| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K101226 |
08/31/2010 |
AUDIT MICROCV RF/CRP LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K093604 |
08/25/2010 |
ETEST MOXIFLOXACIN 0.002-32 UG/ML |
AB BIOMERIEUX |
ASA KARLSSON |
| K101038 |
08/17/2010 |
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER |
ACCELETRONICS DIGITAL IMAGING, LLC. |
STEVE SCHWARZ |
| K101150 |
08/13/2010 |
PICC WAND PEELABLE SAFETY INTRODUCER |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
| K093879 |
08/06/2010 |
MISSION SALIVA ALCOHOL TEST STRIP |
ACON LABORATORIES, INC. |
RICHARD LENART |
| K101717 |
08/20/2010 |
DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING |
AEROBINE, INC |
YONG W KIM |
| K091692 |
08/12/2010 |
AESCULAP PEEK CRANIOFIX |
AESCULAP, INC. |
LISA M BOYLE |
| K102081 |
08/06/2010 |
ENDOSCOPIC CLIP SYSTEM |
AESCULAP, INC. |
DENISE ADAMS |
| K101937 |
08/11/2010 |
HYBRID TROCAR SYSTEM |
AESCULAP, INC. |
DENISE ADAMS |
| K101289 |
08/03/2010 |
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB |
AIR TECHNIQUES, INC. |
PABLO MARTINEZ |
| K093821 |
08/27/2010 |
FS ALIGNER |
ALLESEE ORTHODONTIC APPLIANCES |
Wendy Garman |
| K101561 |
08/27/2010 |
TX1 TISSUE REMOVAL SYSTEM |
AMERICAN OPTISURGICAL, INC. |
DAVID SALZBERG |
| K101950 |
08/31/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K102037 |
08/13/2010 |
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS |
APEX BIOTECHNOLOGY CORP. |
HSUE-MEI LEE |
| K094043 |
08/17/2010 |
LIGAMENTOTAXOR |
AREX USA |
ELLEN HOKANSON |
| K093999 |
08/10/2010 |
ARP POV SPORT |
ARP MANUFACTURING, INC |
LEWIS WARD |
| K100635 |
08/27/2010 |
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 |
ARROW INTL., INC. |
TRACY MADDOCK |
| K100448 |
08/30/2010 |
ASCENSION MODULAR TOTAL SHOULDER SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
STANLEY J HARRIS |
| K100502 |
08/02/2010 |
ASCENSION TOTAL PLATE SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K101004 |
08/16/2010 |
ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT |
ASTRA TECH, INC. |
BETSY A BROWN |
| K100743 |
08/10/2010 |
ATLAS SPINE PIVOTING SYSTEM |
ATLAS SPINE INC. |
JEANNETTE G DAILEY |
| K101647 |
08/06/2010 |
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 |
AVINGER, INC. |
HIMANSHU PATEL |
| K102022 |
08/06/2010 |
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S |
AVINGER, INC. |
HIMANSHU PATEL |
| K101325 |
08/17/2010 |
STELLARIS PC VISION ENHANCEMENT SYSTEM |
BAUSCH & LOMB, INC. |
NED LUCE |
| K101372 |
08/10/2010 |
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K092767 |
08/20/2010 |
BBL CHROMAGAR MRSA II |
BECTON DICKINSON & CO. |
Paul Swift |
| K100622 |
08/27/2010 |
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 |
BELIMED SAUTER AG |
HANS STADLER |
| K101122 |
08/09/2010 |
BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS |
BENZ RESEARCH AND DEVELOPMENT CORP. |
GIOVANNY ESPINOSA |
| K101595 |
08/06/2010 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE |
BETTER CARE PLASTIC TECHNOLOGY CP., LTD |
JIE LIU |
| K100556 |
08/02/2010 |
SLENDERTONE FLEX MAX, MODEL 517 US |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K093954 |
08/24/2010 |
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
Bio-Rad Laboratories |
