| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K100536 |
07/27/2010 |
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE |
3M UNITEK |
NIEDRE M HECKMAN |
| K100647 |
07/09/2010 |
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM |
A-DEC, INC. |
THOMAS H LOUISELL |
| K101434 |
07/22/2010 |
AUDIT MICROCV PROCALCITONIN LINEARITY |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K101648 |
07/08/2010 |
HI-TORQUE WINN GUIDE WIRE FAMILY |
ABBOTT VASCULAR INC. |
LAARNI RICAFORT |
| K093801 |
07/08/2010 |
IMPELLA CONTROLLER |
ABIOMED, INC. |
ROBERT STEWART |
| K102050 |
07/29/2010 |
Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 |
ADVANCED TECHNOLOGY LASER CO., LTD. |
Diana Hong |
| K093024 |
07/15/2010 |
YEAST TRAFFIC LIGHT PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K100121 |
07/13/2010 |
MODEL 300157 CPAP SYSTEM |
AEIOMED, INC. |
DARIN BUSCH |
| K100147 |
07/23/2010 |
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
Lisa Boyle |
| K101281 |
07/30/2010 |
VEGA KNEE SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
KATHY A RACOSKY |
| K100802 |
07/20/2010 |
AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
LISA M BOYLE |
| K100876 |
07/14/2010 |
AESCULAP MONOMAX ABSORBABLE SUTURE |
AESCULAP, INC. |
KATHY A RACOSKY |
| K093493 |
07/27/2010 |
AESCULAP STERILCONTAINER S |
AESCULAP, INC. |
KATHY RACOSKY |
| K100133 |
07/23/2010 |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 |
AIRSTRIP TECHNOLOGIES, LP |
WILLIAM CAMERON POWELL |
| K101206 |
07/23/2010 |
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM |
ALEXANDRIA RESEARCH TECHNOLOGIES, LLC |
MICHAEL LARSON |
| K100051 |
07/06/2010 |
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) |
ALFA SCIENTIFIC DESIGNS, INC. |
NASISHU WANG |
| K100956 |
07/09/2010 |
SPONDY SPINAL FIXATION SYSTEM |
ALLURE SPINE L.L.C. |
JULIA ELLER |
| K101255 |
07/21/2010 |
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM |
ALPHATEC SPINE, INC. |
KARLA SCHAFFNER |
| K101507 |
07/30/2010 |
AMIGO CLASSIC FD |
AMIGO MOBILITY INTL., INC. |
MIKE LABRAKE |
| K101010 |
07/30/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K093262 |
07/13/2010 |
AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD. |
YI LIU |
| K101735 |
07/14/2010 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY |
ANGIOSCORE, INC. |
KIMBERLEY KLINE |
| K091018 |
07/30/2010 |
ARTHREX BIOWIRE |
ARTHREX, INC. |
SALLY FOUST |
| K100925 |
07/12/2010 |
ASCENSION ANKLE FUSION NAIL SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K100909 |
07/23/2010 |
REPROCESSED COMPRESSION SLEEVES |
ASCENT HEALTHCARE SOLUTIONS |
RAMONA KULIK |
| K101087 |
07/16/2010 |
REPROCESSED RESTEP COMPRESSION SLEEVES |
ASCENT HEATLHCARE SOLUTIONS |
AMANDA BOBCOCK |
| K101674 |
07/21/2010 |
WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 |
ATHENA GTX |
SEAN MAHONEY |
| K100640 |
07/22/2010 |
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 |
B. BRAUN MEDICAL, INC. |
MATTHEW HOMA |
| K092328 |
07/26/2010 |
MED-SEG, MODEL BTMS 1000 |
BARTRON MEDICAL IMAGING, INC. |
ZVI LADIN |
| K100958 |
07/23/2010 |
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES |
BAXANO, INC. |
EDWARD J SINCLAIR |
| K101117 |
07/16/2010 |
