FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K111759 |
09/09/2011 |
.DECIMAL ELECTRON APERTURE |
.DECIMAL, INC. |
DANIEL L BENNETT |
K111697 |
09/27/2011 |
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM |
ABBOTT MEDICAL OPTICS INC |
OPHELIA BIGGS |
K102938 |
09/23/2011 |
ACQPOINT THERMAJADE MASSAGE TABLE |
ACQPOINT, INC. |
MORRIS SHEPPARD |
K112159 |
09/21/2011 |
CMS-1000FM CENTRAL MONITORING SYSTEM |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
K112022 |
09/22/2011 |
DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
K112187 |
09/21/2011 |
FM-1000 PLUS FETAL MONITOR |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
K111934 |
09/22/2011 |
PD-100 SERIES ULTRASONIC POCKET DOPPLER |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
K112465 |
09/14/2011 |
VITAL SIGNS MONITOR |
ADVANCED INSTRUMENTS, INC. |
JORGE MILLAN |
K110713 |
09/12/2011 |
WATERPAP VALVE |
AIRWAYS DEVELOPMENT, LLC |
RICHARD J LARKIN |
K103615 |
09/08/2011 |
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
K112031 |
09/13/2011 |
ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION |
ALMA LASERS, INC. |
ANNE WORDEN |
K112047 |
09/13/2011 |
AMCOM COMMTECH MESSENGER |
AMCOM SOFTWARE,INC. |
THOMAS KROENKE |
K102359 |
09/16/2011 |
PICASSO/ PICASSO LITE/ PICASSO PERIO |
AMD LASERS, LLC |
AMY SZENTES |
K112738 |
09/30/2011 |
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE |
ANDON MEDICAL CO., LTD. |
YI LIN |
K111139 |
09/02/2011 |
DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U |
ANSELL HEALTHCARE PRODUCTS, INC. |
NEIL BURRIS |
K111462 |
09/08/2011 |
FIXATE TISSUE BAND |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
K102816 |
09/15/2011 |
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS |
APEX BIOTECHNOLOGY CORP. |
HSUE-MEI LEE |
K112237 |
09/02/2011 |
MICROSUTURE ANCHORS |
ARTHREX, INC. |
COURTNEY SMITH |
K101986 |
09/09/2011 |
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K111287 |
09/26/2011 |
ASTRA TECH IMPLANT SYSTEM |
ASTRA TECH AB |
LINDA K SCHULZ |
K112209 |
09/08/2011 |
PREFILLED CATHETER INFLATION SYRINGE |
AVAIL MEDICAL PRODUCTS, INC. |
STEVEN A HOWELL |
K111704 |
09/09/2011 |
AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX |
AVINGER, INC. |
SEVRINA CIUCCI, RAC |
K111989 |
09/22/2011 |
CORONIS FUSION 4MP DL |
BARCO NV |
LIEVEN DE WANDEL |
K112434 |
09/29/2011 |
BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION |
BD MEDICAL SURGICAL |
JOHN ROBERTS |
K111366 |
09/30/2011 |
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM |
BECTON DICKINSON AND COMPANY (BD) |
RACHEL LEBLANC |
K111270 |
09/13/2011 |
REUSABLE STIMULATING ELECTRODES |
BIO PROTECH, INC. |
JUDY BURTON |
K111003 |
09/15/2011 |
BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL |
BIODENTA SWISS AG |
DAVID EILER |
K111951 |
09/27/2011 |
ISOAMP HSV ASSAY |
BIOHELIX CORPORATION |
FRAN WHITE |
K112324 |
09/06/2011 |
CERALAS 980NM DIODE LASER FAMILY |
BIOLITEC MEDICAL DEVICES, INC |
HARRY HAYES |
K112442 |
09/30/2011 |
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM |
BIOLITEC MEDICAL DEVICES, INC |
HARRY HAYES |
K112253 |
09/20/2011 |
CERALAS 147NM DIODE LASER SYSTEM |
BIOLITEC, INC. |
HARRY HAYES |
K111809 |
09/26/2011 |
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS |
BIOMATERIALS KOREA INC. |
Kevin Walls |
K112075 |
09/15/2011 |
VITEK 2 STRPTOCOCCUS AMPICILLIN |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
K112129 |
09/27/2011 |
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
