| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K151369 |
05/21/2015 |
.decimal p.d |
.DECIMAL, LLC |
KEVIN ERHART |
| K151285 |
05/14/2015 |
VSP Cranial System |
3D Systems, Inc. |
Kim Torluemke |
| K151302 |
05/15/2015 |
Clinpro Varnish |
3m Company |
Shari L. Myszka |
| K151317 |
05/18/2015 |
Armada 18 PTA Catheter |
ABBOTT VASCULAR |
Shu Chi Hsu |
| K151185 |
05/04/2015 |
AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) |
ABL Medical, LLC |
Robert Holladay |
| K151182 |
05/04/2015 |
LiquiBand Exceed |
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
MARTIN MITCHELL |
| K151363 |
05/21/2015 |
Zephyr Vascular Compression Device |
ADVANCED VASCULAR DYNAMICS |
MATTHEW SEMLER |
| K151165 |
05/01/2015 |
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture |
AESCULAP, INC. |
KATHY A. RACOSKY |
| K151242 |
05/11/2015 |
SterilContainer S |
Aesculap, Inc. |
Denise R. Adams |
| DEN150022 |
05/26/2015 |
Ultravision Visual Clearing System |
Alesi Surgical Ltd. |
DOMINIC GRIFFITHS |
| K151310 |
05/18/2015 |
Amendia Interbody Fusion Devices |
AMENDIA, INC. |
BRUCE HOOPER |
| K151322 |
05/18/2015 |
Amendia Interbody Fusion Devices |
AMENDIA, INC. |
BRUCE HOOPER |
| K151168 |
05/01/2015 |
Nexodyn AOS Wound Care Solution |
APR Applied Pharma Research SA |
Giorgio Reiner |
| K151256 |
05/12/2015 |
Arthrex BioSync« Bone Wedge |
Arthex, Inc |
Laura Medlin |
| K151230 |
05/08/2015 |
Arthrex FiberTak Anchors |
Arthrex, Inc. |
Ivette Galmez |
| K151342 |
05/19/2015 |
Arthrex SwiveLock Anchors |
ARTHREX, INC. |
David L. Rogers |
| K151311 |
05/18/2015 |
Safe Block Pen Needle |
Artsana S.P.A |
Cassani Mauro |
| K151211 |
05/06/2015 |
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup |
Assure Tech. Co., Ltd |
Eric Lin |
| K151357 |
05/20/2015 |
MIRI TL |
AT MEDICAL UAB |
THOMAS PEDERSEN |
| K151404 |
05/26/2015 |
ProTrach Dualcare |
ATOS MEDICAL AB |
Ferenc Dahner |
| K151386 |
05/26/2015 |
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic |
ATRIUM MEDICAL CORPORATION |
Timothy J Talcott |
| K151437 |
05/29/2015 |
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug |
ATRIUM MEDICAL CORPORATION |
TIMOTHY J. TALCOTT |
| K151423 |
05/28/2015 |
APEX Compounding System Transfer Set |
B. BRAUN MEDICAL INC. |
TRACY MADDOCK |
| K151391 |
05/26/2015 |
BTI Dental Implant System UnicCa |
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
FERNANDA OLABARRIA ROS |
| K151291 |
05/15/2015 |
BD Veritor (TM) System for the Rapid Detection of Flu A+B |
BECTON DICKINSON AND COMPANY |
GREGORY P PAYNE |
| K151301 |
05/15/2015 |
BD VeritorÖ System Flu A+B Assay |
Becton Dickinson and Company |
Gregory P Payne |
| K151320 |
05/18/2015 |
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml |
BECTON, DICKINSON AND COMPANY |
MONICA E. GIGUERE |
| K151206 |
05/06/2015 |
Fingertip Pulse Oximeter |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
| K151280 |
05/14/2015 |
MultiScan G-Arm System |
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. |
June Li |
| K151219 |
05/07/2015 |
Models 2200DR and 1600DR Digital Stationary Radiographic Systems |