LEV-OR DILATION CATHETER OTW |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K101615 |
07/28/2010 |
POWERWIRE RADIOFREQUENCY GUIDEWIRE |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K101514 |
07/09/2010 |
BD DIRECTIGEN EZ RSV |
BECTON DICKINSON & CO. |
Gregory P Payne |
| K100740 |
07/09/2010 |
MD2000B VITAL SIGN MONITOR, MODEL MD2000B |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
DIANA HONG |
| K101102 |
07/16/2010 |
POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE |
BEST PUTRA GLOVES SDN BHD |
EFFENDI TENANG |
| K101103 |
07/16/2010 |
POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1 |
BEST PUTRA GLOVES SDN BHD |
EFFENDI TENANG |
| K093342 |
07/29/2010 |
BIOGENNIX RPC |
BIOGENNIX, LLC |
EDWIN C SHORS |
| K093383 |
07/06/2010 |
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG |
BIOMERIEUX, INC. |
MARIA OYASKI |
| K100805 |
07/20/2010 |
GALLERY LAMINOPLASTY FIXATION SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
SHIKHA GOLA |
| K101669 |
07/01/2010 |
THERMODILUTION CATHETER |
BIOSENSORS INTL. PTE. LTD. |
MOSES THAM |
| K101776 |
07/23/2010 |
SCOUTPRO ACS |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K101282 |
07/21/2010 |
SCOUTPRO HEMOSTATIC VALVE |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K093926 |
07/28/2010 |
FIREBIRD SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
RUSSELL JOHNSON |
| K101314 |
07/23/2010 |
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORP. |
ELENA NIEVES |
| K101786 |
07/23/2010 |
ADVANIX DOUBLE PIGTAIL BILIARY STENT |
BOSTON SCIENTIFIC CORP. |
ELENA NIEVES |
| K100038 |
07/14/2010 |
DISPOSABLE REFLECTIVE MARKER SPHERES |
BRAINLAB, AG |
ALEXANDER SCHWIERSCH |
| K101261 |
07/29/2010 |
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 |
C.R. BARD, INC. |
Mark Nelson |
| K101703 |
07/13/2010 |
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CLAY ANESELMO |
| K101032 |
07/08/2010 |
CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX |
CARDO MEDICAL, INC |
MICHAEL KVITNITSKY |
| K100253 |
07/08/2010 |
VISUMAX LASER KERATOME |
CARL ZEISS MEDITEC AG |
JUDITH A BRIMACOMBE |
| K101879 |
07/28/2010 |
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 |
CEPHEID |
RUSSEL K ENNS, PH.D. |
| K101043 |
07/21/2010 |
ECT DIGITAL THERMOMETER |
CHANGSHAN ESTAR ELECTRONICS CO., LTD. |
JACOB CHANG |
| K101487 |
07/02/2010 |
CHEETAH NICOM SYSTEM |
CHEETAH MEDICAL INC. |
Rhona Shanker |
| K101276 |
07/28/2010 |
DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 |
CHEMENCE MEDICAL PRODUCTS INC. |
PATRICIA LEHMAN |
| K101411 |
07/12/2010 |
SAVI PREPARATION DEVICE |
CIANNA MEDICAL, INC. |
GARY MOCNIK |
| K093981 |
07/22/2010 |
YRNSORTIP OXIMANOMETER |
Cnoga Medical LTD |
TALI HAZAN |
| K100360 |
07/13/2010 |
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT |
COCHLEAR AMERICAS |
SEAN BUNDY |
| K101651 |
07/09/2010 |
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE |
CORDIS CORP. |
JOAN MARTIN |
| K100511 |
07/09/2010 |
COTEC DENTAL IMPLANT SYSTEM |
COTEC IMPLANT CO., LTD. |
JOYCE BANG |
| K101866 |
07/23/2010 |
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH |
CRYOLIFE, INC. |
JOHN D FERROS |
| K101851 |
07/15/2010 |
VENTRALIGHT ST MESH |
DAVOL INC., SUB. C.R. BARD, INC. |
