FDA 510(k) Applications Received During April, 2011

FDA 510(k) Number Submission Date Device Name Applicant Contact
K111185 04/27/2011 RELYX LUTING PLUS AUTOMIX 3M ESPE DENTAL PRODUCTS BERNARDO MEDELLIN, J.D.
K111023 04/19/2011 ABBOTT ARCHITECT LH CALIBRATORS ABBOTT LABORATORIES JOHN RIZOS
K111138 04/27/2011 THE PICC WAND (R) PEELABLE SAFETY INTRODUCER ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K111110 04/20/2011 APNEA GUARD ADVANCED BRAIN MONITORING, INC. PAUL DRYDEN
K111194 04/28/2011 APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING, INC. ADRIENNE LENZ
K110979 04/07/2011 DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS ADVANCED MEDICAL PRODUCTS SDN BHD ZAHARI DARUS
K111122 04/21/2011 AESCULAP SIBD XP SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K110951 04/04/2011 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA ALCON RESEARCH, LTD. MARTIN A KAUFMAN
K110998 04/11/2011 AFFIRM (TM) VCF SYSTEM ALGEA THERAPIES KELLY J BAKER
K110941 04/07/2011 REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 ALLMED SYSTEMS INC. PETER ALLEN
K111076 04/18/2011 SOLANAS AVALON POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC. KARLA SCHAFFNER
K111034 04/13/2011 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE AM USA KAREN THOMISON
K110962 04/06/2011 AMBU ASCOPE 2 AMBU A/S SANJAY PARIKH
K110794 04/26/2011 "AMECATH CVC" AND "AMECATH PRESSURE CVC" SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS AMECO MEDICAL INDUSTRIES RAY KELLY
K111118 04/21/2011 AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE AMERICAN MEDICAL SYSTEMS MONA INMAN
K110936 04/04/2011 DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC. DAVID A GREER
K111139 04/22/2011 DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U ANSELL HEALTHCARE PRODUCTS, INC. NEIL BURRIS
K110954 04/05/2011 ARJORAD STERILE WRAP ARJO WIGGINS MEDICAL, INC. JON WARD
K110994 04/08/2011 PARKER 500 ARJOHUNTLEIGH INC BRENDA AMMONETTE
K111044 04/15/2011 SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE ARTHROCARE CORPORATION LAURA KASPEROWICZ
K111078 04/18/2011 AEU-26L ELCTRONIC ENDODONTIC SYSTEM ASEPTICO, INC. GRANT RAMALEY
K111018 04/12/2011 POLYFUSE - NEUROBONE ATPAC MEDICAL LLC GARY MALINOWSKI
K111042 04/15/2011 ATRICURE CRYO MODULE ATRICURE, INC. REBECCA WALTERS
K111020 04/12/2011 ATRICURE DISSECTOR ATRICURE, INC. JAMES L LUCKY
K111072 04/18/2011 BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL BIO-RAD LABORATORIES JUANG WANG
K111003 04/20/2011 BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL BIODENTA SWISS AG DAVID EILER
K110926 04/01/2011 BONE PLATE; BONE SCREW BIOMATERIALS KOREA INC. KEVIN WALLS
K110879 04/27/2011 BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR BIOMET SPORTS MEDICINE ELIZABETH WRAY
K111154 04/25/2011 SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 BIOTRONIK, INC. JON BRUMBAUGH
K111043 04/15/2011 ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER BOSTON SCIENTIFIC CORP. JANICE E BROWN, RAC
K111100 04/20/2011 ENCOR ENSPIRE BREAST BIOPSY SYSTEM C.R. BARD, INC. JUSTIN LOVELACE
K111153 04/25/2011 SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM C.R. BARD, INC. ZHENG LIU
K111144 04/22/2011 CANDELA GENTLELASE FAMILY OF LASERS CANDELA CORP. SCOTT BLOOD
K111115 04/21/2011 CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM CAPTIVA SPINE, INC JOHN SANDERS
K111056 04/18/2011 PICCOLO COMPOSITE NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K110921 04/01/2011 NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS CARDINAL HEALTH, INC. TATYANA BOGDAN