BEIJING POLYCON MEDICAL ENGINEERING COMPANY |
XIANGCHEN LIU |
| K151321 |
05/18/2015 |
D-100 HbA1c, D-100 HbA1c Calibrator Pack |
Bio-Rad Laboratories, Inc. |
Jackie Buckley |
| K151295 |
05/15/2015 |
Biodenta Customized Abutment - Titanium |
BIODENTA SWISS AG |
DAVID ELIER |
| K151173 |
05/01/2015 |
Biomet Microfixation RibFix Blu Thoracic Fixation System |
Biomet Microfixation |
Lauren Jasper |
| K151224 |
05/07/2015 |
Lineum OCT Spine System |
BIOMET SPINE |
Spencer Kimber |
| K151296 |
05/15/2015 |
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) |
BIOS S.R.L. |
RICCARDO PISATI |
| K151187 |
05/04/2015 |
QuadraSphere Microspheres |
BIOSPHERE MEDICAL S.A. |
ALIX FONLLADOSA |
| K151409 |
05/26/2015 |
Selectra Catheters and Selectra Accessory Kit |
BIOTRONIK, INC. |
JON BRUMBAUGH |
| K151354 |
05/20/2015 |
Cervello STIM |
BLACKROCK NEUROMED |
SHANNA RYAN |
| K151315 |
05/18/2015 |
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle |
BOSTON SCIENTIFIC CORPORATION |
YINGYING GAO |
| K151313 |
05/18/2015 |
ZelanteDVT Thrombectomy Set |
BOSTON SCIENTIFIC CORPORATION |
ANNE V. ROSSI |
| K151253 |
05/12/2015 |
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter |
BOSTON SCIENTIFIC LIMITED |
LISA MEE |
| K151325 |
05/18/2015 |
Bovie J-Plasma Handpiece |
BOVIE MEDICAL CORPORATION |
Brian Kunst |
| K151177 |
05/01/2015 |
XenMatrix AB Surgical Graft |
C.R. Bard |
Tony John |
| K151445 |
05/29/2015 |
Cardinal Health Sterilization Wrap |
CARDINAL HEALTH 200, LLC |
MEGAN MIDDAUGH |
| K151260 |
05/12/2015 |
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD |
Cardiovascular System, Inc. |
Kim Wallner |
| K151303 |
05/18/2015 |
AirLife Infant Heated Wire Circuit |
CAREFUSION |
ERIKA FERNANDEZ |
| K151255 |
05/12/2015 |
Navigator Aesthetic Delivery System |
CARTICEPT MEDICAL INC |
CARRIBETH RAMEY |
| K151337 |
05/19/2015 |
Strialite |
Centre Light Solutions, LLC |
Carrie Colburn |
| K151226 |
05/07/2015 |
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) |
CEPHEID |
Kerry J Flom |
| K151406 |
05/26/2015 |
Cogent Lateral Interbody System |
COGENT SPINE LLC |
JUDE PAGANELLI |
| K151229 |
05/07/2015 |
ABC D-FLEX PROBE |
CONMED CORPORATION |
SANDY LECLAIR |
| K151379 |
05/22/2015 |
Conventus PRS System |
Conventus Orthopaedics, Inc |
Kent R Lind |
| K151306 |
05/18/2015 |
Solea |
CONVERGENT DENTAL, INC |
Mike Manor |
| K151204 |
05/05/2015 |
HEMO-Bandage |
CORELEADER BIOTECH CO., LTD. |
Ya-Wen Kuo |
| K151408 |
05/26/2015 |
LOSPA IS Spinal System |
CORENTEC CO., LTD |
GOON HEE LEE |
| K151279 |
05/14/2015 |
Counter OTC TENS Device, Model CSD-737Z |
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD |
Jiang Eagle |
| K151381 |
05/22/2015 |
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye |
Covidien |
Danielle Mueller |
| K151163 |
05/01/2015 |
Signia Loading Unit, Tri-Staple 2.0 Cartridge |
Covidien LLC |
Frank Gianelli |
| K151356 |
05/20/2015 |
Spacemaker Pro Access and Dissector System |
Covidien LLC |
Rebecca Magnanimo |
| K151376 |
05/22/2015 |
superDimension Navigation System |
Covidien LLC |
Jenny Jiang |
| K151252 |
05/12/2015 |
Puritan Bennett 840 Series Ventilator System |
