FDA 510(k) Applications Received During October, 2013

FDA 510(k) Number Submission Date Device Name Applicant Contact
K133135 10/04/2013 IMPAX VOLUME VIEWING 3.0 AGFA HEALTHCARE N.V. KOEN COBBAERT
K133321 10/29/2013 ALAMO C ALLIANCE PARTNERS, LLC JENNIFER PALINCHIK
K133221 10/18/2013 ARSENAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. RENEE L MURPHY
K133296 10/25/2013 XCATH ALSEAL YOLANDA SMITH
K133342 10/30/2013 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC. MARIELA CABARCAS
K133275 10/24/2013 MINI TIGHTROPE ARTHREX, INC. NANCY HOFT
K133297 10/25/2013 QUADROSTARPROGREEN, QUADROSTARPROYELLOW ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K133146 10/17/2013 BAUSCH + LUMB, VIS100 INJECTOR SYSTEM BAUSCH & LOMB SHIVANI K CHITALIA
K133242 10/21/2013 STELLARIS VISION ENHANCEMENT SYSTEM BAUSCH & LOMB TIMOTHY W CAPEHART
K133140 10/17/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV BECTON DICKINSON & CO. Gregory P Payne
K133138 10/17/2013 BD VeritorÖ System Flu A+B Assay BECTON DICKINSON & CO. Gregory P Payne
K133158 10/17/2013 ND: YAG LASER SYSTEM BEIJING TOPLASER TECHNOLOGY CO., LTD. ZHANG XIAOSONG
K133303 10/25/2013 PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device BIO-ANALYSIS, INC. REGINA J O'MEARA
K133270 10/23/2013 SPEED ARC BIOMEDICAL ENTERPRISES, INC JOE SOWARD
K133354 10/31/2013 PERI-PROSTHETIC CABLE SYSTEM BIOMET, INC. JULIE LARGENT
K133333 10/29/2013 UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT BLUE OCEAN MEDICAL PRODUCT, LLC. E.J. Smith
K133208 10/18/2013 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. MAUREEN SUNDEEN
K133312 10/28/2013 EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation YINGYING GAO
K133147 10/17/2013 BRACCO INJEENERING TRANSFER SET BRACCO INJENEERING S.A. THOMAS KROENKE
K133251 10/22/2013 BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM C.R. BARD, INC. MICHELE DAVIS
K133335 10/29/2013 POWERPORT IMPLANTABLE PORT C.R. BARD, INC. AMY HONEY
K133223 10/21/2013 XENMATRIX AB SURGICAL GRAFT C.R. BARD, INC. Tony John
K133355 10/31/2013 CADWELL FLEX EEG/PSG CADWELL INDUSTRIES, INC. JOHN CADWELL JR.
K133283 10/25/2013 CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS CANDELA CORP. SAM WADE
K133148 10/17/2013 BIOMARC COAXIAL NEEDLE CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K133236 10/21/2013 TANDEMHEART FEMORAL VENOUS CANNULA SET CARDIAC ASSIST, INC. Greg Johnson
K133293 10/25/2013 15 FR. TANDEMHEART ARTERIAL CANNULA CARDIACASSIST INC. Greg Johnson
K133217 10/18/2013 CIRRUS PHOTO CARL ZEISS MEDITEC AG MANDY AMBRECHT
K133286 10/25/2013 MIDLINE (TM) CENTINEL SPINE, INC. JOHN PARRY
K133200 10/17/2013 STALIF C(R) CENTINEL SPINE, INC. JOHN PARRY
K133357 10/31/2013 CHARRUAPACS SYSTEM CHARRUASOFT SA CARL ALLETTO
K133214 10/18/2013 BLACKBIRD SPINAL SYSTEM CHOICE SPINE, LP KIM FINCH
K133176 10/17/2013 AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL CIBA VISION CORPORATION MARTINA HEIM, PH.D., RAC
K133177 10/17/2013 MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. RHODA SANTOS
K133256 10/23/2013 ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC. ANITA SHAH
K133224 10/21/2013 Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES CONMED CORPORATION NYROBIA FREEMAN
K133306 10/28/2013 SIS HERNIA GRAFT COOK BIOTECH, INC. PERRY W GUINN
