FDA 510(k) Applications Received During August, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K122467 08/13/2012 3M TRUE DEFINITION SCANNER 3M COMPANY GINGER CANTOR
K122569 08/23/2012 LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR 3M COMPANY GINGER CANTOR
K122573 08/23/2012 HI-TORQUE COMMAND GUIDE WIRE FAMILY ABBOTT VASCULAR INC. KAY SETZER
K122449 08/13/2012 ENTERAL NUTRITION WARMER ACACIA, INC. FERGIE FERGUSON
K122538 08/21/2012 ACUMED PELVIC BONE PLATE SYSTEM ACUMED LLC KARA BUDOR
K122446 08/10/2012 LIQUIDBAND FLOW CONTROL ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD MICHAEL BROWNE
K122623 08/28/2012 SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ALLYSON PARKS
K122353 08/03/2012 CRAINFIX 2 TITANIUM CLAMP SYSTEM AESCULAP, INC. DENISE ADAMS
K122333 08/02/2012 MOBILECARE MONITOR AFRAME DIGITAL, INC. JILL THORPE
K122350 08/03/2012 TAP PAP NASAL PILLOW MASK AIRWAY MANAGEMENT, INC. PAUL DRYDEN
K122302 08/01/2012 ACE MAGNESIUM REGENT ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC HYMAN KATZ
K122356 08/03/2012 ALIVECOR HEART MONITOR FOR IPHONE ALIVECOR, INC. MICHAEL RIGHTER
K122501 08/16/2012 AEI DR. TERAUCHI ULTRASONIC TIPS AMERICAN EAGLE INSTRUMENTS, INC. KRISTEN SCHALLIOL
K122685 08/31/2012 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. KIMBERLEY KLINE
K122477 08/14/2012 LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS LLC DONNA DIGANGI
K122476 08/14/2012 LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT ANSELL HEALTHCARE PRODUCTS, LLC DONNA DI GANGI
K122619 08/28/2012 EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET APPLIED MEDICAL JESSICA CHO
K122554 08/21/2012 GENASIS SCANVIEW SYSTEM APPLIED SPECTRAL IMAGING, LTD. ILAN SHARON
K122415 08/08/2012 X-FIX DYNAMIC EXTERNAL DISTRACTOR AREX USA LLC CHARLES HOKANSON
K122330 08/02/2012 FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE ARJOHUNTLEIGH POLSKA SP Z.O.O. DAVID MOYNHAM
K122545 08/21/2012 CG+ ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) ELIZABETH DUNCAN
K122374 08/06/2012 ARTHREX SUTURE (UHMWPE) ARTHREX, INC. IVETTE GALMEZ
K122652 08/31/2012 ARTHROCARE TURBINATOR WAND ARTHROCARE CORPORATION CHERYL FREDERICK
K122334 08/06/2012 CHECKMATE SMALL BONE FUSION SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K122416 08/08/2012 ARTIGLASS L. O.R. GLASS SYRINGE ARTIGLASS SRL FEDERICO BACCARIN
K122469 08/13/2012 ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ ASAHI INTECC CO., LTD. YOSHI TERAI
K122468 08/13/2012 ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO ASAHI INTECC CO., LTD. YOSHI TERAI
K122483 08/14/2012 PEARL DIABETES MANAGEMENT SYSTEM ASANTE SOLUTIONS, INC. ROBIN BUSH
K122611 08/28/2012 COOLRAIL LINEAR PEN MODEL MCRI ATRICURE, INC. JIM LUCKY, RAC
DEN120015 08/24/2012 EEVA 2.0 AUXOGYN, INC. CINDY DOMECUS
K122380 08/06/2012 OCELOT SYSTEM AVINGER, INC. ALBERT BONISKE
K122167 08/24/2012 NEXXIS OR BARCO NV LIEVEN DE WANDEL
K122575 08/23/2012 BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI BAUSCH & LOMB, INC. NANCY A FEHRMAN
K122370 08/06/2012 CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR BAYER HEALTHCARE ROGER SONNENBURG
