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 04/13/2011 ABBOTT ARCHITECT LH CALIBRATORS ABBOTT LABORATORIES JOHN RIZOS
K111138 04/22/2011 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 04/04/2011 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
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 04/11/2011 BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL BIODENTA SWISS AG DAVID EILER
K110926 04/01/2011 BONE PLATE; BONE SCREW BIOMATERIALS KOREA INC. Kevin Walls
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 04/15/2011 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, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL 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 04/11/2011 ACRYLIC HERBST APPLIANCE EMBASSY DENTAL LABORATORY KAREN E WARDEN, PHD
K111061 04/18/2011 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
K110920 04/01/2011 UF-760AG FUKUDA DENSHI CO., LTD. LORAN VAN NOY
K111097 04/20/2011 HUMELOCK CEMENTED SHOULDER PROSTHESIS FX SOLUTIONS CHERYL HASTINGS
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
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 04/18/2011 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 04/18/2011 MRGFUS PELVIC PA COIL MODEL 1.0 INSIGHTECH, LTD ORI LUBIN
K111032 04/13/2011 CMC CABLE FIX INSTRATEK, INC. Jeff Seavey
K111001 04/11/2011 STERILE STORM (R) OPERATING KIT INTELLIGENT ORTHOPAEDICS LTD PETER J OGRODNIK
K111199 04/28/2011 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
K110991 04/08/2011 MESA SPINAL SYSTEM (KEYSTONE RODS) K2M, INC. NANCY GIEZEN
K111135 04/22/2011 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
K110984 04/07/2011 SLIM E30 II CO2 LASER LASERING S.R.L. ALLEN R HOWES
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 04/18/2011 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
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 04/15/2011 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 04/01/2011 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
K110969 04/06/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED CHU XIAOAN
K110972 04/06/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED CHU XIAOAN
K110970 04/06/2011 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED CHU XIAOAN
K110966 04/06/2011 POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED) PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED CHU XIAOAN
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
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
K110957 04/05/2011 M4 MONITOR SPECTRUM MEDICAL, LLP STEVE TURNER
K110992 04/08/2011 ENSPIRE DEBRIDER SYSTEM SPINE VIEW, INC. MBITHI MUTHINI
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K111166 04/26/2011 A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) SPINEWORKS, LLC J.D. WEBB
K111006 04/11/2011 CI-SNAP WOUND CARE SYSTEM SPIRACUR, INC. SARAH CANIO
K111133 04/22/2011 NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS) SSC SURAT THANI WILLIAM E HARRIS , III
K111092 04/19/2011 ENGAGE/ENGAGE TR INTRODUCERS ST. JUDE MEDICAL VENKATA DAMARAJU
K111050 04/15/2011 ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR STARBOARD MEDICAL, LLC ANTHONY BERAN
K111002 04/11/2011 REPROCESSED ENDOSCOPIC TROCARS STERILMED, INC. GARRETT AHLBORG
K111150 04/25/2011 STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR STERITEC PRODUCTS MFG. CO., INC. JONATHAN RUTIGLIANO
K111204 04/29/2011 CELL-DYN 22 PLUS CALIBRATOR Streck Deborah Kipp
K111211 04/29/2011 CELL-DYN 22 PLUS CONTROL Streck Deborah Kipp
K111073 04/18/2011 SURGIVISION INC. CLEARPOINT SYSTEM SURGI-VISION, INC. EDWARD WADDELL
K110924 04/04/2011 DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS SYNERGETICS, INC GARY OLIVEROS
K111189 04/28/2011 SYNTEC DENTAL IMPLANT SYNTEC SCIENTIFIC CORP. CHIA-CHING LEE
K111048 04/15/2011 SYNTHES SCOUT TACK FIXATION SYNTHES SPINE HEATHER GUERIN
K111029 04/13/2011 FORA POCT MANAGMENT SYSTEM TaiDoc Technology Corporation TELING HSU
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K111210 04/29/2011 T:SLIM (TM) INSULIN DELIVERY SYSTEM TANDEM DIABETES CARE, INC. DON CANAL
K111206 04/29/2011 TECO DIAGNOSTICS SALIVA ALCOHOL TEST TECO DIAGNOSTICS JAMES LI
K111117 04/21/2011 CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... Teleflex Medical, Inc. SUZANNE SCHORLE
K110942 04/04/2011 PICA WHOLE-BODY MRI SYSTEM TIME MEDICAL LIMITED JOHN BABY
K111108 04/20/2011 PASCAL STREAMLINE 577 (WITH ACCESSORIES) TOPCON MEDICAL LASER SYSTEMS, INC JOHN JOSSY
K111012 04/12/2011 SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) TRUE GLOVE FACTORY FRANK YANG
K111017 04/12/2011 CLEARTEMP ULTRADENT PRODUCTS, INC. DIANE ROGERS
K111028 04/13/2011 EUS BALLOON UNITED STATES ENDOSCOPY GROUP, INC. CARROLL L MARTIN
K111106 04/20/2011 TRUEBEAM VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K111180 04/27/2011 VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY VASOMEDICAL, INC. RICHARD E GORDON
K111096 04/20/2011 VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY VASOMEDICAL, INC. RICHARD E GORDON
K111167 04/26/2011 XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT VELOPEX INTERNATIONAL, INC. ANTHONY URELLA
K111152 04/25/2011 ROTOGRAPH EVO 3D VILLA SISTEMI MEDICALI S.P.A. PAOLO CASAGRANDE SANTIN
K111063 04/18/2011 VITAL SERUM CONTROLS VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD. MELITA LAMBIRIS
K110944 04/04/2011 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES WANGDA PLASTIC CO., LTD CHU XIAOAN
K111123 04/21/2011 VARILIFT CERVICAL INTERBODY FUSION SYSTEM WENZEL SPINE SOURABH MISHRA
K111141 04/22/2011 BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR WENZHOU BOKANG INSTRUMENTS CO., LTD. JOHNNY CAO
K111191 04/28/2011 AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE WET NOSE TECHNOLOGIES, LLC LIONEL NEWMAN
K110973 04/06/2011 IE-ZEN (IN CLEAR SERIES HEARING AID) WIDEX USA FRANCIS KUK
K110949 04/04/2011 BICERA (TM) RESORBABLE BONE SUBSTITUTE WILTROM CORPORATION LIMITED YUNG-CHIH WU
K110945 04/04/2011 POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES ZHAOYANG PLASTIC CO., LTD CHU ZIAOAN
K111119 04/21/2011 TRABECULAR METAL (TM) FUSION DEVICE ZIMMER SPINE, INC JENNIFER TRIBBETT
K111039 04/14/2011 ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM ZIMMER, INC. STEPHEN H MCKELVEY
K110940 04/04/2011 ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN ZIMMER, INC. CAROL VIERLING
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