FDA 510(k) Applications Received During March, 2011

FDA 510(k) Number Submission Date Device Name Applicant Contact
K110629 03/04/2011 RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER 3B PRODUCTS, INC. NORMA F ESTRIN, PH.D.
K110579 03/01/2011 ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS ABBOTT LABORATORIES DARLA ABANO
K110909 03/31/2011 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. ABBOTT LABORATORIES CHERECE L JONES
K110617 03/03/2011 MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER Abbott Vascular SUZANNE REDMAN
K110845 03/28/2011 IMPELLA CONTROLLER WITH FLOW CONTROL ABIOMED, INC. ROBERT STEWART
K110687 03/11/2011 RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) ACCLARENT, INC. DEAN KNIGHT
K110636 03/04/2011 TULA IONTOPHORESIS SYSTEM ACCLARENT, INC. GURVINDER SINGH NANDA
K110765 03/18/2011 FXA (TM) ACES GMBH FRANK T TRAUTWEIN
K110812 03/23/2011 CT-GUIDE NEEDLE GUIDANCE SYSTEM ACTIVIEWS LTD JOHN J SMITH
K110662 03/08/2011 ADAPTIVE WEDGE ADAPTIVE SPECIALTY, LLC J.D. WEBB
K110705 03/14/2011 APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING INC. ADRIENNE LENZ
K110864 03/29/2011 BIOSPINE VBR SYSTEM AESCULAP IMPLANT SYSTEMS, LLC Lisa Boyle
K110695 03/14/2011 BIPOLAR HF DEVICE AESCULAP, INC. LISA M BOYLE
K110713 03/15/2011 WATERPAP VALVE AIRWAYS DEVELOPMENT, LLC RICHARD J LARKIN
K110793 03/22/2011 AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS AMECO MEDICAL INDUSTRIES Ray Kelly
K110794 03/22/2011 AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS AMECO MEDICAL INDUSTRIES Ray Kelly
K110898 03/30/2011 S.C.O.R.E.S. UNIT AMMED SURGICAL EQUIPMENT, LLC DAVID C FURR
K110767 03/18/2011 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. JONATHAN S KAHAN
K110859 03/28/2011 METAL OPAQUER APEX DENTAL MATERIALS, INC. CHRIS KULTON
K110792 03/21/2011 GELPOINT PATH APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K110804 03/22/2011 AMT G-J TUBE APPLIED MEDICAL TECHNOLOGY, INC. JOSHUA D MEINKE
K110824 03/23/2011 ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT ARAGON SURGICAL INC. ALAN CURTIS
K110709 03/14/2011 ARK CARE DIABETES MANAGMENT SYSTEM ARKRAY Factory USA, Inc. TYLER FOUTCH
K110660 03/07/2011 ARTHREX BIOCOMPOSITE SUTURETAK ARTHREX, INC. COURTNEY SMITH
K110781 03/21/2011 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP ARTHROCARE CORP. VALERIE DEFIESTA-NG
K110584 03/01/2011 ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K110700 03/14/2011 ASCENSION ATLAS HUMERAL PLATING SYSTEM ASCENSION ORTHOPEDICS, INC. SUSAN WALTON
K110640 03/04/2011 ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT ASTRA TECH, INC. BETSY A BROWN
K110842 03/25/2011 ATLAS SPINE PEDICLE SCREW SYSTEM ATLAS SPINE INC. JEANNETTE G DAILEY
K110744 03/17/2011 PRONTOSAN WOUND IRRIGATION SOLUTION B. BRAUN MEDICAL, INC. NANCY SKOCYPEC
K110719 03/15/2011 ORIGIN ZIRCONIA B&D DENTAL TECHNOLOGIES JOON HWANG
K110829 03/24/2011 ACE STAPLER AND CARTRIDGE BAROSENSE, INC SHEILA STEVENS, PHD
K110696 03/14/2011 NEURO CHECK DEVICE WITH IO-FLEX WIRE BAXANO, INC. EDWARD SINCLAIR
K110894 03/30/2011 CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER BAYER HEALTHCARE ROGER SONNENBURG
K110587 03/01/2011 CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) BAYER HEALTHCARE, LLC CHUCK RYAN
K110646 03/04/2011 BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER BEAM-MED LTD RITA KOREMBLUM
