FDA 510(k) Applications Received During June, 2007

FDA 510(k) Number Submission Date Device Name Applicant Contact
K071517 06/04/2007 AP MEDICAL SHARPS CONTAINERS 0,6-12 LT. A.B.M. ITALIA S.P.A FRANCO GRAVA
DEN070014 06/20/2007 MANDOMETER III AB MANDO KIM BLOOM
K071525 06/04/2007 ACTIVATED ASPARTATE AMINOTRANSFERASE ABBOTT LABORATORIES LINDA MORRIS
K071531 06/05/2007 MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K071715 06/22/2007 ACUMED CONGRUENT BONE PLATE SYSTEM ACUMED LLC ED BOEHMER
K071532 06/05/2007 ALPHA INFUSION PUMP, MODEL A200, A450 ADVANCED INFUSION, INC. JAMES CHRISTENSEN
K071537 06/05/2007 STERRAD 100NX TEST PACK ADVANCED STERILIZATION PRODUCTS REUBEN LAWSON
K071699 06/21/2007 AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 AGA MEDICAL CORP. JODI L RAUS
K071682 06/19/2007 CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) ALARA, INC. ROBERT LUNDBERG
K071697 06/20/2007 NEURONAV SYSTEM AND NEURONAV DRIVE ALPHA OMEGA LTD. BAHEEJ DANIAL
K071604 06/12/2007 ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC DONALD V CANAL
K071746 06/27/2007 DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES ANSELL HEALTHCARE PRODUCTS, LLC CYNTHIA A INGRAM
K071671 06/19/2007 SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES PERRY JOHNSTON
K071616 06/13/2007 ARC SURGICAL BIOTRAK PIN SYSTEM ARC SURGICAL LLC. ED BOEHMER
K071538 06/05/2007 ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER ARROW INTERNATIONAL, INC. KIRSTEN STOWELL
K071622 06/14/2007 ARTHREX FIBERWIRE ARTHREX, INC. ANN WATERHOUSE
K071709 06/22/2007 ARTHROCARE SYSTEM 12000 ARTHROCARE CORP. VALERIE DEFIESTA-NG
K071721 06/25/2007 ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371 ASAHI INTECC CO., LTD. YOSHI TERAI
K071602 06/11/2007 IMAGIC V2.0 ASHVA TECHNOLOGIES, PVT. LTD CARL ALLETTO
K071567 06/07/2007 AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE AUTOSAFE-REFELX INC. JOHN D STEPHENS
K071518 06/04/2007 DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS B. BRAUN MEDIZINTECHNOLOGIE GMBH SUSAN OLINGER
K071664 06/18/2007 TRELLIS-6 PERIPHERAL INFUSION SYSTEM BACCHUS VASCULAR, INC. ANTHONY SOWUNMI
K071543 06/05/2007 HALO360' COAGULATION CATHETER BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K071745 06/27/2007 BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K071681 06/19/2007 CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 BECKMAN COULTER, INC. LOURDES COBA
K071623 06/14/2007 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML BECTON, DICKINSON & CO. VICKI K WHITLEY
K071561 06/07/2007 HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D BEIJING NORTH POLE DENTAL HANDPIECE CO., LTD Diana Hong
K071666 06/18/2007 SLENDERTONE ENERVIVE, MODEL 561 BIO-MEDICAL RESEARCH CORP. ANNE-MARIE KEENAN
K071675 06/19/2007 LIQUICHEK TUMOR MARKER CONTROL Bio-Rad Laboratories MARIA ZEBALLOS
K071638 06/15/2007 BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. LINDA K SCHULZ
K071734 06/26/2007 WATERLASE MD DERM BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K071551 06/06/2007 QUICKBRIDGE TM CYLINDER AND CAP BIOMET 3I, INC. DIANA TAYLOR
K071577 06/08/2007 BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER BIOMET MICROFIXATION, INC. KIM REED
K071704 06/21/2007 SLEEVE AND BUTTON SOFT TISSUE DEVICES BIOMET SPORTS MEDICINE, INC. ELIZABETH WRAY
K071569 06/08/2007 ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER BIOMET, INC. ELIZABETH WRAY
K071546 06/06/2007 EOS BIOSPACE MED JOHN J SMITH
