| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K142034 |
01/08/2015 |
3M STERI-VAC STERILIZER/AERATOR |
3M COMPANY |
MATT MORTENSEN |
| K143573 |
01/16/2015 |
Audit MicroControls Linearity FD Tumor Markers II |
AALTO SCIENTIFIC LTD. |
Robert Burda |
| K143571 |
01/23/2015 |
Audit MicroControls Linearity LQ Cystatin-C |
AALTO SCIENTIFIC, LTD. |
ROBERT BURDA |
| K153086 |
11/20/2015 |
RX ACCUNET Embolic Protection System |
ABBOTT VASCULAR |
Aruna Akkapeddi |
| K142816 |
01/14/2015 |
AbbVie J |
ABBVIE INC. |
Katherine Wortley |
| K142792 |
01/14/2015 |
AbbVie NJ |
ABBVIE INC. |
Katherine Wortley |
| K142793 |
01/14/2015 |
AbbVie PEG |
AbbVie Inc. |
Katherine Wortley |
| K152573 |
11/25/2015 |
4Sight |
ACCUTOME, INC. |
ADAM PICKHOLTZ |
| K143394 |
01/23/2015 |
Acumed Small Fragment Base Set |
ACUMED LLC |
Nathan Wolf |
| K141622 |
01/09/2015 |
ILLUMINATED MEDIASTINOSCOPE |
AEGIS SURGICAL LTD |
TAMMY CARREA |
| K150637 |
11/19/2015 |
Aerin Medical Wand Model FG011 |
Aerin Medical, Inc. |
Scott Wolf |
| K141142 |
01/23/2015 |
MAMMAPRINT FFPE |
AGENDIA |
Guido Brink |
| K142316 |
01/06/2015 |
IMPAX Agility |
AGFA HEALTHCARE N.V. |
Jodi Coleman |
| K142284 |
01/26/2015 |
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE |
ALCON LABORATORIES, INC. |
ALICIA PLESNARSKI |
| DEN150001 |
11/20/2015 |
RELIZORB |
ALCRESTA, INC. |
ROBERT GALLOTTO |
| K143630 |
11/18/2015 |
Invisalign System |
ALIGN TECHNOLOGY, INC. |
Margaret Anderson |
| K142743 |
01/27/2015 |
AliveCor Heart Monitor |
AliveCor, Inc. |
Albert Boniske |
| K143149 |
01/05/2015 |
Arsenal Spinal Fixation System |
ALPHATEC SPINE, INC. |
RENEE MURPHY |
| K152939 |
11/25/2015 |
Picasso Plus, Picasso Lite Plus |
AMD GROUP LLC |
SCOTT A. EDWARDS |
| K141852 |
01/06/2015 |
IFS ADVANCED FEMTOSECOND LASER SYSTEM |
AMO MANUFACTURING USA, LLC |
RODNEY HUANG |
| K140932 |
01/23/2015 |
AMSEL OCCLUDER DEVICE |
AMSEL MEDICAL CORPORATION |
LEO BASTA |
| 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 |
| K142889 |
01/27/2015 |
Celerity PICC Tip Confirmation System |
ANGIODYNAMICS, INC. |
Michael Hanley |
| 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 |
| K143757 |
01/08/2015 |
ANUTRA Feedback Aspiration Syringe |
ANUTRA MEDICAL, INC. |
CAMERON PERKINS |
| K150102 |
11/05/2015 |
SnoreSounds |
APPIAN MEDICAL, INC. |
MICHAEL J THOMAS |
| K142256 |
01/07/2015 |
Applied BioPhotonics Phototherapy System ABPT1003 |
APPLIED BIOPHOTONICS LTD. |
ERIC HSIEH |
| K142989 |
01/29/2015 |
Mini ONE Enteral Extension Set |
APPLIED MEDICAL TECHNOLOGY, INC. |
Joshua Meinke |
| K140957 |
01/15/2015 |
GENASIS HIPATH IHC FAMILY |
APPLIED SPECTRAL IMAGING LTD. |
ILAN SHARON |
| K142914 |
01/12/2015 |
DacryoCATH |
ARMADILLO BIOMEDICAL, LLC |
Bruce Becker, M.D. |
| K152272 |
11/23/2015 |
Arrow Endurance Extended Dwell Peripheral Catheter System |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) |
TRACY LARISH |
| K142641 |
01/12/2015 |
Intelliwave4 |
ART OPTICAL CONTACT LENS, INC. |
MICHAEL JOHNSON |
| K152046 |
11/24/2015 |
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) |
ART OPTICAL CONTACT LENS, INC. |
MICHAEL JOHNSON |
| K143139 |
01/16/2015 |
Arthrex Fracture System |
ARTHREX, INC. |
David Rogers |
| K152382 |
11/12/2015 |
Arthrex iBalance TKA System |
ARTHREX, INC. |
LEON BROWN |
| K152252 |
11/16/2015 |
Arthrex iBalance TKA System |
ARTHREX, INC. |
LEON BROWN |
| K143614 |
01/16/2015 |
Arthrex Low Profile Screws |
ARTHREX, INC. |
David L Rogers |
| K153115 |
11/23/2015 |
Arthrex Univers Apex, Size 5 Stem |
ARTHREX, INC. |
COURTNEY SMITH |
| K141189 |
01/30/2015 |
NANOBONE / GRANULATE |
ARTOSS GMBH |
WALTER GERIKE |
| K141751 |
01/30/2015 |
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR |
ASAHI INTECC CO., LTD. |
SEMIH OKTAY |
| K133891 |
01/30/2015 |
MULTIPULSE TM+1470 |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| 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 |
| K142363 |
01/09/2015 |
NUSTAT, NUSTAT XR |
Beeken Biomedical |
Richard Kendall |
| K141024 |
01/13/2015 |
EXTERNAL PULSE OXIMETER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| 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 |
| K141114 |
01/09/2015 |
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D |
Bio-Rad Laboratories |
Juang Wang |
| K151692 |
11/20/2015 |
BioArchitects Patient Specific Cranial/Craniofacial Plate |
BioArchitects USA, LLC |
Mark E. Ulrich |
| K141830 |
01/23/2015 |
STIMULAN KIT, STIMULAN RAPID CURE |
BIOCOMPOSITES LTD. |
MARIE WHALLEY |
| K141132 |
01/09/2015 |
ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT |
BIOFILM, INC. |
Sherry Castello |
| K143178 |
01/30/2015 |
FilmArray 2.0 System |
BioFire Diagnostics, LLC |
Kristen Kanack, PhD |
| K143171 |
01/30/2015 |
FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 |
Biofire Diagnostics, LLC. |
