| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K151687 |
06/23/2015 |
QuantorView |
3DISC AMERICAS |
SIGRID SMITT-JEPPESEN |
| K151566 |
06/10/2015 |
Abbott ARCHITECT Total T4 Calibrators |
ABBOTT LABORATORIES |
Lisa Lukowski |
| 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 |
| K151696 |
06/23/2015 |
Caiman Seal and Cut Technology |
AESCULAP, INC. |
Denise Adams |
| 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 |
| K151460 |
06/01/2015 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO., LTD. |
LIU YI |
| 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 |
| 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 |
| K151505 |
06/04/2015 |
Coronis Uniti |
Barco N.V. |
Franky Dubois |
| K151742 |
06/29/2015 |
Contour Next Control Solution |
BAYER HEALTHCARE |
JENNIFER L. GREGORY |
| 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 |
| 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 |
| K151760 |
06/29/2015 |
Barricade Embolization Coil System |
BLOCKADE MEDICAL |
REBECCA K. PINE |
| K151516 |
06/05/2015 |
Capillus82 |
Capillus, LLC |
PATRICIA SCHNOOR |
| 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 |
| 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 |
| K151509 |
06/04/2015 |
GSI TympStar Pro Middle Ear Analyzer |
Diagnostic Group, dba Grason-Stadler |
Ron Rolfsen |
| K151485 |
06/02/2015 |
GENESIS |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| 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 |
| K151552 |
06/09/2015 |
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II |
ELITechGroup |
Valerie Gourdon |
| K151668 |
06/19/2015 |
S-scan |
ESAOTE S.P.A. |
DONATELLA RAGGHIANTI |
| 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 |
| 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 |
| 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 |
| K151591 |
06/12/2015 |
Angel pedicle screw spinal system |
JIANGSU ANGEL MEDICAL INSTRUMENT CO., LTD |
SHENG XIANG MA |
| K151727 |
06/26/2015 |
Everest Spinal System |
K2M, INC |
NANCY GIEZEN |
| K151465 |
06/01/2015 |
AeroDR SYSTEM 2 |
KONICA MINOLTA, INC. |
SHIGEYUKI KOJIMA |
| 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 |
| K151522 |
06/05/2015 |
DEFENDO Bronchoscopy Suction Valve |
MEDIVATORS, INC. |
Jeff Kasoff |
| K151628 |
06/17/2015 |
Medline ENFit Connectors |
MEDLINE INDUSTRIES, INC. |
STEPHANIE BLAIR |
| 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 |
| K151497 |
06/04/2015 |
EN Snare Endovascular Snare System |
MERIT MEDICAL SYSTEMS INC |
MARK MULLANEY |
| K151543 |
06/08/2015 |
Graft Delivery Device with Integrated Stylet |
Micromedics Inc. (d/b/a Nordson Medical) |
Amy L Peterson |
| 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 |
| K151654 |
06/18/2015 |
PROW FUSION |
NLT SPINE LTD |
Eti Zinger |
| 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 |
| K151488 |
06/02/2015 |
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System |
Orthofix, Inc. |
Jacki Geren |
| 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 |
| 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 |
| K151521 |
06/05/2015 |
Phoenix Thera-Lase System |
PHOENIX THERA-LASE SYSTEMS, LLC |
GARY BELLINGER |
| K151630 |
06/17/2015 |
G.o.c.c.l.e.s. |
PIERREL PHARMA S.R.L. |
FABIO VELOTTI |
| K151530 |
06/08/2015 |
CardioChek Plus Test System |
POLYMER TECHNOLOGY SYSTEMS, INC. |
Megan Burns |
| K151728 |
06/26/2015 |
CoStorSol plus G |
PRESERVATION SOLUTIONS, INC. |
GARY SWANSON |
| K151709 |
06/24/2015 |
Hi-Light Diagnostic Ultrasound Systems |
Qingdao Hisense Medical Equipment Co., Ltd. |
Wang Wei |
| K151753 |
06/29/2015 |
16 ch Tx/Rx Knee SPEEDER |
Quality Electrodynamics, LLC |
Kathleen Aras |
| K151707 |
06/24/2015 |
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i |
RAYENCE CO., LTD |
KEVIN KIM |
| K151756 |
06/29/2015 |
STERISPINE LC CAGE |
SAFE ORTHOPAEDICS |
Pierre Dumouchel |
| 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 |
| K151653 |
06/18/2015 |
8ch Foot Ankle Coil |
SHENZHEN RFTECH CO., LTD. |
KE XI |
| K151462 |
06/01/2015 |
SI-TECHNOLOGY« SI-DESIS« SCREWS |
SI-TECHNOLOGY, LLC |
CHRIS DONNER |
| 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 |
| K151560 |
06/10/2015 |
QuickPlan |
Siris Medical |
Colin M Carpenter |
| K151637 |
06/17/2015 |
UPT Series Medical RO Water System |
Specialty Water Technologies |
Alex Clark |
| 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 |
| 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 |
| K151755 |
06/29/2015 |
OASYS(r) System |
Stryker Corporation |
Garry T Hayeck |
| 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 |
| K151471 |
06/01/2015 |
Radifocus Glidewire Endoscopic Wire |
Terumo Medical Corporation |
Phebe Varghese |
| 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 |
| K151733 |
06/26/2015 |
Xenco Medical Pedicle Screw System |
Xenco Medical, LLC |
GUSTAVO PRADO |
| K151601 |
06/12/2015 |
SECURE-LOOP |
XIROS LTD |
STEPHEN SEED |
| K151586 |
06/11/2015 |
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens |
YUNG SHENG OPTICAL CO., LTD. |
WEN-HAN CHEN |
