2015 |
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K150780 |
03/25/2015 |
Acetabular Cup Orientation System |
MATERIALISE NV |
OLIVER CLEMENS |
| K150548 |
03/03/2015 |
Tek RMD (Tek Robotic Mobilization Device) |
MATIA ROBOTICS MEKATROIK SIS. AR-GE MUH. YAZ.SAN ve TIC.A.S |
Necati Hacikadiroglu |
| K150831 |
03/30/2015 |
Cellvizio 100 Series System with Confocal Miniprobes |
MAUNA KEA TECHNOLOGIES |
Sophie Rehault |
| K150680 |
03/17/2015 |
Freedom Cementless Femoral Component |
MAXX ORTHOPEDICS, INC. |
Gabriela Gottlieb |
| K150804 |
03/26/2015 |
QBioScan |
MEDEIA, INC. |
SLAV DANEV |
| K150788 |
03/25/2015 |
Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices |
MEDITECH SPINE, LLC |
Jason Gromek |
| K150598 |
03/09/2015 |
Blockade Surgical Gown |
Medline Industries, Inc. |
Matt Clausen |
| K150698 |
03/18/2015 |
Gemini Sterilization Wrap |
MEDLINE INDUSTRIES, INC. |
Jennifer Mason |
| K150731 |
03/20/2015 |
Medline Epidural Catheter |
MEDLINE INDUSTRIES, INC. |
Matt Clausen |
| K150776 |
03/24/2015 |
Medrobotics Flex System |
MEDROBOTICS CORPORATION |
JOHN D BONASERA |
| K150611 |
03/10/2015 |
MedSource ClearSafe Safety IV Catheter |
MedSource International |
Laura Riggen |
| K150614 |
03/10/2015 |
Reveal LINQ |
MEDTRONIC INC. |
DIANNA L. JOHANNSON |
| K150728 |
03/20/2015 |
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole |
MEDTRONIC XOMED, INC. |
Gabriela Anchonda |
| K150530 |
03/02/2015 |
Level Sensor, Level Sensor Tape |
Medtronic, Inc |
Rahul Shah |
| K150567 |
03/06/2015 |
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT |
Medtronic, Inc. |
Bruce Backlund |
| K150537 |
03/03/2015 |
MiNi Internal Implant System |
MEGAGEN IMPLANT CO., LTD |
Dong Guk Ha |
| K150777 |
03/25/2015 |
Artoura Breast Tissue Expander |
MENTOR WORLDWIDE LLC |
Manchi Cheung |
| K150657 |
03/13/2015 |
Phoenix XL Dialysate Meter |
Mesa Laboratories, Inc. |
Jamie Louie |
| K150779 |
03/25/2015 |
LipoFilter - Hospital Pack, LipoFilter - Clinic Pack |
MICROAIRE SURGICAL INSTRUMENTS, LLC |
Chris Spofford |
| K150705 |
03/18/2015 |
FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator |
Minimally Invasive Devices, Inc. |
Trudie L Seeger |
| K150574 |
03/06/2015 |
Modular Power Positioning System |
MOTION CONCEPTS |
Dona Bhamra |
| K150746 |
03/23/2015 |
JUSHA-M52C Medical Display |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
MA JING |
| K150842 |
03/30/2015 |
JUSHA-M53 Medical Display |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
JING MA |
| K150623 |
03/11/2015 |
Nanova Flowable Composite |
NANOVA BIOMATERIALS, INC. |
Andrew Ritts |
| K150561 |
03/06/2015 |
NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System |
Narang Medical Limited |
Vivek Narang |
| K150527 |
03/02/2015 |
Xcela Power Injectable PICC |
NAVILYST MEDICAL, INC. |
Wanda Carpinella |
| K150562 |
03/06/2015 |
Safe'n'Sound Staked Passive Delivery System - Plajex version |
Nemera |
James A WERKAMP |
| K150669 |
03/16/2015 |
Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) |
