| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K153086 |
11/20/2015 |
RX ACCUNET Embolic Protection System |
ABBOTT VASCULAR |
Aruna Akkapeddi |
| K152573 |
11/25/2015 |
4Sight |
ACCUTOME, INC. |
ADAM PICKHOLTZ |
| K150637 |
11/19/2015 |
Aerin Medical Wand Model FG011 |
Aerin Medical, Inc. |
Scott Wolf |
| DEN150001 |
11/20/2015 |
RELIZORB |
ALCRESTA, INC. |
ROBERT GALLOTTO |
| K143630 |
11/18/2015 |
Invisalign System |
ALIGN TECHNOLOGY, INC. |
Margaret Anderson |
| K152939 |
11/25/2015 |
Picasso Plus, Picasso Lite Plus |
AMD GROUP LLC |
SCOTT A. EDWARDS |
| K150645 |
11/19/2015 |
AN1087 Dosimeter |
ANDERSEN STERILIZERS, INC. |
William K. Andersen |
| K150644 |
11/18/2015 |
AN85/AN86 EO Indicators |
ANDERSEN STERILIZERS, INC. |
William K. Andersen |
| K151585 |
11/18/2015 |
Andersen EOGas 4 SteriTest |
Andersen Sterilizers, Inc. |
William K Andersen |
| K150646 |
11/18/2015 |
EOGas 4 Ethylene Oxide Gas Sterilizer |
ANDERSEN STERILIZERS, INC. |
WILLIAM K. ANDERSEN |
| K152058 |
11/18/2015 |
Tyvek Sterilization Pouches with Chevron Seal |
Andersen Sterilizers,Inc. |
William K Andersen |
| K150612 |
11/16/2015 |
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 |
11/16/2015 |
Annuy Latex Surgeon's Gloves (Powdered and Powder Free) |
ANHUI ANYU LATEX PRODUCTS CO., LTD |
NONE PROVIDED |
| K150102 |
11/05/2015 |
SnoreSounds |
APPIAN MEDICAL, INC. |
MICHAEL J THOMAS |
| K152272 |
11/23/2015 |
Arrow Endurance Extended Dwell Peripheral Catheter System |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) |
TRACY LARISH |
| K152046 |
11/24/2015 |
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) |
ART OPTICAL CONTACT LENS, INC. |
MICHAEL JOHNSON |
| K152252 |
11/16/2015 |
Arthrex iBalance TKA System |
ARTHREX, INC. |
LEON BROWN |
| K152382 |
11/12/2015 |
Arthrex iBalance TKA System |
ARTHREX, INC. |
LEON BROWN |
| K153115 |
11/23/2015 |
Arthrex Univers Apex, Size 5 Stem |
ARTHREX, INC. |
COURTNEY SMITH |
| K152740 |
11/16/2015 |
Radifocus Glidewire |
ASHITAKA FACTORY OF TERUMO CORP. |
PHEBE VARGHESE |
| K152151 |
11/10/2015 |
ATAL 9 |
ATLAIM CORPORATION |
JOHN ROSS |
| K152923 |
11/05/2015 |
BD ChloraShield IV Dressing with CHG Antimicrobial |
AVERY DENNISON BELGIE BVBA |
LISA BARTAKOVICS |
| K150800 |
11/12/2015 |
Valved Safety Centesis Catheter |
B. Braun Medical Inc |
Nancy Skocypec |
| K152618 |
11/12/2015 |
PANTHER Cutter Stapler |
B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD |
LINA YUN |
| K150942 |
11/25/2015 |
Contour Next USB Blood Glucose Monitoring System |
BAYER HEALTHCARE |
JENNIFER L. GREGORY |
| K152057 |
11/24/2015 |
OsteoCool V-3 RF Ablation System |
BAYLIS MEDICAL COMPANY INC. |
MEGHAL KHAKHAR |
| K150963 |
11/05/2015 |
AnsCare ChitoClot Pad |
BENQ MATERIALS CORPORATION |
Kenix Chang |
| K151469 |
11/25/2015 |
CORVUS Radiation Therapy Planning System |
BEST NOMOS |
VINEET GUPTA |
| K150388 |
11/12/2015 |
Dental Implant System |
BIO CONCEPT CO., LTD |
HUA CAO |
| K151903 |