Kristen Kanack, PhD |
| K142828 |
01/15/2015 |
osteoSPAN Morpheus |
BIOGENNIX |
Edwin Clayton Shors |
| K143022 |
01/08/2015 |
BioHorizons Tapered Internal Implants |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
Michael Davis |
| K143023 |
01/16/2015 |
Nitinol Compression Plating System |
BioMedical Enterprises, Inc. |
Joe Soward |
| K143543 |
01/30/2015 |
Prelude PF Patellae |
BIOMET INC. |
JARED COOPER |
| K143037 |
01/20/2015 |
SnapShot Fixation System |
BIOMET MANUFACTURING CORP. |
Adam Cargill |
| 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 |
| K133733 |
01/28/2015 |
WINSIX Implant System |
BIOSAF IN S.R.L. |
MAURIZIO PANTALEONI |
| K153102 |
11/23/2015 |
QuadraSphere Microspheres |
BIOSPHERE MEDICAL, S.A. |
Alix Fonlladosa |
| K142276 |
01/16/2015 |
MCS Bone Graft |
BIOSTRUCTURES, LLC |
John Brunelle, Ph.D. |
| K143298 |
01/16/2015 |
Ultrasound Scanner System bk2300 |
BK MEDICAL APS |
RANDI HAUERBERG |
| K143006 |
01/16/2015 |
GUARDIAN-SG Inflatable Bone Expander System |
BM KOREA CO., LTD. |
June Han |
| K152853 |
11/20/2015 |
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary |
BOSTON SCIENTIFIC CORP. |
CARAH KUCHARSKI |
| K143587 |
01/15/2015 |
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire |
BOSTON SCIENTIFIC CORPORATION |
NIKKI M WAHLBERG |
| 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 |
| K142922 |
01/16/2015 |
SpyGlass DS Direct Visualization System |
BOSTON SCIENTIFIC CORPORATION |
CARTER NAVARRO |
| K152570 |
11/02/2015 |
Bovie J-Plasma Precise 360 Handpiece |
BOVIE MEDICAL CORPORATION |
BRIAN KUNST |
| K143151 |
01/26/2015 |
Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) |
BSN MEDICAL GMBH |
MARTIN SPENGLER |
| K143040 |
01/15/2015 |
Exilis XP |
BTL INDUSTRIES INC |
Jan Zarsky |
| 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 |
| K143522 |
01/12/2015 |
Presto Inflation Device |
C.R. BARD, INC. |
TIMOTHY WADE |
| K143490 |
01/26/2015 |
VERTA Corpectomy Cage |
CAMBER SPINE |
Daniel A. Pontecorvo |
| K143718 |
01/22/2015 |
Mammography Color Display DP-M3010 |
CANON INC. |
MASAKI TAMURA |
| K143199 |
01/29/2015 |
Capillus 272 Pro |
Capillus, LLC |
Frances Pina Brea |
| K142030 |
01/23/2015 |
STGC-LORDOTIC |
CARDINAL SPINE, LLC |
KEVIN A. THOMAS |
| K141465 |
01/09/2015 |
CARDIOGARD EMBOLI PROTECTION CANNULA |
CARDIOGARD MEDICAL LTD |
SHEILA H HEYER |
| K151125 |
11/24/2015 |
AVAflex Vertebral Balloon System |
CAREFUSION |
Joy Greidanus |
| K141722 |
01/23/2015 |
CAREFUSION GOLD TISSUE MARKER |
CAREFUSION |
JOY GREIDANUS |
| K142529 |
01/08/2015 |
Genesis Reusable Rigid Container System |
CareFusion 2200 Inc |
Jane Weber |
| K142862 |
01/16/2015 |
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). |
Careplus (M) SDN BHD |
Lim Kwee Shyan |
| 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 |
| K143392 |
01/23/2015 |
Quattro Bolt Tenodesis Screw |
CAYENNE MEDICAL, INC |
Shima Hashemian |
| K133412 |
01/08/2015 |
S200, S300 |
CEFLA S.C. |
BERTHOIN CLAUDE |
| K143247 |
01/22/2015 |
Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) |
CENTRAL MEDICARE SDN BHD |
TH Chong |
| K141400 |
01/28/2015 |
DCCERAM SYSTEM |
CERAMAY GMBH & CO.KG |
PAMELA PAPINEAU, RAC |
| K150684 |
11/18/2015 |
WASTON General Spinal System |
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
Jack Lu |
| K142655 |
01/26/2015 |
CB PROT II Posterior Spinal System |
CHIN BONE TECHNIQUE CORP |
CHENG-KUNG CHENG |
| K143396 |
01/23/2015 |
omni TRAX Active Patient Tracker |
CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions |
Amanda Stahle |
| K141608 |
01/16/2015 |
COLLAGEN DURA MEMBRANE |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K150825 |
11/20/2015 |
Collagen Dural Regeneration Matrix |
COLLAGEN MATRIX, INC. |
GLORIA ZUCLICH |
| K143182 |
01/20/2015 |
Speedicath Compact Male |
COLOPLAST A/S |
Brian Schmidt |
| K141685 |
01/26/2015 |
CROC |
COMBAT MEDICAL SYSTEMS, LLC |
Calley Herzog |
| K142825 |
01/20/2015 |
Zmachine |
CONSOLIDATED RESEARCH OF RICHMOND, INC |
Richard Kaplan |
| K133130 |
01/09/2015 |
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER |
COOK, INC. |
DAVID E CHADWICK, PHD., RAC |
| K140893 |
01/03/2015 |
CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY |
CORAMED TECHNOLOGIES, LLC |
NORMAN E BRUNNER |
| K143412 |
01/14/2015 |
ADROIT Guiding Catheter |
CORDIS CORPORATION |
BABU PERIASAMY |
| K150550 |
11/24/2015 |
SilverCoat Silicone Foley Catheter |
COVALON TECHNOLOGIES, INC. |
Kim Crooks |
| K142929 |
01/27/2015 |
Ligasure Blunt Tip Sealer/Divider |
COVIDIEN |
CELSO DURAN |
| K142335 |
01/14/2015 |
RapidVac Smoke Evacuator System |
COVIDIEN |
JOSE MARQUEZ |
| K142656 |
01/29/2015 |
Surgical Gut Suture |
COVIDIEN |
Mary Mellows |
| K151376 |
11/05/2015 |
superDimension Navigation System |
Covidien LLC |
Jenny Jiang |
| K143625 |
