| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K151687 |
06/23/2015 |
QuantorView |
3DISC AMERICAS |
SIGRID SMITT-JEPPESEN |
| K151748 |
06/29/2015 |
Clean & More |
3M DEUTSCHLAND GMBH |
DESI W SOEGIARTO |
| K151455 |
06/01/2015 |
3Shape Abutment Designer Software |
3Shape A/S |
Hanne Nielsen |
| K151566 |
06/10/2015 |
Abbott ARCHITECT Total T4 Calibrators |
ABBOTT LABORATORIES |
Lisa Lukowski |
| K151636 |
06/17/2015 |
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control |
ABBOTT MEDICAL OPTICS INC |
Christine Chun |
| K151595 |
06/12/2015 |
On Call Express Pro Blood Glucose Monitoring System |
ACON Laboratories, Inc. |
Qiyi Xie |
| K151554 |
06/09/2015 |
Occlusion Perfusion Catheter |
ADVANCED CATHETER THERAPIES, INC. |
PAUL JOSEPH FITZPATRIC |
| K151725 |
06/26/2015 |
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer |
ADVANCED STERILIZATION PRODUCTS |
SUN CHOI |
| DEN150028 |
06/19/2015 |
PneumoLiner |
ADVANCED SURGICAL CONCEPTS LTD. |
EDWARD HYLAND |
| K151696 |
06/23/2015 |
Caiman Seal and Cut Technology |
AESCULAP, INC. |
Denise Adams |
| K151722 |
06/25/2015 |
Slim UP ULTRA |
AIME MEDICAL INC |
PAUL GUILBAUD |
| K151717 |
06/25/2015 |
twion |
Alber GmbH |
Bernd Engels |
| K151464 |
06/01/2015 |
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit |
ALERE SCARBOROUGH, INC. |
ANGELA DRYSDALE |
| K151690 |
06/23/2015 |
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A |
ALERE SCARBOROUGH, INC. |
Angela Drysdale |
| K151599 |
06/12/2015 |
iSy Implant System |
Altatec GmbH |
Colleen Boswell |
| K151648 |
06/18/2015 |
Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System |
Altus Partners, LLC |
Claudia Hill |
| K151585 |
06/11/2015 |
Andersen EOGas 4 SteriTest |
Andersen Sterilizers, Inc. |
William K Andersen |
| K151460 |
06/01/2015 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO., LTD. |
LIU YI |
| K151724 |
06/26/2015 |
AngioDynamics Mariner Angiographic Catheters |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K151694 |
06/23/2015 |
Gammex PI Hybrid Surgical Gloves |
ANSELL HEALTHCARE PRODUCTS, LLC |
Vasudev Dobariya |
| K151480 |
06/02/2015 |
Epix Electrosurgical Probe with Smoke Evacuation |
APPLIED MEDICAL RESOURCES |
FRANS VANDENBROEK |
| K151513 |
06/04/2015 |
Arrow Endurance Extended Dwell Peripheral Catheter System |
Arrow Internation, Inc. (subsidiary of Teleflex Inc.) |
Tracy Larish |
| K151732 |
06/26/2015 |
Arthrex Fracture Plates |
ARTHREX, INC. |
COURTNEY SMITH |
| K151527 |
06/08/2015 |
Arthrex Univers Revers CA Heads and Adapters |
ARTHREX, INC. |
COURTNEY SMITH |
| K151660 |
06/19/2015 |
MultiFIX S Knotless Fixation System |
ArthroCare Corporation |
Laura Kasperowicz |
| K151459 |
06/01/2015 |
Integra Total Ankle Replacement System |
Ascension Orthopedics |
Frederic Testa |
| K151678 |
06/22/2015 |
Chameleon PTA Balloon Catheter |
AV Medical Technologies Ltd |
Limor Sandach |
| K151772 |
06/30/2015 |
Actreen Mini Intermittent Urinary Catheters |
B. BRAUN MEDICAL INC. |
SIERRA M. MERTZ |
| K151505 |
06/04/2015 |
Coronis Uniti |
Barco N.V. |
Franky Dubois |
| K151742 |
06/29/2015 |
Contour Next Control Solution |
BAYER HEALTHCARE |
JENNIFER L. GREGORY |
| K151482 |
06/02/2015 |
BCR-30-min BIÖ and RBIP-ST30Ö Readout Accessory |
BCR DIAGNOSTICS, INC. |
BORIS ROTMAN |
| K151489 |
06/02/2015 |
Retrieval bag system |
BEACON SURGICAL, INC. |
ALLAN ALWARD |
| K151698 |