11/06/2015 |
Slendertone connect Abs |
BIO-MEDICAL RESEARCH LTD. |
ANNE-MARIE KEENAN |
| K151692 |
11/20/2015 |
BioArchitects Patient Specific Cranial/Craniofacial Plate |
BioArchitects USA, LLC |
Mark E. Ulrich |
| K151019 |
11/03/2015 |
SternaLock« 360 Sternal Closure System |
BIOMET MICROFIXATION |
LAUREN JASPER |
| K151974 |
11/13/2015 |
Polaris Spinal System |
BIOMET SPINE |
ALEXANDRA BECK |
| K150571 |
11/20/2015 |
3i T3 Short Implants |
BIOMET3I |
CHRIS MCKEE |
| K151296 |
11/19/2015 |
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) |
BIOS S.R.L. |
RICCARDO PISATI |
| K153102 |
11/23/2015 |
QuadraSphere Microspheres |
BIOSPHERE MEDICAL, S.A. |
Alix Fonlladosa |
| K152853 |
11/20/2015 |
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary |
BOSTON SCIENTIFIC CORP. |
CARAH KUCHARSKI |
| K151315 |
11/10/2015 |
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle |
BOSTON SCIENTIFIC CORPORATION |
YINGYING GAO |
| K153049 |
11/13/2015 |
LithoVue System |
BOSTON SCIENTIFIC CORPORATION |
JEANNE O'TOOLE |
| K152570 |
11/02/2015 |
Bovie J-Plasma Precise 360 Handpiece |
BOVIE MEDICAL CORPORATION |
BRIAN KUNST |
| K150353 |
11/13/2015 |
BTL-4000 |
BTL INDUSTRIES, INC |
Jan Zarsky |
| K150514 |
11/20/2015 |
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters |
C.R. Bard, Inc. |
James R. Davis |
| K151125 |
11/24/2015 |
AVAflex Vertebral Balloon System |
CAREFUSION |
Joy Greidanus |
| K153058 |
11/10/2015 |
CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
LEILEI LI |
| K153142 |
11/25/2015 |
Carestream DRX-1 System with DRX Plus 4343 Detectors |
CARESTREAM HEALTH, INC. |
VICTORIA WHEELER |
| K150397 |
11/09/2015 |
Divine 9 |
CarraShield Labs, Inc. |
Dean Fresonke |
| K151638 |
11/13/2015 |
Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter |
Cathera, Inc. |
Victor Ham |
| K150684 |
11/18/2015 |
WASTON General Spinal System |
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
Jack Lu |
| K150825 |
11/20/2015 |
Collagen Dural Regeneration Matrix |
COLLAGEN MATRIX, INC. |
GLORIA ZUCLICH |
| K150550 |
11/24/2015 |
SilverCoat Silicone Foley Catheter |
COVALON TECHNOLOGIES, INC. |
Kim Crooks |
| K151376 |
11/05/2015 |
superDimension Navigation System |
Covidien LLC |
Jenny Jiang |
| K152349 |
11/23/2015 |
Star+ VPS Scannable Impression Material |
DANVILLE MATERIALS LLC |
DONG HUA |
| K151682 |
11/17/2015 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Daxwell, LLC |
Frank Zhang |
| K143310 |
11/19/2015 |
MoisturemeterD |
DELFIN TECHNOLOGIES LTD. |
Theodore Sullivan |
| K150985 |
11/19/2015 |
Medihoney Wound Gel |
DERMA SCIENCES, INC. |
SHARMINI ATHERAY |
| K133178 |
11/24/2015 |
LUXATOR LX HANDPIECE |
DIRECTA AB |
HENRIC KARSK |
| K152110 |
11/20/2015 |
e-1 etchants |
E DENTAL PRODUCTS |
JEFF BANYAS |
| K153023 |
11/06/2015 |
Ablatherm Integrated Imaging |
EDAP TECHNOMED, INC. |
MARC OCZACHOWSKI |
| K151414 |
11/20/2015 |
IQQA Guide |
EDDA TECHNOLOGY |
XIAOLAN ZENG |
| K152225 |
11/24/2015 |