MICHELLE GODIN |
| K101140 |
07/15/2010 |
DENTLIGHT ORAL EXAM LIGHT KIT |
DENTLIGHT INC. |
RICHARD LIU |
| K101240 |
07/23/2010 |
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K100247 |
07/23/2010 |
DETAX IMPLANTLINK SEMI |
DETAX GMBH & CO. KG |
DAGMAR MAESER |
| K100765 |
07/19/2010 |
FIXPINE II SYSTEM |
DIO MEDICAL CO., LTD. |
JOYCE BANG |
| K100595 |
07/09/2010 |
ECLERIS MICROSTAR COLPOSCOPE |
Ecleris USA |
RAYMOND J KELLY IV |
| K093877 |
07/01/2010 |
RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 |
EDWARDS LIFESCIENCES, LLC. |
JASON K LYON |
| K093000 |
07/30/2010 |
EMS PIEZON MASTER 700 |
EMS ELECTRO MEDICAL SYSTEMS SA |
CYNTHIA J.M NOLTE |
| K101457 |
07/01/2010 |
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K101108 |
07/16/2010 |
ERBE ESU MODEL VIO 100 C WITH ACCESSORIES |
ERBE USA, INC. |
JOHN TARTAL |
| K101557 |
07/01/2010 |
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN |
ETEX CORP. |
CHRISTOPHER KLACZYK |
| K100936 |
07/01/2010 |
GYNECARE TVT ABBREVO CONTINENCE SYSTEM |
ETHICON, INC. |
SUSAN LIN |
| K092860 |
07/16/2010 |
LASEMAR 800, 1000, 1500 |
EUFOTON S.R.L. |
PAOLO COSSICH |
| K083418 |
07/22/2010 |
CPR MASK |
FIRSTAR HEALTHCARE CO., LTD. |
YOVETTE MUMFORD |
| K101662 |
07/26/2010 |
SYNAPSE 3D BASIC TOOLS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOCK |
| K100762 |
07/15/2010 |
FLAT PANEL DETECTOR, MODEL FDR D-EVO |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
DEBBIE PEACOCK |
| K092853 |
07/09/2010 |
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM |
GALIX BIOMEDICAL INSTRUMENTATION, INC. |
YOEL PALOMINO |
| K093608 |
07/29/2010 |
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K101855 |
07/23/2010 |
PROFAST+ ASSAY |
GEN-PROBE PRODESSE, INC |
KAREN HARRINGTON |
| K093903 |
07/15/2010 |
ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC |
Genesee BioMedical, Inc. |
JOHN T.M. WRIGHT |
| K100757 |
07/01/2010 |
TILOCK PEDICLE SCREW SYSTEM |
GENESYS SPINE |
JOSH KAUFMANN |
| K093189 |
07/02/2010 |
ACTIPROTECT UC N95 RESPIRATOR |
GLAXOSMITHKLINE CONSUMER HEALTHCARE |
ZINATARA MANJI |
| K101629 |
07/09/2010 |
FIL 1520 |
GLENN MEDICAL SYSTEMS, INC. |
GARY CLEVINGER |
| K100411 |
07/28/2010 |
VARIOUS DENTAL IMPLANTS |
GRUNDY ADVANCED BIOMEDICAL SYSTEMS LLC |
WILLIAM SIMMONS |
| K093910 |
07/12/2010 |
IMPROVACUTER GEL & CLOT ACTIVATOR TUBE |
GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. |
Diana Hong |
| K100816 |
07/01/2010 |
PK SUPERPULSE SYSEM GENERATOR MODEL 744000 |
GYRUS ACMI, INC. |
GRAHAM A.L. BAILLIE |
| K093179 |
07/14/2010 |
MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) |
H&H RESEARCH COMPANY |
JONG HUANG |
| K100620 |
07/02/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 |
HARVARD MEDICAL DEVICES LTD. |
MARTIN MA |
| K100531 |
07/21/2010 |
VISCOPE, MODEL 100P,100S |
HD MEDICAL SERVICES (INDIA) PVT.LTD |
BILL MURPHY |
| K101663 |
07/27/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
HEBEI EXCELLENT PLASTIC CO., LTD. |
CHU XIAOAN |
| K101664 |
07/27/2010 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
HEBEI EXCELLENT PLASTIC CO., LTD. |
CHU XIAOAN |
| K100964 |
07/16/2010 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT |
CHU XIAOAN |
| K100234 |
