| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K093199 |
10/09/2009 |
3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK |
3M COMPANY |
JIZHONG JIN |
| K093169 |
10/07/2009 |
SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) |
A PLUS INTERNATIONAL, INC. |
SOLOMON CHEN |
| K093318 |
10/23/2009 |
ACCELERATOR APS |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K093254 |
10/16/2009 |
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION |
ABBOTT MEDICAL OPTICS INC |
KESLEY E GALLAGHER |
| K093143 |
10/05/2009 |
MISSION BREATH ALCOHOL DETECTOR |
ACON LABORATORIES, INC. |
RICHARD LENART |
| K093192 |
10/09/2009 |
FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE |
ADVANCED VASCULAR DYNAMICS |
HERBERT SEMLER |
| K093210 |
10/13/2009 |
AQUALASE CAPSULE WASH TIP |
ALCON MANUFACTURING, LTD. |
MARTIN A KAUFMAN |
| K093305 |
10/22/2009 |
ENHANCED ULTRA VIT PROBE |
ALCON RESEARCH, LTD. |
MARTIN A KAUFMAN |
| K093186 |
10/09/2009 |
AMBU ASCOPE AND MONITOR |
AMBU A/S |
SANJAY PARIKH |
| K093387 |
10/30/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K093262 |
10/19/2009 |
AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD. |
YI LIU |
| K093166 |
10/06/2009 |
WITTMANN PATCH |
APERTA LLC |
DIETMAR H WITTMANN |
| K093296 |
10/21/2009 |
ALEXIS LAPAROSCOPIC SYSTEM |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
| K093098 |
10/01/2009 |
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM |
ARKRAY, INC. |
KENNETH L BLOCK |
| K093259 |
10/19/2009 |
ARP RX100 |
ARP MANUFACTURING, INC |
LEWIS WARD |
| K093165 |
10/06/2009 |
ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K093183 |
10/09/2009 |
BIS QUATRO SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
VIKRAM VERMA |
| K093187 |
10/09/2009 |
MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM |
AVANTIS MEDICAL SYSTEMS, INC. |
ELAINE APLAON |
| K093197 |
10/09/2009 |
CORONIS FUSION 10MP, MODEL MDCG-10130 |
BARCO NV |
LIEVEN DE WANDEL |
| K093120 |
10/02/2009 |
XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 |
BAXTER HEALTHCARE CORPORATION - RENAL DIVISION |
DIANE RENNPFERD |
| K093346 |
10/26/2009 |
BD GENEOHM MRSA ACP ASSAY |
BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) |
RAYMOND BOULE |
| K093386 |
10/30/2009 |
CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST |
BFW, INC |
LYNN COOPER |
| K093342 |
10/26/2009 |
BIOGENNIX RPC |
BIOGENNIX, LLC |
EDWIN C SHORS |
| K093321 |
10/23/2009 |
BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K093122 |
10/02/2009 |
MBCP+ |
BIOMATLANTE |
JEANNE CHAMOUSSET-ROMAN |
| K093224 |
10/14/2009 |
DENSICHECK PLUS |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K093383 |
10/30/2009 |
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG |
BIOMERIEUX, INC. |
MARIA OYASKI |
| K093123 |
10/02/2009 |
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB |
BIOMERIX CORPORATION |
CHRISTINA L KICHULA |
| K093235 |
10/15/2009 |
RINGLOC + HYBRID ACETABULAR SYSTEM |
BIOMET, INC. |
GARY BAKER |
| K093293 |
10/21/2009 |
VANGUARD 360 REVISION KNEE SYSTEM |
BIOMET, INC. |
GARY BAKER |
| K093376 |
10/29/2009 |
LASSO NAV CATHETER |
BIOSENSE WEBSTER, INC. |
WAYNE HOHMAN |
| K093303 |
10/21/2009 |
SCOUTPRO 7F LONG CATHETERS |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K093379 |
10/29/2009 |
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM |
BL HEALTHCARE, INC. |
MICHAEL MATHUR |
| K093142 |
10/05/2009 |
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
JAMES LEATHLEY |
| K093118 |
10/02/2009 |
BRAINLAB KNEE ARTHROSCOPY |
BRAINLAB AG |
RAINER BIRKENBACH |
| K093117 |
10/02/2009 |
DIGITAL LIGHTBOX |
BRAINLAB AG |
RAINER BIRKENBACH |
| K093367 |
10/29/2009 |
STERILE SALINE SOLUTION |
CACHET PHARMACEUTICALS PVT. LTD. |
SHIVKUMAR AGRAWAL |
| K093211 |
10/13/2009 |
CARECENTER MD |
CARDIAC SCIENCE CORPORATION |
THERESA MYERS |
| K093124 |
10/02/2009 |
PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 |
CARDINAL HEALTH 207, INC. |
MONTHER ABUSHABAN |
| K093094 |
10/01/2009 |
VELA VENTILATOR |
CARDINAL HEALTH 207, INC. |
FAROKH ETEMADIEH |
| K093300 |
10/21/2009 |
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
| K093288 |
10/20/2009 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION |
CARDIONET, INC |
KENT SAYLER |
| K093213 |
10/13/2009 |
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES |
CARL ZEISS MEDITEC INC |
JUDITH A BRIMACOMBE |
| K093229 |
10/14/2009 |
CATHETER CONNECTIONS DUALCAP |
CATHETER CONNECTIONS, INC. |
DONALD D SOLOMON |
| K093134 |
10/05/2009 |
CERNER CAREAWARE IBUS |
CERNER CORP. |
SHELLEY S LOOBY |
| K093139 |
10/05/2009 |
BANTAM,48XXXXXX, 50XXXXXX |
CLEAR STREAM TECHNOLOGIES, LTD. |
FIONA NI MHULLAIN |
| K093243 |
10/15/2009 |
COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM |
COAGUSENSE, INC |
DOUGLAS PATERSON |
| K093184 |
10/09/2009 |
ENVOY GUIDING CATHETERS |
Codman & Shurtleff, Inc. |
KATHRYN LAROSE |
| K093351 |
10/27/2009 |
COLLAWOUND ART |
COLLAMATRIX, INC |
DENNIS J.N. SEAH |
| K093320 |
10/23/2009 |
DRYODINE CADEXOMER-IODINE GEL |
COLLEGIUM PHARMACEUTICAL INCORPORATED |
MARK W TRUMBORE |
| K093112 |
10/01/2009 |
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE |
COLOPLAST MANUFACTURING US, LLC |
JANELL COLLEY |
| K093223 |
10/13/2009 |
COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG |
COMPUMEDICS LIMITED |
STUART KING |
| K093389 |
10/30/2009 |
CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK |
COMPUTERIZED SCREENING, INC. |
SAM KUMAR |
| K093195 |
10/09/2009 |
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O |
COOK IRELAND LTD |
Jacinta Kilmartin |
| K093209 |
10/13/2009 |
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE |
COOK, INC. |
SEAN WERNER |
| K093174 |
10/08/2009 |
SPIROPALM |
COSMED S.R.L. |
ROBERT SCHIFF |
| K093196 |
10/09/2009 |
BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 |
COUSIN BIOTECH S.A.S. |
FRANCK PELLETIER |
| K093372 |
10/29/2009 |
SILS PORT MODEL SILSPT15 |
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
ANGELA VAN ARSDALE |
| K093332 |
10/26/2009 |
DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) |
DELPHI MEDICAL SYSTEMS |
GILBERT ROQUE JR. |
| K093221 |
10/13/2009 |
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K093390 |
10/29/2009 |
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
| K093168 |
10/07/2009 |
MEDIFLASH AND ESTEFLASH |
DERMEO |
E.J. Smith |
| K093371 |
10/29/2009 |
MODEL DGH 6000 SCANMATE A |
DGH TECHNOLOGY, INC. |
M. LUTHER DETWEILER |
| K093233 |
10/14/2009 |
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
Ronald H Lollar |
| K093167 |
10/07/2009 |
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER |
DIAGNOSTICA STAGO, INC. |
UMBERTO V PARROTTA |
| K093101 |
10/01/2009 |
