| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K110383 |
08/01/2011 |
BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 |
A PLUS MEDICAL |
THOMAS C LOESCHER |
| K111686 |
08/01/2011 |
A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS |
A&D COMPANY, LTD. |
JERRY WANG |
| K100015 |
08/09/2011 |
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 |
ABBOTT MOLECULAR, INC. |
PAMELA L SWATKOWSKI |
| K091960 |
08/29/2011 |
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 |
ABBOTT MOLECULAR, INC. |
PAMELA L SWATKOWSKI |
| K112239 |
08/31/2011 |
STEERABLE GUIDE CATHETER |
Abbott Vascular |
CYNTHIA MORROW |
| K111254 |
08/22/2011 |
RELIEVA SOLO ELITE SINUS BALLOON CATHETER |
ACCLARENT, INC. |
KIM KY |
| K103790 |
08/18/2011 |
ACE TRIMARK TRICAM DENTAL IMPLANT |
ACE SURGICAL SUPPLY COMPANY INC. |
DENISE WILLIAMS |
| K112409 |
08/29/2011 |
MATRISTEM WOUND MATRIX |
ACELL, INC |
DEBORAH A BAKER-JANIS |
| K111608 |
08/29/2011 |
SLIC SCREW REPAIR SYSTEM |
ACUMED LLC |
HOLLACE RHODES |
| K111805 |
08/24/2011 |
ECG SERIES ELECTROCARDIOGRAPH |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
| K112135 |
08/05/2011 |
ECG-6 SERIES ELECTROCARDIOGRAPH |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
| K111122 |
08/04/2011 |
AESCULAP SIBD XP SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
LISA M BOYLE |
| K111945 |
08/05/2011 |
IMPAX NEXT GENERATION |
AGFA HEALTHCARE N.V. |
JODI COLEMAN |
| K112235 |
08/26/2011 |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING |
AIRSTRIP TECHNOLOGIES, LP |
ANDY MILLER |
| K102678 |
08/26/2011 |
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS |
ANDON MEDICAL CO., LTD. |
YI LIU |
| K101307 |
08/09/2011 |
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 |
ANDON MEDICAL CO., LTD. |
YI LIU |
| K110027 |
08/05/2011 |
SURGICAL FACE MASK; SURGICAL FACE MASK |
ANGELINE GROUP LTD. |
MICHAEL LEE |
| K112182 |
08/26/2011 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
ANGIOSCORE, INC. |
JONATHAN S KAHAN |
| K101204 |
08/31/2011 |
MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION |
APEX BIOTECHNOLOGY CORP. |
HSUE-MEI LEE |
| K103706 |
08/24/2011 |
THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR |
APPLIED CARDIAC SYSTEMS, INC. |
R. BEN GHADIMI |
| K111253 |
08/02/2011 |
ARTHREX DISTAL EXTREMITY PLATE SYSTEM |
ARTHREX, INC. |
COURTNEY SMITH |
| K111661 |
08/19/2011 |
ARTHREX SCAPHOLUNATE ANCHOR |
ARTHREX, INC. |
COURTNEY SMITH |
| K111044 |
08/09/2011 |
SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE |
ARTHROCARE CORPORATION |
LAURA KASPEROWICZ |
| K110584 |
08/22/2011 |
ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K111799 |
08/19/2011 |
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM |
ASCENSION ORTHOPEDIC |
BRADLEY W STRASSER |
| K102760 |
08/03/2011 |
ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 |
ATLAS MEDICAL |
NOUR AL-AHWAL |
| K112072 |
08/03/2011 |
ATRICURE CRYO MODULE SYSTEM |
ATRICURE, INC. |
JAMES L LUCKY |
| K103028 |
08/11/2011 |
EEVATM PETRI DISH |
AUXOGYN, INC. |
ROBERT NEWMAN |
| K111338 |
08/11/2011 |
WILDCAT CATHETER |
AVINGER, INC. |
KIT CARIQUITAN |
| K110296 |
08/18/2011 |
AXIS-SHIELD ANTI-CCP |
AXIS-SHIELD DIAGNOSTICS, LTD. |
CLAIRE I DORA |
| K111236 |
08/30/2011 |
INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 |
B. BRAUN MELSUNGEN AG |
ANGELA J CARAVELLA |
| K110719 |
08/11/2011 |
ORIGIN ZIRCONIA |
B&D DENTAL TECHNOLOGIES |
JOON HWANG |
| K111991 |
08/11/2011 |
NIO COLOR 2MP |
BARCO NV |
LIEVEN DE WANDEL |