K071665 06/18/2007 SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 BIOTRONIK, INC. Jon Brumbaugh
K071634 06/15/2007 MODIFICATION TO:CONTOUR SE MICROSPHERES BOSTON SCIENTIFIC CORP. SHILPA PREM
K071733 06/26/2007 DL900 SERIES HOLTER RECORDER BRAEMAR, INC. DARREN DERSHEM
K071702 06/21/2007 BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 BREAS MEDICAL AB IBB JESSEN
K071648 06/18/2007 EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS CANTERBURY SCIENTIFIC LTD. MAURICE OWEN
K071631 06/14/2007 NICOM ELECTRODES CHEETAH MEDICAL INC. Rhona Shanker
K071614 06/13/2007 FIDUCIAL MARKERS CIVCO JIM LEONG
K071706 06/21/2007 ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) CLINICAL DATA, INC. WYNN STOCKING
K071663 06/18/2007 VF GEL PLUS COAPT SYSTEMS, INC. LINDA RUEDY
K071776 06/29/2007 ANEUROPLASTIC, MODEL 43-1290 Codman & Shurtleff, Inc. RACHEL CREME
K071557 06/07/2007 COLLAWOUND HYDROGEL COLLAMATRIX CO., INC. DENNIS J.N. SEAH
K071632 06/14/2007 PERFECT TISSUE CONTOURING SYSTEM II COLTENE/WHALEDENT INC. GLENN PERSELLO
K071534 06/05/2007 CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS CONFIRMA, INC. PATRICIA A MILBANK
K071763 06/29/2007 AMADEUS ADAPTIVE COMPRESSION THERAPY CONVATEC MARILYN KONICKY
K071640 06/15/2007 VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM COOK, INC. Theodore Heise
K071736 06/26/2007 AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS COOPERVISION, INC. JACK P DOUGLAS
K071520 06/04/2007 RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X CORE ESSENCE ORTHOPAEDICS, LLC SHAWN T HUXEL
K071533 06/05/2007 FITMATE SERIES COSMED S.R.L. ROBERT SCHIFF
K071550 06/06/2007 PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS CP MEDICAL BETSY CORTELLONI
K071597 06/12/2007 DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 DADE BEHRING, INC. PAMELA A JURGA
K071603 06/12/2007 DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K071767 06/29/2007 DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A DADE BEHRING, INC. PAMELA A JURGA
K071694 06/20/2007 COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX DAIKEN MEDICAL CO, LTD. FUMIAK KANAI
K071701 06/21/2007 TRACKLEAF-10 DIREX SYSTEMS CORP. LARISA GERSHTEIN
K071679 06/19/2007 METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. YAEL RUBIN
K071562 06/07/2007 D3 HEMATOLOGY ANALYZER, MODEL D3 DREW SCIENTIFIC, INC. ROGER BOURREE
K071737 06/26/2007 GENERAL SEMEN ANALYSIS KIT DYN-BIOSHAF (2006) LTD. THOMAS M TSAKERIS
K071722 06/22/2007 DEEP BLUE E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J.M. NOLTE
K071651 06/18/2007 EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES ENDOGASTRIC SOLUTIONS, INC. MICHAEL A DANIEL
K071574 06/08/2007 STIFFER COAXIAL MICRO-INTRODUCER KIT ENPATH MEDICAL, INC. PATRICE STROMBERG
K071581 06/08/2007 BACKPACK MEDICAL OXYGEN SYSTEM ESSEX CRYOGENICS OF MISSOURI, INC. ELIZABETH HUNNICUTT
K071512 06/04/2007 GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS ETHICON, INC. BRYAN A LISA
K071624 06/14/2007 EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR EVERLIFE MEDICAL EQUIPMENT CO., LTD. JEN KE-MIN
K071676 06/19/2007 EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS EXACTECH, INC. GRAHAM CUTHBERT
K071738 06/26/2007 EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER EXACTECH, INC. AMNON TALMOR
K071775 06/29/2007 DASH EZSURGICAL Kevin Walls
K071755 06/28/2007 FALCK APPLANATION TONOMETER (FAT2) FALCK MEDICAL INC. RICHARD E LIPPMAN
K071573 06/08/2007 RUGALIFT, MODEL# V.2.1 FATROTEK S.R.L. FRANSICO PELUSO