Juang Wang |
| K091303 |
08/02/2010 |
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV |
Bio-Rad Laboratories |
SUZANNE S PARSONS |
| K101658 |
08/11/2010 |
WATERLASE MD TURBO PLUS MODEL 7200XXX |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOIU |
| K101485 |
08/26/2010 |
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E |
BISCO, INC. |
MICHELLE SCHULTZ- TAING |
| K101875 |
08/23/2010 |
BK BLANK MODEL 20,40,65,90 |
BK MEDENT CO., LTD. |
Priscilla Chung |
| K102082 |
08/23/2010 |
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 |
BOSTON SCIENTIFIC CORP. |
LAURIE PANNELLA |
| K100843 |
08/17/2010 |
ABREU, MODEL 700 |
BRAIN TUNNELGENIX TECHNOLOGIES CORP |
DANIEL KAMM |
| K101591 |
08/06/2010 |
STINGRAY ORIENTING BALLOON CATHETER |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
| K100786 |
08/13/2010 |
MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX |
BSD MEDICAL CORP. |
DIXIE TOOLSON SELLS |
| K093920 |
08/06/2010 |
BUSSE EPIDURAL CATHETER KIT |
BUSSE HOSPITAL DISPOSABLES |
MUHAMAD ANSARI |
| K101462 |
08/16/2010 |
ASCEND BLUE AC MESH; ASCEND BLUE PC MESH |
CALDERA MEDICAL, INC. |
VICKI GAIL |
| K093725 |
08/30/2010 |
CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C |
CANADA ENDOSCOPE CORPORATION |
ROGER LECLERC |
| K102012 |
08/17/2010 |
DIGITAL RADIOGRAPHY |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
KOJI KUBO |
| K100143 |
08/13/2010 |
PILOT DIODE LASER, MODEL 002-00139 |
CAO GROUP, INC. |
ROBERT LARSEN |
| K101452 |
08/09/2010 |
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW |
CAPINTEC, INC. |
MARY ANNE DELL |
| K100055 |
08/30/2010 |
BLOOD PRESSURE METER, MODEL CH-609 |
CITIZEN SYSTEMS JAPAN CO., LTD. |
NATHAN A BEAVER |
| K101361 |
08/04/2010 |
REEFLEX PTA CATHETER |
CLEARSTREAM TECHNOLOGIES, LTD. |
FIONA N MHULLAIN |
| K100156 |
08/11/2010 |
COLLAGEN DENTAL MEMBRANE V |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K102025 |
08/11/2010 |
COMBAT READY CLAMP |
COMBAT MEDICAL SYSTEMS, LLC |
Calley Herzog |
| K101915 |
08/06/2010 |
VASOPRESS SUPREME MINI MODEL VP500DM |
COMPRESSION THERAPY CONCEPTS, INC. |
LEONARD NASS |
| K101198 |
08/04/2010 |
CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K |
COMPUTERIZED SCREENING, INC. |
SAM KUMAR |
| K101100 |
08/26/2010 |
CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 |
CONMED LINVATEC |
JOHN CUSACK |
| K100879 |
08/04/2010 |
CONTRALCO |
CONTRALCO |
CAMILLE D THORNTON |
| K101728 |
08/25/2010 |
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE |
COOK, INC. |
SEAN WERNER |
| K101877 |
08/06/2010 |
OCCLUSION BALLOON CATHETER MODEL OBC |
COOK, INC. |
LISA WEBB |
| K100841 |
08/19/2010 |
BONEOPTIMIZER |
CURASAN AG |
CYNTHIA J.M. NOLTE, PH.D. |
| K102169 |
08/30/2010 |
CYBERWAND LITHOTRIPTER |
CYBERSONICS, INC. |
JEFF VAITEKUNAS |
| K101719 |
08/25/2010 |
TACAMO MANUAL WHEELCHAIR |
DALTON INSTRUMENT CORP. |
MEI LEIN |
| K101493 |
08/19/2010 |
ADVANCED GLASS IONOMER (K-130) RESTORATIVE |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K091310 |
08/11/2010 |
ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 |
DFINE, INC. |
SANDEEP SABOO |
| K092937 |
08/02/2010 |
STA-HYBRID HEP CALIBRATOR |
DIAGNOSTICA STAGO, INC. |
UMBERTO V PARROTTA |
| K092029 |