| K111952 |
08/19/2011 |
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 |
BECKMAN COULTER, INC. |
KERRIE S OETTER |
| K110350 |
08/03/2011 |
KNEEHAB XP |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K111072 |
08/23/2011 |
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 |
| K111347 |
08/12/2011 |
ISROBOT MONA LISA |
BIOBOT SURGICAL PTE LTD |
CHERITA JAMES |
| K103087 |
08/26/2011 |
COVAMAX RESORBABLE COLLAGEN MEMBRANE |
BIOM'UP SAS |
VALERIE CENTIS |
| K111599 |
08/12/2011 |
VITEK 2 AST-ST LINEZOLID |
BIOMERIEUX, INC. |
NATHAN HARDESTY |
| K111957 |
08/19/2011 |
POLARIS SPINAL SYSTEM |
BIOMET SPINE (EBI LLC) |
VIVIAN KELLY, RAC |
| K110879 |
08/19/2011 |
BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR |
BIOMET SPORTS MEDICINE |
ELIZABETH WRAY |
| K110689 |
08/19/2011 |
INBODY |
BIOSPACE CORPORATION LIMITED |
DANIEL KAMM |
| K111609 |
08/22/2011 |
BOSTON BAND |
BOSTON BRACE INTL., INC. |
JAMES WYNNE |
| K111043 |
08/04/2011 |
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER |
BOSTON SCIENTIFIC CORP. |
JANICE E BROWN, RAC |
| K112103 |
08/12/2011 |
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM |
BOSTON SCIENTIFIC CORP. |
HARLAN JONES |
| K110204 |
08/05/2011 |
BRAINLAB TRAUMA |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| K111963 |
08/10/2011 |
BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
| K112137 |
08/26/2011 |
COMFORTGLIDE INTERMITENT CATHETER |
C.R. BARD, INC. |
STACCI CRONK |
| K112308 |
08/17/2011 |
CROSSER RECANALIZATION SYSTEM |
C.R. BARD, INC. |
TIMOTHY WADE |
| K102511 |
08/24/2011 |
MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT |
C.R. BARD, INC. |
Joni Creal |
| K111745 |
08/01/2011 |
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CLAY ANSELMO |
| K112034 |
08/12/2011 |
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES |
CAREFUSION 209, INC. |
GLEN HERMANSON |
| K111053 |
08/12/2011 |
SENTRYSUITE PRODUCT LINE |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
| K110977 |
08/25/2011 |
VESOFLOW |
CAREMED SUPPLY, INC. |
EDWARD A KROLL |
| K111507 |
08/23/2011 |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
CAPT HYE-JOO KIM, PHARM.D. |
| K103734 |
08/19/2011 |
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE |
CENTRAL MEDICARE SDN BHD |
NICK WANG |
| K112376 |
08/31/2011 |
S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM |
CIRCA SCIENTIFIC, LLC |
FRED PIAZZA |
| K111373 |
08/23/2011 |
CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE |
CIRCLE CARDIOVASCULAR IMAGING INC. |
SHIRANTHA SAMARAPPULI |
| K111881 |
08/17/2011 |
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT |
COLOPLAST A/S |
JANELL A COLLEY |
| K111779 |
08/08/2011 |
Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 |
CONMED LINVATEC |
JOHN CUSACK |
| K111365 |
08/19/2011 |
VITALA CONTINENCE CONTROL DEVICE |
CONVATEC INC. |
MARK R JAKUBOWSKI |
| K111911 |
08/04/2011 |
CORIN OPTIMOM MODULAR HEAD |
CORIN U.S.A. |
LUCINDA GERBER |
| K111917 |
08/24/2011 |
NUVANT, MOBILE CARDIAC TELEMETRY |
CORVENTIS, INC. |
MICHELE CHIN-PURCELL |
| K111817 |
08/30/2011 |
PALINDROME RT CHRONIC CATHETER |
COVIDIEN |
WING NG |
| K111372 |
08/04/2011 |
TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... |
COVIDIEN |
WING NG |
| K110653 |
08/01/2011 |
CURE CATHETER |
CURE MEDICAL LLC. |
ROBYN SCOPIS |
| K111172 |
08/29/2011 |
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES |
DAAVLIN DISTRIBUTING CO. |
MICHELE THIEL |
| K093915 |
08/23/2011 |
DEKA TAC DEVICE |
DEKA RESEARCH & DEVELOPMENT CORP. |