K133338 10/30/2013 LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H DONALD HENTON
K133144 10/17/2013 SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE CrossBay Medical, Inc. CINDY DOMECUS
K133204 10/17/2013 AIRVIEW MINI OWIE DICK TEST PACK CROSSTEX INTERNATIONAL MICHAEL G NOLAN
K133258 10/23/2013 TRUFREEZE SYSTEM CSA MEDICAL, INC. ELLEN SHEETS, MD, MBA
K133254 10/22/2013 REVLITE Q-SWITCHED ND:YAG LASER SYSTEM CYNOSURE, INC. HUDA YUSUF
K133267 10/24/2013 DANA REUSABLE TEST PACK DANA PRODUCTS, INC. HARRY BALA
K133255 10/23/2013 ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS DENTALPOINT AG ROSHANA AHMED
K133279 10/24/2013 MEDIHONEY WOUND DRESSINGS DERMA SCIENCES, INC. SHARMINI ATHERAY
K133209 10/17/2013 FORESEE (4C) IMAGING SYSTEM DIAGNOSTIC PHOTONICS, INC JANICE HOGAN
K133178 10/17/2013 LUXATOR LX HANDPIECE DIRECTA AB HENRIC KARSK
K133175 10/17/2013 DRAEGER JAUNDICE METER JM-105 DRAEGER MEDICAL SYSTEMS, INC. BRYAN OVERTON
K133289 10/25/2013 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. John McIntyre
K133194 10/17/2013 DIAMOND RATTLESNAKE SYSTEM EMINENT SPINE LINDA BRADDON
K133359 10/31/2013 ENDORINGS ENDO-AID, INC. JANICE M HOGAN
K133316 10/28/2013 SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS) EPIMED INTERNATIONAL, INC. PRESTON H FRASIER
K133180 10/17/2013 ERBE ESU MODEL VIO DV WITH ACCESSORIES ERBE USA, INC. JOHN TARTAL
K133314 10/28/2013 HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY ETHICON ENDO-SURGERY, LLC BRIAN GODWIN
K133356 10/31/2013 PROLENE POLYPROPYLENE NONABSORBABLE SUTURE ETHICON, INC. ELLIOTT JANG
K133198 10/17/2013 ULTRAPRO COMFORT PLUG ETHICON, INC. REYNALDO LIBROJO
K133225 10/21/2013 E-FIT EF-1280 EMS MACHINE FIT-PRO KFT LTD. RHONDA ALEXANDER, M.S., M.P.A.
K133187 10/17/2013 FREERIDER FR1, models FR1-13, FR1-15, FR1-17 FREERIDER CORP AARON CHANG
K133299 10/25/2013 ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER DENISE M OPPERMANN
K133134 10/01/2013 X-PORTE ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC. SCOTT PAULSON
K133197 10/17/2013 FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE FUJIREBIO DIAGNOSTICS, INC. KENT PRUETT
K133182 10/17/2013 HTFX-222 GC AMERICA, INC. MARK HEISS
K133278 10/24/2013 DISCOVERY IGS 740 GE MEDICAL SYSTEMS SCS MICHEL GENUER
K133245 10/22/2013 GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM GENESYS SPINE WILLIAM W SOWERS
K133350 10/30/2013 REVERE STABILIZATION SYSTEM GLOBE MEDICAL, INC. CHRISTINA KICHULA
K133343 10/30/2013 WONDFO RAPID STREP A TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K133213 10/18/2013 STARCERAM H.C. STARCK CERAMICS GMBH MAUREEN O'CONNELL
K133222 10/18/2013 SAAD PATIENT MONITOR (SPM) HANIN MEDICAL SERVICES CO. LTD RAYMOND J KELLY
K133252 10/22/2013 HEALTHINTERLINK BEACON HEALTHINTERLINK, LLC SUSAN D GOLDSTEIN-FALK
K133352 10/31/2013 HYPERSOUND AUDIO SYSTEM (HSS) HYPERSOUND HEALTH, INC. JAMES A BARNES
K133346 10/30/2013 SMARTLOG DIABETES MANAGEMENT SOFTWARE i-SENS, Inc. HYE YOUNG KANG
K133228 10/21/2013 ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM ICONACY ORTHOPEDIC IMPLANTS, LLC MARC E RUHLING
K133136 10/04/2013 MISEQDX UNIVERSAL KIT 1.0 ILLUMINA, INC. LEANNE M KIVIHARJU
DEN130042 10/04/2013 MISEQDX UNIVERSAL KIT 1.0 ILLUMINA, INC. LEANNE M KIVIHARJU
K133196 10/17/2013 IMPACT MODEL 323 ASPIRATOR IMPACT INSTRUMENTATION, INC. ALAN GIORDANO