08/06/2010 |
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 |
DRAEGER MEDICAL AG & CO. KG |
JOYCE KILROY |
| K100749 |
08/31/2010 |
FREQUENCER MODEL V2X |
DYMEDSO INC. |
Jean Bigoney |
| K091090 |
08/09/2010 |
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 |
E-WOO TECHNOLOGY |
VINCENT LEE |
| K100376 |
08/06/2010 |
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K101960 |
08/10/2010 |
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER |
EDAN INSTRUMENTS, INC. |
YUE QIUHONG |
| K100988 |
08/17/2010 |
HUMAPEN LUXURA HD |
ELI LILLY AND COMPANY |
STEVEN T JOHNSON PE, MBA |
| K100390 |
08/25/2010 |
SURGIMAX/ SURGIMAX PLUS |
ELLIQUENCE LLC |
JOSEPH AZARY |
| K101967 |
08/12/2010 |
NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' |
ELLMAN INT'L INC. |
JONATHAN ACHENBACH |
| K093622 |
08/20/2010 |
AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 |
ENCISION, INC. |
JUDITH V KING |
| K100741 |
08/02/2010 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K101298 |
08/05/2010 |
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS |
ENDOCHOICE, INC. |
THERON GOBER |
| K092991 |
08/13/2010 |
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) |
ENVIRONMENTAL TECTONICS CORP. |
GENE DAVIS |
| DEN090008 |
08/24/2010 |
ERCHONIA ML SCANNER (MLS) |
ERCHONIA MEDICAL |
Kevin Walls |
| K101605 |
08/31/2010 |
MYLABONE ULTRASOUND SYSTEM |
ESAOTE EUROPE B.V. |
Allison Scott |
| K101272 |
08/20/2010 |
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 |
ESSEX INDUSTRIES, INC. |
KEN SEISE |
| K101909 |
08/02/2010 |
EXACTECH EQUINOXE, PLATFORM FRACTURE STEM |
EXACTECH, INC. |
GRAHAM L CUTHBERT |
| K101981 |
08/02/2010 |
OPTETRAK LOGIC COMBINATION TIBIAL TRAY |
EXACTECH, INC. |
PATRICK HUGHES |
| K102167 |
08/17/2010 |
LO-50 LED LIGHT SOURCE |
FIBEROPTICS TECHNOLOGY, INC. |
ALLAN GUILLOTTE |
| K100753 |
08/20/2010 |
FLIGHT 60 VENTILATOR, MODEL F-60 |
FLIGHT MEDICAL LTD. |
SHOSHANA FRIEDMAN |
| K101152 |
08/18/2010 |
NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 |
FOCUS MEDICAL, LLC. |
JOHN LEE |
| K102149 |
08/13/2010 |
GAUNYING INFRARED LAMP |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
LADI LEE |
| K101387 |
08/03/2010 |
DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN |
FUDAKANG INDUSTRIES CO., LTD |
STEPHEN LING |
| K101878 |
08/31/2010 |
GE LOGIQ P5 MODEL H44662LD |
GE HEALTHCARE |
BRYAN BEHN |
| K102113 |
08/12/2010 |
GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
YALAN WU |
| K102155 |
08/31/2010 |
MR RADIATION ONCOLOGY OPTIONS |
GE MEDICAL SYSTEMS, LLC |
TRACEY FOX |
| K093175 |
08/25/2010 |
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 |
| K100551 |
08/12/2010 |
ORLOCATE SYSTEM MODEL ORL 100 |
HALDOR ADVANCED TECHNOLOGIES LTD |
SARIT GELBART GAL-ROM |
| K100389 |
08/12/2010 |
HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT |
HANDPIECE HEADQUARTERS |
TINA STEFFAINE-OAK |
| K101329 |
08/19/2010 |
SYNERGY CT PICC |
HEALTH LINE INTERNATIONAL CORPORATION |
NOLA BENSTOG |
| K101358 |
08/24/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K100963 |
08/06/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT |
CHU XIAOAN |
| K101892 |
08/27/2010 |
HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- |
HEINE OPTOTECHNIK GMBH & CO. KG. |