ROBERT SWAIN |
| K111433 |
08/30/2011 |
DEPUY STTUNE (TM) PS KNEE SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K110397 |
08/16/2011 |
TRUMATCH PERSONALIZED SOLUTIONS |
DEPUY ORTHOPAEDICS, INC. |
NANCY S FRIDDLE |
| K111589 |
08/23/2011 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG |
DERMA CARE PLUS PRODUCTS, LLC |
JOSEPH NEUSER |
| K102188 |
08/09/2011 |
CYBOW READER, MODELS 300 & 720 |
DFI CO., LTD. |
YANG HO-DONG |
| K102400 |
08/01/2011 |
SYPHILIS HEALTH CHECK |
DIAGNOSTICS DIRECT, LLC. |
Gary Lehnus |
| K110801 |
08/02/2011 |
WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM |
DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC |
LIKUN FU |
| K111376 |
08/03/2011 |
CONSTRUX EXTERNAL FIXATION DEVICE |
EBI, LLC |
MARGARET F CROWE |
| K111808 |
08/01/2011 |
SONOLITH I-MOVE |
EDAP TMS FRANCE |
HOLSTEIN HOWARD |
| K111705 |
08/03/2011 |
EKOSONIC ENDOVASCULAR SYSTEM |
EKOS CORPORATION |
JOCELYN KERSTEN |
| K111095 |
08/03/2011 |
BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025 |
ELECTRO KINETIC TECHNOLOGIES, LLC |
RAYMOND ERBE |
| K112029 |
08/30/2011 |
ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 |
ELITECHGROUP |
DEBRA K HUTSON |
| K103747 |
08/31/2011 |
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS |
ELITECHGROUP SEPPIM S.A.S. |
DEBRA K HUTSON |
| K111742 |
08/31/2011 |
MDRIVE |
EMBLA SYSTEMS |
ROBERT G SCHUEPPERT |
| K111527 |
08/03/2011 |
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT |
ERAGEN BIOSCIENCES, INC. |
DAVID LIM |
| K111195 |
08/03/2011 |
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS |
ETHICON ENDO-SURGERY, INC. |
DENNIS HAHN |
| K103719 |
08/24/2011 |
LIFECARE CONDUCTIVE GARMENTS |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K111535 |
08/26/2011 |
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER |
EXACT MEDICAL MANUFACTURING, INC |
ROBERT O DEAN |
| K103699 |
08/12/2011 |
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC |
EXACTECH, INC. |
SHING JEN TAI, PHD |
| K110316 |
08/19/2011 |
INFOSEND GSM |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
| K111548 |
08/30/2011 |
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
KATHERINE Y CHOI |
| K103802 |
08/02/2011 |
TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR |
GE HEALTHCARE FINLAND OY |
TATJA PASANEN |
| K103448 |
08/12/2011 |
BRIVO XR385 |
GE MEDICAL SYSTEMS, LLC |
JOHN L SCHMIDT |
| K102926 |
08/25/2011 |
GEMORE MUSCLE CONDITIONER; |
GEMORE TECHNOLOGY CO., LTD. |
BODEN LAI |
| K102516 |
08/11/2011 |
LUCINA MODEL MELODI |
GENADYNE BIOTECHNOLOGIES, INC. |
CHIEN MING(ANDREW)GOH |
| K103181 |
08/26/2011 |
ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
GENORAY CO., LTD. |
JAE KIM |
| K111479 |
08/17/2011 |
REVERE CROSSTOP |
GLOBUS MEDICAL INC. |
SARAH M FITZGERALD |
| K111449 |
08/17/2011 |
REVOLVE ADDITIONAL IMPLANTS |
GLOBUS MEDICAL, INC. |
SARAH MARIE FITZGERALD |
| K110758 |
08/12/2011 |
NITRILE POWDER FREE EXAMINATION GLOVES |
HARTALEGA SDN BHD |
NURUL AISYAH KONG BT ABDULLAH |
| K111573 |
08/26/2011 |
MONOBLOC BM SERIES |
HASS CORP. |
Priscilla Chung |
| K111508 |
08/19/2011 |
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 |
HOLOGIC, INC. |
DEBORAH THOMAS |
| K110301 |
08/19/2011 |
SILK'N FX |
HOME SKINOVATIONS LTD. |
AMIR WALDMAN PH. D. |
| K110137 |
08/10/2011 |
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN |
HORIBA ABX S.A.S. |
CAROLINE FERRER |
| K102120 |
08/12/2011 |
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 |
HSINER CO., LTD. |