06/24/2015 |
BD Angiocath IV Catheter, BD Insyte IV Catheter |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
HENRY BOLAND |
| K151766 |
06/30/2015 |
BD Single Use, Hypodermic Syringe |
BECTON, DICKINSON AND COMPANY |
MURTAZA RANA |
| K151589 |
06/12/2015 |
BD MAX CT/GC/TV, BD MAX INSTRUMENT |
BECTON, DICKINSON, AND COMPANY |
KATIE COYLE |
| K151469 |
06/01/2015 |
CORVUS Radiation Therapy Planning System |
BEST NOMOS |
VINEET GUPTA |
| K151692 |
06/23/2015 |
BioArchitects Patient Specific Cranial/Craniofacial Plate |
BioArchitects USA, LLC |
Mark E. Ulrich |
| K151621 |
06/16/2015 |
BioHorizons CAD/CAM Abutments |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K151688 |
06/23/2015 |
chromID MRSA |
bioMerieux, Inc. |
Jewell Coulson |
| K151615 |
06/15/2015 |
TiTHON Staple with OsseoTi Technology |
BIOMET MANUFACTURING CORP. |
Patricia Sandborn Beres |
| K151483 |
06/02/2015 |
Biomet Spine Fusion System |
Biomet Spine LLC. |
Ted Kuhn |
| K151603 |
06/12/2015 |
Arcos One-piece Femoral Revision System |
Biomet, Inc. |
Tracy Johnson |
| K151744 |
06/29/2015 |
Passeo-18 Peripheral Dilation Catheter |
BIOTRONIK, INC. |
JON BRUMBAUGH |
| K151760 |
06/29/2015 |
Barricade Embolization Coil System |
BLOCKADE MEDICAL |
REBECCA K. PINE |
| K151610 |
06/15/2015 |
Comet Pressure Guidewire |
BOSTON SCIENTIFIC CORPORATION |
JAMES KLEINEDLER |
| K151613 |
06/15/2015 |
iLab Polaris Multi-Modality Guidance System |
BOSTON SCIENTIFIC CORPORATION |
ARLENE ROCHE |
| K151516 |
06/05/2015 |
Capillus82 |
Capillus, LLC |
PATRICIA SCHNOOR |
| K151635 |
06/17/2015 |
CapsoCam (SV-1) |
CapsoVision, Inc. |
AZIMUN JAMAL |
| K151499 |
06/04/2015 |
CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor |
CARETAKER MEDICAL, LLC |
JEFF POMPEO |
| K151638 |
06/17/2015 |
Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter |
Cathera, Inc. |
Victor Ham |
| K151535 |
06/08/2015 |
Cavex Cream Alginate |
CAVEX HOLLAND BV |
RICHARD WOORTMAN |
| K151597 |
06/12/2015 |
Family of Steam Sterilizers B 28 series |
CEFLA S.C. |
SILVIA SANSAVINI |
| K151565 |
06/10/2015 |
Xpert« TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit |
CEPHEID |
KERRY J. FLOM |
| K151672 |
06/22/2015 |
Cerner CareAware Event Management |
CERNER CORPORATION |
SHELLEY S. LOOBY |
| K151683 |
06/22/2015 |
SleepWeaver Advance Pediatric Nasal CPAP Mask |
Circadiance, LLC |
David Groll |
| K151569 |
06/10/2015 |
Tranberg CLS Laser Fiber |
Clinical Laserthermia Systems AB |
Lars Erik Eriksson |
| K151676 |
06/22/2015 |
Retracta Detachable Embolization Coil |
COOK INCORPORATED |
DAVID LEHR |
| K151649 |
06/18/2015 |
Valleylab FT10 Electrosurgical Platform |
COVIDIEN |
Sharon McDermott |
| K151548 |
06/09/2015 |
VersaOne Bladed Trocar, VersaOne Bladeless Trocar |
COVIDIEN |
Trang Huynh |
| K151659 |
06/19/2015 |
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks |
Covidien LLC |
Mary Mellows |
| K151500 |
06/04/2015 |
Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) |
CUSTOM ORTHOPAEDIC SOLUTIONS |
Peter D O'Neill |
| K151568 |
06/10/2015 |
Arthrex OrthoVis Preoperative Plan |
Custom Orthopaedic Solutions, Inc. |
Peter O'Neill |
| K151501 |
06/04/2015 |
OrthoVis Web Portal |
CUSTOM ORTHOPAEDIC SOLUTIONS,INC. |
Justin Baker |
| K151514 |
06/05/2015 |
Prestige |
DANVILLE MATERIALS LLC |
DONG HUA |
| K151570 |
06/10/2015 |
Carestation 620/650/650C |
DATEX-OHMEDA, INC. |