Covidien LP |
Kelsey Lee |
| K151270 |
05/13/2015 |
CrossTIE Intraosseous Fixation System |
CrossRoads Extremity Systems LLC |
Vernon Hartdegen |
| K151158 |
05/01/2015 |
ALP VasQcare Take Home System |
Currie Medical Specialties, Inc. |
Owen J Bry |
| K151254 |
05/12/2015 |
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump |
DATASCOPE CORP. |
Helder A Sousa |
| K151439 |
05/29/2015 |
ATLANTIS ISUS |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K151189 |
05/04/2015 |
Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System |
Devon Medical Products |
ROCCO BRAVOCO |
| K151240 |
05/11/2015 |
extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative |
Devon Medical Products |
JOHN SIEGEL |
| K151281 |
05/14/2015 |
AGE Automatic Wrist Blood Pressure Monitor |
DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD |
VICTOR WAN |
| K151298 |
05/15/2015 |
Gemini XXP-HP |
Dornier MedTech America |
John Hoffer |
| K151220 |
05/07/2015 |
Dunamis Interference Screw |
Dunamis LLC |
PRITHVI RAJ CHAVAN |
| K151414 |
05/27/2015 |
IQQA Guide |
EDDA TECHNOLOGY |
XIAOLAN ZENG |
| K151319 |
05/18/2015 |
Eko Electronic Stethoscope System |
Eko Devices, Inc. |
Connor Landgraf |
| K151159 |
05/01/2015 |
Leksell Gamma Knife Perfexion |
ELEKTA INSTRUMENT AB |
MATILDA FORSBERG |
| K151228 |
05/07/2015 |
PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm |
EMERSON & CO. S.R.L. |
Stefano Costigliolo |
| K151340 |
05/19/2015 |
HARMONIC Focus Long Shears + Adaptive Tissue Technology |
ETHICON ENDO-SURGERY, LLC |
MARJORIE MEDINA |
| K151200 |
05/05/2015 |
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device |
ETHICON, INC. |
DONNA MARSHALL |
| K151156 |
05/01/2015 |
Fiagon Navigation System |
FIAGON GMBH |
DIRK MUCHA |
| K151346 |
05/20/2015 |
Frontier Medical Devices Posterior Cable Screw System |
FRONTIER MEDICAL DEVICES, INC. |
BETHANY BYMAN |
| K151378 |
05/22/2015 |
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators |
Fujirebio Diagnostics, Inc. |
Diana Dickson |
| K151372 |
05/21/2015 |
Low Dose CT Lung Cancer Screening Option for Qualified GE Systems |
GE Medical Systems, LLC |
John Jaeckle |
| K151274 |
05/13/2015 |
Dr's Finder |
GOOD DOCTORS CO., LTD. |
Sungro Joo |
| K151287 |
05/14/2015 |
Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Jin Liang |
| K151271 |
05/13/2015 |
BellaFuse |
Hans Biomed Corp. |
Lucy Choi |
| K151343 |
05/19/2015 |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) |
HARTALEGA NGC SDN BHD |
KUAN MUN LEONG |
| K151339 |
05/19/2015 |
SONON Ultrasound Imaging System (Model: SONON 300C) |
HEALCERION CO., LTD. |
JAEYEOB JUNG |
| K151348 |
05/20/2015 |
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
JIANQIU FANG |
| K151362 |
05/21/2015 |
HC Spinal System |
HUNG CHUN BIO-S CO., LTD. |
HSIN TAI HU |
| K151164 |
05/01/2015 |
Assure Prism multi Blood Glucose Monitoring System |
i-Sens, Inc. |
JOON HO JUNG |
| K151307 |
05/18/2015 |
ICONACY(TM) I-Hip (TM) |
ICONACY ORTHOPEDIC IMPLANTS, LLC |
ROY Y HORI |
| K151415 |
05/27/2015 |
Oregon Scientific |
IDT TECHNOLOGY LIMITED |
LILY LI |
| K151232 |
