FDA 510(k) Applications Received During August, 2013

FDA 510(k) Number Submission Date Device Name Applicant Contact
K132673 08/27/2013 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER MEDTRONIC INC. HEATHER MOROSE
K132712 08/29/2013 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER MEDTRONIC INC. LISA STONE
K132649 08/26/2013 REVEAL LINQ INSERTABLE CARDIAC MONITOR MEDTRONIC INC. ERIC KALMES
K132554 08/22/2013 AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K132511 08/12/2013 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM ABBOTT DIABETES CARE INC. VRUSAHLI TEMBE
K132366 08/07/2013 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS ACCEL SPINE AEKTA PATEL
K132433 08/09/2013 ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE ACCLARENT, INC. JAMES PATRICK GARVEY II
K132549 08/19/2013 ACCUTIP COVER ACCUTOME, INC. ADAM PICKHOLTZ
K132474 08/15/2013 CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER ACIST MEDICAL SYSTEMS MATTHEW STEPANEK
K132059 08/09/2013 DIAGNOSTIC ULTRASOUND SYSTEM ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K132077 08/09/2013 PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K132561 08/15/2013 NURO NEUROMODULATION SYSTEM ADVANCED URO-SOLUTIONS, INC. PENNY NORTHCUTT
K132421 08/05/2013 AESCULAP PEEK XP SPINAL IMPLANT SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K132655 08/26/2013 RETROARC RETROPUBIC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. RENEE MELLUM
K132461 08/07/2013 A.I.M. SUTURE ANCHOR ANCHOR INNOVATION MEDICAL, INC. HOWARD L SCHRAYER
K131531 08/12/2013 TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD XIUMING CHONG
K131750 08/06/2013 AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K132342 08/14/2013 XVWEB APTERYX, INC. KEVIN CRUCS
K132590 08/19/2013 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA ARTHROCARE CORPORATION MITCHELL DHORITY
K132513 08/12/2013 Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER ARTHROCARE CORPORATION MITCHELL DHORITY
K132496 08/09/2013 ARTHROSURFACE TOEMOTION ARTHROSURFACE, INC. DAWN J WILSON
K132556 08/26/2013 SHEATHLESS EAUCATH CORONARY GUIDE CATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K132682 08/28/2013 PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA ATHEROMED INC ELISA HEBB
K132422 08/14/2013 PALS PLATINUM NEUROSTIMULATION ELECTRODES AXELGAARD MFG. CO., LTD. DAN P JEFFERY
K132335 08/19/2013 ULTRASOUND SCANNER FLEX FOCUS 1202 B-K MEDICAL APS RANDI HAUERBERG
K132593 08/19/2013 CRYSTALSERT DELIVERY SYSTEM BAUSCH & LOMB YI GAO
K132481 08/08/2013 EASY-LOAD LENS DELIVERY SYSTEM BAUSCH & LOMB JASON SMITH
K132374 08/05/2013 BAYLIS MEDICAL RF PERFORATION PROBE V2.0 BAYLIS MEDICAL COMPANY INC. MEGHAL KHAKHAR
K132674 08/27/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) BECTON, DICKINSON AND COMPANY MONICA E GIGUERE
K132456 08/14/2013 BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV BECTON, DICKINSON AND COMPANY GREGORY P PAYNE, RAC
K132692 08/29/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY GREGORY P PAYNE, RAC
K132642 08/26/2013 LOCKING PLATE SYSTEM BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD. DIANA HONG
K132516 08/12/2013 OXIPROBE E (OXIPROBE) BIO MEDICAL TECHNOLOGIES CO., LTD ELAINE DUNCAN
K132457 08/16/2013 FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER BIOCARE ASIA CORPORATION LTD. SHUCHI CHANG
K132377 08/08/2013 OSTEOSPAN MORPHEUS BIOGENNIX, LLC ELAINE DUNCAN
K132400 08/01/2013 LP(A) CALIBRATORS, AND LP(A) CONTROLS BIOKIT S.A. JOAN GUIXER
K132507 08/28/2013 VITEK 2 AST ST MEROPENEM BIOMERIEUX, INC. NATHAN HARDESTY
K132573 08/16/2013 VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN BIOMERIEUX, INC. NATHAN HARDESTY
K132704 08/29/2013 DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW BIOMET SUZANA OTANO
K132600 08/20/2013 FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING BIOMET MICROFIXATION ELIZABETH WHEELER
K132373 08/02/2013 BIOMET ACCESS SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY, MS, RAC
K132510 08/12/2013 BIOPRO - INFINITY PLATE ANCHOR SYSTEM BIOPRO, INC. AL LIPPINCOTT
K132613 08/21/2013 SONILASE LIGHT THERAPY DEVICE BIORENEW LABS, LLC SUSAN ANTHONEY
K132543 08/23/2013 INFANT INCUBATOR BISTOS CO., LTD. YOUNG CHI
K132483 08/08/2013 INNESIS PEEK CERVICAL CAGE BK MEDITECH CO., LTD. ELAINE DUNCAN
K132482 08/08/2013 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL REBECCA K PINE
K132578 08/16/2013 INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. TODD KORNMANN
K132430 08/05/2013 STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. CHRISTOPHER DACHEL
K132441 08/06/2013 BARD VENTRALEX HERNIA PATCH C.R. BARD, INC. MARIYA BUHARIN
K132708 08/29/2013 BIOMARC FIDUCIAL MARKER CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K132581 08/21/2013 MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE CARDICA, INC. FREDERICK BAUER
K132413 08/14/2013 MZ1000 CAREFUSION MICHELLE J BADAL, RAC
K132711 08/29/2013 CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT CAROLINA LIQUID CHEMISTRIES CORP. PHILIP G SHUGART
K132508 08/12/2013 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM, PHARM.D.