JAMES RASKOB |
| K151682 |
06/22/2015 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Daxwell, LLC |
Frank Zhang |
| K151496 |
06/03/2015 |
Latitude-C Cervical Interbody Spacer System |
Degen Medical |
Craig Black |
| K151525 |
06/08/2015 |
Amia Automated PD System with Sharesource |
DEKA RESEARCH AND DEVELOPMENT |
ROGER LEROUX |
| K151619 |
06/16/2015 |
Prime&Bond Elect Universal Dental Adhesive |
DENTSPLY INTERNATIONAL INC. |
HELEN LEWIS |
| K151509 |
06/04/2015 |
GSI TympStar Pro Middle Ear Analyzer |
Diagnostic Group, dba Grason-Stadler |
Ron Rolfsen |
| K151487 |
06/02/2015 |
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method |
Diatron US, Inc. |
Frank Matusazak |
| K151580 |
06/11/2015 |
D.N.E. External Fixation System |
DNE, LLC |
NICHOLAS RICCIONE |
| K151485 |
06/02/2015 |
GENESIS |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K151458 |
06/01/2015 |
Double Medical Universal Spine System |
Double Medical Technology Inc |
DA ZENG |
| K151693 |
06/23/2015 |
Dr-Ho's Foot Pad Electrode |
DRTV ASIA LTD |
MICHAEL HO |
| K151575 |
06/11/2015 |
Dynarex Eye Cups |
DYNAREX CORPORATION |
JAMES HURLMAN |
| K151561 |
06/10/2015 |
Leksell Gamma Knife Icon |
ELEKTA INSTRUMENT AB |
MATILDA FORSBERG |
| K151666 |
06/19/2015 |
Leksell GammaPlan |
ELEKTA INSTRUMENT AB |
MATILDA FORSBERG |
| K151686 |
06/23/2015 |
HumanPen Ergo II |
ELI LILLY AND COMPANY, INC. |
CHRISTINE A. PHILLIPS |
| K151540 |
06/08/2015 |
MC BIO Supertack Tack 3mm, 4mm and 5mm |
ELI-KA TECHNOLOGIES |
LUIGI GIROTTO |
| K151552 |
06/09/2015 |
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II |
ELITechGroup |
Valerie Gourdon |
| K151594 |
06/12/2015 |
Ellipse Supplemental Instrument Trays |
Ellipse Technologies, Incorporated |
Cora Sim |
| K151475 |
06/02/2015 |
EndoChoice Select Injection Needle |
ENDOCHOICE, INC. |
THERON GOBER |
| K151567 |
06/10/2015 |
ENDOPLUS hand-held laparoscopic instruments |
ENDOPLUS |
Matthew Gudeman |
| K151640 |
06/18/2015 |
ELTRAC 471 |
ENRAF-NONIUS B.V. |
ANNE-MARIE VAN MAURIK |
| K151650 |
06/18/2015 |
SMARTez elastomeric infusion pump |
Epic Medical Pte Ltd |
Freddie Lee |
| K151668 |
06/19/2015 |
S-scan |
ESAOTE S.P.A. |
DONATELLA RAGGHIANTI |
| K151715 |
06/25/2015 |
T3 Software |
Etiometry, Inc. |
DIMITAR BARONOV |
| K151479 |
06/02/2015 |
EV-820 OTC Pain Relief TENS |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
Robert Tu |
| K151491 |
06/03/2015 |
Falck Medical Multifunction Tonometer, FAT1 |
FALCK MEDICAL, INC |
FRANCIS FALCK |
| K151470 |
06/01/2015 |
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus |
FIRST QUALITY HYGIENIC, INC. |
Melanie Leibowitz |
| K151473 |
06/01/2015 |
NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module |
FOCUS MEDICAL, LLC. |
John B Lee |
| K151662 |
06/19/2015 |
iRestore |
Freedom Laser Therapy, Inc. |
Craig Nabat |
| K151474 |
06/01/2015 |
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
MARY MOORE |
| K151502 |
06/04/2015 |
ARCHITECT ROMA |
Fujirebio Diagnostics, Inc. |
Diana Dickson |
| K151674 |
06/22/2015 |
Ultraviolet Sun Tanning Lamp |
G.I.E.- GESELLSCHAFT FUR LICHTTECHNISCHE ERZEUGNISSE MBH |
MICHAEL ANDERS |
| K151528 |
06/08/2015 |
Powder Free Nitrile (Black) Examination Gloves |
GALLANT QUALITY SDN. BHD. |
SUMATHI SARAVANA SAMI |
| K151503 |
06/04/2015 |
NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE |
GBUK Enteral Limited |
Mark Thompson |