05/08/2015 |
VIKINI Diode Laser System |
ILOODA CO., LTD |
Suhee Nam |
| K151268 |
05/13/2015 |
SPINAUT-V, SPINAUT-S, SPINAUT-I |
IMEDICOM CO., LTD. |
BONGGU HA |
| K151203 |
05/05/2015 |
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set |
IMMUNALYSIS CORPORATION |
JOSEPH GINETE |
| K151395 |
05/26/2015 |
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets |
Immunalysis Corporation |
Joseph Ginete |
| K151233 |
05/08/2015 |
Monaco |
IMPAC MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K151360 |
05/20/2015 |
Inion Spinal Graft Containment System |
Inion Oy |
Kati Marttinen |
| K151273 |
05/13/2015 |
InMode FRF Applicator |
Inmode MD Ltd. |
Ahava Stein |
| K151429 |
05/28/2015 |
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
| K151433 |
05/28/2015 |
AUDICOR CA300/CC100 Analyzer with SDB |
INOVISE MEDICAL, INC. |
Earl Anderson |
| K151364 |
05/21/2015 |
Intellijoint HIP(tm) System |
INTELLIJOINT SURGICAL INC. |
BRANDON GINGRICH |
| K151450 |
05/29/2015 |
Endoscope Sterilization Tray |
INTUITIVE SURGICAL, INC. |
Kunal Gunjal |
| K151246 |
05/11/2015 |
Aneroid Sphygmomanometer |
Jiaxing Zhongfa Medical Products Co., Ltd. |
Mao Xiaohua |
| K151400 |
05/26/2015 |
Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products |
JK HOLDING GmbH |
JUERGEN GERSTENMEIER |
| K151216 |
05/06/2015 |
Everest Spinal System |
K2M, Inc |
Nancy Giezen |
| K151394 |
05/26/2015 |
Keeler Slit Lamp |
KEELER LIMITED |
IRINA PROUTSKI |
| K151222 |
05/07/2015 |
Cautery Tip Cleaner |
KEY SURGICAL, INC. |
AMY YANTA |
| K151382 |
05/22/2015 |
Patient Contoured Implant-PEEK (PCI-PEEK) |
KLS MARTIN L.P. |
JENNIFER DAMATO |
| K151221 |
05/07/2015 |
Kubtec DIGIVIEW 395 |
KUB TECHNOLOGIES, INC |
VIKRAM BUTANI |
| K151244 |
05/11/2015 |
Pre-Formed Guidewire |
Lake Region Medical |
Mathew Pexa |
| K151333 |
05/19/2015 |
LightStim for Pain LED Belt |
LED INTELLECTUAL PROPERTIES, LLC |
Steve Marchese |
| K151336 |
05/19/2015 |
LightStim Professional 2-Panel Light |
LED INTELLECTUAL PROPERTIES, LLC |
STEVE MARCHESE |
| K151196 |
05/05/2015 |
Nautilus Spinal System |
LIFE SPINE, INC |
RANDY LEWIS |
| K151269 |
05/13/2015 |
ECG Mini System Continuous ECG Monitor and Arrhythmia Detector |
LifeWatch Technologies Ltd. |
Asher Kassel |
| K151370 |
05/21/2015 |
UV Lamps for Indoor Tanning Devices |
LIGHT SOURCES, INC. |
EUGENE CZAKO |
| K151286 |
05/14/2015 |
OPTIS Integrated System Mobile Workstation |
LIGHTLAB IMAGING, INC. |
Padmini Suravaram |
| K151266 |
05/13/2015 |
Physica CR Knee System |
Limacorporate S.P.A. |
Emanuele Buttazzoni |
| K151331 |
05/19/2015 |
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch |
LUMENIS LTD |
ELISSA BURG |
| K151199 |
05/05/2015 |
SmartDrive Wheelchair Power Assist |
MAX MOBILITY, LLC |
Ben Hemkens |
| K151390 |
05/26/2015 |
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs |
MAXTER GLOVE MANUFACTURING SDN BHD |
YAP PEAK GEEH |
| K151248 |
05/11/2015 |
PIEZOSURGERY WHITE |
MECTRON SPA |
MR. FRANCO ZUNINO |
| K151261 |
05/12/2015 |
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large |
Medela AG |
Orlando Antunes |
| K151377 |