K071744 06/27/2007 AVIAFIT PULSATING LEGBAND FLOWMEDIC LTD. AHAVA STEIN
K071510 06/04/2007 HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 FOCUS DIAGNOSTICS, INC. CONSTANCE BRIDGES
K071511 06/04/2007 PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G FOCUS DIAGNOSTICS, INC. SID MATHUR
K071674 06/19/2007 GC-ZIRCONIA GC AMERICA, INC. TERRY L JORITZ-LYONS
K071570 06/08/2007 GE LUNAR BODY COMPOSITION SOFTWARE GE MEDICAL SYSTEMS LUNAR JAMES P RASKOB
K071523 06/04/2007 FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750 GENEXEL-SEIN, INC. JAY MANSOUR
K071519 06/04/2007 HEMCON CHITOFLEX-SURGICAL DRESSING HEMCON, INC. KEVIN HAWKINS
K071652 06/18/2007 HEMOCUE WBC SYSTEM HEMOCUE AB ALLAN WHITE
K071506 06/01/2007 ECHELON SPECTROSCOPY PACKAGE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K071646 06/18/2007 SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 IDEV TECHNOLOGIES, INC. TIMOTHY R PLACEK
K071526 06/04/2007 UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV IMPACT INSTRUMENTATION, INC. LESLIE H SHERMAN
K071583 06/08/2007 CERMET III ACETABULAR CUP SYSTEM IMPLANTS INTERNATIONAL, LTD MOHAN EMMANUEL
K071516 06/04/2007 INOMAX DS INO THERAPEUTICS LLC RICHARD K BOURNE
K071771 06/29/2007 INSTRUMED RETRACTORS INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K071505 06/01/2007 MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM INTEGRA LIFESCIENCES CORPORATION JON CAPAROTTA
K071669 06/19/2007 INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K071637 06/15/2007 INTRINSIC THERAPEUTICS FIXATION STAPLE INTRINSIC THERAPEUTICS INCORPORATED KRISHNA UPPUGONDURI
K071587 06/11/2007 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY INVERNESS MEDICAL INNOVATIONS, INC. JAMES DELANEY
K071687 06/18/2007 FAMILI OF IRIDEX IQ LASER SYSTEMS IRIDEX CORP. DAVID BUZAWA
K071636 06/15/2007 CODIAGNOSTIX (R) 5.72 IVS SOLUTIONS AG FRANK STOCKMANN
K071710 06/22/2007 BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. DAGMAR OETTE
K071530 06/05/2007 KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE CHEN
K071754 06/28/2007 NEO-VAGINA SURGERY SET AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K071695 06/20/2007 KENSEY NASH MACROPORE SHIELD KENSEY NASH CORP. CINDY VARUGHESE
K071599 06/11/2007 EASYGUIDE KEYSTONE DENTAL, INC. MARTIN J LEIGHTON
K071685 06/20/2007 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES LANGFANG HUILONG PLASTIC PRODUCT CO., LTD. CHU XIAOAN
K071686 06/20/2007 POWDERED VINYL PATIENT EXAMINATION GLOVES LANGFANG HUILONG PLASTIC PRODUCT CO., LTD. CHU XIAOAN
K071633 06/14/2007 LANX DEFORMITY SYSTEM LANX, LLC JANICE HOGAN
K071578 06/08/2007 BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17 LIFESCIENCE PLUS, INC. AUDREY VITALE
K071773 06/29/2007 CPAP NASAL MASK WITH PILLOWS LIFESOURCE PAUL DRYDEN
K071751 06/28/2007 LIFESYNC ADAPTER, MODEL LS-302 LIFESYNC CORPORATION DIANE SUDDUTH
K071759 06/28/2007 LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS) LIVE TISSUE CONNECT, INC. HOWARD M HOLSTEIN
K071761 06/29/2007 LLOYD LINDEN, MODEL E04 LLOYD LINDEN, INC. JUNNATA CHANG
K071542 06/05/2007 DIGITAL STEREOLOC II LORAD, A HOLOGIC CO. GAIL YAEKER-DAUNIS
K071529 06/05/2007 XTRACT CATHETER SYSTEM LUMEN BIOMEDICAL, INC. MARIA E BRITTLE
K071575 06/08/2007 SANDMAN INTRO MALLINCKRODT DEVELOPPEMENT FRANCE JAMES BONDS
K071774 06/29/2007 JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K071612 06/13/2007 MODUS TRILOCK 2.0/2.3/2.5 MEDARTIS AG LINDA SCHULZ
K071642 06/18/2007 MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER MEDIAID INC. JAYESH PATEL