K122496 08/16/2012 AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM BIO-LOGIC SYSTEMS CORP. TIMOTHY KARLOVSKY
K122472 08/14/2012 VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVISION JACKIE BUCKLEY
K122307 08/01/2012 DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM BIOCARE CORPORATION SHUCHI CHANG
K122559 08/22/2012 BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS BIODENTA SWISS AG DAVID EILER
K122368 08/06/2012 WATERLASE IPLUS ALL TISSUE LASER BIOLASE TECHNOLOGY, INC. EHAB ESMAIL
K122547 08/21/2012 GRAM POSTITVE CLINDAMYCIN BIOMERIEUX, INC. ELIZABETH LANDON
K122359 08/03/2012 VITEK 2 STRPTOCOCCUS CEFTRIAXONE BIOMERIEUX, INC. THI MY LAN DANG
K122378 08/06/2012 NEXTGEN ALTIUS OCT SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY
K122437 08/10/2012 NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS BIOMET SPORTS MEDICINE ELIZABETH WRAY
K122443 08/13/2012 UFIT TEN-10 BIOSIGN TECHNOLOGIES, INC. ALLISON SCOTT, RAC
K122525 08/20/2012 SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM BIOTEST MEDICAL CORP. AMANDA CHIANG
K122518 08/17/2012 SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE BM KOREA CO., LTD. PRISCILLA CHUNG
K122565 08/22/2012 ARC ENDOCUFF BODDINGTONS PLASTICS LTD JOHN BOVIS
K122649 08/30/2012 NAVIGATOR HD URETERAL ACCESS SHEATH SET BOSTON SCIENTIFIC CORP. HUDA YUSUF
K122394 08/07/2012 RUBICON 18 SUPPORT CATHETER BOSTON SCIENTIFIC CORP. DIANE NELSON
K122459 08/13/2012 PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM BOSTON SCIENTIFIC CORPORATION MICHELLE BERRY
K122660 08/31/2012 RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 BOSTON SCIENTIFIC CORPORATION THOMAS HIRTE
K122451 08/13/2012 EXACTRAC VERO BRAINLAB AG ALEXANDER SCHWIERSCH
K122633 08/29/2012 TOXCUP DRUG SCREEN CUP BRANAN MEDICAL CORP. OLIVIA CHAN
K122367 08/06/2012 BARD PTV DILATATION CATHETER C.R. BARD, INC. ERIN FOX
K122436 08/10/2012 COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM C.R. BARD, INC. KETI SINO
K122332 08/06/2012 TOWERLOX PEDICLE SCREW SYSTEM CAPTIVA SPINE RICH JANSEN
K122507 08/17/2012 DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION CARDINAL HEALTH 200, LLC LAVENIA FORD
K122632 08/29/2012 GUAVA II CARDIOCOMM SOLUTIONS, INC. JONATHAN WARD
K122400 08/07/2012 CARDIOX FLOW DETECTION SYSTEM CARDIOX CORP. KAREN MATIS
K122427 08/10/2012 CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE CARESTREAM DENTAL LLC DANIEL HOEFER
K122523 08/20/2012 CARESTREAM VUE PACS CARESTREAM HEALTH, INC. ALEXANDRA CHAMBERLAIN
K122418 08/08/2012 IOLMASTER 500 CARL ZEISS MEDITEC AG JUDITH A BRIMACOMBE
K122488 08/15/2012 AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES CATHETER ROBOTICS INC JENNIFER ENGLUND
K122463 08/13/2012 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K122314 08/01/2012 QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K122458 08/13/2012 VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM CELLO PARTNERSHIP D/B/A VERIZON WIRELESS LOLITA FORBES
K122561 08/22/2012 ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN CEREMED, INC. CHELSEA MITCHELL
K122490 08/15/2012 KULAVAC CGBIO CO., LTD JUNGEUN IM
K122440 08/10/2012 RESTORELLE L COLOPLAST CORP. TIM CRABTREE