07/08/2010 |
HM-LAMP II |
HILLUSA, INC. |
MARIA GUMA |
| K101132 |
07/01/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK) |
HONG DI PLASTIC PRODUCTS CO., LTD. |
JIE LIU |
| K101135 |
07/01/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK) |
HONGZE PLASTIC TECHNOLOGY CO., LTD |
KATHY LIU |
| K100840 |
07/12/2010 |
EMBO PLUS EMBOLECTOMY CATHETER |
HOTSPUR TECHNOLOGIES |
Eric Ankerud |
| K101047 |
07/13/2010 |
PTA-DUO PTA BALLOON CATHETER |
HOTSPUR TECHNOLOGIES |
ERIC P ANKERUD |
| K100842 |
07/12/2010 |
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM |
HOTSPUR TECHNOLOGIES |
Eric Ankerud |
| K100702 |
07/20/2010 |
STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS |
HUOT INSTRUMENTS, LLC |
ANNE WARD |
| K100434 |
07/09/2010 |
CLAVE NEUTRON |
ICU MEDICAL, INC. |
TRACY BEST |
| K101796 |
07/15/2010 |
PACSMATE MMD-5201M MONITOR |
IEI TECHNOLOGY CORP. |
HUI-CHEN KAI |
| K092261 |
07/23/2010 |
DEFCON TSA/TSH DENTAL IMPLANT SYSTEM |
IMPLADENT, S.L. |
JOSE-RAMON GUTIERREZ |
| K100031 |
07/19/2010 |
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 |
IND DIAGNOSTIC INC. |
JASON PENG |
| K101833 |
07/23/2010 |
INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 |
INFIMED, INC. |
JIGAR SHAH |
| K101386 |
07/30/2010 |
VIGILANT EEG MONITOR MODEL VIGILANT 2.0 |
INFINITE BIOMEDICAL TECHNOLOGIES, LLC |
MANAN HATHI |
| K101857 |
07/22/2010 |
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V |
INSTRUMENTATION INDUSTRIES, INC. |
DORIS F WALTER |
| K101685 |
07/01/2010 |
IP-SET |
INTEGRAL PROCESS SAS |
CHRISTIAN BERTHON |
| K100441 |
07/15/2010 |
XINIWAVE, MODEL XW-18 |
INTERNATIONAL TRADE GROUP, INC. |
BRENT C REIDER |
| K092306 |
07/09/2010 |
SECURACATH UNIVERSAL |
INTERRAD MEDICAL, INC. |
JONATHAN KAHAN |
| K100766 |
07/21/2010 |
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN B REISS |
| K100979 |
07/02/2010 |
NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE |
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD |
MICHAEL LEE |
| K101232 |
07/21/2010 |
JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001 |
JOINSOON ELECTRONICS MFG CO LTD |
JIGAR SHAH |
| K101322 |
07/28/2010 |
JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 |
JOINSOON ELECTRONICS MFG CO LTD |
JIGAR SHAH |
| K101302 |
07/22/2010 |
ALEUTIAN IBF SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K101022 |
07/09/2010 |
PULMOTRACK 5050 WHOLTER, MODEL 5050 |
KARMELSONIX |
YORAM LEVY |
| K093473 |
07/02/2010 |
KMD-MARK1 TISSUE MARKER |
KENT MEDICAL DEVICES, INC. |
JUSTIN EGGLETON |
| K101423 |
07/30/2010 |
OPTIBOND XTR |
KERR CORPORATION |
Wendy Garman |
| K101596 |
07/21/2010 |
KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- |
KIMBERLY-CLARK |
LESTER F PADILLA |
| K100706 |
07/22/2010 |
VENUS BASIC SPINAL FIXATION SYSTEM |
L & K BIOMED CO., LTD |
HEE KYEONG JOO |
| K101190 |
07/01/2010 |
LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC |
LED INTELLECTUAL PROPERTIES, LLC |
ROBERT T WAGNER |
| K101195 |
07/06/2010 |
6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K093266 |
07/27/2010 |
MAM COOLER |
MAM INTERNATIONAL AG |
MICHAEL TEDESCO |
| K102002 |
07/28/2010 |
TALYMED |
MARINE POLYMER TECHNOLOGIES |
SERGIO FINKIELSZTEIN |
| K100428 |
07/09/2010 |
MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K101214 |
07/23/2010 |
GUARDIAN CONNECTION |
MAULIN MEDICAL LLC |
SARA OWENS |
| K100544 |
07/22/2010 |
IMPIX LUMBAR INTERBODY DEVICE |
MEDICREA TECHNOLOGIES |
JD WEBB |
| K100543 |
07/23/2010 |
MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 |
MEDISISS |
BRANDI JAMES |
| K101455 |
07/19/2010 |
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
| K101829 |
07/16/2010 |
THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
| K101092 |
07/16/2010 |
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 |
MEDIVANCE, INC. |
LYNNE ARONSON |
| K100302 |
07/02/2010 |
MEDLINE PVC URETHRAL CATHETER |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K100432 |
07/09/2010 |
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS |
MEDTRONIC MINIMED |
MARK FAILLACE |
| K101777 |
07/23/2010 |
PIONEER PLUS CATHETER, MODEL PLUS 120 |
MEDTRONIC VASCULAR |
LUCINDA L FOX |
| K090950 |
07/02/2010 |
BONE PLUS BCP |
MEGAGEN IMPLANT CO., LTD |
JOYCE BANG |
| K100414 |
07/02/2010 |
PROTOE ENDOSORB SMALL HAMMER TOE PIN |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K100818 |
07/09/2010 |
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 |
MERIDIAN BIOSCIENCE, INC. |
Michelle L Smith |
| K092859 |
07/02/2010 |
MERITS MODEL N SERIES NEBULIZER COMPRESSORS |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K101570 |
07/13/2010 |
HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS |
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
LAURIE CARTWRIGHT |
| K101512 |
07/01/2010 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4). |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN GOLDSTEIN-FALK |
| K101826 |
07/28/2010 |
HYDROFIX VASO SHIELD, MODEL HVS-001-0610 |
MIMEDX GROUP, INC |
SALLY THORSEN |
| K101101 |
07/23/2010 |
MINI-TONG |
MINI LAP TECHNOLOGIES INC. |
JOSEPH AZARY |
| K101403 |
07/02/2010 |
ELI 250 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
CHIEN HUI (AMY) YANG |
| K101252 |
07/15/2010 |
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 |
NEOTRACT, INC. |
KEVIN MACDONALD |
| K101580 |
07/01/2010 |
NEV'S INK AUTOCLAVE TAPES |
NEV'S INK, INC |
DAVE MAROSE |
| K092573 |
07/09/2010 |
NIHON KOHDEN QP-160AK EEG TREND PROGRAM |
NIHON KOHDEN AMERICA, INC. |
STEVE GEERDES |
| K090661 |
07/21/2010 |
NES REPROCESSED VARICOSE VEIN RF CATHETER |
Northeast Scientific, Inc. |
CRAIG ALLMENDINGER |
| K101711 |
07/01/2010 |
CERULEAU ELECTROSURGICAL PROBE |
NUORTHO SURGICAL, INC |
MARTIN J LEIGHTON |
| K101284 |
07/15/2010 |
FACET SCREW SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K101778 |
07/21/2010 |
GIRAFFE INCUBATOR |
OHMEDA MEDICAL |
AGATA SMIEJA |
| K101788 |
07/21/2010 |
GIRAFFE OMNIBED |
OHMEDA MEDICAL |
AGATA SMIEJA |
| K101804 |
07/21/2010 |
GIRAFFE AND PANDA WARMERS |
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., |
AGATA SMIEJA |
| K100584 |
07/02/2010 |
EVIS EXERAII 180 SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY A KLUESNER |
| K101053 |
07/14/2010 |
OLYMPUS CF TYPE Y0023-L, Y0023I |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY A KLUESNER |
| K100275 |
07/01/2010 |
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS |
OLYMPUS WINTER & IBE GMBH |