K110565 |
09/01/2011 |
ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE |
BIOMET 3I, INC. |
JOSE E CABRERA |
K110400 |
09/30/2011 |
TAPERLOC COMPLETE MICROPLASTY STEM |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
K112356 |
09/19/2011 |
GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE |
BIONOSTICS, INC. |
RANDY BYRD |
K102633 |
09/09/2011 |
BIOTEQ ANGIOGRAPHIC CATHETER |
BIOTEQUE CORP. |
JENNIFER REICH |
K111839 |
09/26/2011 |
SELECTRA ACCESSORY KIT |
BIOTRONIK, INC. |
Jon Brumbaugh |
K112482 |
09/26/2011 |
SELECTRA SLITTER TOOL |
BIOTRONIK, INC. |
Jon Brumbaugh |
K103426 |
09/14/2011 |
LITE PELVIC FLOOR REPAIR KITS |
BOSTON SCIENTIFIC CORP. |
MICHELLE BERRY |
K112198 |
09/14/2011 |
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE |
Boston Scientific Corporation |
ASHLEY PYLE |
K112609 |
09/30/2011 |
DESARA MESH |
CALDERA MEDICAL, INC. |
VICKI GAIL |
K111346 |
09/09/2011 |
RESOLUTIONMD MOBILE MODEL RMB-MOB-2X |
CALGARY SCIENTIFIC, INC. |
KYLE PETERSON |
K101769 |
09/13/2011 |
EPISIL |
CAMURUS AB |
MAUREEN O'CONNELL |
K111694 |
09/15/2011 |
ASTRA |
CANDELIS, INC. |
VINCENT CIPOLLA |
K111612 |
09/14/2011 |
DIGITAL RETINAL CAMERA |
CANON, INC. |
KOJI KUBO |
K112309 |
09/02/2011 |
DIGITAL RADIOGRAPHY |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
KOJI KUBO |
K111682 |
09/02/2011 |
DIGITAL RADIOGRAPHY |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
KOJI KUBO |
K111710 |
09/20/2011 |
FULL AUTO TONOMETER MODEL TX-20 |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
KOJI KUBO |
K111115 |
09/13/2011 |
CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM |
CAPTIVA SPINE, INC |
JOHN SANDERS |
K112372 |
09/15/2011 |
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP |
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC |
HELDER A SOUSA |
K112327 |
09/09/2011 |
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES |
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC |
HELDER A SOUSA |
K110493 |
09/20/2011 |
TANDEMHEART PUMP |
CARDIACASSIST INC. |
ROBERT BOLLINGER |
K111868 |
09/21/2011 |
STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING |
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
TATYANA BOGDAN |
K111878 |
09/29/2011 |
PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
K111649 |
09/23/2011 |
CS 7600 |
CARESTREAM HEALTH, INC. |
DANIEL HOEFER |
K112067 |
09/16/2011 |
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) |
CARTICEPT MEDICAL INC |
Tanya Eberle |
K112474 |
09/23/2011 |
CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE |
CEDARS-SINAI MEDICAL CENTER |
GEOFF POLLARD |
K102778 |
09/16/2011 |
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION |
CELLAVISION AB |
CONSTANCE G BUNDY |
K111390 |
09/12/2011 |
SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. |
CENDRES & METAUX SA |
TANJA BONGNI |
K111322 |
09/14/2011 |
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD |
CHEMTRON BIOTECH, INC. |
Jane Zhang |
K110637 |
09/07/2011 |
ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM |
CILAG GMBH INTERNATIONAL |
FIONA LEEPER |
K103461 |
09/13/2011 |
COLGATE DESENSITIZING DENTAL CREAM |
COLGATE-PALMOLIVE CO. |
CHARLES P IRELAND |
K112386 |
09/08/2011 |
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM |
COLOPLAST CORP. |
TIM CRABTREE |
K112096 |
09/30/2011 |
IMAGELINK |
COMPUTER PROGRAMS AND SYSTEMS, INC. |
MICHAEL HUNT |
K111916 |
09/29/2011 |
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA S SHAH |