01/15/2015 |
truFreeze System |
CSA MEDICAL, INC. |
SHERRIE COVAL-GOLDSMITH |
| K141354 |
01/30/2015 |
NAVAJO PTA BALLOON DILATATION CATHETER |
CURATIVE MEDICAL INC. |
BILL JACQMEIN |
| K143317 |
01/20/2015 |
Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) |
Currie Medical Specialties, Inc. |
Owen J. Bry |
| K141511 |
01/23/2015 |
SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS |
CYNOSURE, INC. |
HUDA YUSUF |
| 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 |
| K142106 |
01/18/2015 |
DECISIO HEALTH PATIENT DASHBOARD |
DECISIO HEALTH, INC. |
RONALD S WARREN |
| K143310 |
11/19/2015 |
MoisturemeterD |
DELFIN TECHNOLOGIES LTD. |
Theodore Sullivan |
| K142932 |
01/22/2015 |
Deltex Medical KDP72 Doppler Probe |
DELTEX MEDICAL LIMITED |
Paul Dwane |
| K150985 |
11/19/2015 |
Medihoney Wound Gel |
DERMA SCIENCES, INC. |
SHARMINI ATHERAY |
| DEN140038 |
01/23/2015 |
Dexcom Share Direct Secondary Displays |
DEXCOM, INC. |
Andrew K Balo |
| K133178 |
11/24/2015 |
LUXATOR LX HANDPIECE |
DIRECTA AB |
HENRIC KARSK |
| K142229 |
01/02/2015 |
Laparoscopic FMsealer |
DOMAIN SURGICAL, INC. |
CURTIS JENSEN |
| K142475 |
01/15/2015 |
EVS 4343 |
DRTECH Corporation |
Choul-Woo Shin |
| K152110 |
11/20/2015 |
e-1 etchants |
E DENTAL PRODUCTS |
JEFF BANYAS |
| K142107 |
01/21/2015 |
ECHO TRUE 3D VIEWER |
ECHO PIXEL INC. |
SERGIO AGUIRRE |
| 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 |
| K141206 |
01/16/2015 |
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM |
EDWARDS LIFESCIENCES LLC. |
Nina Brooke |
| K152762 |
11/23/2015 |
Fogarty Occlusion Catheter |
EDWARDS LIFESCIENCES, LLC. |
Naren Murugan |
| K142749 |
01/18/2015 |
TruWave Disposable Pressure Transducer |
EDWARDS LIFESCIENCES, LLC. |
ANDREW S. MAZURKIEWICZ |
| K152713 |
11/20/2015 |
8MP Color LCD Monitor, RadiForce RX850, RX850-AR |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
| K142599 |
01/16/2015 |
PRECISE Trauma Nail System |
Ellipse Technologies, Incorporated |
Rebecca Shelburne |
| K142155 |
01/20/2015 |
ENDOCHOICE WATER BOTTLE CAP SYSTEM |
ENDOCHOICE, INC. |
DANIEL HOEFER |
| K152580 |
11/03/2015 |
rescuenet |
ENDOCHOICE, INC. |
DANIEL HOEFER |
| K141615 |
01/07/2015 |
ENDOPHYS BLOOD PRESSURE MONITOR |
ENDOPHYS, INC. |
RONALD S WARREN |
| K141275 |
01/07/2015 |
ENDOPHYS PRESSURE SENSING SHEATH KIT |
ENDOPHYS, INC. |
RONALD S WARREN |
| 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 |
| K142773 |
01/22/2015 |
EOS System |
EOS IMAGING |
Karine Chevrie |
| K142207 |
01/23/2015 |
TransferMan 4m Micromanipulator |
EPPENDORF AG |
CORNELIA HILDEBRANDT |
| K150219 |
11/05/2015 |
Equashield Closed System drug Transfer Device (CSTD) |
EQUASHIELD MEDICAL LTD |
Raymond J Kelly |
| K141986 |
01/30/2015 |
ELUX 810 LASER |
EQUIPMED NORTH AMERICA, INC. |
JIM BARLEY |
| K143007 |
01/15/2015 |
Erchonia Zerona Z6 OTC |
ERCHONIA CORPORATION |
Steve Shanks |
| K152490 |
11/25/2015 |
DERMABOND PRINEO Skin Closure System |
ETHICON, INC. |
DONNA MARSHALL |
| K140547 |
01/22/2015 |
EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM |
EXCERA ORTHOPEDICS, INC. |
TIM M LOHNES |
| K152183 |
11/02/2015 |
EXELINT SecureTouch Safety Hypodermic Needle |
EXELINT INTERNATIONAL CO. |
Navid Hamid |
| K143129 |
01/29/2015 |
easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) |
EziSurg Medical Co.,Ltd. |
Johnny Yan |
| 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 |
| K143124 |
01/26/2015 |
KA01 Chitosan Wound Dressing |
FOSHAN UNITED MEDICAL TECHNOLOGIES LTD. |
JOHN CEN |
| K133187 |
01/08/2015 |
FREERIDER FR1, models FR1-13, FR1-15, FR1-17 |
FREERIDER CORP |
AARON CHANG |
| 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 |
| K143452 |
01/29/2015 |
LOGIQ P9, LOGIQ P7 |
GE HEALTHCARE |
BRYAN BEHN |
| K142840 |
01/07/2015 |
Unity Network ID |
GE HEALTHCARE |
Robert Casarsa |
| 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 |
| K143633 |
01/30/2015 |
CREO Stabilization System |
GLOBUS MEDICAL INC. |
Kelly J. Baker |
| 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 |
| K140265 |
01/23/2015 |
ELECTRODE FOR URINARY INCONTINENCE |
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD |
FIELD FU |
| K150923 |
11/06/2015 |
Breast Pump |
Guangzhou Jinxinbao Electronic Co.,Ltd |
Jiacheng Guo |
| K143535 |
01/13/2015 |
CR3 Keyless Split Sample Cup Secobarbital- Methadone |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
Ben Chen |
| K152495 |
11/23/2015 |
Wondfo Propoxyphene Urine Test |
Guangzhou Wondfo Biotech Co., Ltd. |
Ben Chen |
| K142350 |
01/08/2015 |
PK J-HOOK |
GYRUS ACMI INC. |
NEIL KELLY |
| K142759 |
01/13/2015 |
PK Cutting Forceps for ESG-400 Workstation |
GYRUS ACMI, INC. |
DOLAN MILLS |
| K141892 |
01/28/2015 |
QK-SYSTEMIC THERAPEUTIC APPARATUS |
HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD. |
WANG XIANGLIN |