TOM SHANKS |
| K112180 |
08/10/2011 |
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) |
INFIMED, INC. |
CATHERINE MULCAHY |
| K110388 |
08/09/2011 |
COLLACARE DENTAL |
INNOCOLL PHARMACEUTICALS LTD |
AARON WYSE |
| K111158 |
08/10/2011 |
LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
INNOVATIVE GLOVES CO; LTD |
RAJEEV SOOD |
| K111333 |
08/08/2011 |
ANTLIA III WOUND TREATMENT SYSTEM |
INNOVATIVE THERAPIES, INC. |
JUDITH HARBOUR |
| K111032 |
08/31/2011 |
CMC CABLE FIX |
INSTRATEK, INC. |
Jeff Seavey |
| K110031 |
08/24/2011 |
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM |
INSTRUMENTATION LABORATORY CO. |
Jacqueline Emery |
| K111741 |
08/23/2011 |
INTEGRA(TM) CUSA NXT(TM) BONE TIPS |
INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI |
KEVIN J O'CONNELL |
| K110656 |
08/18/2011 |
IMC BLOOD COLLECTION NEEDLE |
INTERNATIONAL MEDSURG CONNECTION |
PETER KIM |
| K110882 |
08/18/2011 |
IMC INSULIN SYRINGE |
INTERNATIONAL MEDSURG CONNECTION |
PETER KIM |
| K111199 |
08/08/2011 |
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS |
INTRA-LOCK INTERNATIONAL, INC. |
ANGELA BLACKWELL |
| K111160 |
08/01/2011 |
INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) |
INTRICON DATRIX CORPORATION |
TANYA O'BRIEN |
| K110451 |
08/26/2011 |
ENDOWRIST ONE SUCTION/IRRIGATOR |
INTUITIVE SURGICAL, INC. |
BRANDON HANSEN |
| K111387 |
08/04/2011 |
LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER |
IQUUM INC |
Lingjun Chen |
| K111931 |
08/05/2011 |
GLIASITE RTS |
ISORAY MEDICAL, INC. |
FREDRIC G SWINDLER |
| K103799 |
08/29/2011 |
INQU PASTE MIX PLUS |
ISTO TECHNOLOGIES, INC. |
PATSY J TRISLER, JD, RAC |
| K110756 |
08/29/2011 |
BLUEPHASE STYLE |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K111439 |
08/24/2011 |
CHESAPEAKE (CERVICAL COMPONENTS) |
K2M, INC. |
NANCY GIEZEN |
| K110991 |
08/02/2011 |
MESA SPINAL SYSTEM (KEYSTONE RODS) |
K2M, INC. |
NANCY GIEZEN |
| K111135 |
08/17/2011 |
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) |
K2M, INC. |
NANCY GIEZEN |
| K103027 |
08/19/2011 |
ELECTROTORQUE TLC |
KALTENBACH & VOIGT GMBH |
CLAUDIA ORTIZ |
| K103308 |
08/29/2011 |
AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL HAGAN |
| K111067 |
08/02/2011 |
JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE |
KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. |
Glen Feye |
| K111288 |
08/02/2011 |
ANCHORWIRE GUIDEWIRE |
LAKE REGION MEDICAL |
MATHEW PEXA |
| K112231 |
08/19/2011 |
LCCS INSULATED SPINAL NEEDLE (RF CANNULA) |
LCCS PRODUCTS LIMITED |
FIELD FU |
| K111714 |
08/16/2011 |
HAIRMAX DUAL 12 |
LEXINGTON INTERNATIONAL, LLC |
CASPER E ULDRICKS ESQ. |
| K111201 |
08/10/2011 |
C7 XR IMAGING SYSTEM |
LIGHTLAB IMAGING,INC. |
BRYAN COWELL |
| K110598 |
08/18/2011 |
SMR REVERSE SHOULDER SYSTEM |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K111987 |
08/17/2011 |
FIBERNET EMBOLIC PROTECTION DEVICE |
LUMEN BIOMEDICAL, INC. |
MICHELLE STRAIGHT |
| K110627 |
08/12/2011 |
NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER |
MARVAO MEDICAL DEVICES, LTD. |
Marybeth Gamber |
| K111047 |
08/08/2011 |
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES |
MAUNA KEA TECHNOLOGIES INC. |
CHRIS TIHANSKY |
| K111145 |
08/16/2011 |
ENDO HEAD |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K100874 |
08/19/2011 |
LIPOSONIX SYSTEM, MODEL 1 P00XXXX |
MEDICIS TECHNOLOGIES CORPORATION |
JONATHAN KAHAN |
| K102406 |
08/23/2011 |
PASS ANTERIOR SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J D WEBB |