K110615 03/03/2011 WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE BEBE TOYS MANUFACTORY LTD. PAUL A WARE
K110703 03/14/2011 BD AUTOSHIELD DUO PEN NEEDLE Becton, Dickinson and Company CYNTHIA LACATENA
K110771 03/21/2011 BD SINGLE USE, HYPODERMIC SYRINGE Becton, Dickinson and Company JOHN ROBERTS
K110778 03/21/2011 BIODENTA CUSTOMIZED ABUTMENT BIODENTA SWISS AG ANGELA BLACKWELL
K110619 03/03/2011 ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS BIOKIT S.A. JOAN GUIXER
K110796 03/22/2011 SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE BIOMERS PRODUCTS, LLC DARYL WISDAHL
K110574 03/01/2011 BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM BIOMET MICROFIXATION, INC. SHERYL MALMBERG
K110650 03/04/2011 ZYSTON ARC INTERBODY SPACER BIOMET SPINE (AKA EBI, LLC) MARGARET F CROWE
K110879 03/30/2011 BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR BIOMET SPORTS MEDICINE ELIZABETH WRAY
K110737 03/16/2011 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 BIONIME CORPORATION JIGAR SHAH
K110689 03/15/2011 INBODY BIOSPACE CORPORATION LIMITED DANIEL KAMM
K110900 03/31/2011 DISPOSABLE THYROID COLLAR BLOXR CORPORATION RAI CHOWDHARY
K110686 03/11/2011 ACCUTRAC BOSTON SCIENTIFIC CORP. LAUREN ANDERSON
K110685 03/11/2011 FLEXIVA TRACTIP BOSTON SCIENTIFIC CORP. LAUREN ANDERSON
K110833 03/25/2011 CRE BALLOON DILATATION CATHETER Boston Scientific Corporation JANIS TARANTO
K110887 03/30/2011 INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER Boston Scientific Corporation ASHLEY PYLE
K110883 03/30/2011 J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA BUSSE HOSPITAL DISPOSABLES MUHAMAD ANSARI
K110820 03/23/2011 VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM C.R. BARD, INC. KETI SINO
K110585 03/01/2011 CAPTIVA SPINE FUSELOX CERVICAL CAGE CAPTIVA SPINE, INC JOHN SANDERS
K110772 03/21/2011 BIOMARC FIDUCIAL MARKER CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K110809 03/23/2011 WIRELESS MONITORING SYSTEM CAREFUSION 303, INC. SIMON PEARMAIN
K110590 03/02/2011 INTRABEAM NEEDLE APPLICATOR CARL ZEISS SURGICAL GMBH JUDITH A BRIMACOMBE, MA
K110682 03/10/2011 STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS CASE MEDICAL, INC. TANIA LUPU
K110637 03/04/2011 ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM CILAG GMBH INTERNATIONAL FIONA LEEPER
K110605 03/02/2011 ROM PLUS CLINICAL INNOVATIONS, LLC DEAN WALLACE
K110849 03/28/2011 PRESTODR 4143 CMT MEDICAL TECHNOLOGIES, LTD. SHLOMI DINES
K110751 03/18/2011 CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER Codman & Shurtleff, Inc. SHARON MCDERMOTT
K110600 03/02/2011 COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN COLLAGEN MATRIX, INC. PEGGY HANSEN
K110788 03/22/2011 INNOVA WHEELCHAIR COLUMBIA MEDICAL MANUFACTURING, LLC SUSAN JOHNSON
K110730 03/16/2011 MONACO RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K110774 03/21/2011 ELECTRONIC SPHYGMOMANOMETER CONTEC MEDICAL SYSTEM CO., LTD. Diana Hong
K110775 03/21/2011 ELECTRONIC SPHYGMOMANOMETER CONTEC MEDICAL SYSTEMS CO., LTD. Diana Hong
K110867 03/29/2011 STERI-DENT, STERI-SURE CPAC, INC. JEFFREY S CRANE
K110581 03/01/2011 PROPATCH SOFT TISSUE REPAIR MATRIX CRYOLIFE, INC. BRYAN BROSSEAU
K110754 03/18/2011 CRYOPEN CRYOSURGICAL SYSTEM, K102214 CRYOPEN, INC. MIKE HAAS, M.D.