THOMAS WEBER |
| K093079 |
08/02/2010 |
TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U |
HOBBS MEDICAL, INC. |
EMILY MADSEN |
| K101677 |
08/11/2010 |
HOSPIRA INFUSION BLOOD SETS |
HOSPIRA, INC. |
KAREN KEENER |
| K101029 |
08/16/2010 |
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH |
HUGE DENTAL MATERIAL CO., LTD. |
JING LI |
| K092892 |
08/03/2010 |
1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 |
I-MING SANITARY MATERIALS CO., LTD. |
SARA HOU |
| K093868 |
08/05/2010 |
I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
| K091529 |
08/04/2010 |
ICAD VERALOOK CTC CAD SOFTWARE |
ICAD, INC. |
JOHN A DELUCIA |
| K101052 |
08/11/2010 |
OMNI III PATIENT MONITOR |
INFINIUM MEDICAL |
JOHN OBRIEN |
| K093204 |
08/23/2010 |
INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM |
INNOVATIVE MED, INC. |
JEFFREY KOLSTER |
| K093783 |
08/23/2010 |
INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT |
INNOVIA, LLC |
BRUCE WEBER |
| K100518 |
08/31/2010 |
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 |
INSTRUMED INTERNATIONAL, INC. |
MICHAEL MASSONG |
| K102127 |
08/27/2010 |
ENDOTRACHEAL TUBE CHANGERS |
INSTRUMENTATION INDUSTRIES, INC. |
DORIS WALTER |
| K100846 |
08/16/2010 |
IMC SURGICAL FACE MASK |
INTERNATIONAL MEDSURG CONNECTION |
PETER KIM |
| K101279 |
08/04/2010 |
CORRIDOR4DM V2010 MODEL: V2010 |
INVIA |
DAVID ROTHKOPF |
| K101359 |
08/20/2010 |
INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) |
INVIRO MEDICAL DEVICES, INC. |
JIM BARLEY |
| K101508 |
08/06/2010 |
MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN B REISS |
| K091539 |
08/31/2010 |
IQ 200 URINE ANALIZER BODY FLUIDS MODULE |
IRIS DIAGNOSTICS |
WILLIAM M DOUGHERTY |
| K100975 |
08/17/2010 |
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE |
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD |
MICHAEL LEE |
| K100978 |
08/12/2010 |
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE |
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD |
MICHAEL LEE |
| K100977 |
08/12/2010 |
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE |
JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD |
MICHAEL LEE |
| K101207 |
08/02/2010 |
NEODENT IMPLANT SYSTEM |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
KEVIN A THOMAS |
| K100098 |
08/13/2010 |
PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE |
JM SYSTEM CO., LTD. |
KEVIN WALLS, RAC |
| K100851 |
08/02/2010 |
RANGE SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K101747 |
08/04/2010 |
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE |
KAZ USA, INC (A SUBSIDIARYOF KAZ INC) |
RAJ KASBEKAR |
| K101660 |
08/11/2010 |
ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 |
KEPLER MEDTEC |
F. DAVID ROTHKOPF |
| K100912 |
08/19/2010 |
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE |
KIRWAN SURGICAL PRODUCTS, INC. |
KEVIN P PRARIO |
| K102014 |
08/31/2010 |
TENS STIMULATOR, MODELS 2800 AND 3000 |
KOALATY PRODUCTS, INC. |
KANG JIANG PING |
| K093043 |
08/20/2010 |
ZIRCONIA SYRINGE NEEDLE |
KUO TAI HOSPITAL MANAGEMENTS & CONSULTANT CO., LTD |
CHAO-SHENT CHAO |
| K101364 |
08/16/2010 |
LANX FACET SCREW SYSTEM |
LANX, INC. |
MICHAEL FUNK |
| K100935 |
08/06/2010 |
LANX SPINAL FIXATION SYSTEM |