K071610 06/13/2007 MEDIAID PULSE OXIMETER M30 AND M34 MEDIAID INC. JAYESH PATEL
K071713 06/22/2007 CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR MEDICAL DECISIONS NETWORK JONATHAN KAHAN
K071552 06/06/2007 PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K071740 06/27/2007 CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES MEDTEXX MANUFACTURING SDN. BHD. OOI LOON SENG
K071655 06/18/2007 REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 MEDTRONIC INC. MICHELLE NIVALA
K071641 06/15/2007 REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) MEDTRONIC INC. MICHELLE NIVALA
K071657 06/18/2007 TRU FLU MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K071548 06/06/2007 WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED MERZ DENTAL GMBH RICHARD G HUNTER
K071741 06/27/2007 TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM MIGADA PLANT YOSSI SHACHAR
K071565 06/07/2007 BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT MOLNLYCKE HEALTH CARE US, LLC STEVEN DOWDLEY
K071700 06/21/2007 BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT MOLNLYCKE HEALTHCARE, US LLC STEVEN DOWDLEY
K071579 06/08/2007 PEF TUBE N.M. BEALE CO. INC. PAMELA PAPINEAU
K071553 06/06/2007 ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR NDO SURGICAL, INC. JOHN J VOZELLA
K071691 06/20/2007 DUAL SHOT ALPHA NEMOTO KYORINDO CO., LTD. MICHAEL HIEDA
K071611 06/13/2007 NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL NEOCOIL BRIAN BROWN
K071639 06/15/2007 QWIX POSITIONING SCREW NEWDEAL SAS JUDITH E O'GRADY
K071596 06/12/2007 POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 NIHON SEIMITSU SOKKI CO., LTD. KOJI KUBO
K071613 06/13/2007 AMIGO INSULIN PUMP NIPRO DIABETES SYSTEMS, INC. HARRY RUSSELL
K071588 06/11/2007 DISPENSER DP 20 NOUVAG AG ERICH FORSTER
K071619 06/13/2007 SPY FLUORESCENT IMAGING SYSTEM NOVADAQ TECHNOLOGIES, INC. ALLISON MANNERS
K071606 06/12/2007 BIOSIGN CENTRAL STATION OBS MEDICAL WAYNE NETHERCUTT
K071764 06/29/2007 REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360 OBTECH MEDICAL SARL ELIZABETH MILLER
K071762 06/29/2007 OMNIWAVE ENDOVASCULAR SYSTEM OMNISONICS MEDICAL TECHNOLOGIES ANNE M KULIS
K071645 06/15/2007 MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S OMRON HEALTHCARE, INC. PAUL DRYDEN
K071673 06/19/2007 ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 ONC SOLUTIONS, INC. JOHN SCHWAMB
K071617 06/13/2007 ORAL NEUTRALIZER ORAL BIOTECH ROBERT BOWERS
K071555 06/07/2007 FORTAGEN ORAL MEMBRANE ORGANOGENESIS, INC. PATRICK R BILBO
K071714 06/22/2007 NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K071768 06/29/2007 ERBIUM FRACTIONAL HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. Sharon Timberlake
K071668 06/19/2007 ORTHOBIOM SPINAL SYSTEM PARADIGM SPINE MARCI HALEVI
K071650 06/18/2007 C350 POWERED WHEELCHAIR PERMOBIL AB JAN ASTROM
K071564 06/07/2007 MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 PHILIPS MEDICAL SYSTEMS RICK SCHUL
K071756 06/28/2007 ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE POINTE CONCEPTION MEDICAL, INC WILLIAM C HAACK
K071593 06/11/2007 PTS PANELS CHOL+HDL PANEL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K071507 06/01/2007 PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K071514 06/04/2007 ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 POSSIS MEDICAL, INC. FRANK B FREEDMAN
K071708 06/21/2007 I45, I45S, I60, AND I60S POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K071688 06/20/2007 RELIANCE S.E.P. RELIANCE ORTHODONTIC PRODUCTS, INC. PAUL GANGE