K110653 03/07/2011 CURE CATHETER CURE MEDICAL LLC. ROBYN SCOPIS
K110642 03/07/2011 SILJETR SYSTEM DANVILLE MATERIALS INC. LINDSAY TILTON
K110753 03/18/2011 MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K110704 03/14/2011 SENSI DIACOUSTIC MEDICAL DEVICES (PTY) LTD. E.J. Smith
K110869 03/29/2011 CARA DIAGNOS, INC Aron Shapiro
K110801 03/23/2011 WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC LIKUN FU
K110593 03/02/2011 OWL RF PROBES DIROS TECHNOLOGY, INC. GEORGE DARMOS
K110759 03/18/2011 TEMPOCEM DMG USA, INC. PAMELA PAPINEAU
K110701 03/14/2011 ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 DNA GENOTEK INC CHANTAL HEMENS-DAVIS
K110881 03/30/2011 ULTRASONIC SURGICAL UNIT DONG IL TECHNOLOGY LTD. PETER CHUNG
K110821 03/24/2011 BARF BAND DOODLEBUG PRODUCTS, LLC BARRY E SANDS
K110888 03/30/2011 ABSOLUTE WHITE LIGHT DR. FRESH, INC. M. JOYCE HEINRICH
K110577 03/01/2011 OSSEOFUSE DENTAL IMPLANT SYSTEM DYNAMIC INNOVATIONS INC. APRIL LEE
K110728 03/16/2011 IMESH TACKER EASYLAP LTD. PAUL DRYDEN
K110597 03/02/2011 EV1000 CLINICAL PLATFORM EDWARDS LIFESCIENCES MARGUERITE THOMLINSON
K110780 03/21/2011 ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II ELITECH GROUP DEBRA K HUTSON
K110830 03/25/2011 ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH ELITECHGROUP DEBRA K HUTSON
K110739 03/17/2011 ENTELLUS MEDICAL SINUS GUIDEWIRE Entellus Medical, Inc. KAREN E PETERSON
K110688 03/11/2011 MYLABGOLD ESAOTE Allison Scott
K110802 03/23/2011 A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 ESAOTE S.P.A. Allison Scott
K110699 03/14/2011 LIGAMAX 5 ETHICON ENDO-SUGERY, LLC EMILY KRUETZKAMP
K110716 03/15/2011 EVERYWAY LOW BACK PAIN RELIEF SYSTEM EVERYWAY MEDICAL INSTRUMENTS CO., LTD. ROBERT TU
K110708 03/14/2011 EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... EXACTECH, INC. LINDY KNISELY
K110706 03/14/2011 EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD EXACTECH, INC. GRAHAM L CUTHBERT
K110734 03/16/2011 NCI SPATULA FISCHER SURGICAL INC. JESSICA DIXON
K110797 03/22/2011 COMMUNIFY PACS VIEWER FLYING SQUIRREL STORAGE LLC CHRIS RELYEA
K110721 03/15/2011 GAUNYING INFRARED LAMP FOSHAN GAUNYING ELECTRONICS CO., LTD. LADI LEE
K110729 03/16/2011 ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM FUJIFILM MEDICAL SYSTEMS, USA INC. PETER ALTMAN
K110641 03/04/2011 FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL FUJIREBIO DIAGNOSTICS, INC JOHN GORMLEY
K110823 03/24/2011 PRISMAFLEX GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K110871 03/29/2011 FIT CHECKER ADVANCED GC AMERICA, INC. MARK HEISS
K110834 03/25/2011 AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION GE HEALTHCARE HELEN PENG
K110875 03/30/2011 CENTRICITY PACS GE HEALTHCARE CHERYL BORK
K110573 03/01/2011 READY VIEW GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) ELIZABETH MATHEW
K110610 03/03/2011 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL GE MEDICAL SYSTEMS, LLC MICHELLE SCHEIDT