| 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 |
| K143187 |
01/27/2015 |
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) |
Healgen Scientific LLC |
Jianqiu Fang |
| K151656 |
11/25/2015 |
HEARTWAY Power Mobility Scooter |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
KE-MIN JEN |
| K142703 |
01/15/2015 |
Powder-free PVC Vinyl Exam Gloves |
Hebei Grandeast Plastic Products Co., Ltd. |
Wei Liu |
| K142837 |
01/29/2015 |
HEINE SIGMA 250 & HEINE SIGMA 250 M2 |
HEINE Optotechnik GmbH & Co. KG |
Bettina Seim |
| 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 |
| K142348 |
01/23/2015 |
OsteoSeal Bone Hemostat |
HEMOSTASIS, LLC |
Bernard Horwath |
| 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 |
| K142368 |
01/14/2015 |
NOBLUS DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI ALOKA MEDICAL, LTD. |
ANGELA VAN ARSDALE |
| K152592 |
11/02/2015 |
PROBEAT-V |
Hitachi, Ltd.,Health Care Company |
NAOYA NISHIMURA |
| K141921 |
01/16/2015 |
HIVOX SPOPAD EMS |
HIVOX BIOTEK, INC. |
Ke-Min Jen |
| K143594 |
01/09/2015 |
VaPro Pocket |
Hollister Incorporated |
Jeanne Lee |
| 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 |
| K142974 |
01/09/2015 |
Extension Sets |
Hospira, Inc |
David Blonski |
| K142622 |
01/15/2015 |
IV Administration |
HOSPIRA, INC. |
DAVID BLONSKI |
| K141789 |
01/16/2015 |
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE |
HOSPIRA, INC. |
Yuliya Matlin |
| K150528 |
11/25/2015 |
Cortisol Saliva Luminescence Immunoassay |
IBL INTERNATIONAL GMBH |
NICOLA KAISER |
| K142057 |
01/13/2015 |
INFIX CANNULATED SCREW SYSTEM |
INFIX MEDICAL LLC |
JAMES C HOLLEY |
| K142952 |
01/13/2015 |
InMode Diolaze Device |
INMODE MD LTD. |
Ahava Stein |
| 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 |
| K141210 |
01/29/2015 |
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
| K140722 |
01/06/2015 |
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS |
INTEGRA LIFESCIENCES CORPORATION |
JANET KAY |
| K151819 |
11/10/2015 |
Integrity Spine Lumbar Interbody Fusion System |
INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM |
LISA PETERSON |
| K142939 |
01/13/2015 |
Revolution Spinal Fixation System |
INTELLIGENT IMPLANT SYSTEMS, LLC |
Michael Nutt |
| K141783 |
01/09/2015 |
TDX SP2 POWER WHEECHAIR |
INVACARE CORPORATION |
DOUG UELMEN |
| K153073 |
11/16/2015 |
UroNav (Version 2.0) |
INVIVO CORPORATION |
Kenneth Revennaugh |
| DEN150008 |
11/02/2015 |
INVOcell |
INVO BIOSCIENCE |
Kathleen Karloff |
| K143154 |
01/02/2015 |
IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) |
IRIDEX CORPORATION |
PAUL H HARDIMAN |
| K143142 |
11/06/2015 |
JDENTALCARE Implant System |
J DENTAL CARE S.r.l |
Giacomo Grandi |
| K141861 |
01/07/2015 |
HILTHERA 4.0 |
JEISYS MEDICAL, INC. |
Priscilla Chung |
| K142957 |
01/30/2015 |
Ideal pedicle screw spinal system |
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. |
Wei Li |
| K143155 |
01/29/2015 |
LISTERINE Sensitivity Defense Mouthrinse |
Johnson & Johnson Healthcare Products, Division of McNeil-PP |
ANGELINA M. HUNT |
| K142360 |
01/21/2015 |
Everest Spinal System |
K2M, Inc |
Nancy Giezen |
| K143334 |
01/09/2015 |
Range/Denali/Mesa Spinal System |
K2M, INC |
NANCY GIEZEN |
| 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 |
| K142625 |
01/27/2015 |
PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) |
KURARAY NORITAKE DENTAL INC. |
Michio Takigawa |
| K140471 |
01/15/2015 |
PRO X OTC 5 |
LA LUMIERE, LLC |
M. JOYCE HEINRICH |
| K132172 |
01/15/2015 |
NEONATALIE RESUSCITATOR |
LAERDAL MEDICAL A/S |
MARI KAADA |
| K142246 |
01/29/2015 |
LightStim for Acne/ LightStim for Acne Mini |
LED INTELLECTUAL PROPERTIES, LLC |
Steve Marchese |
| K141707 |
01/21/2015 |
ULTRASKIN HYDROPHILIC GUIDE WIRE |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. |
ARTHUR GODDARD |
| K140706 |
01/21/2015 |
LEVO MAX |
LEVO AG |
MATT GROW |
| K152282 |
11/20/2015 |
Cam Lock Plating System |
LIFE SPINE, INC |
RANDY LEWIS |
| K143498 |
01/20/2015 |
LifeGlobal Global HP |
LifeGlobal Group, LLC |
MICHAEL D CECCHI |
| K143509 |
01/27/2015 |
MasterSL femoral stem |
LIMACORPORATE S.P.A. |
STEPHEN J PEOPLES |
| K151739 |
11/23/2015 |
Revision Femoral Stem |
LIMACORPORATE S.P.A. |
EMANUELE BUTTAZZONI |
| K142722 |
01/13/2015 |
3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 |
Livetec GMBH |
Klaus Reichenbach |
| 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 |
| K142860 |
01/21/2015 |
Lumenis M22 System |
Lumenis Ltd. |
Yoram Levy |
| K152848 |
11/17/2015 |
AUTOLAP SYSTEM |
M.S.T Medical Surgery Technologies LTD |
Tami Harel |
| K133088 |
01/02/2015 |
ZX-27 |
M&M DENTAL STUDIO INC |
IRVING WIESEN |
| K142606 |
01/26/2015 |
Trident« Tritanium« PST« Acetabular Shells |
MAKO Surgical Corp. |
Jonathan Reeves |
| K133729 |
01/23/2015 |