K133290 10/25/2013 COLLACARE DENTAL INNOCOLL PHARMACEUTICALS AARON WYSE
K133274 10/24/2013 VENA PRO INNOVAMED HEALTH, LLC JOE ADKINS
K133231 10/21/2013 DIGORA OPTIME INSTRUMENTARIUM DENTAL, PALODEX GROUP OY TERHO TURKUMAKI
K133167 10/17/2013 MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD INTUITIVE SURGICAL, INC. BRANDON HANSEN
K133203 10/17/2013 SINGLE-SITE PORT INTUITIVE SURGICAL, INC. EINAV YEMINI
K133318 10/28/2013 ADHESE UNIVERSAL IVOCLAR VIVADENT AG DONNA HARTNETT
K133181 10/17/2013 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K133185 10/17/2013 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K133288 10/25/2013 CASPIAN OCT SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K133276 10/24/2013 V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS KCI USA, INC. MELANIE AVILA
K133232 10/21/2013 PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES KCI USA, INC. (KINETIC CONCEPTS, INC.) BRIAN YOUNG
K133234 10/21/2013 T-TYPE D-KAT, R-TYPE D-KAT KEELER LIMITED EUGENE R VANARSDALE
K133169 10/17/2013 MESO TENDON MATRIX KENSEY NASH CORPORATION DBA DSM BIOMEDICAL BRIANNA JORDAN
K133304 10/28/2013 RXG DISTRACTION SYSTEM KLS-MARTIN L.P. JENNIFER DAMATO
K133211 10/18/2013 ZIRTOUGH KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K133155 10/17/2013 HYDROPHILIC COATED GUIDEWIRE LAKE REGION MEDICAL TRACY MEYER
K133273 10/24/2013 LIGER MEDICAL ESU-110 LIGER MEDICAL, LLC STEVE SMITH
K133349 10/30/2013 SMR TT METAL BACK GLENOID LIMACORPORATE S.P.A. STEPHEN PEOPLES
K133319 10/28/2013 ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 LUMENIS LTD. IMAN KHORSHID
K133272 10/24/2013 VERSACUT + TISSUE MORCELLATOR LUMENIS LTD. YORAM LEVY
K133302 10/25/2013 FLEXMAP 3D LUMINEX CORP. CHRISTIE HUGHES
K133265 10/23/2013 QUADROX-IR ADULT AND SMALL ADULT MAQUET CARDIOPULMONARY AG WHITNEY TORNING
K133149 10/17/2013 BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM MAR COR PURIFICATION, INC. KINNARI SHAH
K133162 10/17/2013 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA MATERIALISE N.V. OLIVER CLEMENS
K133192 10/17/2013 MECTALIF TIPEEK MEDACTA INTERNATIONAL ADAM GROSS
K133261 10/23/2013 MEDOS HILITE 7000 & 7000 LT OXYGENATOR MEDOS MEDIZINTECHNIK AG Leann Christman
K133205 10/18/2013 CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. JULIE BASSETT
K133216 10/18/2013 CRESCENT SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. ANKIT K SHAH
K133157 10/17/2013 TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 MEDTRONIC, INC. JESSICA SIXBERRY
K133295 10/25/2013 QUALIS MENICON CO., LTD. NEW BUSINESS DIVISION MARCIA PALMA
K133230 10/21/2013 INQWIRE DIAGNOSTIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. SIOBHAN KING
K133298 10/25/2013 ENDO SMART META BIOMED, INC. BLIX WINSTON
K133310 10/28/2013 AXIUM DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR ANGELA LAMPREY
K133170 10/17/2013 QUICK JET M MICRON CORP. TAKASHI TERUI
K133235 10/21/2013 THREADED PEEK K-WIRE MTP SOLUTIONS LLC ROBERT HOY
K133229 10/21/2013 TITANIUM SUTURE ANCHOR MTP SOLUTIONS LLC ROBERT HOY
K133264 10/23/2013 NMI PICC III NAVILYST MEDICAL, INC. BRANDON BRACKETT
K133189 10/17/2013 DUAL SHOT ALPHA 7 NEMOTO KYORINDO CO., LTD. KEN WAKABAYASHI
K133281 10/25/2013 NEOTRACT UROLIFT SYSTEM NEOTRACT, INC. Nancy E Isaac
K133351 10/31/2013 NEXUS NIS-6P LUER ACTIVATED DEVICE NEXUS MEDICAL LLC HEATHER TURNER