| K151541 |
06/08/2015 |
G-Fix |
GC America Inc. |
Mark Heiss |
| K151731 |
06/26/2015 |
Rainbow Paste Stain |
GENOSS |
BYUNGSUN KIM |
| K151723 |
06/26/2015 |
Rainbow Trans |
GENOSS |
SANGPIL YOON |
| K151665 |
06/19/2015 |
SUSTAIN Additional Implants |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K151504 |
06/04/2015 |
ICS Impulse |
GN OTOMETRICS |
ANDERS RASMUSSEN |
| K151587 |
06/11/2015 |
Digital Automatic Wrist Blood Pressure Monitor MD3200 |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
Patrick Chow |
| K151583 |
06/11/2015 |
Digital Automatic Wrist Blood Pressure Monitor MD3900 |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K151478 |
06/02/2015 |
Wondfo CR3 Keyless Split Sample Cup |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
BEN CHEN |
| K151463 |
06/01/2015 |
Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components |
HANSEN MEDICAL, INC. |
Elisa Aldridge |
| K151730 |
06/26/2015 |
Magellan Robotic System |
HANSEN MEDICAL, INC. |
TODD MILHOLLAND |
| K151684 |
06/22/2015 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) |
HARTALEGA NGC SDN. BHD. |
KUAN MUN LEONG |
| K151642 |
06/18/2015 |
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card |
HEALGEN SCIENTIFIC LLC |
JIANQIU FANG |
| K151656 |
06/19/2015 |
HEARTWAY Power Mobility Scooter |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
KE-MIN JEN |
| K151679 |
06/22/2015 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
HEZE YUZE GLOVE CO., LTD |
LILY ZHU |
| K151689 |
06/23/2015 |
MetaNeb 4 System |
Hill-Rom Services Pte Ltd |
Huifang Zhu |
| K151542 |
06/08/2015 |
A-Oss |
HIOSSEN INC. |
David Kim |
| K151626 |
06/17/2015 |
ET III Bio-SA Fixture System |
HiOSSEN Inc. |
David Kim |
| K151559 |
06/10/2015 |
ImmuLisa Enhanced Centromere Antibody ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
| K151757 |
06/29/2015 |
IMMEDIATELOAD Dental Implant System |
IMMEDIATELOAD S.A. |
GIOVANNI CANINO |
| K151771 |
06/30/2015 |
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators |
IMMUNALYSIS CORPORATION |
JOSEPH GINETE |
| K151740 |
06/26/2015 |
JAZZ System |
Implanet, S.A. |
Regis Le Couedic |
| K151576 |
06/11/2015 |
Neon EEG |
Incereb Ltd |
PAUL PHILLIPS |
| K151534 |
06/08/2015 |
HemosIL D-Dimer HS |
INSTRUMENTATION LABORATORY CO. |
NIKITA MALLADI |
| K151616 |
06/15/2015 |
AT235 |
INTERACOUSTICS A/S |
ERIK NIELSEN |
| K151564 |
06/10/2015 |
Telio CAD Abutment Solutions |
IVOCLAR VIVADENT AG |
SANDRA CAKEBREAD |
| K151468 |
06/01/2015 |
ARIX Wrist System |
Jeil Medical Corporation |
Jiwon Kang |
| K151727 |
06/26/2015 |
Everest Spinal System |
K2M, INC |
NANCY GIEZEN |
| K151481 |
06/02/2015 |
Sahara Stabilization System |
K2M, INC |
NANCY GIEZEN |
| K151721 |
06/25/2015 |
FIJI SUN FLUORESCENT TANNING UNIT |
KDB INC. (DBA) SPERTI SUNLAMP |
JAMES SHEPERD |
| K151465 |
06/01/2015 |
AeroDR SYSTEM 2 |
KONICA MINOLTA, INC. |
SHIGEYUKI KOJIMA |
| K151750 |
06/29/2015 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile |
KOSSAN INTERNATIONAL SDN. BHD. |
CHO SOW FONG |
| K151719 |
06/25/2015 |
REVE134 |
KW EAR LAB, INC |
Sungwoo Cho |
| K151677 |
06/22/2015 |
LnK Cervical Interbody Fusion Cage System |
L&K BIOMED Co.,Ltd. |
Yerim An |
| K151702 |
06/24/2015 |
Reusable Full Silicone Cover |
LAERDAL MEDICAL AS |
MARI KAADA |
| K151600 |
06/12/2015 |
R-40 EEG Amplifier |
LIFELINES LTD. |
Michael Hulin |