K132463 08/07/2013 CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM CIANNA MEDICAL, INC. GARY MOCNIK
K132505 08/13/2013 ACCULIF TL AND PL CAGE COALIGN INNOVATIONS, INC.
K132585 08/30/2013 ZIBONE CERAMIC DENTAL IMPLANT SYSTEM COHO TECHNOLOGY CO., LTD JENNIFER REICH
K132641 08/26/2013 MODIFIED TREVO PROVUE RETRIEVER CONCENTRIC MEDICAL, INC. SARAH MEYER
K132640 08/23/2013 IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K132307 08/07/2013 VIDA LED SURGICAL LIGHTING SYSTEM CONVIDA HEALTHCARE & SYSTEMS CORPORATION RYAN HUNG
K132660 08/26/2013 NERVE CUFF COOK BIOTECH INCORPORATED MARY A FADERAN
K132592 08/19/2013 FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET COOK, INC. DAVID LEHR
K132504 08/12/2013 TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM CORELINK LLC JUSTIN EGGLETON
K132644 08/26/2013 LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU CORENTEC CO., LTD J.S. DANIEL
K132567 08/15/2013 ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN COVIDIEN DOLLY MISTRY
K132604 08/20/2013 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN KELSEY LEE
K132493 08/09/2013 ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN LLC KATHERINE KASSIM
K132500 08/09/2013 CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED CURE MEDICAL LLC. JOHN BEASLEY
K132596 08/19/2013 PROPOSED OPTIMUS CUSTOM SPINE, INC. HANAA SHAHIN
K132389 08/01/2013 CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED DANIEL & DANIEL CONSULTING MICHAEL A DANIEL
K132530 08/12/2013 GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) DATEX-OHMEDA, INC. JAMES P RASKOB
K132393 08/01/2013 CERCOM II CEMENT DENALI CORPORATION JAN G STANNARD
K132492 08/09/2013 LIAISON 25 TOTAL-D DIASORIN, INC. MARI MEYER
K132515 08/15/2013 LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS DIASORIN, INC. CAROL A DEPOUW
K132672 08/27/2013 EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER DORNIER MEDTECH AMERICA JOHN HOFFER
K132478 08/08/2013 AIR-FLOW HANDY 3.0 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J NOLTE
K132480 08/08/2013 AIR-FLOW HANDY 3.0 PERIO E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J NOLTE
K132443 08/06/2013 PIEZON 150 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA NOLTE
K132445 08/06/2013 PIEZON 250 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA NOLTE
K131903 08/07/2013 EQUINOX CO2 LASER ECLIPSE AESTHETICS, LLC TOM O'BRIEN
K132399 08/01/2013 ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL ELITECH GROUP DEBRA K HUTSON
K132468 08/07/2013 MRSA/SA ELITE MGB, ELITE MGB SOFTWARE ELITECHGROUP EPOCH BIOSCIENCES DEBRA K HUTSON
K132535 08/13/2013 AUTOBAND LIGATOR ENDOCHOICE, INC. DANIEL HOEFER
K132440 08/06/2013 XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC. KAREN E PETERSON
K132340 08/01/2013 ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 ERBE USA, INC. JOHN TARTAL
K132466 08/07/2013 MYLABSEVEN 6400, MYLABALPHA 7400 ESAOTE S.P.A. ALLISON SCOTT
K132609 08/20/2013 EDS ULTRASONIC TIPS ESSENTIAL DENTAL SYSTEMS, INC. JEFFREY WAN
K132522 08/12/2013 HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE ETHICON ENDO-SURGERY, LLC DAVID LOCKE
K132512 08/12/2013 HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE ETHICON ENDO-SURGERY, LLC DAVID LOCKE
K132612 08/21/2013 HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE ETHICON ENDO-SURGERY, LLC BRIAN GODWIN