WOUND DRESSING WITH MANUKA HONEY |
MANUKA HEALTH NEW ZEALAND LTD. |
DAVID BECHTEL |
| K152041 |
11/17/2015 |
Renaissance X System |
Mazor Robotics Ltd. |
Ayelet Matia |
| K142850 |
01/06/2015 |
McKesson Radiology Mammography Plus |
MCKESSON MEDICAL IMAGING COMPANY |
GILBERT WONG |
| 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 |
| K143068 |
01/14/2015 |
Medical Monofilament Sensory Screening Toool |
Medical Monofilament Manufacturing |
Michelle Hardiman |
| K141187 |
01/15/2015 |
IMPIX ALIF S/A |
MEDICREA INTERNATIONAL S.A. |
DAVID RYAN |
| K141398 |
01/09/2015 |
PASS LP SPINAL SYSTEM |
MEDICREA INTERNATIONAL S.A. |
DAVID RYAN |
| K143634 |
01/20/2015 |
MUSE System |
MEDIGUS LTD. |
SHARON KANETY DERESH |
| K140587 |
01/06/2015 |
MR-CT VVA |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
B GOEDHART |
| K150698 |
11/20/2015 |
Gemini Sterilization Wrap |
MEDLINE INDUSTRIES, INC. |
Jennifer Mason |
| K143693 |
11/06/2015 |
MEDLINE SHARPS CONTAINERS |
MEDLINE INDUSTRIES, INC. |
Matt Clausen |
| K142635 |
01/09/2015 |
Medline Silicone Foley Catheter |
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 |
| K141599 |
01/21/2015 |
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
SHWETA SHARMA |
| K143107 |
01/07/2015 |
DLP Vein Graft Cannula |
MEDTRONIC, INC. |
KEVIN LAM |
| K141441 |
01/09/2015 |
MENNTOR X7 |
MENNEN MEDICAL LTD. |
IFAT SHWARTS |
| K152285 |
11/10/2015 |
illumigene Pertussis DNA Amplification Assay |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K143232 |
01/30/2015 |
Universal Digital Interface 2W, UDI 2W |
MERIDIAN MEDICAL SYSTEMS, LLC |
Larry Cornell |
| K151925 |
11/06/2015 |
Elation Wireguided Balloon Dilation Catheter |
MERIT MEDICAL SYSTEMS, INC. |
DAVID THOMAS |
| K143366 |
01/21/2015 |
ADVANCE Porous Coated Spiked Tibial Base |
MicroPort Orthopedics Inc. |
Caroline Fryar |
| 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 |
| K140736 |
01/20/2015 |
STERISAFE HP TABLE-TOP STEAM STERILIZER |
MILTON E PEDRAZZI D.D.S., INC. |
MILTON E PEDRAZZI DDS |
| K143426 |
01/27/2015 |
Wound Matrix TF |
MIROMATRIX MEDICAL INC. |
Jeff Ross |
| 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 |
| K142866 |
01/21/2015 |
Myoscience iovera system |
Myoscience, Inc |
Tracey Henry |
| K142104 |
01/21/2015 |
NANOFUSE DBM |
NANOTHERAPEUTICS, INC. |
DORIS SNOW |
| 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 |
| K141515 |
01/07/2015 |
AED HYSTEROSCOPE AND ACCESSORIES |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE BUTLER |
| 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 |
| K142025 |
01/21/2015 |
NEUROLUMEN PN-1000 |
NEUROLUMEN, LLC |
Doug Durning |
| 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 |
| K141253 |
01/09/2015 |
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM |
NEW ERA ORTHOPAEDICS, LLC |
J.D. WEBB |
| K143061 |
01/26/2015 |
Activ Ankle Locking Plating System |
NEWCLIP TECHNICS |
Gaelle Lussori |
| K141548 |
01/30/2015 |
HIGH TIBIAL OSTEOTOMY SYSTEM |
NEWCLIP TECHNICS |
J.D. WEBB |
| K142590 |
01/16/2015 |
All Safe Huber Safety Infusion Set |
NEXUS MEDICAL, LLC |
Heather Turner |
| 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 |
| K142712 |
01/08/2015 |
Dental Collagen Wound Dressing (Nova Tape and NovaPlug) |
NovaBone Products, LLC |
Lisa Simpson |
| K151361 |
11/06/2015 |
Nox RIP Belts & Cables |
NOX MEDICAL ehf |
KOLBRUN E OTTOSDOTTIR |
| K141588 |
01/08/2015 |
NUTRA STIM HAIR LASER COMB |
NUTRA LUXE MD, LLC |
JILL CREASY |
| K141596 |
01/08/2015 |
NUTRA STIM HAIR LASER COMB |
NUTRA LUXE MD, LLC |
JILL CREASY |
| K143065 |
01/21/2015 |
NuVasive ALIF Buttress Plate System |
NUVASIVE, INCORPORATED |
Michelle Cheung |
| K151275 |
11/13/2015 |
MAKO Device |
nVision Medical |
Surbhi Sarna |
| K142583 |
01/16/2015 |
LaborView LV1000 |
OBMedical Company |
Suha Jhaveri |
| K152055 |
11/23/2015 |
Ceramax Skin Barrier Cream |
OCULUS INNOVATIVE SCIENCES |
BRIAN W. MARTIN |
| K141851 |
01/02/2015 |
NAVILAS LASER SYSTEM |
OD -OS GMBH |
JUDY F GORDON |
| 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 |
| K140671 |
01/08/2015 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE |
OMEGA LABORATORIES, INC. |
ROBERT J BARD |
| K142201 |
01/26/2015 |
OMNI Interface Acetabular System |
OMNLIFE SCIENCE |
Vani Sindwani |
| K152779 |
11/25/2015 |
Avex CX2 |
Opal Orthodontics by Ultradent Products |
Marie Hess |
| K150688 |
11/05/2015 |
IdentEvent |
OPTIMA NEUROSCIENCE, INC. |
Ryan T. Kern |
| K142897 |
01/16/2015 |
P200DTx |
OPTOS PLC. |
GUNHILD PAULSEN |
| K150268 |
11/06/2015 |
CerOX |
OR-NIM MEDICAL LTD. |
MICHA OESTEREICH |
| K151946 |
11/09/2015 |
Thermofit |
ORFIT INDUSTRIES |
EDDY MAROVOET |
| K142209 |
01/16/2015 |
Pulse oximeter NBM-200 |
ORSENSE LTD |
Aharon Weinstein |
| K143039 |
01/16/2015 |
CrossRoads Screw System |
ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM |
VERNON HARTDEGEN |
| K141857 |
01/08/2015 |
CrossTie Intraosseous Fixation System |
ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM |
VERNON HARTDEGEN |
| K142152 |
01/08/2015 |
CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM |
ORTHOFIX, INC. |
NATALIA VOLOSEN |
| K141186 |
01/02/2015 |
FIREBIRD SPINAL FIXATION SYSTEM |
ORTHOFIX, INC. |
JACKI GEREN |
| K152295 |
11/03/2015 |
Talon DistalFix Antegrade/Retrograde Femoral Nail |
ORTHOPEDIC DESIGNS NORTH AMERICA, INC. |
Robin Wilson |
| K140037 |
01/20/2015 |
OPTIMUS CMF SYSTEM |
OSTEONIC CO., LTD. |
Priscilla Chung |
| 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 |
| K142678 |
01/21/2015 |
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm |
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 |
| K142321 |
01/26/2015 |
Benchmark Intracranial Access System |
PENUMBRA, INC. |
Michaela Mahl |
| K142935 |
01/15/2015 |
CareEvent |
PHILIPS MEDICAL SYSTEMS |
Theresa Poole |
| K133659 |
01/23/2015 |
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING |
PHILIPS MEDICAL SYSTEMS |
JOHN PARDO |
| K142273 |
01/30/2015 |
EmboGuide |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
Liselotte Kornmann |
| 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 |
| K141923 |
01/06/2015 |
INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X |
PRISMATIK DENTALCRAFT, INC. |
Marilyn Pourazar |
| 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 |
| K142366 |
01/09/2015 |
Puritan OptiTranz Liquid Stuart Collection and Transport System |
PURITAN MEDICAL PRODUCTS LLC |
Mehdi Karamchi |
| K151212 |
11/04/2015 |
Ziostation2 |
QI IMAGING, LLC |
RICHARD BALL |
| K142222 |
01/26/2015 |
NewTom 5G |
QR S.r.l. |
Lorenzo Bortolotti |
| K141689 |
01/07/2015 |
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit |
Qualigen, Inc. |
Michael Poirier |
| 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 |
| K143000 |
01/23/2015 |
RIS500 |
RAY CO.,LTD |
KYUNGHA SEO |
| 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 |
| K140580 |
01/16/2015 |
REVOLUTION FULLFACE MASK |
RESPIRONICS INC. (DBA PHILIPS RESPIRONICS) |
COLLEEN WITT |
| K142554 |
01/09/2015 |
Revolution Full Face Mask |
Respironics, Inc. |
Amy Macevoy |
| 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 |
| K143481 |
01/08/2015 |
IntellaMap Orion High Resolution Mapping Catheter |
RHYTHMIA MEDICAL, INC |
FRANK JURCZAK |
| K143691 |
01/28/2015 |
LDLC3 LDL-Cholesterol Gen.3 |
Roche Diagnostics Operations (RDO) |
Noel B Mencias |
| K141634 |
01/27/2015 |
NAUTILUS DELTA |
ROMEDEX INTERNATIONAL SRL |
SORIN GRUNWALD |
| 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 |
| K142249 |
01/27/2015 |
SCHOELLY SINUSCOPE |
SCHOELLY FIBEROPTIC GMBH |
SANDRA BAUMANN |
| K151265 |
11/24/2015 |
SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System |
SD BIOSENSOR |
YEON PARK |
| K143483 |
01/08/2015 |
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING |
SEBIA |
Karen Anderson |
| 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 |
| K142675 |
01/15/2015 |
CI../..X liner for NOVAE Dual Mobility Acetabular Cup |
SERF |
Jean-Luc AURELLE |
| K133985 |
01/22/2015 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
Diana Hong |
| K150436 |
11/13/2015 |
ComboRehab |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
Jianping Kang |
| K142552 |
01/23/2015 |
A7 Anesthesia System |
ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
Tang Hao |
| K143472 |
01/02/2015 |
TE7 Diagnostic Ultrasound System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANG ZHAOHUI |
| K141224 |
01/15/2015 |
JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUNAG JIUYUAN PLASTIC CO., LTD |
CHU XIAOAN |
| K150168 |
11/04/2015 |
Dimension Tacrolimus Flex« Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
Anna Marie Kathleen Ennis |
| K143639 |
01/23/2015 |
IMMULITE 2000 CEA Calibration Verification Material |
Siemens Healthcare Diagnostics |
Asha Gartland |
| K143504 |
01/14/2015 |
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material |
Siemens Healthcare Diagnostics Inc. |
Sara Kastrup |
| K143680 |
01/27/2015 |
ADVIA Centaur IgE Master Curve Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Fatima Pacheco |
| 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 |
| K142584 |
01/16/2015 |
iMAR |
Siemens Medical Solutions USA, Inc. |
Eve Davis |
| 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 |
| K143493 |
01/14/2015 |
SignosRT Bladder Ultrasound System |
Signostics Ltd |
Stewart Bartlett |
| K143624 |
01/13/2015 |
Headless Compression Screw System |
SKELETAL DYNAMICS, LLC |
Ana M. Escagedo |
| K142948 |
01/13/2015 |
BIOSURE REGENESORB interference Screw |
Smith & Nephew, Inc |
Vivek Mukhatyar |
| 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 |
| K140861 |