| K151611 |
06/15/2015 |
OneTouch Ultra Plus Flex Blood Glucose Monitoring System |
LIFESCAN EUROPE |
NIKI SKELLY |
| K151739 |
06/26/2015 |
Revision Femoral Stem |
LIMACORPORATE S.P.A. |
EMANUELE BUTTAZZONI |
| K151605 |
06/15/2015 |
Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves |
Lucenxia Prescience AG |
Robert Hill |
| K151607 |
06/15/2015 |
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove |
Lucenxia Prescience AG |
Robert Hill |
| K151644 |
06/18/2015 |
Masimo Root Vital Signs Monitoring System and Accessories |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K151593 |
06/12/2015 |
Cellvizio 100 Series System with Confocal Miniprobes |
MAUNA KEA TECHNOLOGIES |
SOPHIE REHAULT |
| K151531 |
06/08/2015 |
MasterLoc Stem |
MEDACTA INTERNATIONAL |
MICHAEL G. LOITERMAN |
| K151632 |
06/17/2015 |
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental |
MEDELA AG |
Orlando Antunes |
| K151522 |
06/05/2015 |
DEFENDO Bronchoscopy Suction Valve |
MEDIVATORS, INC. |
Jeff Kasoff |
| K151754 |
06/29/2015 |
Glide-On Vinyl Examination Gloves |
MEDLINE INDUSTRIES, INC. |
Jennifer Mason |
| K151628 |
06/17/2015 |
Medline ENFit Connectors |
MEDLINE INDUSTRIES, INC. |
STEPHANIE BLAIR |
| K151773 |
06/30/2015 |
CONCORDE Bullet Lumbar Interbody System |
Medos International, Sarl |
JACLYN PORSOLT |
| K151511 |
06/04/2015 |
ROSA Spine |
MEDTECH S.A. |
MICHAEL CHRIST |
| K151758 |
06/29/2015 |
ALAR Nasal Valve Stent |
MEDTRONIC XOMED INC. |
GABRIELA ANCHONDO |
| K151532 |
06/08/2015 |
KYPHON ELEMENT Inflatable Bone Tamp |
MEDTRONIC, INC. |
PAMELA EDWARDS |
| K151523 |
06/05/2015 |
Uncoated Tubing and Connector Components |
MEDTRONIC, INC. |
JACQUELINE A. HAUGE |
| K151768 |
06/30/2015 |
Menicon Saline Rinse Solution |
MENICON CO.,LTD. |
TOHRU KAWAGUCHI |
| K151762 |
06/29/2015 |
PediatrOS RigidTack/FlexTack |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K151497 |
06/04/2015 |
EN Snare Endovascular Snare System |
MERIT MEDICAL SYSTEMS INC |
MARK MULLANEY |
| DEN150029 |
06/22/2015 |
Permaseal |
MICRO INTERVENTIONAL DEVICES, INC. |
LINDA MORGAN |
| K151671 |
06/22/2015 |
Disposable Multistage Dilation Balloon Catheter |
MICRO-TECH (NANJING) CO., LTD. |
BECK LI |
| K151543 |
06/08/2015 |
Graft Delivery Device with Integrated Stylet |
Micromedics Inc. (d/b/a Nordson Medical) |
Amy L Peterson |
| K151763 |
06/29/2015 |
PerioLase Nd:YAG Pulsed Dental Laser System |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
DAVID M HARRIS |
| K151536 |
06/08/2015 |
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm |
MRI INTERVENTIONS, INC. |
E F WADDELL |
| K151557 |
06/10/2015 |
EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine |
NANTONG EGENS BIOTECH CO., LTD. |
BEN CHEN |
| K151476 |
06/02/2015 |
Beactive Brace |
NATURES PILLOWS, INC. |
WILLIAM McALISTER |
| K151609 |
06/15/2015 |
ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 |
NDS SURGICAL IMAGING LLC |
Jim Leng |
| K151558 |
06/10/2015 |
Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System |
NEUROTHERAPIES RESET GMBH. |
MICHAEL PELHAM MORRIS OLIVE |
| K151706 |
06/24/2015 |
Specular Microscope CEM- 530 |
NIDEK CO., LTD. |
YONEJI MIZUNO |
| K151654 |
06/18/2015 |
PROW FUSION |
NLT SPINE LTD |
Eti Zinger |
| K151708 |
06/24/2015 |
RECON system - Compression Screws |
NORMED MEDIZIN-TECHNIK GMBH |
ARNE BRIEST |
| K151701 |
06/24/2015 |
Tenodesis screw system |