| K103735 |
08/15/2011 |
MEDILED MINI |
MEDIX I.C.S.A. |
JAMES H KNAUSS |
| K111807 |
08/18/2011 |
MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K111319 |
08/05/2011 |
IBIS EXPLORER AND MARKUP SOFTWARE |
MEDQIA |
MAHTAB FATEMI |
| K101934 |
08/03/2011 |
DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 |
MEDSHAPE SOLUTIONS |
DON GRIFFIN |
| K111525 |
08/24/2011 |
PERIMETER INTERBODY FUSION DEVICE |
MEDTRONIC SOFAMOR DANEK |
MIKE SCOTT |
| K111942 |
08/30/2011 |
TSRH SPINAL SYSTEMS |
MEDTRONIC SOFAMOR DANEK USA, INC |
LILA JOE |
| K110543 |
08/09/2011 |
CRESCENT (R) SPINAL SYSTEM TITANIUM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
BECKY RONNER |
| K100967 |
08/05/2011 |
PERIMETER C SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
BRAD SHEALS |
| K111265 |
08/09/2011 |
METASURG SUBTALAR IMPLANT |
METASURG |
JOSHUA SCOTT |
| K111482 |
08/25/2011 |
SONICATOR PLUS 920 |
METTLER ELECTRONICS CORP. |
CHRISTINA CAYUELA |
| K110813 |
08/05/2011 |
HEADWAY 27 MICROCATHETER |
MICRO VENTION, INC. |
Naomi Gong |
| K112089 |
08/24/2011 |
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE |
MOLNLYCKE HEALTHCARE, US LLC |
ANGELA L BUNN, RAC |
| K112163 |
08/30/2011 |
MONICA IF24 |
MONICA HEALTHCARE |
IAN HOW |
| K112124 |
08/19/2011 |
MICROCATHETER |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
| K111668 |
08/19/2011 |
CAVIOS CAVITY LINER |
NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
ROBERT SEIPLE |
| K110410 |
08/04/2011 |
MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K111101 |
08/25/2011 |
NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET |
NORFOLK MEDICAL |
MICHAEL J DALTON |
| K111383 |
08/12/2011 |
ZIRPRIME |
NORITAKE CO., INC. |
IVAN WASSERMAN |
| K100602 |
08/17/2011 |
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K110648 |
08/29/2011 |
NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM |
NOVA BIOMEDICAL CORPORATION |
PAUL W MACDONALD |
| K110486 |
08/12/2011 |
ACCUSOM |
NOVASOM, INC. |
ROGER K RICHARDSON |
| K101973 |
08/16/2011 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) |
OMEGA LABORATORIES, INC. |
ROBERT J BARD |
| K111628 |
08/19/2011 |
P200T |
OPTOS PLC |
HOWARD M HOLSTEIN |
| K103657 |
08/09/2011 |
SAPPHIRE |
ORBUSNEICH MEDICAL, INC. |
JOHN PAZIENZA |
| K110959 |
08/05/2011 |
ORTHOPEDIATRICS BLADE PLATE SYSTEM |
ORTHOPEDIATRICS, CORP |
MARK FOX |
| K111352 |
08/22/2011 |
TALON DISTALFIX PROXIMAL FEMORAL NAIL |
ORTHOPEDIC DESIGNS NORTH AMERICA, INC. |
SETH MASEK |
| K111247 |
08/15/2011 |
CRANIAL REMOLDING ORTHOSIS |
ORTHOTIC CARE SERVICES, LLP |
SCOTT HINSHON |
| K111176 |
08/15/2011 |
OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM |
OSTEOMED L.P. |
PIEDAD PENA |
| K111284 |
08/17/2011 |
FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM |
OSTIAL CORPORATION |
Mark Smutka |
| K111374 |
08/29/2011 |
SONO-SERIES CORNERSTONE TECHNIQUE |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K111431 |
08/01/2011 |
B1P ADHESIVE |
PENTRON CLINICAL |
Wendy Garman |
| K110735 |
08/03/2011 |
TANDA MAX OTC SYSTEM |
PHAROS LIFE CORPORATION |
JOHNATHAN S KAHAN |
| K111083 |
08/17/2011 |
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MICHAEL ASMALSKY |
| K110679 |
08/02/2011 |
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K111632 |
08/11/2011 |
INFILL GRAFT DELIVERY SYSTEM |
PINNACLE SPINE GROUP, LLC |
REBECCA K SPINE |
| K111528 |
08/24/2011 |
PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCINTYRE |
| K111502 |
08/23/2011 |