K132580 08/16/2013 COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, INC. PETER CECCHINI
K132582 08/16/2013 EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM EXACTECH, INC. PATRICK HUGHES
K132619 08/21/2013 CLASSIC INTERMITTENT CATHETER FLEXICARE MEDICAL LTD. CHRISTOPHER WATKINS
K132475 08/12/2013 FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM FLUOPTICS MICHAEL A DANIEL
K132611 08/23/2013 MICROTABLE SYSTEM FRED HAER COMPANY, INC. KERI SEITZ
K132509 08/12/2013 FDR D-EVO FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEMS USA, INC. KATHERINE Y CHOI
K132529 08/29/2013 GALLIEON-1 MEDICAL LASER FUTURE DEVICE AND TECHNOLOGY, INC SOUNGDON CHUNG
K132679 08/28/2013 AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER GALEMED CORP. TOM SHANKS
K132376 08/02/2013 DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) MICHELLE HUETTNER
K132533 08/12/2013 CARESCAPE MONITOR B450 GE HEALTHCARE FINLAND OY JOEL KENT
K132528 08/12/2013 E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES GE HEALTHCARE FINLAND OY JOEL KENT
K132696 08/29/2013 TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR GE HEALTHCARE FINLAND OY JOEL KENT
K132437 08/05/2013 MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. KRISTIN PABST
K132410 08/08/2013 DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W GE MEDICAL SYSTEMS, LLC HELEN PENG
K132559 08/15/2013 MONUMENT SPACERS GLOBUS MEDICAL INC. CHRISTINA KICHULA
K132476 08/08/2013 SHARPS CONTAINER GRP & ASSOCIATES ROBERT SEIPLE
K132630 08/22/2013 WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K132423 08/13/2013 THE GYNOCULAR GYNIUS AB MATTHEW VOLSKY
K132383 08/29/2013 GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER GYRUS ACMI, INC. NEIL KELLY
K132416 08/02/2013 REHASTIM 2, ERIGOPRO (FES) HASOMED GMBH MATTHIAS WEBER
K132520 08/30/2013 NASAL EASE ALLERGY BLOCKER HI-TECH PHARMACAL, INC. GARY APRIL
K132462 08/12/2013 S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA AMMIRATI
K132316 08/01/2013 MULTIVIEW HOLOGIC, INC. EILEEN M BOYLE
K132627 08/22/2013 AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HONSUN (NANTONG) CO., LTD. SELINA QIAN
K132572 08/15/2013 I-HIP TOTAL HIP SYSTEM ICONACY ORTHOPEDIC IMPLANTS, LLC MARC E RUHLING
K132724 08/30/2013 ICONN ANSWER SUTURE ANCHOR ICONN ORTHOPEDICS, LLC WHITT ISRAEL
K132499 08/09/2013 ICRCO CLARITY VIEWER ICRCO INC. GREG WACHTLER
K132539 08/26/2013 RING-LOK MODULAR BIPOLAR SYSTEM IMPLANTS INTERNATIONAL, LTD TRUDIE SEEGAR, PHD
K132406 08/02/2013 ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD PRISCILLA CHUNG
K132651 08/26/2013 ITCLAMP 50 INNOVATIVE TRAUMA CARE INC RICHARD WAITE
K132489 08/08/2013 INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) INOGEN, INC. MARA KORSUNSKY
K132718 08/30/2013 INTEGRITY SPINE CORE SYSTEM INTEGRITY SPINE LISA PETERSON
K132347 08/26/2013 MULTICAM 3000 ECO INTER MEDICAL MEDIZINTECHNIK GMBH WILLIAM CARROLL
K132469 08/21/2013 THE BITE GUARD INTERNATIONAL PROFIT BUILDERS, INC. BRYAN TAPOCIK
K132479 08/08/2013 OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 INTERVENTIONAL SPINE, INC. JANE METCALF
K132359 08/02/2013 MRI PATIENT MONITORING SYSTEM INVIVO CORPORATION RUSTY KELLY
K132668 08/27/2013 IOB DISPOSABLE SPECULUM IOB MEDICAL INC JOE XIA
DEN130040 08/30/2013 IOGYN SYSTEM IOGYN, INC. MARY EDWARDS