K071590 06/11/2007 THERMA-CURE RELIANCE ORTHODONTIC PRODUCTS, INC. PAUL GANGE
K071621 06/14/2007 RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. DAN MARINSIK
K071509 06/04/2007 BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K071591 06/11/2007 RAMP INFLUENZA A/B ASSAY RESPONSE BIOMEDICAL CORP. KEN PILGRIM
K071644 06/15/2007 ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 ROCHE DIAGNOSTICS CORP. DIMITRIS DEMIRTZOGLOU
K071726 06/25/2007 ZUMA SEASPINE, INC. ETHEL BERNAL
K071584 06/11/2007 OASIS RELEASE 1.0 SEGAMI CORPORATION PHILIPPE BRIANDET
K071672 06/19/2007 SENTEC DIGITAL MONITORING SYSTEM SENTEC AG STEPHEN H GORSKI
K071717 06/22/2007 GE OEC ALTITUDE SHIMADZU CORP. AKIRA SHIGEYASU
K071742 06/27/2007 BEAUTIFIL II SHOFU DENTAL CORP. DAVID MORAIS
K071513 06/04/2007 INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY SIEMENS MEDICAL SOLUTIONS RALF HOFMANN
K071730 06/25/2007 STUDIODOP VICORDER SKIDMORE MEDICAL, LIMITED DAVID W WAGNER
K071698 06/21/2007 AURORA LED SERIES SURGICAL LIGHTS SKYTRON, DIV. THE KMW GROUP, INC. LARRY PEREZ
K071549 06/06/2007 SBI RHEAD PLATING SYSTEM SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K071540 06/05/2007 SBI TITANIUM THREADED PIN SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K071541 06/05/2007 SBI TWISTOFIX SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K071586 06/11/2007 BIORAPTOR 2.3 PK SUTURE ANCHOR SMITH & NEPHEW INC., ENDOSCOPY DIVISION JULIE ACKER
K071563 06/07/2007 PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM SMITH & NEPHEW, INC. DAVID HENLEY
K071527 06/04/2007 PNEUPAC VR1 AIR MIX SMITHS MEDICAL INTERNATIONAL, LTD. DONALD ALEXANDER
K071629 06/14/2007 PARIETEX POLYESTER MESH WITH INTRODUCER SOFRADIM PRODUCTION RENEE BORGESANO
K071556 06/07/2007 SOMNOSCREEN EEG10-20 SOMNOMEDICS GMBH CHERITA JAMES
K071725 06/25/2007 M2 MONITOR SPECTRUM MEDICAL LTD STEVE TURNER
K071724 06/25/2007 LUCENT SPINAL ELEMENTS, INC. KERRI DIMARTINO
K071626 06/14/2007 DUREX PLAY SOFT & SENSUAL LUBRICANT SSL AMERICAS CHRIS ROBINSON
K071732 06/26/2007 MARROWMINER STEMCOR SYSTEMS, INC. SHARON ROCKWELL
K071585 06/11/2007 P.004 HEALING ABUTMENTS AND CLOSURE SCREWS STRAUMANN USA ELAINE ALAN
K071628 06/14/2007 STRYKER EXTERNAL FIXATION SYSTEM STRYKER CMF TENNILLE FOLK
K071689 06/20/2007 DEVILBISS INTELLIPAP MODEL DV 5 SERIES SUNRISE MEDICAL JOSEPH E OLSAVSKY
K071571 06/08/2007 SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM SURGIQUEST, INC. KOUROSH AZARBARZIN
K071728 06/25/2007 MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE SURGRX, INC. LINDA OLESON
K071703 06/21/2007 ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC SWISS AMERICAN PRODUCTS, INC. ERIC LUO
K071615 06/13/2007 FIXAFLOSS SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K071735 06/26/2007 MODIFICATION TO DISPOSABLE INFUSION PUMP KIT SYMBIOS MEDICAL PRODUCTS, LLC MICHAEL JAMES
K071503 06/01/2007 SYSTEM, TOMOGRAPHY, COMPUTED EMISSION SYNTERMED, INC. KENNETH F VAN TRAIN
K071667 06/19/2007 SYNTHES VECTRA-ONE SYSTEM SYNTHES SPINE STACEY BONNELL
K071524 06/04/2007 TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL TCM WORLD INC. YUWADEE IMTANAVANICH
K071711 06/22/2007 ASCA-CHEK TECHLAB INC., CORPORATE RESEARCH CENTER CHARLES PENNINGTON
K071712 06/22/2007 LEUKO EZ VUE TECHLAB INC., CORPORATE RESEARCH CENTER CHARLES PENNINGTON
K071661 06/19/2007 ALPHAONE BIOFEEDBACK SYSTEM TELEDIAGNOSTIC SYSTEMS, INC. LARRY WOODWARD
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