01/30/2015 |
SOMNOTOUCH RESP |
SOMNOMEDICS GMBH |
MATTHIAS BROENNER |
| K142945 |
01/22/2015 |
Sonoma Fibula Repair System |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
RICK EPSTEIN |
| K142815 |
01/28/2015 |
S22 Digital Color Doppler Ultrasound System |
SONOSCAPE COMPANY LIMITED |
Toki Wu |
| K142714 |
01/29/2015 |
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System |
SONOSCAPE COMPANY LIMITED |
Toki Wu |
| K142710 |
01/05/2015 |
S9 Portable Digital Color Doppler Ultrasound System |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
| K151713 |
11/06/2015 |
LILLIPUP PMP, LILLIPUT PMP INTEGRATED |
SORIN GROUP ITALIA S.R.L. |
LUIGI VECCHI |
| K143751 |
01/23/2015 |
Visi Mobile Monitoring System |
Sotera Wireless, Inc. |
Eben Gordon |
| K133959 |
01/22/2015 |
PODIATRY X-RAY SYSTEM |
SOURCE-RAY, INC. |
Daniel Kamm |
| K150329 |
11/05/2015 |
elance Vital Signs Monitor, Central Monitor Software |
SPACELABS HEALTHCARE |
Al Van Houdt |
| K142791 |
01/21/2015 |
Spectra Soft Tissue Biopsy Needles |
SPECTRA MEDICAL DEVICES |
Agustin Turriza |
| 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 |
| K140046 |
01/09/2015 |
SPINOUS PROCESS FUSION (SPF) PLATE |
SPINAL SIMPLICITY, LLC |
JANICE M HOGAN |
| K141980 |
01/26/2015 |
LEVA (TM) SPACER SYSTEM |
SPINE WAVE, INC. |
ROALDA RIZKALLAH |
| K142980 |
01/16/2015 |
Proficient (TM) Facet Screw Spine System |
SPINE WAVE, INC. |
ROAIDA JOHNSON |
| K143159 |
01/23/2015 |
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip ╪4.0mm, PediGuard Tri Tip ╪3.2mm, PediGuard Tri Tip ╪2.5mm, PediGuard ╪2.5mm XS, PediGuard Curv, PediGuard Curv |
SpineGuard, S.A. |
Stephane Bette |
| K151710 |
11/19/2015 |
SNaP Wound Care System |
SPIRACUR, INC. |
LAWRENCE HU |
| K140898 |
01/20/2015 |
PATIENT SPECIFIC DISTAL FEMORAL |
STANMORE IMPLANTS WORLDWIDE LTD. |
SAMANTHA SHELLEY |
| K142109 |
01/20/2015 |
STERILUCENT STERILIZATION CONTAINER SYSTEM |
STERILUCENT, INC |
PETER KALKBRENNER |
| K151928 |
11/06/2015 |
PUR Dental Implant System |
STERNGOLD DENTAL, LLC |
MARIA RAO |
| K142667 |
01/07/2015 |
Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm |
Sterngold Dental, LLC |
Maria Rao |
| K142890 |
01/09/2015 |
Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Singl |
STRAUMANN USA, LLC |
Jennifer M. Jackson |
| 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 |
| K142237 |
01/26/2015 |
Aviator Anterior Cervical Plate (ACP) System |
Stryker Corporation |
Soraya King |
| K143163 |
01/26/2015 |
AVS« AL and ALign PEEK Spacers, AVS« PL and UniLIF PEEK Spacers, AVS« TL PEEK Spacer, AVS« Navigator PEEK Spacer, AVS« ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS« Anchor-L Spacer, Aero-AL Lumbar Cage System |
STRYKER CORPORATION |
GARRY T HAYECK |
| K142741 |
01/15/2015 |
OASYS System |
STRYKER CORPORATION |
Garry T Hayeck |
| K152641 |
11/20/2015 |
Pi Drive Plus Motor, Extender |
STRYKER CORPORATION |
DEVAL PATEL |
| K143393 |
01/13/2015 |
Triathlon Tritanium Cone Augments |
STRYKER ORTHOPAEDICS |
Margaret Klippel |
| K143063 |
01/27/2015 |
Stryker SonicPin System, Stryker SonicAnchor System |
STRYKER TRAUMA GMBH |
Estela Celi |
| K131950 |
01/16/2015 |
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET |
SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC. |
RICHELLE HELMAN |
| K142617 |
11/20/2015 |
ArcCHECK |
SUN NUCLEAR CORPORATION |
Noel Downey |
| K143588 |
01/12/2015 |
Surefire Infusion System 021 |
SUREFIRE MEDICAL, INC |
Lynne Aronson |
| K143166 |
01/16/2015 |
Medline ReNewal Reprocessed Compression Limb Sleeves |
Surgical Instrument Service and Savings (dba Medline ReNewal |
Richard D. Wynkoop |
| K140237 |
01/08/2015 |
DISPOSABLE NEBULIZER SET |
SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD |
MIKE GU |
| K143589 |
01/16/2015 |
GEM Flow COUPLER Device and System |
Synovis Life Technologies, Inc. |
Jodi Jorgenson |
| K142447 |
01/07/2015 |
PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch |
Synovis Life Technologies. Inc. |
Jodi Jorgenson |
| K142838 |
01/20/2015 |
Synapse Occipital-Cervical-Thoracic (OCT) System |
SYNTHES USA PRODUCTS, LLC |
KATE LAROSE |
| K150259 |
11/06/2015 |
CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L |
TAIWAN SURGICAL CORPORATION |
Hsiu-Ping Huang |
| K143189 |
01/09/2015 |
t:flex Insulin Delivery System |
Tandem Diabetes Care, Inc. |
John Sheridan |
| K140984 |
01/12/2015 |
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM |
TANGO3, LLC |
LORI HOLDER |
| K141379 |
01/16/2015 |
VICTUS FEMTOSECOND LASER PLATFORM |
TECHNOLAS PERFECT VISION GMBH |
KEN NEHMER |
| K143299 |
01/21/2015 |
Percuvance(R) Percutaneous Surgical System |
Teleflex Medical, Inc. |
Holly Hallock |
| K150603 |
11/27/2015 |
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube |
Teleflex Medical, Inc. |
Lori Pfohl |
| K142500 |