K101273 |
09/30/2011 |
DYNAMIC ECG SYSTEM MODEL TLC5000 |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
K111966 |
09/15/2011 |
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC |
COOPERVISION, INC. |
LISA HAHN |
K111578 |
09/23/2011 |
CORELEADER COLLA-ALGI FIBER MODEL CAW |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
K102944 |
09/07/2011 |
CORELEADER HEMO-PAD MODEL CPII 02030 |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
K111733 |
09/22/2011 |
CORELEADER SCAR-DIMMER |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
K111887 |
09/09/2011 |
CLOSUREFAST RADIOFREQUENCY CATHETER |
COVIDIEN |
Daniel Campion |
K112477 |
09/28/2011 |
PALINDROME H, SI, HSI CHRONIC CATHETER |
COVIDIEN |
WING NG |
K112349 |
09/01/2011 |
VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
ANGELA V ARSDALE |
K110754 |
09/09/2011 |
CRYOPEN CRYOSURGICAL SYSTEM, K102214 |
CRYOPEN, INC. |
MIKE HAAS, M.D. |
K112311 |
09/01/2011 |
ALP 501 RB PUMP SYSTEM |
CURRIE MEDICAL SPECIALTIES, INC. |
BERNICE NAVARRO |
K112196 |
09/14/2011 |
OCTOTMPORT |
DALIM SURGNET CORPORATION |
APRIL LEE |
K111876 |
09/21/2011 |
Z BOND, PRELUDE ONE |
DANVILLE MATERIALS, INC. |
LINDSAY TILTON |
K111116 |
09/09/2011 |
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 |
DATEX-OHMEDA |
MONICA MORRISON |
K100806 |
09/16/2011 |
DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM |
DELBIO INCORPORATION |
NICKY PAN |
K111833 |
09/21/2011 |
VIRTUE |
DIAGNOSOFT, INC. |
JEFFREY ROBERTS |
K103290 |
09/19/2011 |
EDLEN IMAGING - GEMINI DUSB |
EDLEN IMAGING LLC |
FELIX HOVSEPIAN |
K112645 |
09/22/2011 |
RADIFORCE LARGE MONITOR SYSTEM |
EIZO GMBH |
BERND HOMBERG |
K111676 |
09/30/2011 |
APEX |
Elekta Limited |
Patrick Hull |
K111996 |
09/14/2011 |
ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 |
ELITECHGROUP |
DEBRA K HUTSON |
K112421 |
09/01/2011 |
EMG SUCTION UNIT |
EMG TECHNOLOGY CO., LTD. |
PAUL CHO |
K111629 |
09/16/2011 |
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
K110913 |
09/23/2011 |
ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY |
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH |
TAMER IBRAHIM |
K111763 |
09/15/2011 |
PATHASSIST LIGHT FIBER |
Entellus Medical, Inc. |
KAREN E PETERSON |
K112272 |
09/07/2011 |
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
YC LEI |
K111728 |
09/16/2011 |
EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
YC LEI |
K111845 |
09/26/2011 |
THE ESPINER SAC OR E SAC |
ESPINER MEDICAL LIMITED |
EDWIN LINDSAY |
K111490 |
09/16/2011 |
MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS |
EV3 INC |
DANIEL CHER, MD |
K111720 |
09/16/2011 |
AVIAFIT |
FLOWMEDIC LTD. |
AHAVA STEIN |
K110429 |
09/02/2011 |
PROSIM 4, PROSIM 6, PROSIM 8 |
FLUKE BIOMEDICAL |
JOHN NELSON |
K110165 |
09/30/2011 |
FREERIDER MODEL LUGGIE MODEL 168-4IT |
FREERIDER LUGGIE SCOOTERS INC |
JEFFREY L DAVIS |
K111865 |
09/30/2011 |
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOCK |
K110729 |
09/01/2011 |
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM |
FUJIFILM MEDICAL SYSTEMS, USA INC. |
PETER ALTMAN |
K103358 |
09/01/2011 |
ROMA (HE4 EIA + ARCHITECT CA 125 II) |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA L DICKSON |
K111791 |
09/23/2011 |
LUMAGEM MOLECULAR BREAST IMAGING SYSTEM |
GAMMA MEDICA-IDEAS INCORPORATED |
Albert Boniske |
K111731 |
09/15/2011 |
MOLECULAR BREAST IMAGING SOFTWARE |
GAMMA MEDICA-IDEAS INCORPORATED |
Albert Boniske |
K112371 |
09/27/2011 |
LOGIQ P3 |
GE HEALTHCARE |