NORMED MEDIZIN-TECHNIK GMBH |
ARNE BRIEST |
| K151472 |
06/01/2015 |
NuVasive CoRoent Lumbar System |
NuVasive, Incorporated |
Martin A Yahiro |
| K151538 |
06/08/2015 |
NuVasive PEEK Corpectomy Railed System |
NuVasive, Incorporated |
Olga Lewis |
| K151651 |
06/18/2015 |
NuVasive X-CORE Mini Cervical Expandable VBR System |
NUVASIVE, INCORPORATED |
Olga Lewis |
| K151571 |
06/10/2015 |
Mini Needle |
OCUJET, LLC |
REBECCA K. PINE |
| K151738 |
06/26/2015 |
Single Use Aspiration Needle NA-U200H |
OLYMPUS MEDICAL SYSTEMS CORP. |
TOSHIYUKI NAKAJIMA |
| K151743 |
06/29/2015 |
THUNDERBEAT Open Fine Jaw |
OLYMPUS MEDICAL SYSTEMS CORP. |
TOSHIYUKI NAKAJIMA |
| K151737 |
06/26/2015 |
MedicVOD System |
Orpheus Medical Ltd. |
Asaf Omer |
| K151488 |
06/02/2015 |
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System |
Orthofix, Inc. |
Jacki Geren |
| K151746 |
06/29/2015 |
Dyevert Contrast Modulation System |
OSPREY MEDICAL, INC. |
MELANIE HESS |
| K151553 |
06/09/2015 |
Anterior Cervical Plate System |
Osteomed Implantes, LTDA |
J.D. WEBB |
| K151608 |
06/15/2015 |
4plus6Line Abutment System |
OT MEDICAL GMBH |
Martina Behlau |
| K151466 |
06/01/2015 |
MrOpen |
Paramed S.r.l. |
Luisella De Benedetti |
| K151518 |
06/05/2015 |
BRUSH&BOND PLUS |
Parkell, Inc. |
David Mott |
| K151572 |
06/11/2015 |
Penumbra Smart Coil |
PENUMBRA, INC. |
CHARLES DENAULT |
| K151623 |
06/16/2015 |
Penumbra System 110 Aspiration Tubing |
Penumbra, Inc. |
Michaela Mahl |
| K151604 |
06/15/2015 |
23ga Chandelier Illuminator, 25ga Chandelier Illuminator |
PEREGRINE SURGICAL LTD. |
RYAN O'LEARY |
| K151598 |
06/12/2015 |
VesselNavigator Rel. 1.0 |
PHILIPS MEDICAL SYSTEMS NEDERLAND BV |
LISELOTTE KORNMANN |
| K151736 |
06/26/2015 |
Philips IntelliVue GuardianSoftware |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
MICHAEL ASMALSKY |
| K151681 |
06/22/2015 |
IntelliVue Patient Monitor |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
JOHANNES SCHMID |
| K151761 |
06/29/2015 |
SureSigns VS3, SureSigns VS4 |
PHILLIPS MEDICAL SYSTEMS |
Greg Li |
| K151658 |
06/19/2015 |
Gmate Origin Blood Glucose Monitoring System |
Philosys Inc. |
LINDA CHAN |
| K151521 |
06/05/2015 |
Phoenix Thera-Lase System |
PHOENIX THERA-LASE SYSTEMS, LLC |
GARY BELLINGER |
| K151562 |
06/10/2015 |
Resultz Lice & Egg Removal Kit |
Piedmont Pharmaceuticals, LLC |
Kathleen G. Palma |
| K151630 |
06/17/2015 |
G.o.c.c.l.e.s. |
PIERREL PHARMA S.R.L. |
FABIO VELOTTI |
| K151461 |
06/01/2015 |
Hybernite RT |
PLASTIFLEX GROUP NV |
RAF VAN ROY |
| K151530 |
06/08/2015 |
CardioChek Plus Test System |
POLYMER TECHNOLOGY SYSTEMS, INC. |
Megan Burns |
| K151545 |
06/09/2015 |
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K151728 |
06/26/2015 |
CoStorSol plus G |
PRESERVATION SOLUTIONS, INC. |
GARY SWANSON |
| K151584 |
06/11/2015 |
AttraX Putty |
PROGENTIX ORTHOBIOLOGY B.V. |
YVONNE P. BOVELL |
| K151646 |
06/18/2015 |
ProTech Plus |
PROTECH PROFESSIONAL PRODUCTS, INC. |
ADAM BLOCH |
| K151620 |
06/16/2015 |
Firefly Peritoneal Dialysis Connector Disinfection System |
PURACATH MEDICAL, INC. |
JOHN ASHLEY |
| K151709 |
06/24/2015 |
Hi-Light Diagnostic Ultrasound Systems |
Qingdao Hisense Medical Equipment Co., Ltd. |
Wang Wei |
| K151612 |
06/15/2015 |
NewTom VGi evo |
QR S.r.l. |
LORENZO BORTOLOTTI |
| K151753 |
06/29/2015 |
16 ch Tx/Rx Knee SPEEDER |
Quality Electrodynamics, LLC |