01/29/2015 |
One Way Soft Valve |
Terumo Cardiovascular Systems Corporation |
Suzanne Grenier |
| 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 |
| K141448 |
01/23/2015 |
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM |
TEVA MEDICAL LTD., MIGADA PLANT |
ROGER L GRAY |
| 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 |
| K140264 |
01/05/2015 |
MADM |
THORNHILL RESEARCH INC. |
CLIFF ANSEL |
| K142940 |
01/28/2015 |
Endoskeleton TCS System |
TITAN SPINE, LLC |
Jane Rodd |
| K141070 |
01/15/2015 |
SUPER SHEATH |
TOGO MEDIKIT CO., LTD. |
IZUMI MARUO |
| K143059 |
01/26/2015 |
TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) |
TONE-A-MATIC INTERNATIONAL INC. |
MANUEL CHUCK |
| K151673 |
11/27/2015 |
Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K143223 |
01/12/2015 |
CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Paul Biggins |
| K143225 |
01/09/2015 |
INFX-8000V with Wireless Footswitch |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K143281 |
01/29/2015 |
Ultimax-i |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K152785 |
11/25/2015 |
XIDF-AWS801, Angio Workstation, V6.20 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K143113 |
01/28/2015 |
Klassic BiPolar System |
Total Joint Orthopedics |
Chris Weaber |
| K153075 |
11/13/2015 |
Klassic Knee System |
TOTAL JOINT ORTHOPEDICS, INC. |
Chris Weaber |
| K134051 |
01/29/2015 |
TRANSONIC ELSA SYSTEM |
TRANSONIC SYSTEMS, INC. |
NAVEEN THURAMALLA |
| K151034 |
11/21/2015 |
PainKARE |
TrioWave Technologies |
Huiyou Zhu |
| K152019 |
11/16/2015 |
HairMD |
TROPHY SKIN, INC. |
IMRAN KARIM |
| K143311 |
01/15/2015 |
Pre-vacuum Tabletop Autoclave |
TUTTNAUER USA CO. LTD. |
Robert Basile |
| 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 |
| K142553 |
01/14/2015 |
UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle |
UNISIS CORP. |
Tadashi Yasuda |
| K152255 |
11/16/2015 |
BoneCam Suture Anchors |
VALERIS MEDICAL |
DANIEL LANOIS |
| K140359 |
01/07/2015 |
MAXIMIS SPINAL FIXATION SYSTEM |
VALOREM SURGICAL |
PATRICK MOORE |
| K152761 |
11/25/2015 |
Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) |
VARIAN MEDICAL SYSTEMS, INC. |
MARCIA PAGE |
| K142136 |
01/08/2015 |
ACCUCATH MIDLINE CATHETER SYSTEM |
VASCULAR PATHWAYS, INC. |
SCOTT PEASE |
| K151234 |
11/18/2015 |
R350 guidewire |
VASCULAR SOLUTIONS, INC. |
BEKA VITE |
| K140852 |
01/30/2015 |
VECTRAPLEX CMS |
VECTRACOR, INC |
BRAD S SCHRECK |
| K142059 |
01/09/2015 |
FOX MOBILE |
VECTURA GMBH |
PAUL DRYDEN |
| K142946 |
01/08/2015 |
TIVA |
Velano Vascular, Inc. |
Tiffini Diage |
| 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 |
| K141561 |
01/16/2015 |
VM PACS WITH VM MEDICAL WORKSTATION |
VISUAL MEDICA |
MELISSA LLABRES GRAU |
| K143549 |
01/14/2015 |
Vivorte Trabexus |
VIVORTE, INC |
ROBERT BURDEN |
| K143547 |
01/14/2015 |
Vivorte Trabexus EB |
VIVORTE, INC |
Robert Burden |
| K143486 |
01/07/2015 |
Ufi Gel hard C |
VOCO GMBH |
M.Th. Plaumann |
| 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 |
| K143179 |
01/30/2015 |
The LINK« Endo-Model« Knee System |
Waldemar Link GmbH & Co. KG |
Helmut D. Link |
| K142233 |
01/05/2015 |
zenostar MO, Zenostar T, Zenostar VisualiZr |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
Betina Kistner |
| K142144 |
01/15/2015 |
DISPOSABLE INJECTION NEEDLE |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
LIJUAN ZHANG |
| K143460 |
01/23/2015 |
Cannulated Screw System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Tara Conrad |
| K143220 |
01/08/2015 |
SIDEKICK EZ FRAME External Fixation System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Leslie Fitch |
| K142075 |
01/08/2015 |
BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE |
XERIDIEM (FORMERLY MRI) |
JESUS VALENCIA |
| K142297 |
01/08/2015 |
Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set |
XERIDIEM (FORMERLY MRI) |
Jesus Valencia |
| 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 |
| K142283 |
01/16/2015 |
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
Arivalagan Subramaniam |
| K143190 |
01/16/2015 |
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens |
YUNG SHENG OPTICAL CO., LTD. |
WEN-HAN CHEN |
| K142491 |
01/26/2015 |
ZEL TIQ CoolSculpting System |
ZELTIQ AESTHETICS, INC. |
SHRUTI JAYAKUMAR |
| K142539 |
01/08/2015 |
EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set |
ZEVEX, INC. |
Dianne Batch |
| K142572 |
01/21/2015 |
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System |
Zimmer Dental, Inc. |
Christina Boydston |
| 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 |
| K133239 |
01/16/2015 |
ZOLL E SERIES |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
TANMAY B SHUKLA |
| K141549 |
01/15/2015 |
SImmetry Sacroiliac Joint Fusion System |
Zyga Technology, Inc. |
Diane Brinza |