K122581 08/23/2012 MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 CONCENTRIC MEDICAL, INC. CHRISTINA ROWE
K122478 08/14/2012 MODIFIED TREVO RETRIEVER CONCENTRIC MEDICAL, INC. CHRISTINA ROWE
K122512 08/20/2012 CS2 HIP SYSTEM CONSENSUS ORTHOPEDICS, INC. MATTHEW M HULL
K122305 08/01/2012 CORIN TRINITY-I ACETABULAR SHELL CORIN USA DIANA L MARTONE
K122640 08/29/2012 VPULSE COTHERA, LLC JUSTIN EGGLETON
K122531 08/20/2012 SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T COVIDIEN TED KUHN
K122585 08/24/2012 CRUX VENA CAVA FILTER SYSTEM CRUX BIOMEDICAL ELISA HEBB
K122172 08/01/2012 SYSTEM 83 PLUS CUSTOM ULTRASONICS FRANK J WEBER
K122493 08/16/2012 GENESISPLUS CUTERA, INC. CONNIE HOY
K122389 08/10/2012 TRUSCULPT CUTERA, INC. CONNIE HOY
K122405 08/07/2012 AIR-BAND RADIAL COMPRESSION DEVICE DATASCOPE CORP., CARDIAC ASSIST DIVISION CARLA S CERQUEIRA
K122628 08/28/2012 SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES DATASCOPE CORP., CARDIAC ASSIST DIVISION CARLA S CERQUEIRA
K122445 08/10/2012 AESPIRE 7900, AESPIRE VIEW DATEX-OHMEDA JAMES RASKOB
K122582 08/23/2012 DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) DENTERPRISE INTERNATIONAL, INC. CLAUDE BERTHOIN
K122331 08/02/2012 CAVITY VARNISH DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K122424 08/09/2012 ISUS IMPLANT SUPRASTRUCTURES DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K122442 08/10/2012 DEPUY CTA REVERSE SHOULDER SYSTEM DEPUY FRANCE MEGAN BURNS
K122425 08/09/2012 VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT DEPUY MITEK, A JOHNSON & JOHNSON COMPANY YAYOI FUJIMAKI
K122395 08/07/2012 DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS DEPUY ORTHOPAEDICS, INC. MEGAN BURNS
K122595 08/24/2012 HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM DERMAL LIFE LLC DIANE HORWITZ, PH.D., RAC
K122397 08/07/2012 LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM DIASORIN, INC. CAROL A DEPOUW
K122420 08/09/2012 DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA DIAZYME LABORATORIES ABHIJIT DATTA
K122519 08/17/2012 DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM DIO CORPORATION TIMOTHY LEE
K122499 08/16/2012 AIRCAST VENAFLOW ELITE SYSTEM DJO, LLC KEN FISHER
K122562 08/22/2012 E-TENG MODEL EOR 1 E-TENG TECHNOLOGY, INC. JUNNATA CHANG
K122574 08/23/2012 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 EDAN INSTRUMENTS, INC. RANDY JIANG
K122381 08/06/2012 NEXFIN MODEL 2 EDWARDS LIFESCIENCES, LLC. MARGUERITE THOMLINSON
K122444 08/10/2012 CERVICAL CAGE EISERTECH, LLC LUKAS EISERMANN
K122336 08/02/2012 Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM ELEVEN BLADE SOLUTIONS, INC. MICHAEL KOLBER
K122516 08/17/2012 EMBLETTA MPR EMBLA SYSTEMS JENNIFER ARMSTRONG
K122489 08/23/2012 EMERGE MEDICAL SOLID BONE SCREWS EMERGE MEDICAL VICTORIA TRAFKA
K122485 08/14/2012 ENCIRCLE COMPRESSION THERAPY STOCKING ENCIRCLE MEDICAL DEVICES LTD. SIGI CARON
K122580 08/23/2012 AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES ENCISION, INC. JIM LEWIS
K122383 08/06/2012 EM3 AEM MONITOR AEM CONNECTORS ENCISION, INC. JIM LEWIS
K122636 08/29/2012 REVELATION POROUS COATED HIP STEM, SIZE 8 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K122511 08/17/2012 ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH ETHICON ENDO-SURGERY, LLC EMILY KRUETZKAMP