Kathleen Aras |
| K151629 |
06/17/2015 |
Guardian 1000 |
Quanta System SpA |
Francesco Dell'Antonio |
| K151492 |
06/03/2015 |
Kudu |
R82 A/S |
Kent Rasmussen |
| K151707 |
06/24/2015 |
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i |
RAYENCE CO., LTD |
KEVIN KIM |
| K151661 |
06/19/2015 |
Renovo Life Hard Carbon Coated Drill Bit |
Renovo Life LLC |
Harold Crowder |
| K151578 |
06/11/2015 |
Carbamazepine Gen 4 |
Roche Diagnostics Operations (RDO) |
David Tribbett |
| K151756 |
06/29/2015 |
STERISPINE LC CAGE |
SAFE ORTHOPAEDICS |
Pierre Dumouchel |
| K151747 |
06/29/2015 |
STERISPINE PS |
SAFE ORTHOPAEDICS |
Pierre Dumouchel |
| K151506 |
06/04/2015 |
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula |
Salter Labs |
Mara Caler |
| K151685 |
06/22/2015 |
GUA60A, GU60A-65 |
SAMSUNG ELECTRONICS CO., LTD. |
Chulsin Kim |
| K151663 |
06/19/2015 |
RS80A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD. |
KYEONG-MI PAK |
| K151639 |
06/18/2015 |
ABL80 FLEX and ABL80 FLEX CO-OX |
SENDX MEDICAL INC |
VIBEKE AGERLIN |
| K151745 |
06/29/2015 |
FULL CARE Disposable PVC Nelaton Catheter |
SHAOXING FUQING HEALTH PRODUCTS CO., LTD. |
DEAN WU |
| K151653 |
06/18/2015 |
8ch Foot Ankle Coil |
SHENZHEN RFTECH CO., LTD. |
KE XI |
| K151699 |
06/24/2015 |
BEAUTIFIL II Enamel |
SHOFU DENTAL CORPORATION |
Mauro Malyzyner |
| K151700 |
06/24/2015 |
BEAUTIFIL II Gingiva |
SHOFU DENTAL CORPORATION |
MAURO MALZYNER |
| K151718 |
06/25/2015 |
iFuse Implant System |
SI-BONE, INC. |
ROXANNE DUBOIS |
| K151462 |
06/01/2015 |
SI-TECHNOLOGY« SI-DESIS« SCREWS |
SI-TECHNOLOGY, LLC |
CHRIS DONNER |
| K151529 |
06/08/2015 |
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
JULIE WARREN |
| K151767 |
06/30/2015 |
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Laura J. Duggan |
| K151486 |
06/02/2015 |
Biograph mCT and mCT Flow PET/CT Scanners |
Siemens Medical Solutions USA, Inc. |
ALAINE MEDIO |
| K151579 |
06/11/2015 |
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORDELL L. FIELDS |
| K151645 |
06/18/2015 |
MAMMOMAT Fusion |
Siemens Medical Solutions USA, Inc. |
Darren Dorman |
| K151752 |
06/29/2015 |
SOMATOM Emotion 6/16 |
Siemens Medical Solutions USA, Inc. |
Eve Davis |
| K151765 |
06/30/2015 |
SOMATOM Perspective |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K151749 |
06/29/2015 |
somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) |
Siemens Medical Solutions USA, Inc. |
Eve Davis |
| K151704 |
06/24/2015 |
Diplomat« Spinal System |
SIGNUS Medizintechnik GmbH |
Jochim Schneider |
| K151560 |
06/10/2015 |
QuickPlan |
Siris Medical |
Colin M Carpenter |
| K151512 |
06/04/2015 |
Star 60 |
SKANRAY TECHNOLOGIES PRIVATE LIMITED |
MAHADEVAN J |
| K151713 |
06/25/2015 |
LILLIPUP PMP, LILLIPUT PMP INTEGRATED |
SORIN GROUP ITALIA S.R.L. |
LUIGI VECCHI |
| K151637 |
06/17/2015 |
UPT Series Medical RO Water System |
Specialty Water Technologies |
Alex Clark |
| K151770 |
06/30/2015 |
Libra Pedicle Screw System |
Spinal Balance Inc. |
Anand Agarwal |
| K151705 |
06/24/2015 |
Lotus Posterior Cervical/Thoracic Spinal System |
SPINAL ELEMENTS, INC. |
CECILIA SILVA |
| K151741 |
06/26/2015 |
HA Minuteman G3 MIS Fusion Plate |
SPINAL SIMPLICITY LLC |
JULIE MCKEE |
| K151581 |
06/11/2015 |
Leva Spacer System |
SPINE WAVE, INC. |
GAIL YAEKER-DAUNIS |
| K151695 |
06/23/2015 |
Romeo posterior osteosynthesis system |