MAGO 4S |
DIAMEDIX CORP. |
Glenn Gerstenfeld |
| K093357 |
10/28/2009 |
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D |
DIAMOND DIAGNOSTICS, INC. |
KATHY CRUZ |
| K093384 |
10/30/2009 |
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) |
DIAMOND DIAGNOSTICS, INC. |
KATHY CRUZ |
| K093185 |
10/09/2009 |
OWL UNIVERSAL RF SYSTEM URF-3AP (ML) |
DIROS TECHNOLOGY, INC. |
GEORGE DARMOS |
| K093208 |
10/13/2009 |
SIMPLISEAL |
DISCUS DENTAL, LLC |
CLARK D VONAHSEN |
| K093338 |
10/23/2009 |
SELF ADHESIVE COMPOSITE LUTING CEMENT |
DMG USA, INC. |
PAMELA PAPINEAU |
| K093172 |
10/08/2009 |
QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) |
DYNACARDIA, INC. |
|
| K093324 |
10/23/2009 |
EMPI CONTINUUM |
EMPI |
JO P CHIU |
| K093227 |
10/14/2009 |
SILVERSTREAM AND DERMASEPT |
ENZYSURGE, LTD. |
KEREN SHTIEGMAN |
| K093297 |
10/21/2009 |
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE |
EPOCAL, INC. |
ROY LAYER |
| K093236 |
10/15/2009 |
ETHICON ENDO-SURGERYOPTICAL DILATOR |
ETHICON ENDO-SURGERY, INC. |
RENEE ROWE |
| K093286 |
10/20/2009 |
POWERCROSS .018 OTW PTA DILATION CATHETER |
EV3 INC |
SARA BAKKER |
| K093301 |
10/21/2009 |
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM |
EV3 INC |
BRENDA JOHNSON |
| K093340 |
10/26/2009 |
PASR/QUIETNITE |
EXACT SUPPLIES LTD. |
JONATHAN PARKINSON |
| K093275 |
10/19/2009 |
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER |
EXACTECH, INC. |
LINDY KNISELY |
| K093360 |
10/28/2009 |
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T |
EXACTECH, INC. |
PATRICK HUGHES |
| K093218 |
10/13/2009 |
FEMEYE TWO |
FEMSUITE, LLC |
PAVAN SETHI |
| K093252 |
10/16/2009 |
FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER |
FOOTPRINT MEDICAL INC. |
CLYDE BAKER |
| K093162 |
10/06/2009 |
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID |
FOTONA D.D. |
STOJAN TROST |
| K093370 |
10/29/2009 |
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER |
FU HONG INDUSTRIES LTD. |
KEVIN WALLS, RAC |
| K093348 |
10/27/2009 |
3.0T 16 CHANNEL HEAD NECK SPINE COIL |
GE HEALTHCARE COILS (USA INSTRUMENTS INC.) |
ELIZABETH MATHEW |
| K093141 |
10/05/2009 |
MARS HOLTER ANALYSIS WORKSTATION |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
JOE LUCAS |
| K093234 |
10/15/2009 |
INTEGRATED REGISTRATION |
GE MEDICAL SYSTEMS SCS |
SOPHIE LE LOARER |
| K093244 |
10/15/2009 |
UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX |
GERATHERM MEDICAL AG |
ANDREA PECSI |
| K093125 |
10/02/2009 |
ALPHAXENON LIGHT 180 W AND 300 W |
GIMMI GMBH |
ULRICH HENZLER |
| K093189 |
10/09/2009 |
ACTIPROTECT UC N95 RESPIRATOR |
GLAXOSMITHKLINE CONSUMER HEALTHCARE |
ZINATARA MANJI |
| K093161 |
10/06/2009 |
ACTIPROTECT UF N95 RESPIRATOR |
GLAXOSMITHKLINE CONSUMER HEALTHCARE |
ZINATARA A MANJI |
| K093368 |
10/29/2009 |
BUTTERFLY TONER MODEL GYM070 |
GLOBAL MARKETING PARTNERS DBA GYMMAX USA |
NICOLAAS BESSELING |
| K093294 |
10/21/2009 |
REVERE STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
KELLY J BAKER, PH.D |
| K093242 |
10/15/2009 |
PATRIOT TRANSCONTINENTAL LLIF SPACER |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K093343 |
10/26/2009 |
GRAFTY QUICKSET |
GRAFTYS |
ANTHONY LE NAOUR |
| K093232 |
10/14/2009 |
OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER |
Greatbatch Medical |
SHANNON SPRINGER |
| K093175 |
10/08/2009 |
WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES |
Guangzhou Wondfo Biotech Co., Ltd. |
HOWARD MANN |
| K093181 |
10/08/2009 |
GYRUS ACMI PK BUTTON ELECTRODE |
GYRUS ACMI, INC. |
GRAHAM A.L. BAILLIE |
| K093179 |
10/08/2009 |
MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) |
H&H RESEARCH COMPANY |
JONG HUANG |
| K093258 |
10/19/2009 |
BLOM-SINGER INDWELLING TEP OCCLUDER |
HELIX MEDICAL, LLC |
CYNTHIA ANDERSON |
| K093241 |
10/15/2009 |
V7 PORTABLE SUCTION UNITS |
HERSILL, S.L. |
OSCAR JORDAN |
| K093352 |
10/27/2009 |
HG III FIXTURE SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K093126 |
10/02/2009 |
ANAPNOGUARD ENDOTRACHEAL TUBE |
HOSPITECH RESPIRATION LTD. |
YORAM LEVY |
| K093128 |
10/02/2009 |
ILLUMINA BEADXPRESS SYSTEM |
ILLUMINA, INC. |
DONALD R ELLIS |
| K093129 |
10/02/2009 |
ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II |
ILLUMINA, INC. |
DONALD R ELLIS |
| K093204 |
10/13/2009 |
INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM |
INNOVATIVE MED, INC. |
JEFFREY KOLSTER |
| K093256 |
10/19/2009 |
SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 |
INRAD |
MELISSA LALOMIA |
| K093113 |
10/01/2009 |
ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT |
INSTITUT STRAUMANN AG |
ANDREAS PETERMANN |
| K093163 |
10/06/2009 |
INTEGRA TOTAL WRIST FUSION SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
STEPHEN BEIER |
| K093260 |
10/19/2009 |
AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM |
INTERNATIONAL BIOMEDICAL, LTD. |
AMY PIEPER |
| K093217 |
10/13/2009 |
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) |
INTUITIVE SURGICAL, INC. |
KAREN UYESUGI |
| K093284 |
10/20/2009 |
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL |
INVIVO CORPORATION |
ELIZABETH WHEELER |
| K093273 |
10/19/2009 |
VIT KIT - FREEZE AND THAW |
IRVINE SCIENTIFIC SALES CO., INC. |
JAYME YAMAGUCHI-OWENS |
| K093331 |
10/26/2009 |
SR PHONARES NHC |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K093137 |
10/05/2009 |
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL |
KAMIYA BIOMEDICAL CO. |
SHAWN KAPLAN |
| K093298 |
10/21/2009 |
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 |
KEELER INSTRUMENTS, INC. |
EUGENE VAN ARSDALE |
| K093445 |
10/21/2009 |
KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) |
KEELER LTD. |
EUGENE R VANARSDALE |
| K093312 |
10/22/2009 |
KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM |
KIMBERLY-CLARK CORP. |
LESTER PADILLA |
| K093115 |
10/02/2009 |
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 |
KIMBERLY-CLARK CORP. |
MARCIA JOHNSON |
| K093375 |
10/29/2009 |
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) |
KOON SENG SDN.BHD |
JIGAR SHAH |
| K093193 |
10/13/2009 |
LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) |
LA GLOVE (M) SDN. BHD. |
G BASKARAN |
| K093182 |
10/08/2009 |
SET GRI-FILL 3.0 |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K093335 |
10/26/2009 |
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) |
LAGLOVE (M) SDN. BHD. |
G BASKARAN |
| K093285 |
10/20/2009 |
MODIFICATION TO LANX SPINAL FIXATION SYSTEM |
LANX, LLC |
ANDREW LAMBORNE |
| K093144 |
10/05/2009 |
LOUSEBUSTER |
LARADA SCIENCES |
PHIL TRIOLO |
| K093231 |
10/14/2009 |
ALBOGRAFT VASCULAR PROSTHESIS |
LEMAITRE VASCULAR, INC. |
ERIN DALY |
| K093200 |
10/09/2009 |
LIFE SPINE LUMBAR PLATE SYSTEM |
LIFE SPINE |