STACY KLUESNER |
| K101059 |
07/12/2010 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE |
OMEGA LABORATORIES, INC. |
ROBERT J BARD |
| K100644 |
07/15/2010 |
OPTOS LIMITED PANORAMIC 200CAF |
OPTOS PLC |
HOWARD M HOLSTEIN |
| K092399 |
07/01/2010 |
ANTI-MUTATED CITRULLINATED VIMENTIN EIA |
ORGENTEC DIAGNOSTIKA GMBH |
Gary Lehnus |
| K092981 |
07/22/2010 |
PANPAC VAGINAL PESSARY |
Panpac Medical Corporation |
Yen-Ming Pan |
| K092982 |
07/26/2010 |
THE PANPAC SUCTION CURETTE |
Panpac Medical Corporation |
Yen-Ming Pan |
| K101083 |
07/02/2010 |
DSS STABILIZATION SYSTEM |
PARADIGM SPINE LLC |
MICHELLE MCDONOUGH |
| K101295 |
07/28/2010 |
MROPEN |
PARAMED SRL |
RICHARD R GLASHEEN |
| K100661 |
07/01/2010 |
EARPROBE |
PATH MEDICAL GMBH |
KURT RENTEL |
| K100826 |
07/13/2010 |
PENUMBRA CATHERER 025 |
PENUMBRA, INC. |
SETH A SCHULMAN |
| K101474 |
07/02/2010 |
MD VISION SYSTEM |
PERKINS HEALTHCARE TECHNOLOGIES |
ANDREW C KYLE |
| K101521 |
07/29/2010 |
ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O |
PHILIPS MEDICAL SYSTEMS |
LOIS GIEGERICH |
| K100420 |
07/26/2010 |
PHILIPS OBTRACEVUE MODEL SW REV. G.00 |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
MICHAEL ASMALSKY |
| K100817 |
07/01/2010 |
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG, PH.D. |
| K101076 |
07/27/2010 |
PROWESS PANTHER PROARC, MODEL VERSION 5.0 |
PROWESS, INC. |
RACHEL SCARANO |
| K101293 |
07/01/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) |
PT. SMART GLOVE INDONESIA |
CHO S FONG |
| K100813 |
07/23/2010 |
QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB |
PULSE BIOMEDICAL, INC. |
SALEEM HASAN |
| K100558 |
07/22/2010 |
QUANTA DIODE LASER SYSTEM |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K100678 |
07/21/2010 |
SUPRA SCAN DELIVERY SYSTEM |
QUANTEL MEDICAL |
PATRICK QUERO |
| K101172 |
07/27/2010 |
RDT3 HANDPIECE HEAD MODEL RDT3 |
REDENT NOVA LTD |
JONATHAN S KAHAN |
| K093964 |
07/09/2010 |
VENOFER PUMP |
RENAL SOLUTIONS INC. |
DAVID VANELLA |
| K100461 |
07/08/2010 |
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT |
RIVERPOINT MEDICAL |
DOUG ROWLEY |
| K100611 |
07/16/2010 |
RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) |
RIVERSTONE RESOURCES SDN. BHD. |
CHONG CHU MEE |
| K100603 |
07/16/2010 |
RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) |
RIVERSTONE RESOURCES SDN. BHD. |
CHONG CHU MEE |
| K093664 |
07/28/2010 |
AMPHETAMINES II ASSAY |
ROCHE DIAGNOSTICS CORP. |
MICHELLE L NEFF |
| K091409 |
07/06/2010 |
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 |
ROCHE MOLECULAR SYSTEMS, INC. |
LARRY PIETRELLI |
| K093775 |
07/15/2010 |
EVGUIDE TIP LOCATION SYSTEM |
ROMEDEX INTERNATIONAL SRL |
SORIN GRUNWALD |
| K093489 |
07/29/2010 |
IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY |
RYMED TECHNOLOGIES, INC. |
JOSEPH AZARY |
| K082573 |
07/21/2010 |
SARGON NON-EXPANDABLE DENTAL IMPLANT |
SARGON ENT., INC. |
DANIEL J MANELLI |
| K092813 |
07/16/2010 |
ASTRASONIC SPIROMETER, MODEL 29-8000 |
SDI DIAGNOSTICS, INC. |
COSIMO CARIOLO |
| K100439 |
07/16/2010 |
MEDIWORKS SLIT LAMP |
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. |
LISA ZHANG |
| K101949 |
07/28/2010 |
PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