K111015 04/11/2011 STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING CARDINAL HEALTH, INC. TATYANA BOGDAN
K111159 04/25/2011 HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME CARDIO COMM SOLUTIONS, INC. JONATHAN WARD
K111131 04/21/2011 TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES CAREFUSION 209, INC. GLEN HERMANSON
K111053 04/18/2011 SENTRYSUITE PRODUCT LINE CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K110977 04/07/2011 VESOFLOW CAREMED SUPPLY, INC. EDWARD A KROLL
K110919 04/01/2011 CARESTREAM PACS CARESTREAM HEALTH, INC. LINDA STEWART
K111157 04/25/2011 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, OPTIC DISC, MACULAR, GANGLION CELL AND ASIAN NORMATIVE DATABASES CARL ZEISS MEDITEC INC JUDITH A BRIMACOMBE
K111128 04/21/2011 LABONACHECK A1C CERAGEM INTERNATIONAL, INC. RAYMOND CHUNG
K111164 04/26/2011 EUNITY CLIENT OUTLOOK INC CHRISTIE EBY
K110996 04/11/2011 BAHA 3 POWER SOUND PROCESSOR COCHLEAR AMERICAS SEAN BUNDY
K110950 04/04/2011 CONSENSUS KNEE SYSTEM CONSENSUS ORTHOPEDICS, INC. MATTHEW M HULL
K111046 04/15/2011 CORIN MINIHIP FEMORAL STEM CORIN USA LUCINDA GERBER
K111187 04/27/2011 PATCH, PLEDGET AND INTRACARDIAC CORMATRIX CARDIOVASCULAR, INC. KIT CARIQUITAN
K111120 04/21/2011 CSM SUBMERGED-R IMPLANT SYSTEM CSMIMPLANT APRIL LEE
K111105 04/20/2011 CURASAN OSSEOLIVE DENTAL CURASAN AG ROGER GRAY
K111099 04/20/2011 ISSYS LP SPINAL FIXATION SYSTEM CUSTOM SPINE, INC. SAAD ATTIYAH
K111172 04/26/2011 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES DAAVLIN DISTRIBUTING CO. MICHELE THIEL
K110912 04/01/2011 SMART TOUCH UVTHERAPY MULTIPLE MACHINE DAAVLIN DISTRIBUTING CO. MICHELE THIEL
K111116 04/21/2011 ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 DATEX-OHMEDA MONICA MORRISON
K111162 04/25/2011 SLIM ONEBODY SYSTEM DENTIUM CO., LTD. EUNKYUNG SON
K111077 04/18/2011 ORTHOSORB RESORBABLE PINS DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K111136 04/22/2011 EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K111142 04/22/2011 ECHOSOFT(TM) ECHOMETRIX LLC LARRY A KROGER
K110999 04/11/2011 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM EDAN INSTRUMENTS, INC. RANDY JIANG
K110922 04/01/2011 PATIENT MONITOR EDAN INSTRUMENTS, INC. RANDY JIANG
K110915 04/01/2011 CERVICAL CAGE EISERTECH, LLC LUKAS EISERMANN
K111016 04/12/2011 SAFEPORT MANIFOLD (TM) (OR STOPCOCK) ELCAM MEDICAL A.C.A.L. NATASHA EVRONYAN
K111095 04/20/2011 BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025 ELECTRO KINETIC TECHNOLOGIES, LLC RAYMOND ERBE
K111009 04/14/2011 ACRYLIC HERBST APPLIANCE EMBASSY DENTAL LABORATORY KAREN E WARDEN, PHD
K111061 04/29/2011 REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) ENCORE MEDICAL, L.P. TEFFANY HUTTO
K110913 04/01/2011 ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH TAMER IBRAHIM
K111195 04/28/2011 VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS ETHICON ENDO-SURGERY, INC. DENNIS HAHN
K111111 04/20/2011 ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO ETHICON ENDO-SURGERY, LLC LINDA HILL
K111010 04/11/2011 SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC BRENDA JOHNSON
K111155 04/25/2011 XTRAFIX EXTERNAL FIXATION SYSTEM EXTRAORTHO INC MARCOS VELEZ-DURAN
K110993 04/08/2011 FEMCHEC PRESSURE MANAGEMET DEVICE FEMASYS INC. LISA PEACOCK
K110165 04/07/2011 FREERIDER MODEL LUGGIE MODEL 168-4IT FREERIDER LUGGIE SCOOTERS INC JEFFREY L DAVIS
K110920 04/01/2011 UF-760AG FUKUDA DENSHI CO., LTD. LORAN VAN NOY
K110930 04/04/2011 ACTIVE WASTE GAS SCAVENGER G. DUNDAS CO.,INC. MICHELLE NORRIE