K133287 10/25/2013 PRESSON SPINAL FIXATION SYSTEM NEXUS SPINE, LLC CHRIS HARMSTON
K133358 10/31/2013 NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT NIDEK CO., LTD ENRICO BISSON
K133301 10/25/2013 ZOE FLUID STATUS MONITOR NONINVASIVE MEDICAL TECHNOLOGIES, INC. MARC O'GRIOFA
K133311 10/28/2013 ENDOLED OLYMPUS WINTER & IBE GMBH SHERI L MUSGNUNG
K133250 10/22/2013 STARLIGHT ORTHOMERICA PRODUCTS, INC. DAVID L HOOPER
K133174 10/17/2013 ORTHOSCAN FD MINI C-ARM ORTHOSCAN, INC. ADAM MENZIES
K133308 10/28/2013 TINNITUS SOUNDSUPPORT OTICON A/S SOREN JUEL WITT
K133271 10/24/2013 OPTEO, VIDEOGRAPH HD OWANDY Claude Berthoin
K133317 10/28/2013 PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX PENUMBRA, INC. SETH SCHULMAN
K133292 10/25/2013 ALLURA XPER FD; OR TABLE PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. KLIEN VAN DAM
K133233 10/21/2013 PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE PJUR GROUP LUXEMBOURG SA CANDACE CEDERMAN
K133336 10/29/2013 PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE PJUR GROUP,LUXEMBOURG S.A. CANDACE CEDERMAN
K133263 10/23/2013 PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) PROTEUS DIGITAL HEALTH, INC. JAFAR SHENASA
K133257 10/23/2013 BIOPSY PIPETTES RESEARCH INSTRUMENTS LTD. DAVID LANSDOWNE
K133345 10/30/2013 REVEEL ENDOSCOPIC RETRACTOR RETRACTION LIMITED STUART MORAN
K133282 10/25/2013 REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM REVERSE MEDICAL CORPORATION JEFFREY VALKO
K133243 10/22/2013 OPTION ELITE VENA CAVA FILTER SYSTEM REX MEDICAL LP SUSAN D GOLDSTEIN-FALK
K133193 10/17/2013 RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) RIVERSTONE RESOURCES SDN. BHD. SURESH KUMAR
K133284 10/25/2013 ELECSYS CK-MB CALCHECK 5 Roche Diagnostics KELLI TURNER
K133210 10/17/2013 B&B BUBBLER S & T MEDICAL TECHNOLOGIES, INC. DERICK CORRENTE
K133329 10/29/2013 UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD PARK KYEONG-MI
K133268 10/24/2013 TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS SCHUTZ-DENTAL GMBH MICHAEL WIERZ
K133344 10/30/2013 MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS SEBIA KAREN ANDERSON
K133325 10/29/2013 BLUE NITRILE POWDER FREE EXAM GLOVES SHANDONG XINSHI MEDICAL PRODUCTS CO., LTD. RAY ZHOU
K133307 10/28/2013 BLACK NITRILE POWDER FREE EXAM GLOVES SHANDONG YUANHANG MEDICAL PRODUCTS CO., LTD. RAY ZHOU
K133201 10/17/2013 SHASER V-MINI 2 HAIR REMOVAL SYSTEM SHASER, INC. ANTHONY BURNS
K133320 10/28/2013 SICAT FUNCTION SICAT GMBH & CO. KG MANFRED BREUER
K133156 10/17/2013 ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA Siemens Healthcare Diagnostics Inc. PHILIP LIU
K133226 10/21/2013 BIOGRAPH MMR SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
K133259 10/23/2013 YSIO MAX SIEMENS MEDICAL SOLUTIONS USA, INC. DARREN DORMAN
K133348 10/30/2013 STIM PROBE SPES MEDICA S.R.L. GIORGIO FACCO
K133218 10/18/2013 Crystal «; Mosaic «; Vertu « SPINAL ELEMENTS, INC. JULIE LAMOTHE
K133207 10/18/2013 STAXX(R) SYSTEM SPINE WAVE, INC. JOSEPH MERCADO
K133153 10/17/2013 SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM SPINEFRONTIER, INC. PAUL L SPEIDEL
K133340 10/30/2013 SPINEWORKS ANTERIOR LUMBAR DEVICE SPINEWORKS, LLC ROBERT POGGIE, PHD
K133137 10/11/2013 CISNAP CLOSED INCISION SYSTEM SPIRACUR, INC. LORI E ADELS, PH.D.