LANX, INC. |
ANDREW LAMBORNE |
| K101645 |
08/26/2010 |
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF |
LATEXX MANUFACTURING SDN.BHD. |
TERENCE LIM SIN KOOI |
| K102129 |
08/27/2010 |
LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR |
LEVITRONIX LLC. |
FARZAD PARSAIE |
| K101691 |
08/10/2010 |
LIFELINES PHOTIC STIMULATOR |
LIFELINES LTD. |
E. J AMITH |
| K101098 |
08/17/2010 |
REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 |
LIL DRUG STORE PRODUCTS, INC. |
PATRICIA MILLER |
| K101241 |
08/17/2010 |
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) |
LIL DRUG STORE PRODUCTS, INC. |
PATRICIA L MILLER |
| K091047 |
08/18/2010 |
NEONATE ARRAY COILS |
LMT MEDICAL SYSTEMS GMBH |
KRISTINA LUETJE |
| K093420 |
08/26/2010 |
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
GLORIA LEE |
| K101199 |
08/27/2010 |
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, |
MAQUET CRITICAL CARE AB |
WHITNEY TORNING |
| K101503 |
08/04/2010 |
DUSIMETRY CHECK |
MATH RESOLUTIONS, LLC. |
WENDEL D RENNER |
| K102130 |
08/26/2010 |
TENZING SYSTEM |
MAZOR SURGICAL TECHNOLOGIES LTD. |
AHAVA STEIN |
| K093753 |
08/26/2010 |
MDPO FRAME SYSTEM |
MDPO, LLC |
MARIE MARLOW |
| K101832 |
08/27/2010 |
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT |
MEDICAL DEVICE TECHNOLOGIES, INC. |
TRUDY D ESTRIDGE |
| K101134 |
08/09/2010 |
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 |
MEDICEL AG |
JOHN COGGAN |
| K102065 |
08/06/2010 |
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
PARK KYEONG-MI |
| K101070 |
08/31/2010 |
EXPEDIUM SPINE SYSTEM |
MEDOS INTERNATIONAL SARL |
DAPHNEY GERMAIN |
| K100693 |
08/10/2010 |
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING |
MEDTRADE PRODUCTS LIMITED |
JONATHAN D RANFIELD |
| K101339 |
08/31/2010 |
ARCHER SUPER STIFF GUIDEWIRES |
MEDTRONIC INC. |
COLLEEN MULLINS |
| K093828 |
08/12/2010 |
KYPH X HV-R BONE CEMENT |
MEDTRONIC INC. |
MARY ROSE |
| K101212 |
08/07/2010 |
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R |
MEDTRONIC INC. |
BECKY HANNACK |
| K101168 |
08/24/2010 |
LEGEND POWER ADAPTER MODEL: 6475000 |
MEDTRONIC SOFAMOR DANEK |
THERESA LEISTER |
| K100763 |
08/27/2010 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K094021 |
08/06/2010 |
ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I |
MICROSULIS MEDICAL LIMITED |
DENISE REXHAUS |
| K101542 |
08/06/2010 |
HEADWAY 17 ADVANCED MICROCATHETER |
MICROVENTION, INC. |
Naomi Gong |
| K101330 |
08/27/2010 |
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE |
MIDWEST REPROCESSING CENTER LLC |
JEROME JAMES |
| K101702 |
08/27/2010 |
MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS |
MIDWEST REPROCESSING CENTER LLC |
JEROME JAMES |
| K101653 |
08/02/2010 |
MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES |
MILTEX, INC. |
JENNIFER BOSLEY, MBA, RAC |
| K102148 |
08/17/2010 |
CURIEPACS (DICOM PACS SOFTWARE) |
MOKSHA DIGITAL SOFTWARE PVT LIMITED |
DEEPAK SHARMA |
| K093689 |
08/31/2010 |
1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS |
MR MEDICAL SOLUTIONS LLC |
FAHAD ALRADADY |
| K093304 |
08/11/2010 |
PROTEKTOR 32 |
NATUS MEDICAL, INC. |
GOLDY SINGH |
| K101632 |
08/24/2010 |
METAFLEXCOIL |
NEOCOIL, LLC |
BRIAN BROWN |
| K100288 |