K132695 08/30/2013 IOGYN SYSTEM IOGYN, INC. MARY EDWARDS
K132179 08/01/2013 ARASYS ION GENIUS INC XANYA SOFRA-WEISS, PH.D
K132557 08/14/2013 EWNL SAFETY SYRINGE WITH NEEDLE JIAMEI-UN CO., LTD. YU-HONG CHEN
K132428 08/26/2013 IDEAL JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. GONG BO
K132321 08/01/2013 JMS SYRINGE JMS NORTH AMERICA CORPORATION SHO HOSOKI
K132472 08/19/2013 JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD JUSTRIGHT SURGICAL, LLC MICHELE LUCEY
K132725 08/30/2013 JUVORA DENTQAL DISC JUVORA SELINA SHAW
K132361 08/07/2013 EVEREST SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K132597 08/19/2013 BLACK COLOURED CONDOM KAREX INDUSTRIES SDN BHD MARY GOH YIN
K132343 08/07/2013 MARIGEN WOUND DRESSING KERECIS LIMITED GUDMUNDUR F SIGURJONSSON
K132514 08/12/2013 KINSA SMART THERMOMETER KINSA, INC. LAEL J PICKETT
K132450 08/06/2013 CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K132589 08/30/2013 ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) LIFE SPINE, INC RANDY LEWIS
K132618 08/28/2013 ONETOUCH REVEAL LIFESCAN, INC. GABRIELLE LOGAN
K132661 08/26/2013 LIGHTSCALPEL LIGHTSCALPEL LLC DAVID WALTERS
K132605 08/20/2013 DOSIMETRY CHECK VERSION 4 RELEASE 1 MATH RESOLUTIONS, LLC. WENDEL DEAN RENNER
K132498 08/20/2013 VALVED TEARAWAY INTRODUCER GENERATION II MEDCOMP (MEDICAL COMPONENTS, INC.) TIMOTHY HOLWICK
K132395 08/01/2013 LIGAPASS MEDICREA INTERNATIONAL AUDREY VION
K132574 08/22/2013 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL AUDREY VION
K132575 08/22/2013 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL AUDREY VION
K132545 08/13/2013 MEDIVALVE ACWIRE MEDIVALVE LTD. LEO BASTA
K132333 08/19/2013 BONDILOXS TOPICAL HEMOSTATIC DRESSING MEDTRADE PRODUCTS LTD. CLAIRE RYAN
K132623 08/22/2013 MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE MEDTRONIC MONICA HERNANDEZ-SOTO
K132471 08/07/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. SOWMYA SHETTY
K132639 08/28/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. SHWETA SHARMA
K132584 08/16/2013 PERIMETER C SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. MICHAEL SCOTT
K132700 08/29/2013 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK, INC. ANKIT K SHAH
K132617 08/26/2013 MEDTRONIC INPUT PS INTRODUCER MEDTRONIC, INC. NISARG SHAH
K132645 08/23/2013 THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES MEDTRONIC, INC. CHELSEA PIOSKE
K132409 08/02/2013 CONCIERGE GUIDING CATHETER MERIT MEDICAL SYSTEMS, INC. VICKI GODWIN
K132720 08/30/2013 HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH MERIT MEDICAL SYSTEMS, INC. ALINA STUBBS
K132506 08/23/2013 SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY MICHAEL D. WILLIAMS,DDS PA MICHAEL D WILLIAMS
K132599 08/23/2013 SMILEBOND SYSTEM MILLENNIUM COMPANY LLC STEPHEN J GOLDNER, JD, RAC
K132026 08/05/2013 V SERIES MONITORING SYSTEM, 12.1" DCU/V12 AND 21.0" DCU/V21 MINDRAY DS USA, INC. RUSSELL OLSEN
K132547 08/20/2013 ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) MONARCH MEDICAL TECHNOLOGIES ANN A GRAHAM
K132444 08/06/2013 ATAMA SYSTEM MONTERIS MEDICAL BRIAN J EDWARDS
K132163 08/08/2013 MOORLDLS-BI LASER DOPPLER BURNS IMAGER MOOR INSTRUMENTS LTD. XIABING HUANG
K132436 08/09/2013 VARIOGUIDE DRILL KIT MRI INTERVENTIONS, INC. E. F WADDELL
K132713 08/30/2013 NMI COAXIAL MICROINTRODUCER SET NAVILYST MEDICAL, INC. MICHAEL P HANLEY