K110946 04/04/2011 ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE GALIL MEDICAL LTD. LYNNE DAVIES
K111209 04/29/2011 INTEGRATED INNOVA - S5I SYSTEM OPTION GE HEALTHCARE FAYCAL KHERRA
K110943 04/04/2011 LOGIQ E9 GE HEALTHCARE BRYAN BEHN
K111200 04/29/2011 MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM GE HEALTHCARE CAROL ALLOIAN
DEN110012 04/13/2011 APTIMA TRICHOMONAS VAGINALIS ASSAY GEN-PROBE INCORPORATED MARIA CARMELITA S BALUYOT
K110968 04/06/2011 PROFLU+ ASSAY GEN-PROBE PRODESSE, INC KAREN HARRINGTON
K111132 04/22/2011 GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM GENESYS SPINE BRIAN J BERGERON
K110963 04/06/2011 ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER, PH.D
K110932 04/04/2011 TINNITUS SOUND GENERATOR MODULE GN RESOUND A/S LARS HAGANDER
K110899 04/12/2011 GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
K110990 04/08/2011 GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM GOLD STANDARD ORTHOPEDICS LLC JAMES RITTER
K111059 04/18/2011 GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) GYRUS ACMI, INC. LORRAINE CALZETTA
K111102 04/20/2011 RADIOVISION HAAS SOFTWARE DAVID L STARK
K111004 04/11/2011 HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER HANSEN MEDICAL, INC. KATE WHITIN
K111163 04/26/2011 CHITOGAUZE FUSION HEMCON MEDICAL TECHNOLOGIES, INC. KENDRA RATHKEY
K111065 04/19/2011 STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS CALUDIA WIESEMANN
K110985 04/08/2011 ICON ADULT MANUAL ICON WHEELCHAIRS INC TOM HORTON
K111098 04/20/2011 INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN IMAGING DYNAMICS COMPANY LTD. DANIEL KAMM
K111158 04/25/2011 LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) INNOVATIVE GLOVES CO; LTD RAJEEV SOOD
K111060 04/19/2011 MRGFUS PELVIC PA COIL MODEL 1.0 INSIGHTECH, LTD ORI LUBIN
K111032 04/14/2011 CMC CABLE FIX INSTRATEK, INC. JEFF SEAVEY
K111001 04/22/2011 STERILE STORM (R) OPERATING KIT INTELLIGENT ORTHOPAEDICS LTD PETER J OGRODNIK
K111199 04/29/2011 INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS INTRA-LOCK INTERNATIONAL, INC. ANGELA BLACKWELL
K111160 04/25/2011 INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) INTRICON DATRIX CORPORATION TANYA O'BRIEN
K111030 04/13/2011 E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM INTROMEDIC CO., LTD JINYOUNG LEE
K110987 04/08/2011 CARDIAC TRIGGER MONITOR IVY BIOMEDICAL SYSTEMS, INC. DICK LISTRO
K111177 04/27/2011 JUELL HARD CURE JUELL DENTAL ANGELA BLACKWELL
K111178 04/27/2011 JUELL SOFT CURE JUELL DENTAL ANGELA BLACKWELL
K111135 04/25/2011 PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) K2M, INC. NANCY GIEZEN
K111165 04/26/2011 KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL HAGAN
K110960 04/05/2011 ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE KOON SENG SDN.BHD KEVIN WALLS
K111067 04/18/2011 JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. GLEN FEYE
K111169 04/26/2011 PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF KWANG MYUNG DAICOM INC PRISCILLA CHUNG
K111064 04/18/2011 TIGERPAW SYSTEM II LAAX, INC. MICHAEL A DANIEL
K110983 04/07/2011 CENTRIMAG DRAINAGE CANNULA KIT LEVITRONIX LLC LYDIA SAKAKEENY
K110980 04/07/2011 CENTRIMAG RETURN CANNULA KIT LEVITRONIX LLC. LYDIA SAKAKEENY
K111201 04/29/2011 C7 XR IMAGING SYSTEM LIGHTLAB IMAGING,INC. BRYAN COWELL
K111212 04/29/2011 SMR SHOULDER SYSTEM- REVISION STEMS LIMACORPORATE S.P.A. CHERYL HASTINGS
K111014 04/11/2011 LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES LSI SOLUTIONS, INC. JUDE S SAUER, M.D.