08/03/2010 |
NEOMED ENTERAL ONLY EXTENSION SET |
NEOMED, INC. |
PENNY NORTHCUTT |
| K102028 |
08/04/2010 |
NEOTRACT ANCHOR SYSTEM MODEL TAS400 |
NEOTRACT, INC. |
KEVIN F MACDONALD |
| K100512 |
08/20/2010 |
NOBELPROCERA IPS E.MAX CROWN |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K101714 |
08/31/2010 |
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K101633 |
08/27/2010 |
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K100102 |
08/31/2010 |
CS-SERIES-FP |
OMEGA MEDICAL IMAGING, INC. |
James Princehorn |
| K100819 |
08/02/2010 |
THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER |
ONSET MEDICAL CORPORATION |
JOSEPH BISHOP |
| K100367 |
08/27/2010 |
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 |
ORIGIO A/S |
RONALD G LEONARDI |
| K100245 |
08/17/2010 |
HS/HG PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K091424 |
08/18/2010 |
OSTA MAXIGRO AND REGIGRO |
OSTA TECHNOLOGIES |
JAY MANSOUR |
| K100354 |
08/17/2010 |
PRIMAL OK INTERSPINOUS FUSION SYSTEM |
OSTEOMED L.P. |
KAREN E WARDEN |
| K082800 |
08/26/2010 |
STAR/VENT INTERNAL HEX SCREW IMPLANT |
PARK DENTAL RESEARCH CORP. |
DANIEL J MANELLI |
| K093916 |
08/23/2010 |
NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U |
PERKINELMER, INC. |
KAY TAYLOR |
| K093553 |
08/13/2010 |
POSTURETEK |
PERSEUS ALTHETICS,LLC |
KEITH BARRITT |
| K093459 |
08/13/2010 |
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 |
PHADIA US INC. |
MARTIN ROBERT MANN |
| K101424 |
08/17/2010 |
PHARMACARIBE INHALED SALINE SOLUTIONS |
PHARMACARIBE |
PAUL DRYDEN |
| K102005 |
08/09/2010 |
ALLURA XPER OR TABLE SERIES |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
LYNN HARMER |
| K101600 |
08/31/2010 |
INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
| K093692 |
08/11/2010 |
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES |
PIONEER SURGICAL TECHNOLOGY |
EMILY M DOWNS |
| K093771 |
08/10/2010 |
QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
EMILY DOWNS |
| K101889 |
08/27/2010 |
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE |
PIVOTAL HEALTH SOLUTIONS |
PHILLIP KLEIN |
| K101342 |
08/20/2010 |
OSIRIX MD |
PIXMEO SARL |
CARL ALLETTO |
| K100918 |
08/09/2010 |
VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 |
PURICORE INC. |
DENNIS MAHONEY |
| K100124 |
08/31/2010 |
FASTX STERNAL INTRAOSSEOUS DEVICE |
PYNG MEDICAL CORP. |
MAYA BUTTERFIELD |
| K101390 |
08/13/2010 |
FASTPACK TSH IMMUNOASSAY |
Qualigen, Inc. |
MICHAEL S POIRIER |
| K102175 |
08/25/2010 |
RAPIDVUE HCG TEST |
QUIDEL CORPORATION |
Michelle Bodien |
| K101068 |
08/23/2010 |
ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS |
RADIANT EXPRESS LLC |
RYAN CHIOU |
| K092686 |
08/06/2010 |
ABL90 FLEX SERIES |
RADIOMETER MEDICAL APS |
LONE RONNEMOES PEDERSEN |
| K101479 |
08/11/2010 |
WINGMAN EXTENDABLE TIP SUPPORT CATHETER |
REFLOW MEDICAL |
REBECCA PINE |
| K093362 |
08/13/2010 |
2008 HEMODIALYSIS SORBENT SYSTEM |
RENAL SOLUTIONS INC. |
DAVID J VANELLA |
| K102044 |
08/31/2010 |
ELECSYS DIGOXIN CALCHECK 5 |
Roche Diagnostics |
KELLY COLLEEN O'MAINE ADAMS |
| K102157 |
08/27/2010 |
ELECSYS PRECICONTROL MULTIMARKER |
Roche Diagnostics |
Sarah Baumann |
| K101196 |
08/27/2010 |
ACCU-CHEK ULTRFLEX INFUSION SET |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K100382 |