Edwards eSheath Introducer Set |
EDWARDS LIFESCIENCES |
KAREN REYNOLDS |
| K152762 |
11/23/2015 |
Fogarty Occlusion Catheter |
EDWARDS LIFESCIENCES, LLC. |
Naren Murugan |
| K152713 |
11/20/2015 |
8MP Color LCD Monitor, RadiForce RX850, RX850-AR |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
| K152580 |
11/03/2015 |
rescuenet |
ENDOCHOICE, INC. |
DANIEL HOEFER |
| K152435 |
11/20/2015 |
PassAssist LED Light Fiber |
ENTELLUS MEDICAL, INC. |
KAREN E. PETERSON |
| K152434 |
11/20/2015 |
XprESS Multi-Sinus Dilation System |
ENTELLUS MEDICAL, INC. |
KAREN E. PETERSON |
| K150219 |
11/05/2015 |
Equashield Closed System drug Transfer Device (CSTD) |
EQUASHIELD MEDICAL LTD |
Raymond J Kelly |
| K152490 |
11/25/2015 |
DERMABOND PRINEO Skin Closure System |
ETHICON, INC. |
DONNA MARSHALL |
| K152183 |
11/02/2015 |
EXELINT SecureTouch Safety Hypodermic Needle |
EXELINT INTERNATIONAL CO. |
Navid Hamid |
| K151470 |
11/02/2015 |
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 |
| K152953 |
11/05/2015 |
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER |
FRESENIUS MEDICAL CARE NORTH AMERICA |
Denise Oppermann |
| K152138 |
11/05/2015 |
FDR D-EVO GL Flat Panel Detector System |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
Katherine Y Choi |
| K152983 |
11/12/2015 |
FUJIFILM SonoSite iViz Ultrasound System |
FUJIFILM SONOSITE,INC. |
PATRICIA LIAU |
| K151378 |
11/24/2015 |
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators |
Fujirebio Diagnostics, Inc. |
Diana Dickson |
| K150488 |
11/13/2015 |
Humelock II Reversible Shoulder System |
FX SOLUTIONS |
Jean-Jacques Martin |
| K152567 |
11/06/2015 |
Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System |
GE Healthcare |
Ayesha Pergadia |
| K150298 |
11/12/2015 |
Entropy Module, E-ENTROPY-01 |
GE HEALTHCARE FILAND OY |
JOEL KENT |
| K152758 |
11/18/2015 |
Venue 50 |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
TRACEY ORTIZ |
| K152242 |
11/24/2015 |
G3┐ Active Plate« Large Fragment System |
GENESIS FRACTURE CARE, INC. |
MICHAEL BOTTLANG |
| K151504 |
11/16/2015 |
ICS Impulse |
GN OTOMETRICS |
ANDERS RASMUSSEN |
| K150358 |
11/12/2015 |
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System |
GOLD STANDARD DIAGNOSTICS |
NAPOLEON MONCE |
| K150094 |
11/19/2015 |
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla |
Good Clean Love, Inc. |
Wendy Strgar |
| K143497 |
11/04/2015 |
Safety Auto-Disable Syrine with Needle (Auto-Lock) |
GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD |
HU YIHAN |
| K150923 |
11/06/2015 |
Breast Pump |
Guangzhou Jinxinbao Electronic Co.,Ltd |
Jiacheng Guo |
| K152495 |
11/23/2015 |
Wondfo Propoxyphene Urine Test |
Guangzhou Wondfo Biotech Co., Ltd. |
Ben Chen |
| K152838 |
11/24/2015 |
HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 |
HARDY DIAGNOSTICS |
WENDY HADLEY |
| K152846 |
11/24/2015 |
HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 |
HARDY DIAGNOSTICS |
WENDY HADLEY |