05/22/2015 |
ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare |
MEDICAL COMPRESSION SYSTEM (DBN) LTD. |
EYAL SANDACH |
| K151235 |
05/11/2015 |
Medline Foot Plates and Screws |
MEDLINE INDUSTRIES, INC. |
Jennifer Mason |
| K151352 |
05/20/2015 |
CONCORDE Bullet Spinal System |
MEDOS INTERNATIONAL SARL |
JEFFREY SHIFFMAN |
| K151359 |
05/20/2015 |
ROSA Brain |
MEDTECH S.A. |
MICHAEL CHRIST |
| K151227 |
05/07/2015 |
KYPHON XPEDE Bone Cement |
MEDTRONIC |
KATHY L REMSEN |
| K151236 |
05/11/2015 |
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) |
MEDTRONIC MINIMED, INC. |
Liane R. Miller |
| K151172 |
05/01/2015 |
MASTERGRAFT Contain |
MEDTRONIC SOFAMOR DANEK USA, INC |
Gregory K Maschek |
| K151373 |
05/21/2015 |
Corvocet Coaxial Introducer |
Merit Medical Systems, Inc. |
Ileana Garcia |
| K151447 |
05/29/2015 |
Axium Detachable Coil System |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
PATRICIA CASING |
| K151358 |
05/20/2015 |
AZUR CX Detachable 35 Coils |
Micro Vention, Inc. |
Cynthia Valenzuela |
| K151330 |
05/19/2015 |
Microlife Wrist Watch Blood Pressure Monitor |
MICROLIFE INTELLECTUAL PROPERTY GmbH, SWITZERLAND |
GERHARD FRICK |
| K151396 |
05/26/2015 |
MIVI Mi-AXUS Guide Catheter |
MIVI NEUROSCIENCE, INC |
Matthew Ogle |
| K151238 |
05/11/2015 |
JUSHA-M23C LCD Monitor |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
Ma Jing |
| K151239 |
05/11/2015 |
NMI DUAL PORT II |
NAVILYST MEDICAL, INC. |
ROBIN FULLER |
| K151383 |
05/22/2015 |
NeuViz 128 Multi-slice CT Scanner System |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YUEHUI |
| K151403 |
05/26/2015 |
Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YUEHUI |
| K151160 |
05/01/2015 |
Arcus Staple System |
NEXTREMITY SOLUTIONS, INC. |
Ryan Schlotterback |
| K151305 |
05/18/2015 |
SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) |
NONIN MEDICAL INC. |
LAURA J. LIND |
| K151341 |
05/19/2015 |
Turbo High-Flow Non-coring Needle |
NORFOLK MEDICAL |
NATAN PHEIL |
| K151407 |
05/26/2015 |
RECON system |
NORMED MEDIZIN-TECHNIK GMBH |
ARNE BRIEST |
| K151277 |
05/14/2015 |
Airlock« osteosynthesis plate system |
NOVASTEP |
GILLES AUDIC |
| K151361 |
05/21/2015 |
Nox RIP Belts & Cables |
NOX MEDICAL ehf |
KOLBRUN E OTTOSDOTTIR |
| K151272 |
05/13/2015 |
Henschke Titanium Applicator Set |
NUCLETRON B.V. |
Lizette Van de Streek |
| K151214 |
05/06/2015 |
ALIF Interfixated System |
NuVasive, Incorporated |
Cynthia Adams |
| K151374 |
05/22/2015 |
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System |
NuVasive, Incorporated |
Olga Lewis |
| K151167 |
05/01/2015 |
NuVasive PEEK Corpectomy System |
NUVASIVE, INCORPORATED |
OLGA LEWIS |
| K151275 |
05/13/2015 |
MAKO Device |
nVision Medical |
Surbhi Sarna |
| K151191 |
05/04/2015 |
OES ELITE Telescopes, Protective Tube |
OLYMPUS WINTER & IBE GMBH |
KATHARINA SCHNACKENBURG |
| K151207 |
05/06/2015 |
Proton Immobilization Solution |
ORFIT INDUSTRIES NV |
EDDY MARIVOET |
| K151300 |
05/15/2015 |
AVERT Contrast Modulation System |
OSPREY MEDICAL, INC. |
MELANIE HESS |
| K151262 |
05/13/2015 |
Hyflex Heavy, Hyflex Mono, Hyflex Light |