STREAMLINE TL SPINAL SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCINTYRE |
| K111739 |
08/12/2011 |
KIDS ROCK 3 CHAIR |
PRIDE MOBILITY PRODUCTS CORP. |
KIMBERLY BLAKE |
| K111300 |
08/12/2011 |
SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE) |
PT. MAHAKARYA INTI BUANA |
LINA NG |
| K111592 |
08/25/2011 |
YOULASER CO2 LASER SYSTEM |
QUANTA SYSTEM, S.P.A. |
Maurizio Bianchi |
| K110856 |
08/10/2011 |
RALCO |
RALCO S.R.L. |
DANIEL KAMM |
| K110468 |
08/05/2011 |
FREEWAY COMFORT BITE GUARD |
RANDMARK DENTAL PRODUCTS, LLC |
NORMAN F ESTRIN |
| K102831 |
08/19/2011 |
RSI 4200 |
REIMERS SYSTEMS, INC. |
NAYIL ALAM |
| K111207 |
08/23/2011 |
RESPIRE BLUE SERIES |
RESPIRE MEDICAL |
DANIELA LEVY |
| K110795 |
08/19/2011 |
V200 INTELLI-TRAK OPTION |
RESPIRONICS CALIFORNIA, INC. |
ROBERT M MARSHALL |
| K110293 |
08/09/2011 |
OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER |
RESPIRONICS NEW JERSEY, INC. |
Lauren Ziegler |
| K110129 |
08/30/2011 |
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION |
RIGHTMEDICAL PRODUCTS, LLC |
MELANIE DESLAURIERS |
| K112104 |
08/25/2011 |
ELECSYS N-MID OSTEOCALCIN CALCHECK 5 |
Roche Diagnostics |
JANE E PHILLIPS |
| K111590 |
08/08/2011 |
ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR |
ROG SPORTS MEDICINE, INC. |
CURTIS RAYMOND |
| K110858 |
08/02/2011 |
LO-BAK TRAX |
ROLAND F BERTHIAUME, DC |
ROLAND F BERTHIAUME |
| K110016 |
08/23/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
RONGYAO PLASTIC PRODUCE CO., LTD |
ZHAO GANG |
| K111616 |
08/19/2011 |
E-CUBE |
SAESHIN PRECISION CO., LTD. |
Y S LEE |
| K112339 |
08/29/2011 |
ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
KYEONG-MI PARK |
| K101517 |
08/05/2011 |
SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY |
SEDECAL S.A. |
DANIEL KAMM, P.E. |
| K110776 |
08/24/2011 |
DIGITAL THERMOMETER MT SERIES |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
REN YUNHUA |
| K102706 |
08/19/2011 |
CKMB UDR ASSAY |
SENTINEL CH. SpA |
FABIO ROTA |
| K112112 |
08/25/2011 |
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS |
SENTINEL MEDICAL, INC. |
JOAN MEDLEY |
| K103274 |
08/18/2011 |
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING |
SENTINELLE MEDICAL, INC. |
CAMERON PIRON |
| K111572 |
08/29/2011 |
NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL |
SERF |
J.D. WEBB |
| K103619 |
08/10/2011 |
SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED) |
SHANDONG BLUE SAIL INNOVATION CO., LTD. |
YONGCHEN ZHANG |
| K110707 |
08/03/2011 |
CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR |
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
KANG JIAN PING |
| K110934 |
08/25/2011 |
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY |
SIEMENS HEALTHCARE DIAGNOSTICS |
Sandra D White |
| K101572 |
08/01/2011 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K110277 |
08/15/2011 |
RAPIDPOINT 405 NEONATAL BILIRUBIN |
SIEMENS HEALTHCARE DIAGNOSTICS |
Steven Goldberg |
| K110736 |
08/17/2011 |
ADVIA CHEMISTRY FERRITIN (FRT) METHOD |
Siemens Healthcare Diagnostics Inc. |
KIRA GORDON |
| K111677 |
08/04/2011 |
MICROSCAN(R) MICROSTREP PLUS(R) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
JENIFER DAWSON DRISCOLL |
| K112020 |
08/18/2011 |
SYNGO.CT VASCULAR ANALYSIS |
SIEMENS MEDICAL SOLUTIONS, INC. |
RALF HOFMANN |
| K102158 |
08/02/2011 |
SIGMA STERILIZATION POUCH & ROLL |
SIGMA MEDICAL SUPPLIES CORP. |
UTA SHIH |
| K111620 |
08/23/2011 |
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS |
SKELETAL DYNAMICS, LLC |
ANA M ESCAGEDO |