BRYAN BEHN |
K112122 |
09/23/2011 |
VENUE 40 |
GE HEALTHCARE |
BRYAN BEHN |
K112213 |
09/01/2011 |
VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM |
GE HEALTHCARE |
BRYAN BEHN |
K111614 |
09/26/2011 |
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
JEME WALLACE |
K103327 |
09/30/2011 |
DISCOVERY MR750W 3.0T |
GE HEALTHCARE JAPAN CORPORATION |
TORU SHIMIZU |
K102933 |
09/02/2011 |
GEM-TONE BODY TRAINING SYSTEM |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S LAI |
K103489 |
09/09/2011 |
GE VEO RECONSTRUCTION OPTION |
GENERAL ELECTRIC CO. |
ANDREW J MENDEN |
K112071 |
09/23/2011 |
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K112310 |
09/08/2011 |
WONDFO METHADONE URINE TEST,OPIATE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K112236 |
09/19/2011 |
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K112395 |
09/09/2011 |
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K111059 |
09/01/2011 |
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) |
GYRUS ACMI, INC. |
LORRAINE CALZETTA |
K112320 |
09/30/2011 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR |
HEALTH & LIFE CO., LTD. |
SARAH SU |
K111832 |
09/29/2011 |
PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID |
HERAEUS KULZER, LLC |
CHERYL ZIMMERMAN |
K112502 |
09/19/2011 |
PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 |
HILL-ROM CO. |
CHAD HODSON |
K110673 |
09/27/2011 |
HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
K112556 |
09/28/2011 |
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS |
HOWMEDICA OSTEONICS CORP |
VALERIE GIAMBANCO |
K110290 |
09/27/2011 |
EXETER HIP STEM |
HOWMEDICA OSTEONICS CORP |
VALERIE GIAMBANCO |
K112455 |
09/22/2011 |
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES |
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
STEPHANIE FITTS |
K103396 |
09/27/2011 |
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION |
i-SENS, Inc. |
STANLEY R GOODMAN |
K110033 |
09/15/2011 |
FEEL-DRCS |
IMFOU CO., LTD |
Ho Dong Yang |
K111650 |
09/06/2011 |
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
K111660 |
09/13/2011 |
XELIS CARDIAC |
INFINITT CO., LTD. |
CARL ALLETTO |
K111613 |
09/08/2011 |
XELIS FUSION |
INFINITT CO., LTD. |
CARL ALLETTO |
K112329 |
09/08/2011 |
OMNI PATIENT MONITOR |
INFINIUM MEDICAL |
JOHN O'BRIEN |
K111857 |
09/21/2011 |
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE |
INMED GLOVES FACTORY |
XIAOBING LI |
K103648 |
09/14/2011 |
COLLAGEN POWDER |
INNOCOLL PHARMACEUTICALS LTD |
AARON WYSE |
K111060 |
09/09/2011 |
MRGFUS PELVIC PA COIL MODEL 1.0 |
INSIGHTECH, LTD |
ORI LUBIN |
K110086 |
09/09/2011 |
IFS PROFILE PLATES, SCREWS, AND WASHERS |
INTERNAL FIXATION SYSTEMS, INC. |
CHRIS ENDARA |
K111484 |
09/12/2011 |
DISCOVERY |
INTUITIVE SPINE, LLC |
JENNIFER PALINCHIK |
K112584 |
09/29/2011 |
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT |
INTUITIVE SURGICAL, INC. |
KIM T SERVANCE |
K101185 |
09/20/2011 |
NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY |
IRIS MOLECULAR DIAGNOSTICS |
ROBERT KLEM |
K111838 |
09/26/2011 |
INQU PASTE MIX |
ISTO TECHNOLOGIES, INC. |
PATSY J TRISLER |
K111743 |
09/14/2011 |
THE INSYNC CERAMIC SYSTEM |
JENSEN INDUSTRIES, INC. |
GARY PHELPS |
K111177 |
09/12/2011 |
JUELL HARD CURE |
JUELL DENTAL |
ANGELA BLACKWELL |
K111178 |
09/12/2011 |
JUELL SOFT CURE |
JUELL DENTAL |
ANGELA BLACKWELL |
K111370 |
09/21/2011 |
ODALYS PEDICLE SCREW SYSTEM |
KALITEC DIRECT, LLC |
J.D. WEBB |
K110462 |
09/26/2011 |
KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE |
KEPLER MEDTEC |
SHARYN ORTON, PHD |
K103150 |
09/23/2011 |
KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK |
KIMBERLY-CLARK |
ANN WATERHOUSE |
K103810 |
09/14/2011 |
KJ SUBMERGED SYSTEM |
KJ MEDITECH CO., LTD |
Priscilla Chung |
K110766 |
09/15/2011 |
KOLPLUX SYSTEM |
KOLPLAST CI LTDA |
E.J. Smith |
K112136 |
09/29/2011 |
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE |
KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. |
Glen Feye |
K110327 |
09/30/2011 |
LDR SPINE ROI-A INTERBODY FUSION SYSTEM |
LDR SPINE USA |
MARITZA ELIAS |
K110891 |
09/13/2011 |
THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER |
LEMAITRE VASCULAR INC. |
ANDREW HODGKINSON |
K111837 |
09/27/2011 |
RADIAL ARTERY COMPRESSION TOURNIQUET |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
SHAN ZHAO |
K112524 |
09/26/2011 |
HAIRMAX LASERCOMB |
LEXINGTON INTERNATIONAL, LLC |
DAVID MICHAELS |
K111729 |
09/07/2011 |
PILOT SPINAL SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
K111355 |
09/16/2011 |
ECHOBRIGHT |
LIFE-TECH, INC. |
SKIP RIMER |
K110370 |
09/15/2011 |
Q-CLEAR |
LIGHT AGE, INC. |
ELIZABETH REDDINGTON |
K111516 |
09/27/2011 |
NMR LIPOPROFILE (R) TEST AND NMR PROFILER |
LIPOSCIENCE, INC |
SUZETTE M WARNER |
K103217 |
09/28/2011 |
LITE-MED LM-9200 ELMA |
LITE-MED INC |
WALT HSU |
K111816 |
09/29/2011 |
EQUIMATRIX |
LUITPOLD PHARMACEUTICALS, INC. |
MARSHA SIMON |
K112199 |
09/01/2011 |
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
LUBNA SYED |
K110606 |
09/29/2011 |
MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE |
M.V. S.R.L. |
ENRICO BISSON |
K112360 |
09/15/2011 |
QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
K111888 |
09/23/2011 |
MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS |
MASIMO CORPORATION |
ANIL BHALANI |
K111641 |
09/26/2011 |
SURGICASE ORTHOGNATHIC SOFTWARE WIZARD |
MATERIALISE N.V. |
OLIVER CLEMENS |
K110659 |
09/13/2011 |
MEDICAL CONCEPTS INTERBODY FUSION SYSTEM |
MEDICAL CONCEPTS, INC. |
CHRISTOPHER CANIS |
K111734 |
09/06/2011 |
MYSAFETY SYRINGE |
MEDICALCHAIN INTL. CORP. |
ROBIN HWANG |
K111350 |
09/29/2011 |
MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM |
MEDICAM INC. |
PHILIPPE AMAR |
K110497 |
09/26/2011 |
PASS LP SPINAL SYSTEM |
MEDICREA INTERNATIONAL |
J.D. WEBB |
K110062 |
09/01/2011 |
MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG |
MEDIPURPOSE PTE. LTD. |
JULIE STEPHENS |
K111577 |
09/08/2011 |
MEDLINE VIAL DECANTER |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
K111457 |
09/15/2011 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
K112555 |
09/27/2011 |
CD HORIZON(R) SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRIS MCKEE |
K111510 |
09/15/2011 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
KEVIN FORD |
K112226 |
09/29/2011 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
LARAINE PANGELINA |
K111451 |
09/20/2011 |
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX |
MICROVENTION, INC. |
LARAINE PANGELINA |
K110741 |
09/29/2011 |
SCEPTER C OCCLUSION BALLOON CATHETER |
MICROVENTION, INC. |
Naomi Gong |
K103089 |
09/15/2011 |
SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS |
MIS - IMPLANT TECHNOLOGIES LTD. |
IMAN KHORSHID |
K112257 |
09/20/2011 |
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE |
MOLNLYCKE HEALTH CARE US, LLC |
ANGELA L BUNN |
K111802 |
09/08/2011 |
SV BRAIN ARRAY, SIEMENS 3T |
MRI INTERVENTIONS, INC. |