K132587 08/16/2013 MD242C2 24" DIAGNOSTIC IMAGING LCD MONITOR NED DISPLAY SOLUTIONS LTD. TONY HSU
K132653 08/26/2013 NEOPLATE SPINE ANTERIOR FIXATION SYSTEM NEOORTHO PRODUCTOS ORTHOPEDICOS S/A TARA CONRAD
K132607 08/20/2013 NS 2500 HOLMIUM LASER SYSTEM NEW STAR LASERS, INC. PAMELA M BUCKMAN, MSN
K132412 08/02/2013 INERTIA MIS PEDICLE SCREW SYSTEM NEXXT SPINE LLC JUSTIN EGGLETON
K132323 08/02/2013 RS-3000 ADVANCE NIDEK CO., LTD. LENA SATTLER
K132329 08/05/2013 NIVATOPIC PLUS NIVAGEN PHARMACEUTICALS INC. LARA NOAH
K132402 08/09/2013 SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM NONIN MEDICAL, INC. BRODIE PEDERSEN
K132411 08/07/2013 AFFIX II SPINOUS PROCESS PLATE SYSTEM NUVASIVE, INCORPORATED OLGA LEWIS
K132601 08/20/2013 COROENT STERILE IMPLANTS SYSTEM NUVASIVE, INCORPORATED OLGA LEWIS
K132694 08/29/2013 NUVASIVE NVM5 SYSTEM NUVASIVE, INCORPORATED SHEILA BRUSCHI
K132602 08/20/2013 STREAMLINE EXPRESS NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K132633 08/22/2013 OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD. JEN KE-MIN
K132703 08/29/2013 THUNDERBEAT OLYMPUS MEDICAL SYSTEMS CORP. GRAHAM BAILLIE
K132464 08/12/2013 PTFE SURGICAL SUTURE OMNIA SPA MARCO MANDUCHI
K132595 08/19/2013 ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS ONTEX BVBA RACHEL PAUL
K132591 08/19/2013 MAXLOCK EXTREME SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K132401 08/01/2013 MEGA ISQ OSSTELL AB CHERITA JAMES
K132620 08/30/2013 INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL PAN MEDICAL LTD JENNIE BUDDING
K132670 08/27/2013 PANPAC INFLATABLE DOCUT PESSARY PANPAC MEDICAL CORPORATION YEN-MING PAN
K132614 08/21/2013 PEREGRINE CURVED ILLUMINATING LASER PROBE PEREGRINE SURGICAL, LTD. RYAN O'LEARY
K132631 08/22/2013 EIA SMDP IMMUNOASSAY PHADIA US INC. MARTIN ROBERT MANN
K132524 08/27/2013 CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION PHILIPS MEDICAL SYSTEMS SUSAN QUICK
K132563 08/27/2013 PINOOK MASSAGER PINOOK USA TEJAS SHAH
K132626 08/22/2013 PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) PIPELINE BIOTECHNOLOGY TERRY POWELL
K132526 08/30/2013 KNIT-PAK+ PREMIER DENTAL PRODUCTS CO. VINCENT D'ALLESANDRO
K132465 08/13/2013 BIOSIGN FLU A + B, STATUS FLU A & B PRINCETON BIOMEDITECH CORP. KYUNG-AH KIM, PH.D.
K132390 08/20/2013 INSTINCT; PLAIN, DOTTED, ULTRA THIN PROFILATEX, S.A. DE C.V. JUAN ERNESTO DE LA PUENTE
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K132638 08/23/2013 DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS INC. LAURA J DUGGAN, PH.D.
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K132594 08/19/2013 CROSSCHECK PLATING SYSTEM SOLANA SURGICAL, LLC JOE CLIFT
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K132646 08/30/2013 SUNETICS CLINICAL BIO-STIMULATION LASER SUNETICS INTERNATIONAL MARKETING GROUP, LLC JOHN CARULLO
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K132233 08/07/2013 K-PACK II NEEDLE - 27G X 3/4" THIN WALL TERUMO EUROPE N.V. M.J. AERTS
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K132454 08/06/2013 VITAHEAT PATIENT WARMING SYSTEM VITAHEAT MEDICAL, LLC JACK SLOVICK
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K132484 08/08/2013 DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE WRP ASIA PACIFIC SDN. BHD. KIRK PENNER
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