K111149 04/25/2011 HANAROSTENT BILIARY (NNN) M.I. TECH CO., LTD. PAUL SUMNER
K111093 04/19/2011 BILLY BOY MALE LATEX CONDOM MAPA GMBH GERMAN FRANK
K111047 04/15/2011 CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES INC. CHRIS TIHANSKY
K111021 04/12/2011 CUBESCAN / BIOCON-700 MCUBE TECHNOLOGY CO., LTD. SEUNGTAI KIM
K111058 04/18/2011 URETRON MODEL URT MED-SONICS CORP WILLIAM A STOLL
K111145 04/22/2011 ENDO HEAD MEDACTA INTERNATIONAL ADAM GROSS
K111005 04/11/2011 ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL MEDICA CORP. PHOTIOS MAKRIS
K111036 04/14/2011 EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT MEDICA CORPORATION PHOTIOS MAKRIS
K110956 04/05/2011 MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR MEDIVANCE, INC. LYNNE ARONSON
K111147 04/25/2011 MEDLINE VESSEL CANNULA MEDLINE, INDUSTRIES, INC. MATT CLAUSEN
K111182 04/27/2011 ANGIOJET SOLENT OMNI THROMBECTOMY SET MEDRAD, INC. DOUG ATKINS
K111049 04/15/2011 MOBILE VERSA LIGHT MEDTEK LIGHTING CORP ROBERT WAGNER
K110955 04/05/2011 ANYRIDGE INTERNAL IMPLANT SYSTEM MEGAGEN CO., LTD. APRIL LEE
K111091 04/19/2011 MERIT MEDICAL 20 ML SYRINGE MERIT MEDICAL SYSTEMS, INC. MICHAELA RIVKOWICH
K111008 04/11/2011 MICROWARE BONE PLATES AND BONE SCREW MICROWARE PRECISION CO., LTD. HARRISON DU
K111007 04/11/2011 MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE MIDWEST REPROCESSING CENTER LLC SCOTT SENNER
K111066 04/20/2011 MIGRA TAB, QUICKSPLINT MIGRAINE MIGRATHERAPY LLC BRADLEY ELI
K111137 04/22/2011 HYDROFIX VASO SHIELD MIMEDX GROUP INC SALLY THORSEN
K110976 04/07/2011 ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM NANOTHERAPEUTICS, INC. DENNIS TOMISAKA
K110971 04/06/2011 TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT NAVOTEK MEDICAL LTD STEVEN B DATLOF
K111019 04/12/2011 SURGIMAP (TM) SPINE NEMARIS INC KEITH A BARRITT
K110967 04/06/2011 ENTERPRISE ELECTROPHYSIOLOGY SYSTEM NEURALYNX INC MIKE JOHNSON
K110989 04/08/2011 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K111146 04/22/2011 NEWPORT HT70 VENTILATOR NEWPORT MEDICAL INSTRUMENTS, INC. TOM COLONNA
K111101 04/20/2011 NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET NORFOLK MEDICAL MICHAEL J DALTON
K111107 04/20/2011 SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE NORITAKE CO., INC. IVAN WASSERMAN
K110925 04/01/2011 NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT NOVABONE PRODUCTS, LLC DAVID M GAISSER
K111174 04/27/2011 NXSTAGE PUREFLOW SL NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K110953 04/05/2011 VISENSIA, VISENSIA WITH ALERT OBS MEDICAL CHRIS WEATHERALL
K111161 04/25/2011 PERFSCAPE V2.0 OLEA MEDICAL KRISTI GUSMAN
K111202 04/29/2011 SURGICAL TISSUE MANAGEMENT SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. STACY A KLUESNER, M.S., RAC
K111087 04/19/2011 FOUNDATION OLYMPUS TERUMO BIOMATERIALS CORPORATION PATSY J TRISLER
K111193 04/28/2011 APEX ARC HIP STEM OMNILIFE SCIENCE INC. RADHIKA PONDICHERRY
K110947 04/04/2011 APEX K1 HIP STEM OMNILIFE SCIENCE INC. RADHIKA PONDICHERRY
K111062 04/18/2011 APEX KNEE SYSTEM, APEX ALL POLY TIBIA OMNILIFE SCIENCE INC. CHRISTINE NASSIF
K111184 04/27/2011 APEX PS KNEE SYSTEM - PS-C INSERT OMNILIFE SCIENCE INC. RADHIKA PONDICHERRY
K110986 04/08/2011 OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 OPTOMED OY LAURA PIILA
K110309 04/06/2011 FOB ONE STEP RAPID TEST ORIENT GENE BIOTECH GARY LEHNUS
K111183 04/27/2011 ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS) ORTHOFIX INC. DARLA CHEW
K111041 04/14/2011 MINI VARIABLE SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K110959 04/05/2011 ORTHOPEDIATRICS BLADE PLATE SYSTEM ORTHOPEDIATRICS, CORP MARK FOX