Osstem Implant Co., Ltd |
Heekwon Son |
| K151195 |
05/04/2015 |
OsteoMed IMF Screw |
OSTEOMED |
Piedad Pena |
| K151169 |
05/01/2015 |
OsteoReady ZircoSeal Abutments |
OsteoReady LLC |
Michael D Silverman |
| K151432 |
05/28/2015 |
NaturalLine Abutment |
OT MEDICAL GMBH |
MARTINA BEHLAU |
| K151418 |
05/28/2015 |
Monster Screw System |
PARAGON 28 |
FRANK S. BONO |
| K151366 |
05/21/2015 |
Philips CS770 IntelliSpace Critical Care and Anesthesia |
PHILIPS MEDICAL SYSTEMS |
KRISTEN PHILLIPS |
| K151435 |
05/28/2015 |
MRCAT |
PHILIPS MEDICAL SYSTEMS MR FINLAND |
JANNE MARVOLA |
| K151184 |
05/04/2015 |
InFill Interbody Fusion Devices |
PINNACLE SPINE GROUP, LLC |
REBECCA K PINE |
| K151314 |
05/18/2015 |
CinchLock Flex Knotless Suture Anchor |
Pivot Medical |
Kelly Kucharczyk |
| K151422 |
05/28/2015 |
Reform Pedicle Screw System |
Precision Spine, Inc. |
Michael C. Dawson |
| K151188 |
05/04/2015 |
BodyGuardian Remote Monitoring System |
PREVENTICE |
CHARLIE RECTOR |
| K151375 |
05/22/2015 |
Inclusive Titanium Abutments compatible with: Hiossen HG Implant System |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
| K151413 |
05/27/2015 |
Always/Tampax bladder supports |
PROCTER & GAMBLE |
LENORE FAULHABER |
| K151249 |
05/12/2015 |
PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON |
PUREWAY COMPLIANCE, INC |
JEFFERY MIGLICCO |
| K151212 |
05/06/2015 |
Ziostation2 |
QI IMAGING, LLC |
RICHARD BALL |
| K151438 |
05/29/2015 |
Dentrix Ascend Imaging |
REALCLOUD IMAGING INC. |
DOUGLAS A. GOLAY |
| K151446 |
05/29/2015 |
Recovr Rehabilitation System |
Recovr,Inc |
Austen Hayes |
| K151282 |
05/14/2015 |
core nova Complete Operating Room Endoscopy |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
MICHELE MCDONALD |
| K151171 |
05/01/2015 |
TRAUS SUS10 |
SAESHIN PRECISION CO., LTD. |
SAE KWAN CHOI |
| K151421 |
05/28/2015 |
Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines |
Salter Labs |
Mara Caler |
| K151419 |
05/28/2015 |
GF50A |
SAMSUNG ELECTRONICS CO., LTD. |
Chulsin Kim |
| K151186 |
05/04/2015 |
Stay Fresh Hydrocolloid dressing |
SARASOTA MEDICAL PRODUCTS, INC. |
WALTER F. LEISE |
| K151426 |
05/28/2015 |
ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ |
SCANDIDOS AB |
THOMAS MATZEN |
| K151180 |
05/04/2015 |
ScandiDos Delta4 Phantom+ |
SCANDIDOS AB |
THOMAS MATZEN |
| K151308 |
05/18/2015 |
Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set |
SCHOELLY FIBEROPTIC, GMBH |
SANDRA BAUMANN |
| K151399 |
05/26/2015 |
Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow |
SCHUTZ DENTAL GMBH |
ANTJE MAURER |
| K151265 |
05/13/2015 |
SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System |
SD BIOSENSOR |
YEON PARK |
| K151329 |
05/18/2015 |
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet |
SENTEC AG |
ANKE WEISBRICH |
| K151258 |
05/12/2015 |
Arm automatic blood pressure monitor |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
Xie Qiongyu |
| K151259 |
05/12/2015 |
Sysmex Automated Blood Coagulation Analyzer CS-2100i |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
NILS NEUMANN |
| K151192 |
05/04/2015 |