SPINEART |
FRANCK PENNESI |
| K151710 |
06/24/2015 |
SNaP Wound Care System |
SPIRACUR, INC. |
LAWRENCE HU |
| K151622 |
06/16/2015 |
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 |
| K151590 |
06/12/2015 |
Straumann RN Gold Abutment for Bridge |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
| K151667 |
06/19/2015 |
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm |
Stryker |
Rhoda M Santos |
| K151726 |
06/26/2015 |
AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer |
Stryker Corporation |
Garry T Hayeck |
| K151755 |
06/29/2015 |
OASYS(r) System |
Stryker Corporation |
Garry T Hayeck |
| K151769 |
06/30/2015 |
Anchorage 2 CP System |
STRYKER GMBH |
KURDEA LYON |
| K151520 |
06/05/2015 |
Oscar 2 |
SunTech Medical, Inc. |
Charles Setzer |
| K151680 |
06/22/2015 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
SUQIAN XINGYE GLOVE CO, LTD |
JIAN ZHONG-DENG |
| K151617 |
06/15/2015 |
Livewire Electrophysiology Catheter |
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN |
BRANDI J. PANTELEON |
| K151592 |
06/12/2015 |
Gemmed pedicle screw spinal system |
SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. |
Xue Fang Zhou |
| K151526 |
06/08/2015 |
Zone, ZoneFree, Zone A1 |
SYBRON DENTAL SPECIALTIES |
COURTNEY CLARK |
| K151655 |
06/18/2015 |
CO2RE System |
SYNERON MEDICAL LTD. |
Ruthie Amir |
| K151588 |
06/11/2015 |
maxFit II Dental Implant System |
Taiwan Implant Technology Company, Ltd. |
Ching-Chieh Huang |
| K151471 |
06/01/2015 |
Radifocus Glidewire Endoscopic Wire |
Terumo Medical Corporation |
Phebe Varghese |
| K151759 |
06/29/2015 |
Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS |
THE BINDING SITE GROUP LTD. |
STEPHANIE THOULESS |
| K151508 |
06/04/2015 |
IRENE Locking Compression Plate System |
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD |
YIFAN FU |
| K151596 |
06/12/2015 |
Endoskeleton TCS Interbody Fusion Device |
TITAN SPINE, LLC |
JANE RODD |
| K151673 |
06/22/2015 |
Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K151735 |
06/26/2015 |
TriMed Humeral Supracondylar Fixation System |
TriMed, Inc. |
Michael Capellan |
| K151647 |
06/18/2015 |
Uberlube |
UBERLUBE LLC |
JACK MAGNUSEN |
| K151533 |
06/08/2015 |
Respiratory Gating for Scanners |
VARIAN MEDICAL SYSTEMS, INC |
PETER J. CORONADO |
| K151657 |
06/19/2015 |
Shielded Applicator Set, Cervical Stop |
VARIAN MEDICAL SYSTEMS, INC |
PETER J. CORONADO |
| K151456 |
06/01/2015 |
Small Bone Nail Implant |
VILEX IN TENNESSEE, INC |
SYLVIA SOUTHARD |
| K151714 |
06/25/2015 |
Disposable Endoscope Valves Set A |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
LIJUAN ZHANG |
| K151733 |
06/26/2015 |
Xenco Medical Pedicle Screw System |
Xenco Medical, LLC |
GUSTAVO PRADO |
| K151601 |
06/12/2015 |
SECURE-LOOP |
XIROS LTD |
STEPHEN SEED |
| K151764 |
06/30/2015 |
YAMAHACHI PMMA DISKS |
YAMAHACHI DENTAL PRODUCTS USA, INC. |
LAWRENCE G. GREENWALD |
| K151586 |
06/11/2015 |
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens |
YUNG SHENG OPTICAL CO., LTD. |
WEN-HAN CHEN |
| K151498 |
06/04/2015 |
Breathing circuit bacterial/viral filter |
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. |
HU JUBIN |
| K151716 |
06/25/2015 |
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System |
ZIMMER, INC. |
Patrick McCullagh |
| K151490 |
06/03/2015 |
PRETTAU ANTERIOR T0 |
ZIRKONZAHN GMBH |
HEINRICH STEGER |