K111086 04/19/2011 ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM ORTHOPEDIATRICS, CORP MARK FOX
K111176 04/27/2011 OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM OSTEOMED L.P. PIEDAD PENA
K111069 04/18/2011 OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT OSTEOSYMBIONICS, LLC ELAINE DUNCAN
K111045 04/18/2011 CENTRO FAMILY OF MANUAL WHEELCHAIRS OTTO BOCK HEALTHCARE, LP WILLIAM KABITZ
K111000 04/11/2011 PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR PARCUS MEDICAL, LLC BARTON BRACY
K111055 04/15/2011 GALAXY SYSTEM; JUPITER PERSONAL HEALTH INSTITUTE INTERNATIONAL KUMAR KULKARNI
K110914 04/11/2011 TRIPLE LUMEN PFM PICC PFM MEDICAL, INC SALVADORE PALOMARES
K111114 04/21/2011 SURESIGNS VS2 VITAL SIGNS MONITOR PHILIPS MEDICAL SYSTEMS KRISTEN LESSARD
K111024 04/12/2011 JETPACK 2.0 PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. LORI R PETERSON
K111083 04/19/2011 PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MICHAEL ASMALSKY
K111031 04/14/2011 PAINFUSOR CATHETER PLAN 1 HEALTH, S.R.L. SIGI CARON
K111026 04/13/2011 APOLLO POLLOGEN LTD YORAM LEVY
K111143 04/22/2011 POLY-CHEM 90 TOTAL BILIRUBIN POLYMEDCO, INC. HELEN LANDICHO
K111168 04/25/2011 PRECISION SKIN EMULSION PRECISION DERMATOLOGY INCORPORATED RONALD M GURGE, PH.D
K111121 04/21/2011 VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH PROXY BIOMEDICAL LTD. ELAINE DUNCAN
K110856 04/29/2011 RALCO RALCO S.R.L. DANIEL KAMM
K111085 04/19/2011 SHARPS TANK REUSABLE SHARPS CONTAINER REHRIG PACIFIC COMPANY DAVID OLMSTEAD
K110965 04/06/2011 RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM RENOVIS SURGICAL TECHNOLOGIES, LLC DAVID J COLLETTE, MD
K111148 04/22/2011 S8 ASPEN WITH H4I PLUS RESMED CORP. DAVID D'CRUZ
K111207 04/29/2011 RESPIRE BLUE SERIES RESPIRE MEDICAL DANIELA LEVY
K111103 04/20/2011 DIGITAL X-RAY IMAGING SYSTEM RF CO., LTD KOJI KUBO
K111188 04/27/2011 COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B ROCHE DIAGNOSTICS SARAH BAUMANN
K110923 04/01/2011 COBAS 4800 CT / NG TEST ROCHE MOLECULAR SYSTEMS, INC. JAMES BONDS
K111013 04/11/2011 ACEM SANDHILL SCIENTIFIC, INC. LEWIS WARD
K110981 04/07/2011 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES SHANDONG YINGHONG MEDICAL PRODUCTS CO., LTD. FRANK LIU
K110928 04/04/2011 BODY ANALYSIS SCALE, MODEL BG 17 SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD CHARLIE MACK
K111134 04/22/2011 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS SIEM AEMPEMED CORP., LTD WILLIAM E HARRIS, III
K111079 04/18/2011 SYNGO.VIA WEB VIEWER SIEMENS AG, MEDICAL SOLUTIONS SVEN KNOKE
K110934 04/04/2011 ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY SIEMENS HEALTHCARE DIAGNOSTICS SANDRA D WHITE
K111205 04/29/2011 MICROSCAN (R) MICROSTREP PLUS (R) PANELS SIEMENS HEALTHCARE DIAGNOSTICS, INC. SHANNON POPSON
K111052 04/15/2011 SYNGO NEURO PBV-IR SIEMENS MEDICAL SOLUTIONS USA, INC. GARY L JOHNSON
K111179 04/27/2011 ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN SIESTA MEDICAL, INC. MICHAEL KOLBER
K111068 04/18/2011 STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 SKELETAL DYNAMICS, LLC ANA M ESCAGEDO, ESQ
K111170 04/26/2011 PICO SMITH & NEPHEW, INC. TERRY MCMAHON
K111025 04/13/2011 TRIGEN LOW PROFILE BONE SCREW SMITH & NEPHEW, INC. NATALIE P WILLIAMS
K110958 04/05/2011 VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH SMITH & NEPHEW, INC. LAURA REYNOLDS
K102909 04/29/2011 SOMNOBRUX SPLINTS SOMNOMED INC BRADLEY SOUTHWORTH
K110957 04/05/2011 M4 MONITOR SPECTRUM MEDICAL, LLP STEVE TURNER
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