K122428 08/09/2012 FAXITRON SPECIEN RADIOGRAPHY SYSTEM FAXITRON BIOPTICS LLC DOUGLAS C WIEGMAN
K122658 08/31/2012 FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 FEMASYS INC. LISA PEACOCK
K122337 08/02/2012 OVUSENSE FERTILITY FOCUS LTD PENNY NORTHCUTT
K122432 08/10/2012 ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS FISHER & PAYKEL HEALTHCARE, LTD. ROBERT PETRY
K122413 08/08/2012 PATIENT POSITIONING SYSTEM FORTE AUTOMATION SYSTEMS, INC. PHIL REECE
K122454 08/13/2012 FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K122535 08/20/2012 FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K122627 08/28/2012 GIO DIGITAL PRESSURE GUAGES GALEMED CORP. TOM SHANKS
K122515 08/17/2012 C2-9-D ULTRASOUND TRANSDUCER GE HEALTHCARE BRYAN BEHN
K122457 08/13/2012 GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS GE HEALTHCARE MALCA
K122327 08/01/2012 VOLUSON E6/E8/E8EXPERT/E10 GE HEALTHCARE BRYAN BEHN
K122387 08/06/2012 VOLUSON P6, VOLUSON P8 GE HEALTHCARE BRYAN BEHN
K122625 08/28/2012 GETINGE 800HC- SERIES STEAM STERILIZER GETINGE SOURCING LLC BARB SMITH
K122550 08/21/2012 ICS IMPULSE GN OTOMETRICS DANIEL KAMM
K122605 08/27/2012 PKS BILL GYRUS ACMI, INC. NEIL KELLY
K122807 08/30/2012 DENTAL IMPLANT SYSTEM HAGER & MEISINGER GMBH ALEX MILLER
K122438 08/10/2012 HAMILTON-MR1 HAMILTON MEDICAL AG RALPH AGUILA
K122502 08/16/2012 BRIDGE EXTRACELLULAR COLLEGEN MATRIX HARBOR MEDTECH, INC. JERRY MEZGER
K122494 08/17/2012 POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT HEMOSTASIS, LLC BERNARD HORWATH
K122473 08/14/2012 TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 HILL-ROM ANN WATERHOUSE
K122341 08/02/2012 PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 HITACHI ALOKA MEDICAL, LTD.
K122537 08/20/2012 PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL AMERICA) RICHARD J CEHOVSKY
K122563 08/22/2012 MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL HOLOGIC, INC. SARAH FAIRFIELD
K122498 08/16/2012 MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) HOLOGIC, INC. SARAH FAIRFIELD
K122408 08/10/2012 POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) HONGYE PLASTIC PRODUCTS CO., LTD. KATHY LIU
K122308 08/01/2012 AXSOS DISTAL LATERAL FEMUR TS LONG PLATES HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS STEPHANIE M FITTS
K122325 08/06/2012 SKINTEMP II HUMAN BIOSCIENCES, INC. JACK SLOVICK
K122510 08/17/2012 ICRCO 3600M ICRCO INC. GREG WACHTLER
K122546 08/21/2012 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM IDEV TECHNOLOGIES, INC. DARLENE GARNER
K122453 08/14/2012 MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY INDUSTRIAL CLOTHINGS, LTD. S.N. HARI
K122464 08/14/2012 MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE INDUSTRIAL CLOTHINGS, LTD. S.N. HARI
K122465 08/20/2012 MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK INDUSTRIAL CLOTHINGS, LTD. S.N. HARI
K122584 08/24/2012 HEMOSIL READIPLAS TIN INSTRUMENTATION LABORATORY CO. JACQUELINE EMERY
K122480 08/15/2012 INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST INTERNATIONAL BIOPHYSICS CORPORATION H. DAVID SHOCKLEY JR.