Neoss Ltd |
Karin Darle Olsson |
| K150772 |
03/24/2015 |
Snap-Off Self-Compressive Screw |
NEOSTEO |
JD Webb |
| K150647 |
03/12/2015 |
Polyscrew Pedicle Screw System |
New Era Orthopedics, LLC |
Mark De Baca |
| K150729 |
03/20/2015 |
SpectraShield 9500 Surgical N95 Respirator |
Nexera Medical Inc. |
Paul Sallarulo |
| K150792 |
03/25/2015 |
Next Science Wound Gel |
NEXT SCIENCE, LLC |
MATTHEW MYNTTI |
| K150742 |
03/23/2015 |
Muscle Stimulation System 110 |
NIVEUS MEDICAL, INC. |
Brian Fahey |
| K150826 |
03/30/2015 |
Nutra Face Lift Model PE8050 |
NUTRA LUXE MD, LLC |
PETER VON BERG |
| K150786 |
03/25/2015 |
Rezum System |
NxThera, Inc. |
J. Robert Paulson, JD |
| K150828 |
03/30/2015 |
O-RING Condom |
O-RING Products LLC |
William Mistler |
| K150633 |
03/11/2015 |
ULTRA Telescopes |
OLYMPUS WINTER & IBE GMBH |
KATHARINA SCHNACKENBURG |
| K150688 |
03/17/2015 |
IdentEvent |
OPTIMA NEUROSCIENCE, INC. |
Ryan T. Kern |
| K150830 |
03/30/2015 |
CompleClear Plastic Orthodontic Bracket and Wire Appliance |
ORACREW |
PAWAN GAUTAM |
| K150619 |
03/10/2015 |
CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K150822 |
03/27/2015 |
Centurion POCT System |
ORTHOFIX, INC. |
JACKI GEREN |
| K150655 |
03/13/2015 |
OIC Intramedullary Nail System |
ORTHOPAEDIC IMPLANT COMPANY |
Douglas Fulton |
| K150600 |
03/10/2015 |
Response 5.5/6.0 Spine System |
ORTHOPEDIATRICS CORP. |
MARK FOX |
| K150663 |
03/16/2015 |
Diagnostic X-ray System |
OSKO, INC. |
WANG CHOI |
| K150607 |
03/10/2015 |
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml |
OSSEON LLC |
Keith Burger |
| K150558 |
03/04/2015 |
Eclipse System |
Pelvalon, Inc. |
MILES ROSEN |
| K150618 |
03/10/2015 |
PENTAX Medical EPK-i7010 Video Processor with GI Family |
PENTAX OF AMERICA, INC. |
KRISHNA GOVINDARAJAN |
| K150597 |
03/09/2015 |
ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite |
PHADIA AB |
Carina Magnusson |
| K150854 |
03/31/2015 |
ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut |
PHADIA AB |
Carina Magnusson |
| K150665 |
03/16/2015 |
Philips Spectral CT Applications |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
NONE PROVIDED |
| K150581 |
03/09/2015 |
Tritium Sternal Cable Plate System |
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
Sarah Pleaugh |
| K150557 |
03/04/2015 |
Podimetrics Remote Temperature Monitoring System |
Podimetrics, Inc. |
Jon Bloom |
| K150856 |
03/31/2015 |
Reform Pedicle Screw System |
PRECISION SPINE, INC. |
Michael Dawson |
| K150851 |
03/31/2015 |
Sure Lok Mini Posterior Cervical/Upper Thoracic System |
PRECISION SPINE, INC. |
Michael Dawson |
| K150601 |
03/10/2015 |
Zeramic Adhesive Resin Cement |
Premier Dental Company Products |
VINCENT D'ALESSANDRO |
| K150806 |
03/26/2015 |
PulseFlowDF |
PulseFlow Technologies |
Les Lindsay |
| K150719 |
03/19/2015 |
OARtrac System with Skin Sensors |
RadiaDyne, LLC |
John K. Isham |
| K150819 |
03/27/2015 |
Triglycerides |
Randox Laboratories Limited |
Pauline Armstrong |
| K150654 |
03/13/2015 |