08/05/2010 |
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 |
SALUMEDICA, L.L.C. |
BOB BRADEN |
| K101391 |
08/04/2010 |
SCANDIA-45 GAMMA CAMERA SYSTEM |
SCANDIA CORPORATION |
DAVID ASKEW |
| K100307 |
08/31/2010 |
GELSCAN, MODEL 1206 |
SEBIA |
KAREN ANDERSON |
| K101141 |
08/06/2010 |
SEILER COLPOSCOPE, MODELS 935, 955 AND 985 |
SEILER PRECISION MICROSCOPES |
DAN MEYER |
| K100966 |
08/03/2010 |
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES |
SHEATHING TECHNOLOGIES, INC. |
JENNIFER DOWNING |
| K092449 |
08/30/2010 |
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K101036 |
08/26/2010 |
SHIMADZU COLLIMATOR R-20J |
SHIMADZU CORP. |
DONALD KARLE |
| K102117 |
08/06/2010 |
TISSU TRANS FILTRON SYRINGE FILL |
SHIPPERT MEDICAL TECHNOLOGIES CORP. |
SARAH LAKE SHIPPERT |
| K101603 |
08/23/2010 |
BEAUTIFIL FLOW PLUS |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K101621 |
08/23/2010 |
LITE ART |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K093785 |
08/18/2010 |
MODULAR ENDOSCOPE |
SIALO TECHNOLOGY, LTD. |
AHAVA STEIN/ EYAL OZERI |
| K101666 |
08/10/2010 |
SYNGO. PLAZA VA20A |
SIEMENS AG, MEDICAL SOLUTIONS |
SABINE SCHROEDEL |
| K100200 |
08/02/2010 |
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 |
SIEMENS HEALTHCARE DIAGNOSTICS |
KIRA GORDON |
| K101749 |
08/16/2010 |
SYNGO TRUED SOFTWARE |
SIEMENS MEDICAL SOLUTIONS |
JAMES E KUHN |
| K100141 |
08/27/2010 |
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K093963 |
08/27/2010 |
QUASAR BLUE LIGHT THERAPY SYSTEM |
SILVER BAY, LLC |
PETER NESBITT |
| K093269 |
08/20/2010 |
PROCEDURE REHEARSAL STUDIO |
SIMBIONIX LTD. |
SHOSHANA FRIEDMAN |
| K092721 |
08/03/2010 |
ALIGN RADIAL HEAD SYSTEM |
SKELETAL DYNAMICS, LLC |
JOSEPH AZARY |
| K101499 |
08/26/2010 |
JOURNEY CR KNEE SYSTEM |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
| K102001 |
08/06/2010 |
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY |
SMITH & NEPHEW, INC. |
LAURA REYNOLDS |
| K101180 |
08/03/2010 |
GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, |
SMITHS MEDICAL MD, INC. |
SAINT PAUL |
| K093510 |
08/23/2010 |
LUMENVU CATHETER GUIDANCE SYSTEM |
SONOSITE,INC. |
JANICE HOGAN |
| K101757 |
08/12/2010 |
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM |
SONOSITE,INC. |
MARY K MOORE |
| K093373 |
08/24/2010 |
LARYNGEAL SURFACE ELECTRODE |
SPES MEDICA S.R.L. |
ALFREDO SPADAVECHIA |
| K101623 |
08/13/2010 |
INQUIRY AFOCUSII DIAGNOSTIC CATHETER |
ST. JUDE MEDICAL |
QUYNH PHUONG LE |
| K101789 |
08/19/2010 |
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS |
STERILMED, INC. |
GARRETT AHLBORG |
| K101409 |
08/02/2010 |
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K101709 |
08/18/2010 |
LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) |
STEVEN B. LAMBERG, DDS |
EMILY B ROSSITER |
| K101335 |
08/23/2010 |
CELL-CHEX |
Streck |
KERRIE OETTER |
| K093206 |
08/04/2010 |
ORTHOMAP 3D 1.1 MODULE |
STRYKER CORP. |
LILIAN ECKERT |
| K100865 |
08/11/2010 |
AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX |
STRYKER SPINE |
KIMBERLY S LANE |
| K101051 |
08/12/2010 |
AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX |
STRYKER SPINE |
KIMBERLY S LANE |
| K102235 |