| K111760 |
08/09/2011 |
NAVIAID(TM) BGC DEVICE |
SMART MEDICAL SYSTEMS, LTD. |
ADVA YOSELZON |
| K110958 |
08/01/2011 |
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH |
SMITH & NEPHEW, INC. |
LAURA REYNOLDS |
| K111386 |
08/29/2011 |
MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) |
SMITHS MEDICAL MD, INC. |
JAMES CHAPMAN |
| K110663 |
08/11/2011 |
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
| K111550 |
08/19/2011 |
SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
CHARLES L NELSON |
| K111293 |
08/24/2011 |
SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM |
SOUNDCURE INC |
NANCY LINCE |
| K111913 |
08/31/2011 |
CAPSURE(R) PS SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K102315 |
08/19/2011 |
STAXX XDL SYSTEM |
SPINE WAVE, INC. |
DENISE DUCHENE |
| K112108 |
08/19/2011 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANK P ENNESI |
| K111127 |
08/11/2011 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
| K110733 |
08/25/2011 |
DAYTONA ANTERIOR CERVICAL CAGE |
SPINENET, LLC |
J.D. WEBB |
| K112341 |
08/29/2011 |
SNAP WOUND CARE SYSTEM |
SPIRACUR, INC. |
SARAH CANIO |
| K111282 |
08/11/2011 |
DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES |
STARBOARD MEDICAL, LLC |
ANTHONY BERAN |
| K083577 |
08/29/2011 |
HARMONIE SYSTEM |
STELLATE SYSTEMS |
GOLDY SINGH |
| K110076 |
08/18/2011 |
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER |
STERILMED, INC. |
GARRETT AHLBORG |
| K102394 |
08/18/2011 |
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K102330 |
08/12/2011 |
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM |
STERIS Corporation |
ROBERT F SULLIVAN |
| K110172 |
08/19/2011 |
SONAFINE WOUND DRESSING |
STRATUS PHARMACEUTICAL |
ALBERTO HOYO |
| K110580 |
08/12/2011 |
NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS |
STRAUMANN USA |
ELAINE ALAN |
| K112059 |
08/08/2011 |
T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP |
Stryker |
VALERIE GIAMBANCO |
| K111478 |
08/04/2011 |
STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT) |
STRYKER CORPORATION |
TIFFANI ROGERS |
| K110828 |
08/23/2011 |
DDRELEMENT |
SWISSRAY MEDICAL AG |
JOHN MONAHAN |
| K110005 |
08/04/2011 |
SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE |
SYNCRO MEDICAL INNOVATIONS, INC. |
WILLIAM G MCLAIN |
| K111540 |
08/08/2011 |
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM |
SYNTHES (USA) |
THOMAS N SHEA |
| K111437 |
08/10/2011 |
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) |
SYNTHES (USA) PRODUCTS LLC |
ANGELA F LASSANDRO |
| K111974 |
08/15/2011 |
ION HEALTH USB INSTA-SCAN THERMOMETER |
TaiDoc Technology Corporation |
TELING HSU |
| K101635 |
08/31/2011 |
TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
TELING HSU |
| K103673 |
08/18/2011 |
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK |
TECHLAB INC., CORPORATE RESEARCH CENTER |
DONNA T LINK |
| K111900 |
08/17/2011 |
NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER |
Teleflex Medical, Inc. |
SUZANNE SCHORLE |
| K103796 |
08/03/2011 |
TELEMEDCARE HEALTH MONITOR |
TELEMEDCARE PTY LTD |
STEVEN M MOODY |
| K101533 |
08/10/2011 |
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM |
Tem Innovations GmbH |
VOLKER-JOACHIM FRIEMERT |
| K111675 |
08/02/2011 |
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
DALE DAVISON |
| K111108 |
08/11/2011 |
PASCAL STREAMLINE 577 (WITH ACCESSORIES) |
TOPCON MEDICAL LASER SYSTEMS, INC |
JOHN JOSSY |
| K111633 |
08/25/2011 |