Cholesterol |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K150563 |
03/06/2015 |
Marrow Cellution Bone Marrow Aspiration Needle |
RANFAC CORP |
CHRISTOPHER P. WHELAN |
| K150627 |
03/11/2015 |
Rapid Aid Instant Disposable Infant Heel Warmer |
RAPID AID CORP. |
Rose Ren |
| K150797 |
03/26/2015 |
Digital Dental Intra Oral Sensor, EzSensor Smart |
Rayence Co., Ltd |
Kevin Kim |
| K150572 |
03/06/2015 |
Respire Pink Series-Herbst-EF |
Respire Medical Holding |
David Walton |
| K150639 |
03/11/2015 |
AF541 EE Full Face Mask |
RESPIRONICS, INC. |
Shaylee Masilunas |
| K150638 |
03/11/2015 |
AF541 SE Full Face Mask |
Respironics, Inc. |
Shaylee Masilunas |
| K150617 |
03/10/2015 |
cobas HSV 1 and 2 Test |
ROCHE MOLECULAR SYSTEMS, INC. |
DAVID W. GATES |
| K150521 |
03/02/2015 |
Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System |
RTI SURGICAL, INC. dba RTI BIOLOGICS |
Jennifer Bonacci |
| K150754 |
03/23/2015 |
ARGOS |
SANTEC CORPORATION |
CHANGHO CHONG |
| K150566 |
03/06/2015 |
Oniris |
SAS Oniris |
Thibault Vincent |
| K150515 |
03/02/2015 |
IQSense Flow Sensor Mouthpiece |
SDI DIAGNOSTICS, INC. |
COSIMO CARIOLO |
| K150545 |
03/03/2015 |
Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
REN YUNHUA |
| K150816 |
03/27/2015 |
Jumong Series |
SG HEALTHCARE CO LTD |
YOSEP PARK |
| K150549 |
03/03/2015 |
Reactor(TM) Trocar and Sleeve |
Sharp Medical Prducts, LLC |
Chris Salvino |
| K150664 |
03/16/2015 |
NeoLas |
SHEAUMANN LASER, INC |
Katina Sousa |
| K150632 |
03/11/2015 |
Hypervisor IX Monitoring System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANHONG BAI |
| K150687 |
03/17/2015 |
DripAssist |
Shift Labs |
Beth Kolko |
| K150714 |
03/19/2015 |
SI-BONE iFuse Implant System |
SI-BONE, Inc. |
Roxanne Dubois |
| K150843 |
03/30/2015 |
syngo«.via (version VB10A) |
Siemens AG |
Martin Meyer |
| K150678 |
03/16/2015 |
Sysmex Automated Blood Coagulation Analyzer CS-5100 |
Siemens Healthcare Diagnostic Products Gmbh |
DONNA NOEH |
| K150606 |
03/10/2015 |
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
FRANCES A. DILLON |
| K150785 |
03/25/2015 |
syngo.CT Dental |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
EVE DAVIS |
| K150757 |
03/23/2015 |
syngo.CT Dual Energy |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Kimberly Mangum |
| K150713 |
03/19/2015 |
syngo.CT Myocardial Perfusion |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
EVE DAVIS |
| K150745 |
03/23/2015 |
syngo.CT Single Source Dual Energy |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K150750 |
03/23/2015 |
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray |
Sirona Dental Systems GMBH |
Thomas Diesch |
| K150675 |
03/16/2015 |
Dorsal Spanning Plate |
SKELETAL DYNAMICS, LLC |
ANN M. ESCAGEDO |
| K150685 |
03/17/2015 |
Skynector CPAP Mask |
SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD. |
Field Fu |
| K150790 |
03/25/2015 |
REDAPT Porous Acetabular Shell and Cemented Liner |
SMITH & NEPHEW, INC. |
JEFF SPRAGUE |
| DEN150011 |
03/23/2015 |
Sonablate 450 |
SonaCare Medical, LLC. |