08/24/2010 |
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K101816 |
08/19/2010 |
STN PROBE |
SUMMIT DOPPLER SYSTEMS, INC. |
KEN JARRELL |
| K100776 |
08/03/2010 |
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
| K100952 |
08/05/2010 |
MODIFICATION TO SYNTHES MATRIX SYSTEM |
SYNTHES SPINE |
JASON LIPMAN |
| K100887 |
08/09/2010 |
VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY |
T.A.G. MEDICAL PRODUCTS |
GEORGE J HATTUB |
| K092875 |
08/13/2010 |
ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K101287 |
08/30/2010 |
TEPHAFLEX COMPOSITE MESH |
TEPHA, INC. |
MARY P LEGRAW |
| K102119 |
08/27/2010 |
SUR-G GLOV AND MAXITEX |
TERANG NUSA SDN BHD |
ROBERT HILL |
| K100946 |
08/02/2010 |
INTRAVSCULAR ADMINISTRATION SET |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K100588 |
08/16/2010 |
HUMAN IGA2 KIT FOR USE ON THE SPAPLUS |
THE BINDING SITE GROUP LTD |
JAY GELLER |
| K100179 |
08/13/2010 |
SPAPLUS |
THE BINDING SITE GROUP, LTD. |
JAY GELLER |
| K100970 |
08/12/2010 |
STAINLESS STEEL SPINAL SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K093847 |
08/25/2010 |
DUFLO CATHETER (HEPARIN COATED) |
THERMOPEUTIX INC. |
THOMAS SCHROEDER |
| K101798 |
08/19/2010 |
SPI VARIOMULTI ANGLED ABUTMENT |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| K100304 |
08/27/2010 |
ST AIA PACK HBA1C |
Tosoh BioScience, Inc. |
Judith Ogden |
| K090947 |
08/16/2010 |
21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) |
TOTOKU ELECTRIC CO., LTD. |
MIKIO HASEGAWA |
| K100210 |
08/26/2010 |
TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T |
TRANS1 INCORPORATED |
CHERYL WAGONER |
| K100998 |
08/30/2010 |
1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1 |
UNILIFE MEDICAL SOLUTIONS LIMITED |
MELISSA L DEHASS |
| K093322 |
08/05/2010 |
MULTI-PURPOSE HEALTH DEVICE |
UPC MEDICAL SUPPLIES, INC. DBA UNITED PACIFIC CO. |
DANIEL HUE |
| K093145 |
08/13/2010 |
SPECTRA SERIES BREAST PUMP |
UZINMEDICARE CO. |
YONG J CHOI |
| K101751 |
08/10/2010 |
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
VY TRAN |
| K100684 |
08/26/2010 |
CELLTRACKS AUTOPREP SYSTEM MODEL:9541 |
VERIDEX, LLC |
SARAH MCMANUS |
| K101810 |
08/30/2010 |
3DHJD CAMERA SYSTEM MODEL |
VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS |
CHRISTINE E NICHOLS RAC |
| K102128 |
08/11/2010 |
VITABLOCS |
VITA ZAHNFABRIK H. RAUTER GMBH & CO. |
ELIZABETH WOLFSEN |
| K101213 |
08/19/2010 |
GRANDIO FLOW |
VOCO GMBH |
M PLAUMANN |
| K101000 |
08/09/2010 |
WELLMIEN SURGICAL MASK |
WELLMIEN (SUZHOU) IMPORT & EXPORT TRADING CO., LTD |
CHENGYU SHEN |
| K100820 |
08/05/2010 |
WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM |
WENZEL SPINE |
SOURABH MISHRA |
| K100973 |
08/10/2010 |
EVOLUTION UNICONDYLAR KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Danielle Mueller |
| K100886 |
08/26/2010 |
INBONE II TOTAL ANKLE REPLACEMENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| DEN090002 |
08/24/2010 |
ZELTIQ AESTHETICS DERMAL COOLING DEVICE |
ZELTIQ AESTHETICS |
LOUIS-PIERRE MARCOUX |
| K101565 |
08/17/2010 |
POWDER - FREE PATIENT EXAMINATION GLOVES |
ZIBIO YINGJIE MEDICAL PRODUCTS CO., LTD |
FRANK LIU |
| K101704 |
08/18/2010 |
ZIMMER DTO PIN PRESS INSTRUMENT |
ZIMMER SPINE, INC. |
TIM CRABTREE |