K110798 03/22/2011 SENOGRAPHE DS, SENOGRAPHE ESSENTIAL GENERAL ELECTRIC COMPANY STEVEN KACHELMEYER
K110601 03/02/2011 SENTINELLA 102 GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A SEVERINE MOINE
K110786 03/22/2011 ESENSOR WARFARIN SENSITIVITY SALIVA TEST GENMARK DIAGNOSTICS, INC JOHN RIOLO
K110835 03/25/2011 GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS GEO MEDICAL CO., LTD. ALBERT REGO
K110899 03/30/2011 GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
K110745 03/17/2011 HELICOBACTER PYLORI ELISA IGG TEST KIT GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
K110852 03/28/2011 DOLPHIN 3 FLUID MANAGEMENT SYSTEM GYRUS ACMI, INC. GRAHAM BAILLIE
K110758 03/18/2011 NITRILE POWDER FREE EXAMINATION GLOVES HARTALEGA SDN BHD NURUL AISYAH KONG BT ABDULLAH
K110752 03/18/2011 HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER HIGHLAND INSTRUMENTS LEO BASTA
K110673 03/09/2011 HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K110862 03/29/2011 VAPRO PLUS INTERMITTENT CATHETER HOLLISTER, INCORPORATED CHRIS STUKEL
K110901 03/31/2011 SYMBIQ INFUSION AND ADMINSTRATION SET HOSPIRA, INC. Ray Silkaitis
K110603 03/03/2011 HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) I.E.M. GMBH PETER KNIPP
K110764 03/18/2011 FILMARRAY RP PANEL IDAHO TECHNOLOGY, INC. BETH LINGENFELTER
K110889 03/30/2011 IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) IND DIAGNOSTICS INC. KAI LOU
K110635 03/04/2011 INOMAX DS(IR) (DELIVERY SYSTEM) INO THERAPEUTICS LLC/DBA IKARIA LARRY LEPLEY
K110656 03/07/2011 IMC BLOOD COLLECTION NEEDLE INTERNATIONAL MEDSURG CONNECTION PETER KIM
K110882 03/30/2011 IMC INSULIN SYRINGE INTERNATIONAL MEDSURG CONNECTION PETER KIM
K110639 03/04/2011 ENDOWRIST ONE VESSEL SEALER INTUITIVE SURGICAL, INC. BRANDON HANSEN
K110810 03/23/2011 ANASCIENT BREATH MONITOR INVOY TECHNOLOGIES, LLC LUBNA M AHMAD
K110826 03/24/2011 CUROS PORT PROTECTOR IVERA MEDICAL DON CANAL
K110756 03/18/2011 BLUEPHASE STYLE IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K110819 03/23/2011 SINGHMED ROOLIP MANIPULATOR J.SINGH INSTRUMENTS CAROLINE TONTINI
K110694 03/14/2011 CONCORDE BULLET SPINAL SYSTEM JOHNSON & JOHNSON DAPHNEY GERMAIN-KOLAWOLE
K110843 03/25/2011 ALEUTIAN SPACER SYSTEM K2M, INC. NANCY GIEZEN
K110747 03/17/2011 TEMPFLEX KERR CORPORATION Wendy Garman
K110766 03/18/2011 KOLPLUX SYSTEM KOLPLAST CI LTDA E.J. Smith
K110717 03/15/2011 KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM KONICA MINOLTA MEDICAL & GRAPHIC, INC. JILLIAN M REED
K110783 03/21/2011 VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE L & K BIOMED CO., LTD HEE KYEONG JOO
K110891 03/30/2011 THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER LEMAITRE VASCULAR INC. ANDREW HODGKINSON
K110598 03/02/2011 SMR REVERSE SHOULDER SYSTEM LIMACORPORATE S.P.A. CHERYL HASTINGS
K110847 03/28/2011 SMR SHOULDER SYSTEM - CTA HUMERAL HEADS LIMACORPORATE S.P.A. CHERYL HASTINGS