| K151656 |
11/25/2015 |
HEARTWAY Power Mobility Scooter |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
KE-MIN JEN |
| K150916 |
11/10/2015 |
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO |
HemCon Medical Technologies, Inc. |
Jody Oyama |
| K151679 |
11/27/2015 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
HEZE YUZE GLOVE CO., LTD |
LILY ZHU |
| K152661 |
11/16/2015 |
HICAT Air |
HICAT GmbH |
Frederik Kunze |
| K152592 |
11/02/2015 |
PROBEAT-V |
Hitachi, Ltd.,Health Care Company |
NAOYA NISHIMURA |
| K152723 |
11/13/2015 |
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices |
HOLOGIC, INC |
CATHERINE EATON |
| K153219 |
11/20/2015 |
ProFlu+ Assay |
HOLOGIC, INC. |
RON DOMINGO |
| K150528 |
11/25/2015 |
Cortisol Saliva Luminescence Immunoassay |
IBL INTERNATIONAL GMBH |
NICOLA KAISER |
| K150799 |
11/19/2015 |
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula |
INNOVACYN, INC. |
Victor Torcat Mallen |
| K153150 |
11/24/2015 |
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 |
Inova Diagnostics, Inc. |
Gabriella Lakos |
| K151819 |
11/10/2015 |
Integrity Spine Lumbar Interbody Fusion System |
INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM |
LISA PETERSON |
| K153073 |
11/16/2015 |
UroNav (Version 2.0) |
INVIVO CORPORATION |
Kenneth Revennaugh |
| DEN150008 |
11/02/2015 |
INVOcell |
INVO BIOSCIENCE |
Kathleen Karloff |
| K143142 |
11/06/2015 |
JDENTALCARE Implant System |
J DENTAL CARE S.r.l |
Giacomo Grandi |
| K153031 |
11/17/2015 |
RANGE/DENALI/MESA Spinal System |
K2M, Incorporated |
NANCY GIEZEN |
| K150743 |
11/12/2015 |
Water Based Personal Lubricant with Flavours |
KAREX INDUSTRIES SDN. BHD. |
MS. MARY GOH YIN |
| K150525 |
11/20/2015 |
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 |
| K152236 |
11/04/2015 |
KATOR Suture Anchor |
KATOR LLC |
Robert Hoy |
| K150006 |
11/06/2015 |
Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing |
KCI USA, INC. |
MELANIE AVILA |
| K151382 |
11/09/2015 |
Patient Contoured Implant-PEEK (PCI-PEEK) |
KLS MARTIN L.P. |
JENNIFER DAMATO |
| K152203 |
11/06/2015 |
UTERMOHLEN CRYO PROFESSIONAL |
KONINKLIJKE (ROYAL) UTERMOHLEN |
MR.D VAN HOOF |
| K152270 |
11/13/2015 |
Denture base resin |
KOREA ENGINEERING PLASTICS CO., LTD. |
SONG-YI CHONG |
| K152282 |
11/20/2015 |
Cam Lock Plating System |
LIFE SPINE, INC |
RANDY LEWIS |
| K151739 |
11/23/2015 |
Revision Femoral Stem |
LIMACORPORATE S.P.A. |
EMANUELE BUTTAZZONI |
| K151605 |
11/16/2015 |
Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves |
Lucenxia Prescience AG |
Robert Hill |
| K151607 |
11/16/2015 |
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove |
Lucenxia Prescience AG |
Robert Hill |
| K152848 |
11/17/2015 |
AUTOLAP SYSTEM |
M.S.T Medical Surgery Technologies LTD |
Tami Harel |
| K152041 |
11/17/2015 |
Renaissance X System |
Mazor Robotics Ltd. |
Ayelet Matia |
| K152318 |
11/17/2015 |
MD-2300S Ultrasonic A/B Scanner for Ophthalmology |