E.F. WADDELL |
K111687 |
09/29/2011 |
EMG SYSTEM |
MYOTRONICS-NOROMED, INC. |
F. ADIB |
K111019 |
09/30/2011 |
SURGIMAP (TM) SPINE |
NEMARIS INC |
KEITH A BARRITT |
K111666 |
09/07/2011 |
EVADYNE TEMPORARY CROWN AND BRIDGE RESIN |
NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
ROBERT SEIPLE |
K112131 |
09/29/2011 |
NEODYNE DRESSING |
NEODYNE BIOSCIENCES, INC. |
PEGGY MCLAUGHLIN |
K111767 |
09/15/2011 |
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
MONICA STACHURA,JD |
K111576 |
09/20/2011 |
NT 2000 LESIONING GENERATOR |
NEUROTHERM, INC. |
F. DAVID ROTHKOPF |
K110140 |
09/30/2011 |
NEUROVISION NERVE LOCATOR MONITOR |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
K111973 |
09/21/2011 |
VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET |
NUCLETRON |
MICHAEL PAUL |
K103515 |
09/15/2011 |
EQUAL DOSE |
NUCLETRON CORPORATION |
MANAL YOUSOF |
K111329 |
09/06/2011 |
NM-7000 |
NUGA MEDICAL CO., LTD |
CHARLIE MACK |
K112400 |
09/12/2011 |
SMARTSHEARS |
NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC |
NIKOLE GOLDSMITH |
K111174 |
09/19/2011 |
NXSTAGE PUREFLOW SL |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
K112176 |
09/15/2011 |
SILICONE SPHERES |
OCULO PLASTIK, INC. |
SYLVAIN DESROSIERS |
K103132 |
09/08/2011 |
FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI |
OCULUS PRIVATE LIMITED |
Kevin Walls |
K110860 |
09/02/2011 |
COMP A-I-R |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
K111505 |
09/08/2011 |
RTVUE CAM WITH CORNEAL POWER UPGRADE |
OPTOVUE, INC. |
JOHN TALARICO |
K103808 |
09/01/2011 |
SAPPHIRE NC |
ORBUSNEICH MEDICAL, INC. |
JOHN PAZIENZA |
K110309 |
09/14/2011 |
FOB ONE STEP RAPID TEST |
ORIENT GENE BIOTECH |
Gary Lehnus |
K111936 |
09/21/2011 |
ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD |
ORTHO DEVELOPMENT |
TOM HAUETER |
K111069 |
09/22/2011 |
OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT |
OSTEOSYMBIONICS, LLC |
ELAINE DUNCAN |
K111278 |
09/16/2011 |
Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE |
OTTO BOCK HEALTHCARE, LP |
WILLIAM KABITZ |
K112525 |
09/29/2011 |
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS |
PAREXELINTERNATIONAL |
BARRY SALL |
K110914 |
09/21/2011 |
TRIPLE LUMEN PFM PICC |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
K102673 |
09/30/2011 |
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
PHADIA US INC. |
MARTIN M MANN |
K110572 |
09/23/2011 |
MAMMODIAGNOST DR |
PHILIPS MEDICAL SYSTEMS |
LINDA JALBERT |
K110474 |
09/30/2011 |
PHILIPS INTELLIVUE TCG10 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
JENS-PETER SEHER |
K111443 |
09/29/2011 |
X12 STERILE REFLECTIVE MARKER SPHERE |
PINSCO INC. DBA B & L ENGINEERING |
LEE A BARNES |
K112496 |
09/28/2011 |
PIONEER CROSSFUSE II IBF/VBR SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC. |
EMILY M DOWNS |
K111361 |
09/23/2011 |
PLANMED NUANCE EXCEL |
PLANMECA USA, INC. |
BOB PIENKOWSKI |
K110818 |
09/08/2011 |
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS |
POLYMEDCO, INC. |
HELEN LANDICHO |
K111143 |
09/01/2011 |
POLY-CHEM 90 TOTAL BILIRUBIN |
POLYMEDCO, INC. |
HELEN LANDICHO |
K111765 |
09/06/2011 |
FULL CORE BIOPSY SYSTEM |
PROMEX TECHNOLOGIES, LLC |
Allison Scott |
K111522 |
09/29/2011 |
CHARTIS CATHETER MODEL CHR-CA-12.0 |
PULMONX, INC. |
HANS SCHULZ |
K112448 |
09/22/2011 |
PULSIOFLEX |
PULSION MEDICAL SYSTEMS, INC. |
Jamie Sulley |
K112313 |
09/09/2011 |
TOSHIBA 3T EXTRA LARGE KNEE COIL |
QUALITY ELECTRODYNAMICS |
CHRISTIE ZYDYK |