K110606 03/03/2011 MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE M.V. S.R.L. ENRICO BISSON
K110761 03/18/2011 MICT TSH MAGNABIOSCIENCES, LLC JAMES L WYATT
K110655 03/07/2011 MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM MAHE MEDICAL GMBH ANDREA PECSI
K110880 03/30/2011 VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT MAINE STANDARDS COMPANY, LLC HOLLY CRESSMAN
K110578 03/01/2011 MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM MAR COR PURIFICATION, INC. Brent Geiger
K110627 03/04/2011 NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER MARVAO MEDICAL DEVICES, LTD. Marybeth Gamber
K110723 03/16/2011 M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS MASIMO CORPORATION SHELLY HARRIS
K110911 03/31/2011 RENAISSANCE SYSTEM MAZOR ROBOTICS LTD AHAVA STEIN
K110927 03/28/2011 MECTALIF MEDACTA INTERNATIONAL ADAM GROSS
K110658 03/07/2011 APTUS CANNULATED COMPRESSION SCREWS MEDARTIS AG KEVIN A THOMAS
K110908 03/31/2011 APTUS FOOT 3.5 SYSTEM MEDARTIS AG KEVIN A THOMAS
K110630 03/03/2011 F10 MEDIANA CO., LTD. AMY M.H. KIM
K110612 03/03/2011 FM20 MEDIANA CO., LTD. AMY KIM
K110675 03/10/2011 EASYRA UREA NITROGEN AND CREATININE REAGENTS MEDICA CORP. Photios Makris
K110659 03/07/2011 MEDICAL CONCEPTS INTERBODY FUSION SYSTEM MEDICAL CONCEPTS, INC. CHRISTOPHER CANIS
K110676 03/10/2011 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK KEVIN FORD
K110623 03/03/2011 PILLAR PALATAL IMPLANT SYSTEM MEDTRONIC XOMED, INC. ROZANNE PACIEJ
K110693 03/11/2011 PACEART OPTIMA SYSTEM SOFTWARE MEDTRONIC, INC. RACHEL U LIBI
K110620 03/03/2011 PREMIER C. DIFFICILE GDH MERIDIAN BIOSCIENCE, INC. SUSAN BOGAR
K110643 03/04/2011 MERIT MARQUIS FLOW SWITCH MERIT MEDICAL SYSTEMS, INC. MARK MULLANEY
K110813 03/24/2011 HEADWAY 27 MICROCATHETER MICRO VENTION, INC. Naomi Gong
K110616 03/03/2011 THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO MICROGENICS CORP. LISA CHARTER
K110738 03/17/2011 THERMO SCIENTIFIC MAS OMNI-CORE Microgenics Corporation LISA CHARTER
K110741 03/16/2011 SCEPTER C OCCLUSION BALLOON CATHETER MICROVENTION, INC. Naomi Gong
K110715 03/15/2011 INTERDRY SILVER MILLIKEN HEALTHCARE PRODUCTS, LLC BRIAN J LINDSAY
K110750 03/17/2011 PERIOPATCH MIS IMPLANTS TECHNOLOGIES LTD. IMAN KHORSHID
K110591 03/02/2011 MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL MR INSTRUMENTS, INC. JOSHUA J HOLWELL
K110712 03/14/2011 DRYTOUCH SUCTION STIMULATOR PROBE NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K110628 03/03/2011 SIMPLEABI NEWMAN MEDICAL SPENCER NEWMAN
K110594 03/02/2011 GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS NIHON KOHDEN CORP. STEVE GEERDES
K110648 03/04/2011 NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K110903 03/31/2011 PTS-X SIZING BALLOON CATHETER NUMED, INC. NICHELLE LAFLESH
K110748 03/17/2011 OLYMPUS INSTRUMENT TRAY OLYMPUS WINTER & IBE GMBH STACY KLUESNER
K110724 03/16/2011 SURGICAL PROCEDURE PACKS OMNIA SPA JAMIE AUSTIN
K110860 03/29/2011 COMP A-I-R OMRON HEALTHCARE, INC. PAUL DRYDEN