MEDA CO.,LTD |
Yusheng ZHANG |
| K151632 |
11/05/2015 |
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 |
| K143669 |
11/23/2015 |
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter |
MEDGYN PRODUCTS, INC. |
AMAR AGADI |
| K150698 |
11/20/2015 |
Gemini Sterilization Wrap |
MEDLINE INDUSTRIES, INC. |
Jennifer Mason |
| K143693 |
11/06/2015 |
MEDLINE SHARPS CONTAINERS |
MEDLINE INDUSTRIES, INC. |
Matt Clausen |
| K150238 |
11/27/2015 |
SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color |
MEDLINE INDUSTRIES, INC. |
CLAIRE WELLINGHOFF |
| K151773 |
11/20/2015 |
CONCORDE Bullet Lumbar Interbody System |
Medos International, Sarl |
JACLYN PORSOLT |
| K151227 |
11/16/2015 |
KYPHON XPEDE Bone Cement |
MEDTRONIC |
KATHY L REMSEN |
| K152623 |
11/12/2015 |
ATLANTIS Anterior Cervical Plate System |
MEDTRONIC SOFAMOR DANEK USA, INC |
LAVEEDA LEFLORE |
| K152277 |
11/13/2015 |
PIVOX(tm) Oblique Lateral Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC |
Lila Joe |
| K152248 |
11/05/2015 |
CD HORIZON Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Becky Ronner |
| K152285 |
11/10/2015 |
illumigene Pertussis DNA Amplification Assay |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K151925 |
11/06/2015 |
Elation Wireguided Balloon Dilation Catheter |
MERIT MEDICAL SYSTEMS, INC. |
DAVID THOMAS |
| K152298 |
11/16/2015 |
EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base |
MICROPORT ORTHOPEDICS, INC. |
BYRON LEDBETTER |
| K151825 |
11/16/2015 |
Viradius Neurowire |
MIVI NEUROSCIENCE, INC. |
RANDY LABOUNTY |
| K151872 |
11/02/2015 |
Avance Y-Connector S |
MOLNLYCKE HEALTH CARE, US LLC |
ANGELA BUNN |
| K152004 |
11/17/2015 |
Nanova Universal Composite |
NANOVA BIOMATERIALS INC |
ANDREW RITTS |
| K152643 |
11/02/2015 |
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana |
NANTONG EGENS BIOTECH CO., LTD. |
Yan Cao |
| K150561 |
11/25/2015 |
NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System |
Narang Medical Limited |
Vivek Narang |
| K152936 |
11/13/2015 |
Sirius Max Dental Diode Curing Light |
NATIONAL DENTAL INC. |
EDWIN FIRST |
| K151609 |
11/06/2015 |
ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 |
NDS SURGICAL IMAGING LLC |
Jim Leng |
| K153182 |
11/25/2015 |
SELF- COMPRESSIVE SCREW |
NEOSTEO |
JD WEBB |
| K151383 |
11/04/2015 |
NeuViz 128 Multi-slice CT Scanner System |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YUEHUI |
| K151403 |
11/02/2015 |
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 |
| K151080 |
11/05/2015 |
Nihon Kohden CSM 1901 Bedside Monitor |
Nihon Kohden |
Tom Bento |
| K152256 |
11/05/2015 |
RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws |
NORMED MEDIZIN-TECHNIK GMBH |
ARNE BRIEST |
| K151361 |
11/06/2015 |
Nox RIP Belts & Cables |
NOX MEDICAL ehf |
KOLBRUN E OTTOSDOTTIR |
| K151275 |
11/13/2015 |
MAKO Device |
nVision Medical |
Surbhi Sarna |
| K152055 |
11/23/2015 |
Ceramax Skin Barrier Cream |
OCULUS INNOVATIVE SCIENCES |