AQUILION LB MOVEMENT BASE KIT |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K112054 |
08/05/2011 |
INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
PAUL BIGGINS |
| K102489 |
08/02/2011 |
VANTAGE TITAN 3T |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
PAUL BIGGINS |
| K111762 |
08/05/2011 |
ST AIA-PACK DHEA-S CALIBRATOR SET |
Tosoh BioScience, Inc. |
JUDITH K OGDEN |
| K103532 |
08/26/2011 |
AUTOREADER 2 |
TREK DIAGNOSTIC SYSTEMS |
Cynthia Knapp |
| K111429 |
08/18/2011 |
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... |
TREK DIAGNOSTIC SYSTEMS, LTD. |
CYNTHIA C KNAPP |
| K110757 |
08/19/2011 |
TL-CERMIDE SKIN BARRIER EMULSION |
TRIGEN LABORATORIES, INC. |
GEORGE MCCAULEY |
| K102785 |
08/19/2011 |
TRIMED RADIOCARPAL FUSION SYSTEM |
TRIMED, INC. |
DAVID ANDERSON |
| K112281 |
08/17/2011 |
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX |
TRIREME MEDICAL, INC. |
SHIVA ARDAKANI |
| K103659 |
08/18/2011 |
CS 9300, CS 9300C |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K101543 |
08/30/2011 |
TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K111441 |
08/19/2011 |
UNIMAX VERESS NEEDLE |
UNIMAX MEDICAL SYSTEMS, INC. |
MICHAEL LEE |
| K111715 |
08/11/2011 |
EMBRYOSCOPE |
UNISENSE FERTILITECH A/S |
METTE MUNCH |
| K103733 |
08/02/2011 |
UNITED U2 XPE TOTAL KNEE SYSTEM |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K110245 |
08/04/2011 |
UNITED UTF STEM |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K111106 |
08/18/2011 |
TRUEBEAM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K111334 |
08/01/2011 |
BENELLI ACCESS DEVICE |
VASCULAR SOLUTIONS, INC. |
JENNIFER RUETHER |
| K102078 |
08/10/2011 |
RADIOLOGICAL IMAGE PROCESSING SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
| K111167 |
08/18/2011 |
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT |
VELOPEX INTERNATIONAL, INC. |
ANTHONY URELLA |
| K101234 |
08/25/2011 |
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY |
VENTANA MEDICAL SYSTEMS, INC. |
Judy Howe |
| K111395 |
08/01/2011 |
PRIMEWIRE PRESTIGE PLUS |
VOLCANO CORPORATION |
MARILYN POURAZAR |
| K110269 |
08/26/2011 |
WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL |
WELL LEAD MEDICAL CO. LTD |
JOHN OBRIEN |
| K111314 |
08/31/2011 |
MORPHEUS OX |
WIDEMED LTD |
JOHN SMITH |
| K111432 |
08/19/2011 |
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ANGELA SMITH |
| K111698 |
08/19/2011 |
PROFEMUR(R) E CEMENTLESS HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
GREGORY NEAL |
| K111699 |
08/19/2011 |
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
GREGORY NEAL |
| K110289 |
08/30/2011 |
FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE |
XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. |
ZHAI YING CHUAN |
| K111584 |
08/25/2011 |
XYLOS MACRO-POROUS SURGICAL MESH |
XYLOS CORPORATION |
GONZALO C SERAFICA |
| K110342 |
08/22/2011 |
YOLO CURVE |
YOLO MEDICAL INC. |
ROBERT J KRZNARIC |
| K110621 |
08/24/2011 |
SHENGKUN CHEMICAL |
ZIBO SHENGKUN CHEMICAL INDUSTRIAL CO., LTD |
JASON LIU |
| K111852 |
08/11/2011 |
ANODIZED HEALING COLLAR |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
| K111301 |
08/26/2011 |
INSTINCT JAVA SYSTEM |
ZIMMER SPINE |
ELSA A LINKE |
| K110348 |
08/11/2011 |
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM |
ZIMMER SPINE |
ELSA A LINKE |
| K111594 |
08/17/2011 |
ZOLL E SERIES |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
CHUCK KOLIFRATH |
| K111308 |
08/30/2011 |
ZYTO HAND CRADLE |
ZYTO TECHNOLOGIES, INC |
VAUGHN R COOK |