K122532 08/20/2012 DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES INTUITIVE SURGICAL, INC. MELISSA S GONZALEZ
K122646 08/30/2012 DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T INVIVO CORPORATION LISA SIMPSON
K122549 08/21/2012 DENTO TEMP ITENA CLINICAL LOUIS-PAUL MARIN
K122522 08/20/2012 DEUTOETCH QUICKBOND BOND ACTIRATOR ITENA CLINICAL LOUIS-PAUL MARIN
K122521 08/20/2012 PREVENT SEAL ITENA CLINICAL LOUIS-PAUL MARIN
K122551 08/21/2012 PROVITEMP ITENA CLINICAL LOUIS-PAUL MARIN
K122329 08/01/2012 BIOJET JET SOFT SRL PETER-M KLEWS
K122653 08/31/2012 MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES KIMBERLY-CLARK CORPORATION DAVID LEE
K122421 08/09/2012 TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K122474 08/14/2012 LANSINOH POWERED ELECTRIC BREAST PUMP LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN, TIC. LTD CALLEY HERZOG
K122556 08/29/2012 VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) LEICA BIOSYSTEMS NEWCASTLE LTD BARBARA-ANN CONWAY-MAYERS
K122414 08/08/2012 AB COMMAND DUAL CHANNEL FITNESS BELT LETO ENTERPRISES INCORPORATION SABRINA WEI
K122536 08/20/2012 AMCAD-UT DETECTION MODEL 2.0 LIN & ASSOCIATES, LLC. CHIU S LIN
K122622 08/28/2012 ENDURAMESH LUCERO MEDICAL, LLC JENNIFER PALINCHIK
K122612 08/27/2012 HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX MAQUET CARDIOVASCULAR, LLC MARYLOU INSINGA
K122589 08/24/2012 DFP4343C7 MDI CONSULTANTS, INC. JIGAR SHAH
K122322 08/01/2012 PIEZOSURGERY TOUCH MECTRON S.P.A. ROGER GRAY
K122641 08/29/2012 MPACT EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K122423 08/13/2012 VASU-PICC MEDICAL COMPONENTS INC JESSICA LEO
K122497 08/16/2012 ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM MEDICAL DESIGN LLC. KRISTI VONDRA
K122433 08/10/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. CHRIS MCKEE
K122513 08/17/2012 CLEARED UNDER GRAFTON II EDBM MEDTRONIC SOFAMOR DANEK, INC. KELLY ANGLIN
K122591 08/24/2012 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. BECKY RONNER
K122434 08/10/2012 MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL MEDTRONIC XOMED ANTOINE KOUCHAKJY
K122391 08/07/2012 MEDTRONIC XOMED, INC. MEDTRONIC XOMED, INC. DOUGLAS JOHNSON
K122321 08/01/2012 BASIXCONPAK ANALOG INFLATION SYRINGE MERIT MEDICAL IRELAND, LTD. STEPHANIE ERSKINE
K122357 08/03/2012 MERITS MODEL P322FWD POWERED WHEELCHAIR MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K122362 08/06/2012 SMART-WELL INCUBATOR MESA LABORATORIES, INC. JOLE WILSON
K122526 08/29/2012 360 GAS ASSISTED ENDOSCOPIC APPLICATOR MICROMEDICS, INC. JODI L RAUS
K122316 08/01/2012 AZUR DETACHABLE 35 MICROVENTION, INC. CYNTHIA VALENZUELA
K122543 08/21/2012 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 MICROVENTION, INC. LARAINE PANGELINA
K122643 08/29/2012 VANTAGE MODEL V5000, V5100, V5000C, V5100C MIDMARK CORP. MARK GREENWOOD
K122393 08/23/2012 TG-BODY MI&BODY S-TRAINER MIGA MEDICAL CO., LTD. YANG HO DONG
K122384 08/06/2012 MINISPIR MIR MEDICAL INTL. RESEARCH SRL GERDA VAN HOUTS
K122450 08/13/2012 MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS MITSUBISHI HEAVY INDUSTRIES, LTD. YOICHI WAKIYAMA
K122456 08/13/2012 MRII CRAINIAL DRILL MRI INTERVENTIONS, INC. E.F. WADDELL
K122606 08/27/2012 PHT-6500; PHT-60CFO; PAX-I3D MTECH GROUP DAVE KIM
K122411 08/08/2012 J-SCOPE SYSTEM MYELOTEC BLIX WINSTON
K122514 08/17/2012 VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST NANOSPHERE, INC MARK DEL VECCHIO
K122373 08/06/2012 NEOMED ORAL/ENTERAL SYRINGE NEOMED, INC. MELINDA HARRISON
K122503 08/16/2012 PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON NEURO THERM, INC. F. DAVID ROTHKOPF
K122347 08/03/2012 ELISIO-H AND ELISIO-M HEMODIALYZERS NIPRO MEDICAL CORPORATION CAROLYN GEORGE
K122343 08/03/2012 PUREFLUX-H HEMODIALYZER NIPRO MEDICAL CORPORATION CAROLYN GEORGE
K122602 08/27/2012 NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS NOBEL BIOCARE AB PHUONG NGUYEN SON
K122435 08/10/2012 NOVA ONE BLOOD GLUCOSE MONITOR NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K122352 08/03/2012 NUVASIVE PRECEPT SPINAL SYSTEM NUVASIVE, INC. ELIAS KETCHUM
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