syngo.via MI Workflows |
SIEMENS MEDICAL SOLUTIONS USA, INC |
VERONICA PADHARIA |
| K151353 |
05/20/2015 |
syngo.MR Neurology, syngo.MR Oncology |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORDELL L. FIELDS |
| K151380 |
05/22/2015 |
syngo.via RT Image Suite |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
EVE DAVIS |
| K151209 |
05/06/2015 |
InterOss |
SigmaGraft, Inc |
Megan Holden |
| K151436 |
05/28/2015 |
PICO Single Use Negative Pressure Wound Therapy System |
SMITH & NEPHEW MEDICAL LTD |
SAMANTHA NEILSON |
| K151326 |
05/18/2015 |
RENASYS┐ EZ PLUS Negative Pressure Wound Therapy Device |
Smith & Nephew, Inc. |
Laura Reynolds |
| K151194 |
05/04/2015 |
KLOCKNER DENTAL IMPLANT ABUTMENTS (II) |
SOADCO, S.L. |
Maria Mitjaneta |
| K151215 |
05/06/2015 |
Mercury Spinal System |
Spinal Elements Inc. |
JULIE LAMOTHE |
| K151198 |
05/05/2015 |
A-CIFT SoloFuse |
SPINEFRONTIER, INC. |
MANTHAN J DAMANI |
| K151328 |
05/18/2015 |
PURE Ceramic Implants |
STRAUMANN USA |
CHRIS KLACZYK |
| K151247 |
05/11/2015 |
NC Straumann Screw Retained Abutments |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
| K151157 |
05/01/2015 |
NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
| K151324 |
05/18/2015 |
Straumann Variobase for CEREC |
STRAUMANN USA, LLC |
Christopher Klaczyk |
| K151201 |
05/05/2015 |
Stryker ICONIX with Needles |
Stryker |
TAYLOR WHITE |
| K151387 |
05/26/2015 |
Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade |
STRYKER |
JONATHAN SCHELL |
| K151243 |
05/11/2015 |
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] |
Stryker Endoscopy |
GOLNAZ MOEINI |
| K151264 |
05/13/2015 |
Restoration Anatomic Shell |
STRYKER ORTHOPAEDICS |
Allison M Ling |
| K151178 |
05/04/2015 |
VariAx 2 Wrist Fusion System |
Stryker Trauma AG |
DR. HEIKE GUSTKE |
| K151166 |
05/01/2015 |
Instru-Safe Instrument Protection System |
Summit Medical Inc. |
Nicole Dove |
| K151405 |
05/26/2015 |
Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology |
Surgical Instrument Services and Savings(dba Medline ReNewal |
Brandi Panteleon |
| K151332 |
05/19/2015 |
Nexus Universal, Nexus Universal Chroma |
SYBRON DENTAL SPECIALTIES |
COURTNEY CLARK |
| K151241 |
05/11/2015 |
Synchro-Medical TIGER TRACK Screw System |
Synchro Medical |
Danilo Campani |
| K151276 |
05/13/2015 |
DePuy Synthes T-PAL Ti Spacer |
SYNTHES USA PRODUCTS LLC |
Eric Zhu |
| K151263 |
05/13/2015 |
Venturi Gauze Wound Care Sets with Portal Drain |
TALLEY GROUP LTD. |
ROBERT MACDONALD |
| K151161 |
05/01/2015 |
VICTUS Femtosecond Laser Platform |
TECHNOLAS PERFECT VISION GMBH |
FRIEDRICH MORITZ |
| K151392 |
05/26/2015 |
Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less |
TERANG NUSA SDN BHD |
ROBERT HILL |
| K151368 |
05/21/2015 |
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter |
TERUMO BCT |
Nicholas Wong |
| K151349 |
05/20/2015 |
Advanced Perfusion System 1 |
Terumo Cardiovascular Systems Corporation |
John Chesney |
| K151389 |
05/26/2015 |
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir |
Terumo Cardiovascular Systems Corporation |
Garry A Courtney |
| K151398 |