Dawn Byrd Burleson |
| K150564 |
03/06/2015 |
Spaulding Electrocardiograph 2100iQ |
Spaulding Clinical Research, LLC |
Andre Leak |
| K150634 |
03/11/2015 |
AngioSculpt PTA Scoring Baloon Catheters |
Spectranetrics |
Kimberley Kline |
| K150631 |
03/11/2015 |
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter |
St. Jude Medical |
Harlan Jones |
| K150517 |
03/02/2015 |
Freedom Spinal Cord Stimulator System |
STIMWAVE TECHNOLOGIES INCORPORATED |
Elizabeth Greene |
| K150814 |
03/27/2015 |
Straumann Screw-Retained Abutment |
STRAUMANN USA, LLC |
Manuela Ventur |
| K150584 |
03/09/2015 |
Stryker Suture Tape |
Stryker |
Taylor White |
| K150700 |
03/18/2015 |
ACP 1 Anterior Cervical Plating System |
STRYKER CORPORATION |
Tina Mornak |
| K150753 |
03/23/2015 |
OASYS System |
STRYKER CORPORATION |
Garry T Hayeck |
| K150539 |
03/03/2015 |
OASYS System |
Stryker Corporation |
GARRY T. HAYECK |
| K150801 |
03/26/2015 |
Stryker Maestro Air Motors |
STRYKER CORPORATION |
DEVAL PATEL |
| K150582 |
03/09/2015 |
Vertaplex« High Viscosity (HV) Radiopaque Bone Cement |
STRYKER CORPORATION |
KRISTI ASHTON |
| K150538 |
03/03/2015 |
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider |
STRYKER SUSTAINABILITY SOLUTIONS |
SCOTT ENGLISH |
| K150540 |
03/03/2015 |
Instru-Safe Instrument Protection System |
SUMMIT MEDICAL, INC. |
Nicole Dove |
| K150848 |
03/31/2015 |
Dose Calculator |
SUN NUCLEAR CORPORATION |
JAMES LUKER |
| K150524 |
03/02/2015 |
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology |
Surgical Instrument Services and Savings, Inc |
Richard D Wynkoop |
| K150559 |
03/06/2015 |
Life Fast Set, Life Regular Set |
SYBRON DENTAL SPECIALTIES |
Kerri Casino |
| K150673 |
03/16/2015 |
SYNFIX Evolution Secured Spacer System |
SYNTHES (USA) PRODUCTS LLC |
EUGENE BANG |
| K150796 |
03/26/2015 |
Dental Bone Cutting Instruments |
SYNTHES (USA) PRODUCTS, LLC |
SUSAN LEWANDOWSKI |
| K150603 |
03/10/2015 |
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube |
Teleflex Medical, Inc. |
Lori Pfohl |
| K150533 |
03/02/2015 |
Terason uSmart3200T Ultrasound System |
TERATECH CORP. |
Steven R Broadstone |
| K150536 |
03/03/2015 |
Terumo Circuit Tubing |
Terumo Cardiovascular Systems Corporation |
Garry Courtney |
| K150542 |
03/03/2015 |
Terumo Pump Tubing |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
JOSHUA EWING |
| K150576 |
03/06/2015 |
TGM Biolox delta Ceramic Heads |
TGM MEDICAL, INC. |
Gordon Smith |
| K150658 |
03/13/2015 |
Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit |
THE BINDING SITE GROUP LTD |
Andrea Thomas |
| K150526 |
03/02/2015 |
Optilite IgG4 Kit |
THE BINDING SITE GROUP LTD |
Andrea Thomas |
| K150783 |
03/25/2015 |
Progressive Orthopaedic Total Knee System |
The Progressive Orthopaedic Company, LLC |
Scott Keiser |
| K150676 |
03/16/2015 |
L-Mesitran Dressing Family II- Soft and Tulle |
Theo Manufacturing BV |
Monique Gottgens |
| K150556 |
03/04/2015 |
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) |
THERMO FISHER SCIENTIFIC |