K101898 |
09/15/2011 |
R4 ACERT ULTRASOUND REPORTING SYSTEM |
R4 LLC |
CRISTIAN NEGRILA |
K110846 |
09/30/2011 |
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
K110904 |
09/30/2011 |
RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K111438 |
09/12/2011 |
REKA E100 |
REKA PTE LTD |
LARRY PETERSEN |
K111814 |
09/14/2011 |
PADLOCK |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PAULA WENDLAND |
K112435 |
09/22/2011 |
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES MEWBORNE |
K101299 |
09/21/2011 |
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM |
Roche Diagnostics |
ANDRENE HERON |
K112113 |
09/14/2011 |
ELECSYS MYOGLOBIN CALCHECK 5 |
Roche Diagnostics |
KELLY COLLEEN O'MAINE ADAMS |
K111285 |
09/09/2011 |
AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING |
SALIENT SURGICAL TECHNOLOGIES, INC. |
RITA M CALNAN |
K111559 |
09/16/2011 |
SURGICAL MASKS |
SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. |
Diana Hong |
K111359 |
09/13/2011 |
SHEAUMANN PL-1064 |
SHEAUMANN LASERS |
TIMOTHY J SHEA |
K111360 |
09/14/2011 |
SHEAUMANN PL-980 |
SHEAUMANN LASERS |
TIMOTHY J SHEA |
K112431 |
09/22/2011 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
Diana Hong |
K112530 |
09/30/2011 |
3DI INCLUDING CSCORE |
SHINA SYSTEMS LTD. |
DAN LAOR |
K111782 |
09/16/2011 |
BEAUTISEALANT |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
K111685 |
09/02/2011 |
IP TEMP CEMENT |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
K110061 |
09/21/2011 |
CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
Ernest Joseph |
K111912 |
09/19/2011 |
MOBILETT MIRA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
K112596 |
09/16/2011 |
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
SHELLY PEARCE |
K110403 |
09/08/2011 |
PROLINK ADHESIVES (PROLINK, PROLINK SE) |
SILMET LTD. |
MOSHE ZALSMAN |
K111711 |
09/16/2011 |
JOURNEY II BCS KNEE SYSTEM |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
K111635 |
09/09/2011 |
SMITH & NEPHEW RJ CONSTRAINED LINERS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
K112451 |
09/16/2011 |
S8 DIAGNOSTIC ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
Diana Hong |
K112225 |
09/20/2011 |
SORIN CENTRIFUGAL PUMP 5 (CP5) |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
K112245 |
09/06/2011 |
XTRA |
SORIN GROUP ITALIA S.R.L |
BARRY SALL |
K112025 |
09/15/2011 |
SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM |
SPINAL USA |
FRANKIE CUMMINS |
K111553 |
09/28/2011 |
SPINEFRONTIER LUMBAR IBF SYSTEM |
SPINEFRONTIER, INC. |
HANNAH CROWE |
K111880 |
09/26/2011 |
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE |
Spineology Inc. |
BRYAN BECKER |
K111166 |
09/08/2011 |
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) |
SPINEWORKS, LLC |
J.D. WEBB |
K111943 |
09/29/2011 |
AGILLS PF DELIVERY SYSTEM |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
GEENA GEORGE |
K111475 |
09/28/2011 |
AURIGA XL |
STARMEDTEC GMBH |
GREGOR WEIDEMANN |
K111412 |
09/30/2011 |
SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK |
STEERABLE TECHNOLOGIX |
GLEN JORGENSEN |
K111223 |
09/20/2011 |
AMSCO CHIMERON SMALL STEAM STERILIZER |
STERIS Corporation |
ROBERT F SULLIVAN |
K111810 |
09/02/2011 |
AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS |
STERIS Corporation |
ROBERT SULLIVAN |
K103331 |
09/01/2011 |
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES |
STERIS Corporation |
ROBERT F SULLIVAN |
K111724 |
09/12/2011 |
STRAUMANN TIBRUSH |
