FDA 510(k) Applications Received During October, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K123085 10/01/2012 FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE 3M COMPANY LISA NELSON
K123225 10/15/2012 BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 AAP BIOMATERIALS GMBH & CO. KG VOLKER STIRNAL
K123081 10/01/2012 BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 AAP BIOMATERIALS GMBH & CO. KG VOLKER STIRNAL
K123089 10/01/2012 FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 ABBOTT LABORATORIES DAVID G LAMBERT
K123279 10/22/2012 MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN Abbott Vascular SUZANNE REDMAN
K123067 10/01/2012 PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY ABBOTT VASCULAR INC. SEAN MULLIN
K123349 10/31/2012 A-SCAN PLUS CONNECT ACCUTOME, INC. ADAM PICKHOLTZ
K123115 10/03/2012 ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P ACME FILTER MASK INC. JEN KE-MIN
K123354 10/31/2012 REVITIVE IX Actegy Ltd JOHN J SMITH
K123133 10/04/2012 BARLE TISSUE ADHESIVE ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD MICHAEL BROWNE
K123352 10/31/2012 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K123102 10/02/2012 SOVEREIGN MINI AESCULAP, INC. DENISE ADAMS
K123216 10/15/2012 AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN AIMAGO SA MARC ANDRE
K123308 10/24/2012 PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM ALBAHEALTH, L.L.C. PATRICK FRANK
K123120 10/03/2012 LENSX LASER SYSTEM ALCON LENSX, INC. JUDY GORDON, DVM
K123322 10/26/2012 ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC HYMAN KATZ PH.D.
K123128 10/04/2012 SERI SURGICAL SCAFFOLD ALLERGAN CONNIE GARRISON
K123218 10/15/2012 ILLICO FS FACET FIXATION SYSTEM ALPHATEC SPINE, INC. TREVOR DENBO
K123135 10/05/2012 AXERA 2 ACCESS SYSTEM MODEL AXE200 ARSTASIS, INC. DEBRA COGAN
K123268 10/19/2012 SMARTSTITCH PERFECTPASSER SYSTEM ARTHOCARE CORPORATION CHERYL FREDERICK
K123241 10/17/2012 ARTHREX FRACTURE PLATES ARTHREX, INC. COURTNEY SMITH
K123341 10/31/2012 ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON ARTHREX, INC. CHRISTINA FLORES
K123353 10/31/2012 CIQ CONTROLLER, CIQ WANDS ARTHROCARE CORPORATION MITCHELL DHORITY
K123240 10/16/2012 SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT ARTHROCARE CORPORATION CHERYL FREDERICK
K123139 10/05/2012 ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES ASI MEDICAL, INC. JOHN MCPEEK
K123248 10/17/2012 CPR RSQ ASSIST AVANTECH, INC. STEVEN B DATLOF
K123099 10/02/2012 Best-AV2 Pro-Sport(tm) AVAZZIA, INC. TAMMY LAHUTSKY
K123254 10/18/2012 ULTRASOUND SCANNER FLEX FOCUS B-K MEDICAL APS RANDI HAUERBERG
K123300 10/23/2012 BD PEN NEEDLE BECTON DICKINSON & CO. PASQUALE AMATO
K123213 10/15/2012 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE BECTON DICKINSON & CO. JOHN ROBERTS
K123266 10/19/2012 BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN Becton, Dickinson and Company MONICA E GIGUERE
K123198 10/11/2012 LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA Bio-Rad Laboratories SUZANNE PARSONS
K123061 10/01/2012 ACE MONOPOLAR ATTACHMENT BIOECONEER INC. MICHAEL LEE
K123297 10/22/2012 COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM BIOMET MANUFACTUTING CORP. PATRICIA BERES
K123228 10/15/2012 INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) BIOSPACE CORPORATION LIMITED DANIEL KAMM
K123324 10/26/2012 SELECTRA 7F CATHETERS BIOTRONIK, INC. Jon Brumbaugh
K123338 10/31/2012 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL Rebecca K Pine
K123214 10/15/2012 ENCORE 26 ADVANTAGE KIT BOSTON SCIENTIFIC CORP. RACHEL OWENS
K123179 10/09/2012 AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING C.R. BARD, INC. MICHELE DAVIS
K123337 10/31/2012 VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM CALDERA MEDICAL VICKI GAIL
K123186 10/11/2012 RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 CALGARY SCIENTIFIC, INC. KYLE PETERSON
K123208 10/12/2012 DIGITAL RETINAL CAMERA CANON, INC.-MEDICAL EQUIPMENT GROUP IZUMI MARUO
K123217 10/15/2012 CARDEASCREEN CARDEA ASSOCIATES INC DAVID M HADLEY
K123289 10/22/2012 DURABLUE STERILIZATION WRAP CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES LAVENIA FORD
K123065 10/01/2012 CATHETER CONNECTIONS DUALCAP SOLO CATHETER CONNECTIONS, INC. DONALD D SOLOMON
K123258 10/18/2012 THE ADVANCE CATHETER FOR HSG AND SIS CATHETER RESEARCH, INC. BABACAR DIOUF
K123191 10/11/2012 XPERT FLU CEPHEID RUSSEL K ENNS
K123080 10/01/2012 CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS CHEMTRON BIOTECH, INC. Jane Zhang
K123122 10/04/2012 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) CLEVELAND CLINIC STEPHEN J PEOPLES, VMD, MS
K123281 10/22/2012 ACCULIF TL-PEEK CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K123260 10/18/2012 DETACHATIP III CONMED CORPORATION LISA ANDERSON
K123175 10/09/2012 DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 CONMED CORPORATION ANNA D'LIMA
K123235 10/16/2012 EQUAFLOW MULTIVALVE INFUSION CATHETER COOK INCORPORATED AMBER BROWN
K123202 10/12/2012 PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS COOPERVISION, INC. KARIN GASTINEAU
K123109 10/04/2012 ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE COVIDIEN RENEE BORGESANO
K123083 10/01/2012 COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT COVIDIEN STACEY A STRAND
K123196 10/11/2012 PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH COVIDIEN JENNIFER SULLIVAN
K123066 10/01/2012 ACCUMESH DEPLOYMENT SYSTEM Covidien LLC ELIZABETH MCMENIMAN
K123318 10/25/2012 IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H SARAH RIZK
K123211 10/12/2012 A5 ANESTHESIA DELIVERY SYSTEM DATASCOPE CORP., PATIENT MONITORING DIVISION RUSSELL OLSEN
K123125 10/04/2012 GE DATEX-OHMEDA AVANCE CS2 DATEX-OHMEDA, INC. JAMES P RASKOB
K123209 10/12/2012 SOFTVUE DELPHINUS MEDICAL TECHNOLOGIES, INC ANDREA N WALLEN
K123259 10/18/2012 MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM DEVICOR MEDICAL PRODUCTS, INC. SHAWNA M ROSE
K123188 10/11/2012 DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC DORNOCH MEDICAL SYSTEMS, INC. LARRY SMITH
K123263 10/18/2012 HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS ECKERT & ZIEGLER BEBIG GMBH HUB VAN DE BERGH
K123249 10/17/2012 DIAGNOSTIC ULTRASOUND SYSTEM EDAN INSTRUMENTS, INC. RANDY JIANG
K123298 10/23/2012 FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC. DANNETTE CROOMS
K123303 10/23/2012 FEMORAL ACCESS VENOUS CANNULAE EDWARDS LIFESCIENCES, LLC. DANNETTE CROOMS
K123187 10/11/2012 RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA EDWARDS LIFESCIENCES, LLC. KAREN JONES
K123084 10/01/2012 DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD ELCAM MEDICAL A.C.A.L. AHARON COHEN
K123366 10/31/2012 SURGITRON 4.0 DUAL RF S5-IEC ELLMAN INTERNATIONAL, INC. Alison Sathe
K123257 10/18/2012 EMVERA DIOLUX EMVERA TECHNOLOGIES, INC.
K123223 10/15/2012 EC SINGLE USE, POLYPECTOMY SNARE ENDOCHOICE, INC. SHOSHANA FRIEDMAN
K123151 10/09/2012 ENDOSEE MODEL 8000 U-SCOPE ENDOSEE CORP XIAOLONG(BRUCE) OUYANG
K123237 10/16/2012 ZERONA 2.0 LASER ERCHONIA CORPORATION Kevin Walls
K123234 10/15/2012 ERMIS STERILIZATION CONTAINER SYSTEM ERMIS MEDIZINTECHNIK ANDRE WEINGERL
K123141 10/05/2012 ENSEAL TRIO TISSUE SEALING DEVICE ETHICON ENDO-SURGERY, LLC EMILY KREUTZKAMP
K123212 10/15/2012 ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS ETHICON ENDO-SURGERY, LLC LIPING WU
K123114 10/03/2012 ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE ETHICON, INC. SUSAN LIN
K123261 10/18/2012 EUROIMMUN ANTI-NRNP/SM ELISA (IGG) EUROIMMUN US KATHRYN KOHL
K123342 10/31/2012 OPTETRAK LOGIC CRC TIBIAL INSERT EXACTECH, INC. PATRICK HUGHES
K123079 10/01/2012 OLYMPIC BRAINZ MONITOR EXCEL-TECH LTD. (XLTEK) DANIEL RAMIREZ
K123361 10/31/2012 ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM FIAB SPA FRANCESCO BATISTINI
K123169 10/09/2012 ORALID FORWARD SCIENCE LLC BRIAN PIKKULA
K123262 10/18/2012 OPTIFLUX ULTRA DIALYZER FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K123255 10/18/2012 G.HLAMP G.TEC MEDICAL ENGINEERING GMBH CHRISTOPH GUGER
K123174 10/10/2012 CENTRICITY PACS-IW WITH UNIVERSAL VIEWER GE HEALTHCARE CHERYL BORK
K123327 10/26/2012 1.5T GEM RT OPEN ARRAY GE HEALTHCARE COILS (USA INSTRUMENTS INC.) ANDREW MENDEN
K123195 10/11/2012 CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES GE HEALTHCARE FINLAND OY RAUNO RUOHO
K123144 10/05/2012 VIVO 50 GE HEALTHCARE, BREAS MEDICAL AB SHLOMI DELER
K123238 10/16/2012 ACHILLES GE MEDICAL SYSTEMS CHINA CO., LTD. LIU ZHAO
K123068 10/01/2012 OPTIMA MR 430S GE MEDICAL SYSTEMS, LLC YUAN MA
K123274 10/19/2012 PROGASTRO SSCS ASSAY GEN-PROBE PRODESSE, INC. KAREN HARRINGTON
K123090 10/01/2012 GLB BENECHECK PREMIUM GLU MONITORING SYSTEM GENERAL LIFE BIOTECHNOLOGY CO., LTD. Feng-Yu Lee
K123136 10/05/2012 GENESIS HEALTH RECORD SYSTEM, (GHRS) GENESIS HEALTH TECHNOLOGIES KATHLEEN JOHNSON
K123231 10/16/2012 CALIBER SPACERS GLOBUS MEDICAL INC. CHRISTINA KICHULA
K123193 10/11/2012 IPM WOUND GEL BIO GLYCOBIOSCIENCES, INC KEVIN DRIZEN
K123113 10/03/2012 L.A.M. IMP WOUND GEL GLYCOBIOSCIENCES, INC JAMES JOHNSON
K123073 10/01/2012 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K123076 10/01/2012 PROFTHAND MECHANICAL WHEELCHAIR HARMONY HILL INTERNATIONAL TINA LAI
K123077 10/01/2012 VASCULAR CLAMPS HEBU MEDICAL GMBH ANGELIKA SCHERP
K123316 10/25/2012 HEINE OMEGA 500 HEINE OPTOTECHNIK GMBH & CO. KG. JORG RONNAU
K123278 10/22/2012 IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF HERAEUS KULZER, LLC JAMIE MEARNA
K123171 10/09/2012 ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT HORIBA ABX S.A.S. CAROLINE FERRER
K123166 10/09/2012 TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P HOWMEDICA OSTEONICS CORP AUDREY WITKO
K123302 10/23/2012 IB CLINIC IMAGING BIOMETRICS, LLC MIKE SCHMAINDA
K123253 10/17/2012 IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K123230 10/15/2012 MOSAIQ ONCOLOGY INFORMATION SYSTEM IMPAC MEDICAL SYSTEMS, INC. KATHRYN STINSON
K123091 10/02/2012 VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T IMRIS, INC. Sanjay Shah
K123108 10/03/2012 TVC IMAGING SYSTEM MODEL NIRS-MC7-70 Infraredx, Inc. STEVEN J CHARTIER
K123111 10/03/2012 V8 TRANSLUMINAL BAV CATHETER INTERVALVE, INC JULIE BODMER
K123229 10/15/2012 REMOTE PRESENCE SYSTEM, MODEL RP-VITA INTOUCH HEALTH, INC. STEVE SIDWELL
K123264 10/18/2012 DK-PTCA BALLOON CATHETER INTUIT MEDICAL, LLC JACK C GRIFFIS
K123329 10/26/2012 DA VINVI SURGICAL SYSTEM INTUITIVE SURGICAL, INC. CINDY DOMECUS
K123330 10/26/2012 IOGYN ENDOSCOPE IOGYN, INC. Mary J Edwards
K123158 10/09/2012 ION MAGNUM GENIUS ION GENIUS INC XANYA SOFRA-WEISS
K123304 10/24/2012 SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO IVOCLAR VIVADENT AG DONNA M HARTNETT
K123100 10/02/2012 INTESS LUMBAR CAGE KALITEC DIRECT, LLC J D WEBB
K123172 10/09/2012 KOGENT BIPOLAR FORCEPS KATALYST SURGICAL, LLC MONA DEAN
K123344 10/31/2012 K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) KAWASUMI LABORATORIES, INC. CHRISTINA HENZA
K123267 10/19/2012 SURFFLASH(R) PLUS SAFETY I.V. CATHETER KOFU FACTORY OF TERUMO CORP. SANDI HARTKA
K123219 10/15/2012 URGOCLEAN ABSORBENT WOUND DRESSING LABORATOIRES URGO SOPHIE FORTIN
K123177 10/09/2012 STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM LASERSTIM, INC. DAVID C FURR
K123134 10/05/2012 EASYSPINE SYSTEM LDR SPINE USA INC. MARITZA ELIAS
K123332 10/26/2012 NAOMI-CT LK CONSULTING GROUP Priscilla Chung
K123127 10/04/2012 VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 MAINE STANDARDS CO. JAMES W CHAMPLIN
K123288 10/22/2012 HEMOCONCENTRATOR MAQUET CARDIOPULMONARY AG INGRID RICHTER
K123149 10/05/2012 SERVO-I VENTILATOR SYSTEM MAQUET CRITICAL CARE AB WHITNEY TORNING
K123206 10/12/2012 MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM MAXIM SURGICAL CHRIS REEG
K123325 10/26/2012 Medafor Direct Gas-Assisted Application System MEDAFOR, INC. MELISSA YOUNG
K123292 10/22/2012 T3 MEDCOMP TIMOTHY HOLWICK
K123138 10/05/2012 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL LAURE AVIRON-VIOLET
K123095 10/02/2012 MEDLINE BLOOD PRESSURE TRANSDUCER MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K123167 10/09/2012 DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM MEDOS INTERNATIONAL SARL EUGENE BANG
K123350 10/31/2012 ECLIPSE SOFT TISSUE FASTENER MEDSHAPE, INC JACK C GRIFFIS III
K123201 10/12/2012 AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER MEDTRONIC ADVANCED ENERGY, LLC JANET KWIATKOWSKI
K123314 10/25/2012 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE MEDTRONIC INC. MARY E DONLIN
K123153 10/09/2012 ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT MEDTRONIC IRELAND DEIRDRE MCMAHON
K123351 10/31/2012 AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE MEDTRONIC PERFUSION SYSTEMS JULIA A NELSON
K123246 10/17/2012 CD HORIZON SPIRE Z SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK JULIE BASSETT
K123270 10/19/2012 POWEREASE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. JULIE BASSETT
K123358 10/31/2012 PACIFIC PLUS MEDTRONIC VASCULAR DIANA JOHNSON
K123276 10/19/2012 MM-SEAL MICRO-MEGA SOCIETE ANONYME PHILIPPE CONCHE
K123271 10/19/2012 ABBOTT PHENOBARBITAL ASSAY MICROGENICS CORP. KAREN LEE
K123343 10/31/2012 THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS MICROGENICS CORP. KAREN LEE
K123197 10/11/2012 VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) NANOSPHERE, INC MARK DEL VECCHIO
K123272 10/19/2012 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM NEOCOIL, LLC KATIE GONZALEZ
K123280 10/22/2012 NEOCLOSE HASSON, NEOCLOSE UNIVERSAL NEOSURGICAL LTD ORLA BRENNAN
K123082 10/01/2012 MOBILECT VIEWER NEPHOSITY, INC. MICHAEL PAN
K123163 10/09/2012 NEUROPACE BURR HOLE COVER MODEL 8110 NEUROPACE INC ISABELLA ABATI
K123328 10/22/2012 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK NITRILIST GLOVES MANUFACTURING SDN BHD LAU SIONG HUT
K123306 10/24/2012 NORDIC TUMOREX NORDICNEUROLAB CHANDANA G BHANDARI
K123347 10/31/2012 NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 NORMED MEDIZIN-TECHNIK GMBH DAVID C FURR
K123194 10/11/2012 JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 NORTH AMERICAN RESCUE PRODUCTS, INC. WILLIAM SLEVIN
K123339 10/31/2012 TK1 TOTAL KNEE SYSTEM NOVOSOURCE INC JAMES PINKSTON
K123045 10/01/2012 BRIGADE STANDALONE SYSTEM NUVASIVE, INC. Cynthia Adams
K123307 10/24/2012 NUVASIVE NVM5 SYSTEM NUVASIVE, INC. Sheila Bruschi
K123309 10/24/2012 GIRAFFE AND PANDA WARMERS OHMEDA MEDICAL AGATA ANTHONY
K123359 10/31/2012 OVS1 VIDEO SYSTEM OLIVE MEDICAL CORP. BRIAN DEAN
K123365 10/31/2012 OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 OLYMPUS MEDICAL SYSTEMS CORP. SHERI L MUSGNUNG
K123317 10/25/2012 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N OLYMPUS MEDICAL SYSTEMS CORPORATION SHERI L MUSGNUNG
K123319 10/26/2012 GYRUS ACMI BICOAG HEMOSTASIS PROBE OLYMPUS SURGICAL TECHNOLOGIES AMERICA NEIL KELLY
K123170 10/09/2012 VARI-PASS VARIABLE LENGTH ACCESS SHEATH OLYMPUS SURGICAL TECHNOLOGIES AMERICA DEANA BOUSHELL
K123357 10/31/2012 ONQ RTS ONCOLOGY SYSTEMS, INC. CARL WALKER
K123118 10/03/2012 INSIGNIA DIGICAST ORMCO CORP. Wendy Garman
K123243 10/17/2012 HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC. Howard Schrayer
K123203 10/12/2012 MAXLOCK EXTREME SYSTEM MODEL MXL ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K123207 10/12/2012 PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM OSTEOMED LP PIEDAD PENA
K123148 10/05/2012 PARACE MD EKOSCOPE IS100 PARACE LLC VANDETTE CARTER
K123326 10/26/2012 SHERPA PAK CARDIAC TRANSPORT SYSTEM PARAGONIX TECHNOLOGIES, INC. LEO BASTA
K123290 10/22/2012 M300 & M400 PERMOBIL AB JAN ASTROM
K123275 10/19/2012 IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM PHADIA AB MARTIN MANN
K123265 10/19/2012 RMGI LOW VISCOSITY PULPDENT CORPORATION KENNETH J BERK
K123071 10/01/2012 VASHE SKIN AND WOUND HYDROGEL PURICORE, INC. ART MORSE
K123072 10/01/2012 VASHE WOUND THERAPY SOLUTION PURICORE, INC. ART MORSE
K123168 10/09/2012 Q-PLUS T+ IPL LASER SYSTEM Quanta System SpA Maurizio Bianchi
K123355 10/31/2012 AMPLIVUE C. DIFFICILE ASSAY QUIDEL CORPORATION Ronald H Lollar
K123311 10/25/2012 QXMEDICAL ACCESS & SUPPORT CATHETER QXMEDICAL, LLC FERNANDO DI CAPRIO
K123345 10/31/2012 DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA RAYENCE CO., LTD DAVE KIM
K123348 10/31/2012 CLEAR ALIGNER ADHESIVE RELIANCE ORTHODONTIC PRODUCTS, INC. PAULA WENDLAND
K123154 10/09/2012 ARTAS SYSTEM FROM RESTORATION ROBOTICS RESTORATION ROBOTICS, INC JIM TALBOT
K123356 10/31/2012 FORTIVA PORCINE DERMIS RTI BIOLOGICS, INC. ESTHER CARBON
K123226 10/15/2012 LESSRAY SAFERAY SPINE, LLC Calley Herzog
K123106 10/02/2012 DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A SAMSUNG ELECTRONICS CO., LTD. CHARLIE MACK
K123098 10/02/2012 XGEO GC80 SAMSUNG ELECTRONICS CO., LTD. CHARLIE MACK
K123105 10/02/2012 XGEO GU60 SAMSUNG ELECTRONICS CO., LTD. CHARLIE MACK
K123182 10/10/2012 OSOM INFLUENZA A&B TEST MODEL 190 SEKISUI DIAGNOSTICS, LLC MARK STAVRO
K123126 10/04/2012 MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) SHANGHAI MOTEX HEALTHCARE CO., LTD. JEN KE-MIN
K123185 10/10/2012 DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD ZHAI PEI
K123074 10/01/2012 IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K123155 10/09/2012 LUNA DENTAL IMPLANT SYSTEM SHINHUNG MST CO., LTD SUNBYUNG LEE
K123119 10/03/2012 CERARESIN BOND SHOFU DENTAL CORPORATION DAVID P MORAIS
K123320 10/26/2012 DIMENSION AMMONIA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS ROSE T MARINELLI
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