05/26/2015 |
K-Pack II Needle - 29G x 5/16 Thin Wall |
TERUMO EUROPE N.V. |
M. J. Aerts |
| K151424 |
05/28/2015 |
The Progressive Orthopaedic Total Hip System |
The Progressive Orthopaedic Company, LLC |
Scott Keiser |
| K151347 |
05/20/2015 |
MIS Spine Frame Instrument Case |
THOMPSON SURGICAL INSTRUMENTS |
STEPHANIE MYERS |
| K151245 |
05/11/2015 |
Rhythm View Workstation (non-streaming, steaming option) |
TOPERA, INC. |
Dennis Pozzo |
| K151250 |
05/12/2015 |
Smart Set |
TOPSPINS, INC. |
FREDERICK PRINCE |
| K151293 |
05/15/2015 |
Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis |
Tornier SAS |
Severine Bonneton |
| K151170 |
05/01/2015 |
Tosama 100% Organic Cotton Menstrual Tampon |
TOSAMA D.O.O. |
MARJETKA KRALJ KUNCIC |
| K151451 |
05/29/2015 |
Aplio 500/400/300 Diagnostic Ultrasound System V6.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K151440 |
05/29/2015 |
Klassic HD Hip System |
TOTAL JOINT ORTHOPEDICS, INC. |
CHRIS WEABER |
| K151371 |
05/21/2015 |
Corporate Dental Imaging (CDI) Application |
U.S. ARMY DENTAL COMMAND (DENCOM) |
WILLIAM K. PORTER |
| K151213 |
05/06/2015 |
UCP Drug Test Mini Cups |
UCP BIOSCIENCES, INC |
NANCY CHEN |
| K151344 |
05/19/2015 |
Cytoflex Tefguard Ti-Enforced Membrane |
Unicare Biomedical, Inc. |
Stan Yang |
| K151316 |
05/18/2015 |
U2 Hip Stem, Ti Porous Coated, Matrix |
United Orthopedic Corporation |
Karen Ho |
| K151345 |
05/19/2015 |
BioGuard Air/Water Valve, BioGuard Suction Valve |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L. MARTIN |
| K151197 |
05/05/2015 |
Lariat snare |
UNITED STATES ENDOSCOPY GROUP, INC. |
SAGAR PIMPALWAR |
| K151234 |
05/08/2015 |
R350 guidewire |
VASCULAR SOLUTIONS, INC. |
BEKA VITE |
| K151312 |
05/18/2015 |
VerteLP Interbody Fusion Device |
VGI, LLC |
Tov Vestgaarten |
| K151283 |
05/14/2015 |
Lung Analysis Software |
Vital Images, Inc. |
Parthiv Shah |
| K151208 |
05/06/2015 |
Powder Free Nitrile Examination Glove |
VRG KHAI HOAN JOINT STOCK COMPANY |
PHAM NGOC THANH |
| K151237 |
05/11/2015 |
Nutrisafe 2- ENFit Adaptor |
VYGON |
Jillian Mikovich |
| K151441 |
05/29/2015 |
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test |
W.H.P.M., INC. |
JOHN WAN |
| K151367 |
05/21/2015 |
Sydney IVF Hyaluronidase |
WILLIAM A. COOK AUSTRALIA PTY LTD |
GORDANA POZVEK |
| K151442 |
05/29/2015 |
TOTAL COMPRESSION PLATING (TCP) SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Val Myles |
| K151284 |
05/14/2015 |
Electric Double Breast Pumps |
Wuxi Xinzhongrui Baby Supplies Co.,Ltd |
Shaozhong Chen |
| K151290 |
05/15/2015 |
Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff |
XUZHOU MAICUFF TECHNOLOGY CO.,LTD. |
LI ZHAOQIAN |
| K151309 |
05/18/2015 |
Wartie Advanced Wart Remover or other proprietary name |
YOUMEDICAL CORP BV |
FRANCESCA MAPPA |
| K151179 |
05/04/2015 |
ZELTIQ CoolSculpting System |
ZELTIQ AESTHETICS, INC. |
SHRUTI JAYAKUMAR |
| K151448 |
05/29/2015 |
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems |
ZIMMER, INC. |
KEITH PROCTOR |
| K151175 |
05/01/2015 |
ZONARE ZS3 Diagnostic Ultrasound System |
ZONARE MEDICAL SYSTEMS, INC. |
STEVE GEERDES |