BRIAN W. MARTIN |
| K151738 |
11/20/2015 |
Single Use Aspiration Needle NA-U200H |
OLYMPUS MEDICAL SYSTEMS CORP. |
TOSHIYUKI NAKAJIMA |
| K151191 |
11/24/2015 |
OES ELITE Telescopes, Protective Tube |
OLYMPUS WINTER & IBE GMBH |
KATHARINA SCHNACKENBURG |
| K152779 |
11/25/2015 |
Avex CX2 |
Opal Orthodontics by Ultradent Products |
Marie Hess |
| K150688 |
11/05/2015 |
IdentEvent |
OPTIMA NEUROSCIENCE, INC. |
Ryan T. Kern |
| K150268 |
11/06/2015 |
CerOX |
OR-NIM MEDICAL LTD. |
MICHA OESTEREICH |
| K151946 |
11/09/2015 |
Thermofit |
ORFIT INDUSTRIES |
EDDY MAROVOET |
| K152295 |
11/03/2015 |
Talon DistalFix Antegrade/Retrograde Femoral Nail |
ORTHOPEDIC DESIGNS NORTH AMERICA, INC. |
Robin Wilson |
| K151432 |
11/05/2015 |
NaturalLine Abutment |
OT MEDICAL GMBH |
MARTINA BEHLAU |
| K152067 |
11/23/2015 |
Ponto bone anchored hearing system |
OTICON MEDICAL AB |
Carolina Anker Wessling |
| K151852 |
11/10/2015 |
PacEndo Sodium Hyprochlorite |
PAC-DENT INTERNATIONAL, INC. |
WENYING ZHU |
| K152711 |
11/20/2015 |
Parcus GFS Naked |
PARCUS MEDICAL, LLC |
PAUL VAGTS |
| K150504 |
11/16/2015 |
GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor |
PCI MEDICAL, INC. |
Kevin Mader |
| K150558 |
11/12/2015 |
Eclipse System |
Pelvalon, Inc. |
MILES ROSEN |
| K150618 |
11/24/2015 |
PENTAX Medical EPK-i7010 Video Processor with GI Family |
PENTAX OF AMERICA, INC. |
KRISHNA GOVINDARAJAN |
| K153022 |
11/18/2015 |
Philips IntelliSpace Cardiovascular |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
Dave J.W. Bierhuizen |
| K150299 |
11/19/2015 |
Gmate SMART Blood Glucose Monitoring System |
Philosys Inc. |
Linda Chan |
| K152259 |
11/19/2015 |
InFill Interbody Fusion Device |
Pinnacle Spine Group, LLC |
Rebecca K Pine |
| K150077 |
11/25/2015 |
SonicLift |
PRETIKA CORPORATION |
Thomas Nichols |
| K151798 |
11/16/2015 |
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
| K151154 |
11/10/2015 |
FIBERGRAFT BG Morsels |
PROSIDYAN INC. |
CHARANPREET S BAGGA |
| K142941 |
11/02/2015 |
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. |
PT MEDISAFE TECHNOLOGIES |
Anil Taneja |
| K151212 |
11/04/2015 |
Ziostation2 |
QI IMAGING, LLC |
RICHARD BALL |
| K152695 |
11/18/2015 |
8 CH Knee SPEEDER |
QUALITY ELECTRODYNAMICS, LLC. |
KATHLEEN ARAS |
| K152847 |
11/17/2015 |
DIVA ZSP5812CMI with QUBYX PerfectLum bundle |
QUBYX LTD. |
MARC LEPPLA |
| K153060 |
11/10/2015 |
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S |
RAYENCE CO., LTD |
KEVIN KIM |
| K151901 |
11/05/2015 |
AirView |
RESMED LTD. |
Jasjit Baveja |
| K143584 |
11/02/2015 |
PGA RESORBA, PGA RESOQUICK, GLYCOLON |
RESORBA MEDICAL GMBH |
KARL JOSEF BECK |
| K150455 |
11/19/2015 |
RT2 Trabeculite Titanium Cervical Cage System |
RHAUSLER, INC. |
TERRY JOHNSTON |
| K142211 |
11/25/2015 |
OT EQUATOR |
Rhein '83 SRL |
Claudia Nardi |
| K152962 |
11/02/2015 |
HS70A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD. |
KYEONG-MI PARK |
| K151186 |
11/27/2015 |