K133322 10/29/2013 STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR STERITEC PRODUCTS MFG., CO., INC. JONATHAN RUTIGLIANO
K133285 10/25/2013 STRYKER TEMPORARY CONDYLAR PROSTHESIS Stryker JAMSHED BADARPURA
K133328 10/29/2013 AERO-AL LUMBAR CAGE SYSTEM STRYKER CORPORATION TIFFANI ROGERS
K133188 10/17/2013 MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL STRYKER SPINE SORAYA KING
K133238 10/21/2013 CONTOUR I V3.1 SYSTEM SYNERON MEDICAL LTD JANICE M HOGAN
K133202 10/17/2013 HEM-O-LOK LIGATING CLIP TELEFLEX MEDICAL ASHLEA RICCI
K133173 10/17/2013 RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET Teleflex Medical, Inc. LORI PFOHL
K133280 10/25/2013 TERUMO SURFLO I.V. CATHETER TERUMO (PHILIPPINES) CORPORATION PHILLIP LESTER
K133151 10/17/2013 SARNS HIGH FLOW AORTIC ARCH CANNULA TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K133244 10/22/2013 TAMPAX M PLASTIC TAMPONS, UNSCENTED THE PROCTER & GAMBLE COMPANY KATHLEEN BLIESZNER, PH.D.
K133260 10/23/2013 MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM TIANJIN EMPECS MEDICAL DEVICE CO., LTD. Priscilla Chung
K133305 10/28/2013 RHYTHM VIEW WORKSTATION TOPERA, INC. DENNIS POZZO
K133277 10/24/2013 XARIO 100 TOSHIBA MEDICAL SYSTEMS CORPORATION CHARLEMAGNE CHUA
K133324 10/29/2013 SURESUBTRACTION LUNG TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN PAUL BIGGINS
K133166 10/17/2013 INS HILDEN TIBIAL ARZZT TRUEMED GROUP, LLC RHONDA ALEXANDER
K133191 10/17/2013 PROBEAM PROTON THERAPY SYSTEM VARIAN MEDICAL SYSTEMS VY TRAN
K133331 10/29/2013 4D INTEGRATED TREATMENT CONSOLE VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K133247 10/22/2013 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K133227 10/21/2013 SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K133240 10/21/2013 VARIAN MULTILEAF COLLIMATOR VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K133237 10/21/2013 GEL-BEAD EMBOLIZATION SPHERES VASCULAR SOLUTIONS, INC. ELLIE GILLESPIE
K133334 10/29/2013 VERITRACT ENTERAL FEEDING TUBE SYSTEM VERITRACT, INC. TIM NIEMAN
DEN130044 10/25/2013 INFLOW INTRAURETHRAL VALVE-PUMP VESIFLO, INC. KEVIN M CONNOLLY
K133139 10/17/2013 VIZION ULTRA VIZTEK LLC DANIEL KAMM, P.E.
K133323 10/29/2013 VOLCANO IFR MODALITY VOLCANO CORPORATION NEETA SHARMA
K133142 10/17/2013 VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION VOLCANO CORPORATION ELAINE ALAN
K133168 10/17/2013 DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE WRP ASIA PACIFIC SDN. BHD. KIRK PENNER
K133212 10/18/2013 ZELTIQ COOLSCULPTING SYSTEM ZELTIQ AESTHETICS, INC. SHRUTI JAYAKUMAR
K133327 10/29/2013 SATURNO(TM) OVERDENTURE IMPLANT SYSTEM ZEST ANCHORS, LLC LINDA SCHULZ
K133339 10/30/2013 ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED ZIMMER DENTAL INC. JULIE L CORMAN
K133184 10/17/2013 ARDIS INTERBODY SYSTEM ZIMMER SPINE, INC MICHELLE LENZ
K133164 10/17/2013 DYNESYS TOP-LOADING SPINAL SYSTEM ZIMMER SPINE, INC MICHELLE LENZ
K133291 10/25/2013 ST360 DEGREES SPINAL FIXATION SYSTEM ZIMMER SPINE, INC MICHELLE LENZ
K133246 10/22/2013 ZIMMER DISTAL RADIUS PLATING SYSTEM ZIMMER, INC. ROMIL SHETH
K133239 10/21/2013 ZOLL E SERIES ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS TANMAY B SHUKLA
K133269 10/24/2013 ZOLL X SERIES ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS TANMAY B SHUKLA
K133206 10/17/2013 Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM ZUMA DENTAL, LLC ALBERT REGO


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact