FDA 510(k) Applications Received During October, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K123314 10/25/2012 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE MEDTRONIC INC. MARY E DONLIN
K123085 10/16/2012 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
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 10/17/2012 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 10/31/2012 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
K123048 10/17/2012 PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
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
K123120 10/10/2012 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 10/31/2012 ILLICO FS FACET FIXATION SYSTEM ALPHATEC SPINE, INC. TREVOR DENBO
K123135 10/22/2012 AXERA 2 ACCESS SYSTEM MODEL AXE200 ARSTASIS, INC. DEBRA COGAN
K123268 10/19/2012 SMARTSTITCH PERFECTPASSER SYSTEM ARTHOCARE CORPORATION CHERYL FREDERICK
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
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
K123021 10/03/2012 BIOPLEX 2200 EBV IGM KIT BIO-RAD LABORATORIES JUANG WANG
K123198 10/25/2012 LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA BIO-RAD LABORATORIES SUZANNE PARSONS
K123061 10/25/2012 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 10/30/2012 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 10/22/2012 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 10/16/2012 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 10/25/2012 CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS CHEMTRON BIOTECH, INC. JANE ZHANG
K123122 10/22/2012 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) CLEVELAND CLINIC STEPHEN J PEOPLES, VMD, MS
K123260 10/22/2012 DETACHATIP III CONMED CORPORATION LISA ANDERSON
K123175 10/31/2012 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
K122940 10/09/2012 ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 COOK, INC. ELYSIA EASTON
K122917 10/09/2012 CODA BALLOON CATHETER COOK, INC. ELYSIA EASTON
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
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
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 10/16/2012 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
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 10/17/2012 DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD ELCAM MEDICAL A.C.A.L. AHARON COHEN
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 10/31/2012 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 10/05/2012 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 10/25/2012 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 10/31/2012 ACHILLES GE MEDICAL SYSTEMS CHINA CO., LTD. LIU ZHAO
K123068 10/16/2012 OPTIMA MR 430S GE MEDICAL SYSTEMS, LLC YUAN MA
K123274 10/19/2012 PROGASTRO SSCS ASSAY GEN-PROBE PRODESSE, INC. KAREN HARRINGTON
K123090 10/23/2012 GLB BENECHECK PREMIUM GLU MONITORING SYSTEM GENERAL LIFE BIOTECHNOLOGY CO., LTD. FENG-YU LEE
K123136 10/16/2012 GENESIS HEALTH RECORD SYSTEM, (GHRS) GENESIS HEALTH TECHNOLOGIES KATHLEEN JOHNSON
K113126 10/15/2012 ACRYLIC HERBST APPLIANCE GERGENS ORTHODONTIC LAB KAREN E WARDEN, PHD
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
K123316 10/25/2012 HEINE OMEGA 500 HEINE OPTOTECHNIK GMBH & CO. KG. JORG RONNAU
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
K123091 10/10/2012 VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T IMRIS, INC. SANJAY SHAH
K123108 10/17/2012 TVC IMAGING SYSTEM MODEL NIRS-MC7-70 INFRAREDX, INC. STEVEN J CHARTIER
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
K123304 10/25/2012 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 10/11/2012 INTESS LUMBAR CAGE KALITEC DIRECT, LLC J D WEBB
K122983 10/17/2012 KSEA BIPOLAR ELECTRODE KARL STORZ ENDOSCOPY-AMERICA, INC. WINKIE WONG
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
K123332 10/26/2012 NAOMI-CT LK CONSULTING GROUP PRISCILLA CHUNG
K123288 10/22/2012 HEMOCONCENTRATOR MAQUET CARDIOPULMONARY AG INGRID RICHTER
K123206 10/12/2012 MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM MAXIM SURGICAL CHRIS REEG
K123325 10/26/2012 ARISTA DIRECT GAS-ASSISTED APPLICATION SYSTEM MEDAFOR, INC. MELISSA YOUNG
K123292 10/22/2012 T3 MEDCOMP TIMOTHY HOLWICK
K123095 10/11/2012 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
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
K123271 10/19/2012 ABBOTT PHENOBARBITAL ASSAY 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 10/05/2012 MOBILECT VIEWER NEPHOSITY, INC. MICHAEL PAN
K123163 10/11/2012 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
K123194 10/25/2012 JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 NORTH AMERICAN RESCUE PRODUCTS, INC. WILLIAM SLEVIN
K123013 10/09/2012 ENDOSCOPIC INTRODUCER NOVADAQ TECHNOLOGIES, INC. TIM VERSPAGEN
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
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 C350 PERMOBIL AB JAN ASTROM
K123275 10/19/2012 IMMUNOCAP ALLERGEN I3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN 14, PAPER WASP VENOM PHADIA AB MARTIN MANN
K123265 10/19/2012 RMGI LOW VISCOSITY PULPDENT CORPORATION KENNETH J BERK
K123071 10/09/2012 VASHE SKIN AND WOUND HYDROGEL PURICORE, INC. ART MORSE
K123072 10/09/2012 VASHE WOUND THERAPY SOLUTION PURICORE, INC. ART MORSE
K123168 10/09/2012 Q-PLUS T+ IPL LASER SYSTEM QUANTA SYSTEM SPA MAURIZIO BIANCHI
K123311 10/25/2012 QXMEDICAL ACCESS & SUPPORT CATHETER QXMEDICAL, LLC FERNANDO DI CAPRIO
K123154 10/23/2012 ARTAS SYSTEM FROM RESTORATION ROBOTICS RESTORATION ROBOTICS, INC JIM TALBOT
K123356 10/31/2012 FORTIVA PORCINE DERMIS RTI BIOLOGICS, INC. ESTHER CARBON
K123106 10/16/2012 DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A SAMSUNG ELECTRONICS CO., LTD. CHARLIE MACK
K123098 10/16/2012 XGEO GC80 SAMSUNG ELECTRONICS CO., LTD. CHARLIE MACK
K123105 10/16/2012 XGEO GU60 SAMSUNG ELECTRONICS CO., LTD. CHARLIE MACK
K123182 10/10/2012 OSOM INFLUENZA A&B TEST MODEL 190 SEKISUI DIAGNOSTICS, LLC MARK STAVRO
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 10/15/2012 IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
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
K123321 10/26/2012 DIMENSION CHEMISTRY III CALIBRATORY SIEMENS HEALTHCARE DIAGNOSTICS ROSE T MARINELLI
K123269 10/19/2012 PROCEDURE REHEARSAL STUDIO SIMBIONIX LTD. SHOSHANA FRIEDMAN
K123184 10/10/2012 FINN CHAMBERS AQUA SMART PRACTICE KIM SULLIVAN
K123161 10/15/2012 SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE SMARTGUARD, INC. SHELLY GARG
K123159 10/09/2012 SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS SMITH & NEPHEW, INC. MARTIN OSTMANN
K123093 10/02/2012 STABILINK MIS SPINAL FIXATION SYSTEM SOUTHERN SPINE, LLC JULIE STEPHENS
K123164 10/22/2012 SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM SPINEFRONTIER, INC. FREDY H VARELA
K123232 10/16/2012 SPINEOLOGY SPINOUS PROCESS PLATE SPINEOLOGY, INC. BRYAN BECKER
K123299 10/23/2012 MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS ST. JUDE MEDICAL NEUROMODULATION TERRINA WILDER, RAC
K123096 10/02/2012 REPROCESSED VESSEL SEALER STERILMED, INC. JASON SKRAMSTED
K123178 10/23/2012 STRYKER VENOM ELECTRODES AND CANNULAE STRYKER INSTRUMENTS, INSTRUMENTS DIV. CHRISTINA MCKEE
K123334 10/26/2012 REPROCESSED STEERABLE INTRODUCER STRYKER SUSTAINABILITY SOLUTIONS, INC. AMANDA BABCOCK
K123335 10/26/2012 SUNRAY FETAL MONITOR SUNRAY MEDICAL APPARATUS CO., LTD. SABRINA WEI
K123110 10/15/2012 PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 SURGICAL INNOVATIONS PLC TRACEY FEARNLEY
K123180 10/23/2012 FALCON SPACER SYNTHES (USA) PRODUCTS LLC MONIKA MCDOLE-RUSSELL
K123205 10/12/2012 ESOPHAGEAL TTS STENT TAEWOONG MEDICAL CO., LTD CALLEY HERZOG
K123176 10/10/2012 ISO-GARD CLEARAIR MASK TELEFLEX MEDICAL, INC. ANGELA BOUSE
K123273 10/19/2012 HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) TEMREX CORP. HABIB LAFIR
K123256 10/18/2012 HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS THE BINDING SITE GROUP, LTD. JILL CONSTANTINE
K123092 10/25/2012 CERAMIN BRACKETS Z TOMY, INC. CAROLYN PRIMUS
K123094 10/25/2012 ORTHODONTIC CERAMIC BRACKETS TOMY, INC. CAROLYN PRIMUS
K123056 10/09/2012 PASCAL LASER INDIRECT OPHTHALMOSCOPE TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS) PAMELA M BUCKMAN
K123101 10/04/2012 TRC-50DX RETINAL CAMERA TOPCON MEDICAL SYSTEMS, INC. MAUREEN O'CONNELL
K123295 10/22/2012 RHYTHM VIEW TOPERA, INC. MELISSA WALKER
K123097 10/10/2012 DOSE TRACKING SYSTEM MODEL XIDF-DTS801 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K123131 10/26/2012 ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI TOSOH BIOSCIENCE, INC. ROBERT L WICK
K123282 10/22/2012 DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS ULTRAPURE & INDUSTRIAL SERVICES LLC GREG FRANKS
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