K110690 03/11/2011 ONE PERSONAL LUBRICANT (SILICONE) ONE SHARON PIETILA
K110691 03/11/2011 ONE PERSONAL LUBRICANT (WATER BASED) ONE SHARON PIETILA
K110895 03/30/2011 ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS ORTHO SOLUTIONS LIMITED AL LIPPINCOTT
K110661 03/08/2011 ACCELEDENT ORTHOACCEL TECHNOLOGIES, INC MICHAEL E KAUFMAN
K110805 03/23/2011 GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) ORTHOFIX INC. MARY BIGGERS
K110787 03/21/2011 TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) ORTHOGEM LIMITED WE-JEN LO
K110907 03/31/2011 PALOMAR ICON (TM) AESTHETIC SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC. Sharon Timberlake
K110626 03/04/2011 JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC. BRIAN CLEARY
K110735 03/16/2011 TANDA MAX OTC SYSTEM PHAROS LIFE CORPORATION JOHNATHAN S KAHAN
K110572 03/01/2011 MAMMODIAGNOST DR PHILIPS MEDICAL SYSTEMS LINDA JALBERT
K110825 03/23/2011 PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES PHILIPS MEDICAL SYSTEMS PAUL SCHRADER
K110803 03/23/2011 SURESIGNS VSI VITAL SIGNS MONITOR PHILIPS MEDICAL SYSTEMS MARY KRUITWAGEN
K110622 03/03/2011 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HERBERT VAN DYK
K110679 03/10/2011 DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM PHYGEN, LLC HARTMUT LOCH
K110588 03/02/2011 LEUCADIA PEDICLE SCREW SYSTEM PHYGEN, LLC HARTMUT LOCH
K110692 03/11/2011 STREAMLINE TL SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY, INC. EMILY M DOWNS
K110608 03/03/2011 SEVOFLURANE VAPORIZER ADAPTOR PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC) JAMIE KELLER
K110818 03/24/2011 POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS POLYMEDCO, INC. HELEN LANDICHO
K110727 03/16/2011 HYLATOPICPLUS CREAM PRECISION DERMATOLOGY INCORPORATED RONALD M GURGE
K110732 03/16/2011 EMULSION SB PRUGEN IP HOLDINGS, INC ROBERT L KNECHTEL
K110856 03/28/2011 RALCO RALCO S.R.L. DANIEL KAMM
K110846 03/28/2011 RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K110904 03/31/2011 RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K110722 03/15/2011 RPS ADENO DETECTOR PLUS RAPID PATHOGEN SCREENING, INC. Douglas Bueschel
K110896 03/30/2011 RELIANCE SPINAL SCREW SYSTEM Reliance Medical Systems, LLC Bret M Berry
K110795 03/22/2011 V200 INTELLI-TRAK OPTION RESPIRONICS CALIFORNIA, INC. ROBERT M MARSHALL
K110613 03/03/2011 ELECSYS PROLACTIN II CALCHECK 5 Roche Diagnostics KELLY COLLEEN O'MAINE ADAMS
K110726 03/16/2011 ROCHE ACETAMINOPHEN ASSAY Roche Diagnostics ANGELO PEREIRA
K110858 03/28/2011 LO-BAK TRAX ROLAND F BERTHIAUME, DC ROLAND F BERTHIAUME
K110625 03/04/2011 SAFETYMATE TALKING FIRST AID SAFETYMATE, INC. SHARON COHEN, PH.D
K110897 03/30/2011 CORTEX CO2 / ER:YAG LASER SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LLC MARK ROHRER
K110768 03/18/2011 COMPUTED DENTAL RADIOGRAPHY SCHICK TECHNOLOGIES, INC. SCOTT DOYLE
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