CHARLES GILL |
| K093093 |
10/01/2009 |
SMALL PLATEAU SPACER SYSTEM |
LIFE SPINE |
CHARLES P GILL |
| K093087 |
10/01/2009 |
BWF-5 MEDICAL LASER SERIES |
LITECURE, LLC |
LIANG LU |
| K093207 |
10/13/2009 |
ENDURAMESH, MODEL 762.XXX |
LUCERO MEDICAL, LLC |
JENNIFER PALINCHIK |
| K093266 |
10/19/2009 |
MAM COOLER |
MAM INTERNATIONAL AG |
MICHAEL TEDESCO |
| K093309 |
10/22/2009 |
PRO-LINE CT (BASIC TRAY) MODEL MR28036101 |
MEDCOMP (MEDICAL COMPONENTS) |
JEAN CALLOW |
| K093336 |
10/26/2009 |
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM |
MEDICAL NUMERICS, INC. |
DOUGLAS M TUCKER |
| K093364 |
10/28/2009 |
SOLO MICROPUMP INSULIN DELIVERY SYSTEM |
MEDINGO LTD. |
ARAVA HACOHEN |
| K093349 |
10/27/2009 |
MEDLINE CURAD WOUND DRESSINGS |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K093247 |
10/15/2009 |
MEDSYNAPSE PACS SOFTWARE |
MEDSYNAPTIC PRIVATE, LTD. |
DANIEL KAMM |
| K093203 |
10/13/2009 |
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 |
MEDTRONIC INC. |
MARY E DONLIN |
| K093104 |
10/01/2009 |
MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM |
MEDYSSEY CO., LTD. |
PATRICK D MOORE |
| K093194 |
10/09/2009 |
MGB DISPOSABLE RETRIEVAL BAG LAPBAG |
MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) |
PATRICK GAENSICKE |
| K093081 |
10/01/2009 |
POCKET BVM |
MICROBVM SYSTEMS LTD |
ELI ORBACH |
| K093114 |
10/01/2009 |
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY |
MICROGENICS CORP. |
HEWUAN TAKKELE |
| K093160 |
10/06/2009 |
HEADWAY 21 MICROCATHETER, MODEL: MC212150S |
MICROVENTION, INC. |
Naomi Gong |
| K093358 |
10/28/2009 |
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K093397 |
10/30/2009 |
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE |
MICROVENTION, INC. |
Naomi Gong |
| K093111 |
10/01/2009 |
MIKRO-CATH, MODEL 825-0101 |
MILLAR INSTRUMENTS, INC. |
FATMA ALI |
| K093188 |
10/09/2009 |
AFM ULTRA AG DRESSINGS |
MILLIKEN & CO. |
MARY MCNAMARA-CULLINANE |
| K093339 |
10/26/2009 |
ELI PC ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
CHARLES MORREALE |
| K093380 |
10/29/2009 |
MIZZY EXPRESS |
MYCONE DENTAL SUPPLY CO., INC. |
NICK PALMER |
| K093329 |
10/26/2009 |
SCOPE INTRODUCER MODEL 7400 |
N.M. BEALE CO. INC. |
PAMELA PAPINEAU |
| K093337 |
10/26/2009 |
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM |
NANOSPHERE, INC |
GREGORY SHIPP |
| K093304 |
10/21/2009 |
PROTEKTOR 32 |
NATUS MEDICAL, INC. |
GOLDY SINGH |
| K093392 |
10/30/2009 |
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
| K093366 |
10/29/2009 |
NMI PICC II |
NAVILYST MEDICAL, INC. |
LORRAINE HANLEY |
| K093308 |
10/22/2009 |
MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD |
NIDEK MEDICAL PRODUCTS, INC. |
JENNIFER MCWILLIAMS |
| K093102 |
10/01/2009 |
AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270 |
NIHON SEIMITSU SOKKI CO., LTD. |
KOJI KUBO |
| K093306 |
10/22/2009 |
SINGLE-PATIENT USE DISPOSABLE SENSOR |
NONIN MEDICAL, INC. |
LORI ROTH |
| K093109 |
10/01/2009 |
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') |
NOVO NORDISK INC. |
CINDY CAO |
| K093319 |
10/23/2009 |
NUVASIVE VUEPOINT OCT SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K093106 |
10/01/2009 |
ENDOSCOPE REPROCESSOR OER-PRO |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K093395 |
10/30/2009 |
OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K093251 |
10/16/2009 |
OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K093280 |
10/20/2009 |
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 |
OPTI MEDICAL SYSTEMS INC. |
LEN OWENS |
| K093388 |
10/30/2009 |
SMART CAPNOLINE GUARDIAN |
ORIDION MEDICAL 1987 LTD. |
RACHEL WEISSBROD |
| K093086 |
10/01/2009 |
ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 |
ORTHODYNAMIX, LLC |
BRIAN S ZIMOVAN |
| K093105 |
10/01/2009 |
VISTEO |
OWANDY |
JAY MANSOUR |
| K093205 |
10/13/2009 |
PADCHECK |
PADTEST, LLC |
JAMES R GREENWOOD |
| K093307 |
10/22/2009 |
ASEPT PLEURAL DRAINAGE SYSTEM |
PFM MEDICAL, INC |
Salvadore Palomares, RAC |
| K093177 |
10/08/2009 |
INTELLIBRIDGE SYSTEM |
PHILIPS MEDICAL SYSTEMS |
CLAIRE ARAKAKI |
| K093355 |
10/27/2009 |
PCR ELEVA 1.2 |
PHILIPS MEDICAL SYSTEMS, INC. |
LYNN HARMER |
| K093268 |
10/19/2009 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K093333 |
10/26/2009 |
PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 |
PRIMUS STERILIZER COMPANY, LLC. |
CONNIE MANSFIELD |
| K093159 |
10/06/2009 |
PR CREAM |
PRUGEN IP HOLDINGS, INC |
ROBERT L KNECHTEL |
| K093156 |
10/06/2009 |
PRUCLAIR NONSTEROIDAL CREAM |
PRUGEN IP HOLDINGS, INC |
ROBERT L KNECHTEL |
| K093155 |
10/06/2009 |
VASHE WOUND CLEANSING SYSTEM |
PURICORE INC. |
DENNIS MAHONEY |
| K093263 |
10/19/2009 |
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE |
QINGDAO LANG HUI IMPORT & EXPORT CO., LTD |
MARSHAL MA |
| K093264 |
10/19/2009 |
VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED |
QINGDAO LANG HUI IMPORT & EXPORT CO., LTD |
MARSHAL MA |
| K093295 |
10/21/2009 |
RIDASCREEN NOROVIRUS 3RD GENERATION EIA |
R-BIOPHARM AG |
GARY LEHNUS |
| K093154 |
10/06/2009 |
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM |
RADIOMETER MEDICAL APS |
JANA HELLMAN |
| K093377 |
10/29/2009 |
POLARIS CONTACT LENS CASE |
RELIANCE DESIGN & MANUFACTURING CORP. |
TRAVIS HSU |
| K093362 |
10/28/2009 |
2008 HEMODIALYSIS SORBENT SYSTEM |
RENAL SOLUTIONS INC. |
DAVID J VANELLA |
| K093116 |
10/02/2009 |
MODIFICATION TO: RAMP INFLUENZA A/B ASSAY |
RESPONSE BIOMEDICAL CORP. |
KEN PILGRIM |
| K093089 |
10/01/2009 |
MAGNUM NAIL |
ROBERT REID INC. |
KAREN WARDEN |
| K093084 |
10/01/2009 |
ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP |
ROLENCE ENT. INC. |
JEN KE-MIN |
| K093253 |
10/16/2009 |
AMID STAPLER |
SAFESTITCH LLC |
STEWART DAVIS |
| K093327 |
10/26/2009 |
INTCO TAB ELECTRODE |
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. |
CHRIS HEALY |
| K093359 |
10/28/2009 |
1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133 |
SHANGHAI LITTLE DOCTOR CO. LIMITED |
JANUSUN WANG |
| K093100 |
10/01/2009 |
REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) |
SHENZHEN COMFORT TECHNOLOGY CO., LTD. |
JEAN ASQUITH |
| K093138 |
10/05/2009 |
MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
ZHIGANG ZHAO |
| K093394 |
10/30/2009 |
BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN GOLDSTEIN |
| K093090 |
10/01/2009 |
GALILEOS IMPLANT, VERSION 1.7 |
SICAT GMBH & CO. KG |
MARKUS PFISTER |
| K093107 |
10/01/2009 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K093269 |
10/19/2009 |
PROCEDURE REHEARSAL STUDIO |
SIMBIONIX LTD. |
SHOSHANA FRIEDMAN |
| K093391 |
10/30/2009 |
SIMUPLAN TREATMENT PLANNING SYSTEM |
SIMUPLAN S.L. |
LU ANNE JOHNSON |
| K093363 |
10/28/2009 |
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K093228 |