Stay Fresh Hydrocolloid dressing |
SARASOTA MEDICAL PRODUCTS, INC. |
WALTER F. LEISE |
| K151004 |
11/17/2015 |
PULLUP« Adjustable Juxtacortical Fixation Device |
SBM SCIENCES FOR BIO MATERIALS |
DENIS CLEMENT |
| K151265 |
11/24/2015 |
SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System |
SD BIOSENSOR |
YEON PARK |
| K152426 |
11/09/2015 |
Wrist - Type Fully Automatic Digital Blood Pressure Monitor |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
REN YUNHUA |
| K153096 |
11/25/2015 |
LARIAT RS Suture Delivery Device |
SentreHEART, Inc. |
KIT CARIQUITAN |
| K150436 |
11/13/2015 |
ComboRehab |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
Jianping Kang |
| K150168 |
11/04/2015 |
Dimension Tacrolimus Flex« Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
Anna Marie Kathleen Ennis |
| K151792 |
11/20/2015 |
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System |
Siemens Healthcare Diagnostics,Inc. |
Philip Liu |
| K152928 |
11/13/2015 |
Multitom Rax |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
DARREN A. DORMAN |
| K151752 |
11/12/2015 |
SOMATOM Emotion 6/16 |
Siemens Medical Solutions USA, Inc. |
Eve Davis |
| K142955 |
11/24/2015 |
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Kimberly Mangum |
| K150713 |
11/02/2015 |
syngo.CT Myocardial Perfusion |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
EVE DAVIS |
| K151209 |
11/06/2015 |
InterOss |
SigmaGraft, Inc |
Megan Holden |
| K152757 |
11/13/2015 |
SIGN Hip Construct (SHC) |
SIGN FRACTURE CARE INTERNATIONAL |
Rob Teeter |
| K150790 |
11/16/2015 |
REDAPT Porous Acetabular Shell and Cemented Liner |
SMITH & NEPHEW, INC. |
JEFF SPRAGUE |
| K152976 |
11/12/2015 |
VLP Mini-Mod Talus Plates |
Smith & Nephew, Inc. |
Samantha Staubach |
| K152000 |
11/25/2015 |
SMV Scientific Bone Plate and Screw System |
SMV Scientific |
Nephi Zufelt |
| K151713 |
11/06/2015 |
LILLIPUP PMP, LILLIPUT PMP INTEGRATED |
SORIN GROUP ITALIA S.R.L. |
LUIGI VECCHI |
| K150329 |
11/05/2015 |
elance Vital Signs Monitor, Central Monitor Software |
SPACELABS HEALTHCARE |
Al Van Houdt |
| K152181 |
11/12/2015 |
Turbo-Power Laser Atherectomy Catheter |
SPECTRANETICS, INC. |
Priscila Tapia |
| K151770 |
11/20/2015 |
Libra Pedicle Screw System |
Spinal Balance Inc. |
Anand Agarwal |
| K151710 |
11/19/2015 |
SNaP Wound Care System |
SPIRACUR, INC. |
LAWRENCE HU |
| K151928 |
11/06/2015 |
PUR Dental Implant System |
STERNGOLD DENTAL, LLC |
MARIA RAO |
| K151667 |
11/13/2015 |
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm |
Stryker |
Rhoda M Santos |
| K152304 |
11/19/2015 |
Tritanium PL Cage |
Stryker |
SIMONA VOIC |
| K152641 |
11/20/2015 |
Pi Drive Plus Motor, Extender |
STRYKER CORPORATION |
DEVAL PATEL |
| K142617 |
11/20/2015 |
ArcCHECK |
SUN NUCLEAR CORPORATION |
Noel Downey |
| K150259 |
11/06/2015 |
CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L |
TAIWAN SURGICAL CORPORATION |
Hsiu-Ping Huang |
| K150603 |
11/27/2015 |
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube |
Teleflex Medical, Inc. |
Lori Pfohl |
| K151791 |
11/19/2015 |
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
JAIME LEE |
| K152525 |
11/10/2015 |
TR BAND Radial Compression Device |
TERUMO MEDICAL CORPORATION |
LIANG LU |
| K151759 |
11/06/2015 |
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 |
| K151816 |
11/19/2015 |
TLC-2000 Therapeutic Medical Laser System |
Theralase Inc. |
Roger Dumoulin-White |
| K151673 |
11/27/2015 |
Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K152785 |
11/25/2015 |
XIDF-AWS801, Angio Workstation, V6.20 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K153075 |
11/13/2015 |
Klassic Knee System |
TOTAL JOINT ORTHOPEDICS, INC. |
Chris Weaber |
| K151034 |
11/21/2015 |
PainKARE |
TrioWave Technologies |
Huiyou Zhu |
| K152019 |
11/16/2015 |
HairMD |
TROPHY SKIN, INC. |
IMRAN KARIM |
| K153180 |
11/25/2015 |
Tyber Medical MST Trauma Screw |
TYBER MEDICAL LLC |
Mark F. Schenk |
| K150386 |
11/05/2015 |
Tyece OTC TENS Device |
TYECE LTD |
Parshid Falahati |
| K152678 |
11/17/2015 |
TYRX Neuro Antibacterial Envelope |
TYRX, INC. |
REGINA NOVAK |
| K151344 |
11/19/2015 |
Cytoflex Tefguard Ti-Enforced Membrane |
Unicare Biomedical, Inc. |
Stan Yang |
| K152255 |
11/16/2015 |
BoneCam Suture Anchors |
VALERIS MEDICAL |
DANIEL LANOIS |
| K152761 |
11/25/2015 |
Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) |
VARIAN MEDICAL SYSTEMS, INC. |
MARCIA PAGE |
| K151234 |
11/18/2015 |
R350 guidewire |
VASCULAR SOLUTIONS, INC. |
BEKA VITE |
| K153101 |
11/19/2015 |
BladderScan Prime System |
VERATHON INCORPORATED |
Rhonda M Kops |
| K152518 |
11/30/2015 |
Vonflex S Putty |
VERICOM CO., LTD |
MYUNG-HWAN OH |
| K152822 |
11/25/2015 |
VidiStar HeartView |
VIDISTAR, LLC |
CRAIG WALKER |
| K150211 |
11/10/2015 |
EzFuze Implant System |
VILEX IN TENNESSEE, INC. |
SYLVIA SOUTHARD |
| K152829 |
11/19/2015 |
Visions PV.014P RX Digital IVUS Catheter |
Volcano Corporation |
Mary Stanners |
| K143704 |
11/23/2015 |
Advanced Air System |
W & H Dentalwerk Buermoos GmbH |
Anja Lindner |
| K152551 |
11/09/2015 |
First Sign« Drug of Abuse Buprenorphine Cup Test, First Sign« Drug of Abuse Buprenorphine Dip Card Test, First Sign« Drug of Abuse Butalbital Cup Test, First Sign« Drug of Abuse Butalbital Dip Card Test, First Sign« Drug of Abuse Morphine Cup Test, First |
W.H.P.M., INC. |
JOHN WAN |
| K151764 |
11/23/2015 |
YAMAHACHI PMMA DISKS |
YAMAHACHI DENTAL PRODUCTS USA, INC. |
LAWRENCE G. GREENWALD |
| K152514 |
11/18/2015 |
Clickfine AutoProtect Pen Needle |
YPSOMED AG |
STEPHAN AFFOLTER |
| K151992 |
11/02/2015 |
FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control |
ZIMMER, INC. |
PATRICK MCCULLAGH |
| K152494 |
11/25/2015 |
Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments |
ZIMMER, INC. |
MARK D WARNER |
| K152841 |
11/24/2015 |
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws |
ZIMMER, INC. |
DOROTHY SNYDER |