JIE HUANG |
| K101858 |
07/14/2010 |
PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
JIE HUANG |
| K100488 |
07/22/2010 |
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
ZHIGANG ZHAO |
| K101736 |
07/06/2010 |
NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED |
SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD. |
DENG AIGUO |
| K101840 |
07/16/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHIJIAZHUANG SAIL PLASTIC CO., LTD. |
CHU XIAOAN |
| K101841 |
07/16/2010 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHIJIAZHUANG SAIL PLASTIC CO., LTD. |
CHU XIAOAN |
| K101343 |
07/16/2010 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG STAR PLASTIC CO., LTD |
CHU XIAOAN |
| K100907 |
07/09/2010 |
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL |
SIAM SEMPERMED CORP. LTD. |
WILLIAM HARRIS |
| K090346 |
07/28/2010 |
ADVIA 2120/2120I BODY FLUIDS |
SIEMENS HEALTHCARE DIAGNOSTICS |
Ernest Joseph |
| K101460 |
07/09/2010 |
LOCI 8 CALIBRATOR, MODEL KC 646 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA MARIE ENNIS |
| K101060 |
07/08/2010 |
SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM |
SIESTA MEDICAL, INC. |
MICHAEL KOLBER |
| K093648 |
07/14/2010 |
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION |
SIMPLISSE INC. |
Glen Feye |
| K100986 |
07/20/2010 |
CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION |
SKELETAL KINETICS, LLC |
CHRISTINE KUO |
| K101191 |
07/27/2010 |
NAVIAID ICVI DEVICE |
SMART MEDICAL SYSTEMS, LTD. |
ADVA YOSELZON |
| K100481 |
07/15/2010 |
SMITH & NEPHEW MDF MODULAR SLEEVE |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
| K101972 |
07/22/2010 |
SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS |
SOLARIS MEDICAL TECHNOLOGY, INC. |
RACHEL CHENG |
| K092329 |
07/20/2010 |
SOPIX 2 |
SOPRO |
RICK ROSATI |
| K101085 |
07/01/2010 |
SPINESMITH CYNCH SPINAL SYSTEM |
SPINE SMITH PARTNERS L.P. |
LAURA LEBOEUF |
| K101720 |
07/16/2010 |
JULIET OL |
SPINEART |
FRANCK PENNESI |
| K101678 |
07/28/2010 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
| K101328 |
07/14/2010 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K101667 |
07/02/2010 |
ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K101144 |
07/08/2010 |
MODIFICATION TO:RADIUS SPINAL SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K100109 |
07/15/2010 |
LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE |
SURGICAL INNOVATIONS PLC |
MIKE WHITE |
| K100634 |
07/01/2010 |
SYNTHES MATRIX SYSTEM |
SYNTHES (USA) |
AMNON TALMOR |
| K093724 |
07/29/2010 |
FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K100732 |
07/09/2010 |
FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 |
TaiDoc Technology Corporation |
NICKY PAN |
| K100405 |
07/09/2010 |
FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
NICKY PAN |
| K100658 |
07/09/2010 |
U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
NICKY PAN |
| K100057 |
07/08/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
TANGSHAN KANGYUAN GLOVE CO., LTD. |
CHU XIAOAN |
| K100059 |
07/01/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) |
TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K101576 |
07/22/2010 |
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES |
TEAM INNOVATIONS, INC |
MARK TIEGS |
| K101254 |
07/15/2010 |
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM |
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
ROBERT J BARD, JD |
| K102008 |
07/21/2010 |
GLIDESHEATH |
TERUMO MEDICAL CORP. |
DANIEL R PLONSKI |
| K093497 |
07/15/2010 |
THD BANDY |
THD SPA |
GUIDO BONAPACE |
| K101705 |
07/02/2010 |
MISTRAL-AIR WARMING SYSTEM |
THE SURGICAL COMPANY INTERNATIONAL BV |
ADRIAAN P INTVELD |
| K101415 |
07/08/2010 |
THERACLEAR |
THERAVANT CORPORATION |
Marcy Moore |
| K091939 |
07/23/2010 |
THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 |
THERMEDX, LLC |
JEFF B WILLIAMS |
| K092819 |
07/15/2010 |
REMEL SPECTRA VRE |
Thermo Fisher Scientific |
MARY ANN SILVIUS |
| K100889 |
07/29/2010 |
ENDOSKELETON TC |
TITAN SPINE, LLC |
JOHN J SMITH |
| K092713 |
07/16/2010 |
SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM |
TRANSAMERICAN MEDICAL IMAGING |
ROBERT H WOODWARD |
| K100287 |
07/06/2010 |
JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 |
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND |
ROBERT E MILLER |
| K100752 |
07/16/2010 |
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K101146 |
07/16/2010 |
WATER BOTTLE CAP SYSTEM |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K100890 |
07/13/2010 |
VARIAN HIGH ENERGY LINEAR ACCELERATOR |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K093967 |
07/12/2010 |
VARIAN TREATMENT |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K101625 |
07/19/2010 |
COHEN CROSSOVER CATHETER |
VASCULAR SOLUTIONS, INC. |
JENNIFER RUETHER |
| K092830 |
07/21/2010 |
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 |
VATECH CO., LTD. |
VINCENT LEE |
| K100950 |
07/13/2010 |
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE |
VENNER MEDICAL (SINGAPORE) PTE LTD |
JUDY BURTON |
| K101026 |
07/27/2010 |
POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K100600 |
07/09/2010 |
PROSTHODONTIC SCREWDRIVER , MODEL IA-400 |
W & H DENTALWERK BUERMOOS GMBH |
JOHANN G SCHARL |
| K100682 |
07/23/2010 |
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U |
WALLAC OY |
KAY TAYLOR |
| K101680 |
07/09/2010 |
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES |
WELCH ALLYN, INC. |
HUY DOAN |
| K100066 |
07/15/2010 |
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 |
WELLDOC, INC |
MALINDA PEEPLES |
| K101095 |
07/19/2010 |
DIRECT PERORAL CHOLANGIOSCOPY BALLOON |
WILSON-COOK MEDICAL, INC. |
SCOTTIE FARIOLE |
| K101109 |
07/15/2010 |
VIVATRAK |
WIRELESS MEDCARE, LLC |
PAUL SUMNER |
| K101165 |
07/23/2010 |
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| K100984 |
07/07/2010 |
XYLOS VESSEL GUARD |
XYLOS CORPORATION |
JOYCE ELKINS |
| K100728 |
07/06/2010 |
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K093784 |
07/16/2010 |
ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K101296 |
07/30/2010 |
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS |
ZIMMER, INC. |
CHRISTINA FORNEY |
| K100654 |
07/29/2010 |
ZOLL PROPAQ MD |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
PAUL DIAS |
| K100705 |
07/08/2010 |
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 |
ZYNO MEDICAL LLC |
CHAOYOUNG LEE |