STRAUMANN USA |
ELAINE ALAN |
K112385 |
09/15/2011 |
TRAGET DETACHABLE COIL |
STRYKER NEUROVASCULAR |
JAMES LEATHLEY |
K112232 |
09/26/2011 |
REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
STRYKER SUSTAINABILITY SOLUTIONS |
AMANDA BABCOCK |
K102483 |
09/13/2011 |
SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 |
SUNSET HEALTHCARE SOLUTIONS, LLC |
Kevin Walls |
K112399 |
09/07/2011 |
UNITE BIOMATRIX |
SYNOVIS ORTHOPEDIC & WOUNDCARE |
AMY BOUCLY |
K101631 |
09/02/2011 |
FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
TELING HSU |
K110800 |
09/27/2011 |
META-LOCK SUTURE ANCHOR SYSTEM |
TARSUS MEDICAL INC. |
NICHOLAS MOURLAS |
K101356 |
09/20/2011 |
Spacer-G and Spacer-K |
TECRES SPA |
CHRISTINE BRAUER |
K111946 |
09/26/2011 |
TEPHAFLEX MESH |
TEPHA, INC. |
MARY P LEGRAW |
K111797 |
09/22/2011 |
27 G X 1/2 K-PACK SURSHIELD NEEDLE |
TERUMO EUROPE N.V. |
M.J. AERTS |
K111472 |
09/06/2011 |
HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON |
TGM MEDICAL |
DENNIS H CRANE |
K111570 |
09/29/2011 |
MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR |
THAYER MEDICAL CORPORATION |
ERIKA S STRICKLAND |
K112293 |
09/30/2011 |
HTS EXTREMITY COIL, HTS SURFACE COIL |
TIME MEDICAL SYSTEMS INC |
JOHN BABY |
K111626 |
09/09/2011 |
ENDOSKELETON(R) TAS |
TITAN SPINE, LLC |
RICH JANSEN |
K110878 |
09/23/2011 |
RHYTHMVIEW (TM) |
TOPERA, INC. |
RUCHIR SEHRA |
K112366 |
09/15/2011 |
4CH FLEX SPEEDER |
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
PAUL BIGGINS |
K111496 |
09/26/2011 |
21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR |
TOTOKU ELECTRIC CO., LTD |
TSUKASA TASHIRO |
K110583 |
09/22/2011 |
SENSITITRE OPTIREAD |
TREK DIAGNOSTIC SYSTEMS, LTD. |
CYNTHIA C KNAPP |
K111775 |
09/13/2011 |
JBAIDS INFLUENZA A&B DETECTION KIT |
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY |
PATRICIA BEVERLY |
K111778 |
09/13/2011 |
JBAIDS INFLUENZA A SUBTYPING KIT |
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY |
PATRICIA M BEVERLY |
K111696 |
09/07/2011 |
OPAL BAND CEMENT |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
K111836 |
09/16/2011 |
PERMASHADE VENEER CEMENT |
ULTRADENT PRODUCTS, INC. |
COREY JASEPH |
K112517 |
09/23/2011 |
ULTRASEAL XT HYDRO |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
K112726 |
09/27/2011 |
SONIX ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
CHAS YU |
K111622 |
09/09/2011 |
UNIMAX ANTI-FOG SOLUTION |
UNIMAX MEDICAL SYSTEMS, INC. |
MICHAEL LEE |
K112463 |
09/23/2011 |
UNITED 36MM CERAMIC FEMORAL HEAD, DELTA |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
K110435 |
09/21/2011 |
EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM |
US DIAGNOSTICS, INC. |
JONATHAN JOHNSON |
K111351 |
09/29/2011 |
TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET |
US INFUSION DBA TRUECARE BIOMEDIX |
AARON COMPTON |
K112347 |
09/22/2011 |
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE |
VASCULAR PATHWAYS, INC. |
MICHAEL A DANIEL |
K103639 |
09/15/2011 |
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
JAMES LEE |
K110944 |
09/01/2011 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
WANGDA PLASTIC CO., LTD |
CHU XIAOAN |
K110945 |
09/13/2011 |
POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES |
ZHAOYANG PLASTIC CO., LTD |
CHU ZIAOAN |
K110791 |
09/02/2011 |
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
K111279 |
09/20/2011 |
NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM |
ZYNEX MEDICAL, INC. |
JIM ARNOLD |