10/15/2009 |
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
CHRISTINA FLORES |
| K093257 |
10/19/2009 |
TORQMAX SHEATH GRIP ACCESSORY |
SPECTRANETICS CORP. |
BRANDON HANSEN |
| K093373 |
10/29/2009 |
LARYNGEAL SURFACE ELECTRODE |
SPES MEDICA S.R.L. |
ALFREDO SPADAVECHIA |
| K093170 |
10/07/2009 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
| K093130 |
10/05/2009 |
ENGAGE TR INTRODUCER |
ST. JUDE MEDICAL |
LINH PHAM |
| K093176 |
10/08/2009 |
MED-LOK |
STA-MED, LLC |
GREG HOLLAND |
| K093092 |
10/01/2009 |
ODYSSEY WORKSTATION |
STEREOTAXIS, INC. |
DENNIS POZZO |
| K093206 |
10/13/2009 |
ORTHOMAP 3D 1.1 MODULE |
STRYKER CORP. |
LILIAN ECKERT |
| K093108 |
10/01/2009 |
STRYKER BIPOLAR FORCEPS |
Stryker Leibinger GmbH & Co. KG |
ROB YAMASHITA |
| K093393 |
10/30/2009 |
LIFEDOP MODEL 300ABI |
SUMMIT DOPPLER SYSTEMS, INC. |
KEN JARRELL |
| K093341 |
10/23/2009 |
CENTURY MODEL 105C |
SYBRON DENTAL SPECIALTIES, INC. |
CLAUDIA ORTIZ |
| K093310 |
10/22/2009 |
GEM FLOW COUPLER DEVICE AND SYSTEM |
SYNOVIS MICRO COMPANIES ALLIANCE, INC. |
MELISSA J FORTH |
| K093361 |
10/28/2009 |
SYNTHES AIR PEN DRIVE (APD) SYSTEM |
SYNTHES (USA) |
JILL YELTON |
| K093299 |
10/21/2009 |
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM |
SYNTHES (USA) |
ALAN T HALEY |
| K093240 |
10/15/2009 |
BELRAY II |
TAKARA BELMONT CORP. |
KUNIHIKO SOUE |
| K093270 |
10/19/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN EXCELLENCE GLOVE CO., LTD. |
CHU XIAOAN |
| K093277 |
10/19/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN GREEN HEALTHCARE CO., LTD. |
CHU XIAOAN |
| K093272 |
10/19/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN HUAMEI HEALTHCARE CO., LTD. |
CHU XIAOAN |
| K093276 |
10/19/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN KANGYUAN GLOVE CO., LTD. |
CHU XIAOAN |
| K093261 |
10/19/2009 |
MOVES |
THORNHILL RESEARCH INC |
CLIFF ANSEL |
| K093313 |
10/22/2009 |
SYNERGY |
TOPCON MEDICAL SYSTEMS, INC. |
MAUREEN O'CONNELL |
| K093171 |
10/08/2009 |
VIAMO SSA-640A VERSION 1.2 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K093322 |
10/23/2009 |
MULTI-PURPOSE HEALTH DEVICE |
UPC MEDICAL SUPPLIES, INC. DBA UNITED PACIFIC CO. |
DANIEL HUE |
| K093145 |
10/05/2009 |
SPECTRA SERIES BREAST PUMP |
UZINMEDICARE CO. |
YONG J CHOI |
| K093250 |
10/16/2009 |
PROTON THERAPY MULTILEAF COLLIMATOR |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K093291 |
10/21/2009 |
VARIAN INTERSTITIAL TITANIUM NEEDLES |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K093135 |
10/05/2009 |
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE |
VENNER MEDICAL (SINGAPORE) PTE LTD |
JUDY BURTON |
| K093146 |
10/05/2009 |
IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 |
VERAN MEDICAL TECHNOLOGIES, INC. |
SCOTT WRIGHTSTONE |
| K093271 |
10/19/2009 |
EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD |
VICTUS, INC. |
ILEANA YANES |
| K093279 |
10/20/2009 |
NAVIX ACCESS DEVICE |
XLUMENA |
WITNEY MCKIERNAN |
| DEN090002 |
10/13/2009 |
ZELTIQ AESTHETICS DERMAL COOLING DEVICE |
ZELTIQ AESTHETICS |
LOUIS-PIERRE MARCOUX |
| K093164 |
10/06/2009 |
3.25 SPLINE TWIST IMPLANT, HA COATED |
ZIMMER DENTAL INC. |
LARISSA D'ANDREA MCMULLIN |
| K093127 |
10/02/2009 |
TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET |
ZIMMER TRABECULAR METAL TECHNOLOGY |
KATHLEEN RUTHERFORD |
