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 |
K111127 |
04/21/2011 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
K110933 |
04/04/2011 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
BRYAN BECKER |
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 |
K110948 |
04/04/2011 |
HEALTH CARE SYSTEM SOFTWARE |
TaiDoc Technology Corporation |
TELING HSU |
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 |
K110978 |
04/07/2011 |
ONESTEP PEDIATRIC MFE'S |
ZOLL MEDICAL CORPORATION |
ROBERT MORSE |