CYNTHIA KNAPP |
| K150741 |
03/23/2015 |
TSolution One w/ACG surgical System |
THINK SURGICAL INC. |
IN K. MUN |
| K150727 |
03/20/2015 |
ESTECEM |
TOKUYAMA DENTAL CORPORATION |
Fumio Takahashi |
| K150641 |
03/11/2015 |
MagVita TMS Therapy System |
TONICA ELEKTRONIK A/S |
Lise Terkelsen |
| K150715 |
03/19/2015 |
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors |
TORNIER, INC. |
Kaitlyn Rainbow |
| K150583 |
03/09/2015 |
Aequalis PerFORM+ Shoulder System |
TORNIER, INC. |
Kris Miller |
| K150613 |
03/10/2015 |
LaserCap LC Pro and LC Elite |
TRANSDERMAL CAP, INC. |
MICHAEL RABIN |
| K150570 |
03/06/2015 |
ANAX OCT Spinal System |
U&I Corporation |
Young-Geun Kim |
| K150650 |
03/12/2015 |
neon3 |
ULRICH GMBH & CO. KG |
Christoph Ulrich |
| K150666 |
03/16/2015 |
uNion Cervical Plate System |
ulrich medical USA |
Hans Stover |
| K150832 |
03/30/2015 |
U2 Femoral Component, CR, Porous Coated, Additional Sizes |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K150829 |
03/30/2015 |
U2 Total Knee System- Additional Sizes |
UNITED ORTHOPEDIC CORPORATION |
Fang-Yuan Ho |
| K150716 |
03/19/2015 |
Varaya Sport |
VARAYA PHOTOCEUTICALS, LLC |
Myk Lum |
| K150839 |
03/30/2015 |
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 |
| K150636 |
03/11/2015 |
VariSeed 9.0 |
VARIAN MEDICAL SYSTEMS, INC. |
Peter J. Coronado |
| K150706 |
03/18/2015 |
VitalBeam |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J. CORONADO |
| K150628 |
03/11/2015 |
VentriPoint Medical System |
VENTRIPOINT, INC. |
JIM BODTKE |
| K150588 |
03/09/2015 |
OVA1 Next Generation |
VERMILLION, INC. |
Benjamin A Kimball |
| K150725 |
03/20/2015 |
Visaris Avanse |
VISARIS d.o.o. Belgrade |
Milan Ratkovic |
| K150738 |
03/20/2015 |
VitreaView |
Vital Images, Inc |
PARTHIV SHAH |
| K150784 |
03/25/2015 |
Admira Fusion |
VOCO GMBH |
M TH PLAUMANN |
| K150551 |
03/04/2015 |
GORE SEAMGUARD Reinforcement |
W. L. GORE & ASSOCIATES, INC. |
BARBARA L. SMITH |
| K150554 |
03/04/2015 |
NuBrilliance Light Pain Therapy |
WELLQUEST INTERNATIONAL, INC. |
YVETH KAN |
| K150580 |
03/09/2015 |
UltraVision 2 Diagnostic Ultrasound System |
WINPROBE CORPORATION |
ROSE MALCHOW |
| K150520 |
03/02/2015 |
DARCO Locking Bone Plate System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE REDDEN |
| K150640 |
03/11/2015 |
RX-FIX Mini Rail External Fixator |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K150834 |
03/30/2015 |
Atrax Anterior Cervical Plating System |
X-Spine Systems, Inc |
David Kirschman |
| K150662 |
03/13/2015 |
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) |
YPSOMED AG |
Stephen Affolter |
| K150630 |
03/11/2015 |
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear |
YUNG SHENG OPTICAL CO., LTD. |
Wen-Han Chen |
| K150730 |
03/20/2015 |
Zimmer PSI Shoulder System |
ZIMMER |
CHRISTOPHER MCLEAN |
| K150626 |
03/11/2015 |
Rush Medullary Pins |
Zimmer, Inc. |
Patrick McCullagh |
| K150818 |
03/27/2015 |
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System |
ZIMMER, INC. |
PATRICK MCCULLAGH |
