| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K101834 |
09/03/2010 |
3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM |
3M COMPANY |
JIZHONG JIN |
| K101249 |
09/08/2010 |
STERIGAGE MODEL 1243RA, 1243RB, 1243RE |
3M COMPANY |
SUZANNE LEUNG |
| K100718 |
09/03/2010 |
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 |
AALTO SCIENTIFIC LTD. |
BRANDON J PEREZ |
| K093254 |
09/15/2010 |
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION |
ABBOTT MEDICAL OPTICS INC |
KESLEY E GALLAGHER |
| K101170 |
09/17/2010 |
ACUTE INNOVATIONS STERNAL FIXATION SYSTEM |
ACUTE INNOVATIONS LLC |
MARIAH KNIGHT |
| K101555 |
09/17/2010 |
CO2 LASER SYSTEM |
ADVANCED TECHNOLOGY LASER CO., LTD. |
Diana Hong |
| K100037 |
09/23/2010 |
ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD |
ADVANCED VERTEBRAL SOLUTIONS, LLC |
MIKE DUGERY |
| K101034 |
09/02/2010 |
NIOX MINO MODEL 09-1000 |
AEROCRINE AB |
JOHANNA KARLING |
| K100243 |
09/02/2010 |
QUINTEX CERVICAL PLATING SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
Lisa Boyle |
| K102716 |
09/28/2010 |
MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS |
ALMA LASERS, INC. |
TATIANA EPSTEIN |
| K101958 |
09/29/2010 |
AMSINO I.V. ADMINISTRATION AND EXTENSION SETS |
AMSINO INTERNATIONAL, INC. |
JESUS FARINAS |
| K101824 |
09/13/2010 |
AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER |
AMSINO INTERNATIONAL, INC. |
JESUS FARINAS |
| K102353 |
09/17/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K102356 |
09/20/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K100221 |
09/14/2010 |
INTELLIWAVE3 |
ART OPTICAL CONTACT LENS, INC. |
MARTIN DALSING |
| K100479 |
09/21/2010 |
PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K100578 |
09/22/2010 |
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K101568 |
09/20/2010 |
MODEL SB100II FINGER PULSE OXIMETER |
ATLANTEAN |
PAUL DRYDEN |
| K100727 |
09/14/2010 |
LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK |
BIO-RAD, DIAGNOSTICS GRP. |
SUZANNE PARSONS |
| K100985 |
09/09/2010 |
BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K100726 |
09/15/2010 |
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM |
BIOLITEC, INC. |
HARRY HAYES |
| K102107 |
09/03/2010 |
OSSTAPLE CHILL |
BIOMEDICAL ENT., INC. |
JOE W SOWARD |
| K101566 |
09/28/2010 |
VITEK 2 YEAST CASPOFUNGIN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K100114 |
09/29/2010 |
FAT CONCENTRATION SYSTEM |
BIOMET, INC. |
LONNIE WITHAM |
| K101086 |
09/03/2010 |
TAPERLOC COMPLETE |
BIOMET, INC. |
GARY BAKER |
| K101064 |
09/14/2010 |
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P |
BREDENT GMBH & CO.KG |
ANDREA PECSI |
| K102211 |
09/03/2010 |
CRUISER 18 GUIDEWIRE |
BRIVANT, LTD. |
TOMAS FUREY |
| K101537 |
09/30/2010 |
AIM 200, MAJOR SURGICAL LIGHT |
BURTON MEDICAL PRODUCTS CORP. |
SCOT KINGHORN |
| K101097 |
09/22/2010 |
CALGAESEAL MODEL: CAS |
BZ MEDICAL INC |
BYRON ZAHLER |
| K101825 |
09/29/2010 |
CRYOBALLOON ABLATION SYSTEM |
C2 THERAPEUTICS |
PETER GARCIA-MEZA |
| K093367 |
09/10/2010 |
STERILE SALINE SOLUTION |
CACHET PHARMACEUTICALS PVT. LTD. |
SHIVKUMAR AGRAWAL |
| K102373 |
09/30/2010 |
CALYPSO SYSTEM WITH DYNAMIC EDGE GATING |
CALYPSO MEDICAL TECHNOLOGIES INC |
ED VERTATSCHITSCH |
| K101814 |
09/27/2010 |
DIRECT CROWN NATURAL 1 |
CANDULOR USA, INC. |
DONNA MARIE HARTNETT |
| K100540 |
09/23/2010 |
ASCENT F-COAT MODEL: 006-00097 |
CAO GROUP, INC. |
ROBERT LARSEN |
| K094062 |
09/27/2010 |
PERCU-PRO GUIDEWIRE |
CARDIOSOLUTIONS INC |
MICHELE LUCEY |
| K101661 |
09/16/2010 |
MYRAY HYPERION |
CEFLA DENTAL GROUP |
CYNTHIA J NOLTE, PH.D. |
| K101301 |
09/24/2010 |
STALIF MIDLINE |
CENTINEL SPINE |
JUSTIN EGGLETON |
| K101429 |
09/15/2010 |
ECO SUPERGEL |
CERACARTA SPA |
ELAINE DUNCAN |
| K101366 |
09/17/2010 |
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) |
CHROMOGENEX TECHNOLOGIES LTD |
PETER R BEVAN |
| K101589 |
09/20/2010 |
BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS |
CINCINNATI SUB-ZERO PRODUCTS, INC. |
STEVEN J BERKE |
| K102303 |
09/10/2010 |
BLOOD PRESSURE METER, MODEL CH-658 |
CITIZEN SYSTEMS JAPAN CO., LTD. |
NATHAN A BEAVER |
| K101567 |
09/02/2010 |
SHARPS CONTAINER |
CIXI LEINUO PLASTIC CO. LTD |
CHARLES MACK |
| K094050 |
09/16/2010 |
ITOTAL CR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA S SHAH |
| K102291 |
09/15/2010 |
COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY |
COVIDIEN |
TIM M LOHNES |
| K100418 |
09/03/2010 |
SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE |
COVIDIEN |
WING NG |
| K101983 |
09/21/2010 |
CRITICAL CARE ASSESSMENT |
CRITICAL PATIENT CARE, INC. |
MARIE COSGROVE |
| K101602 |
09/01/2010 |
VITAL SIGNS MONITOR |
CRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
| K101587 |
09/16/2010 |
PROPATCH SOFT TISSUE REPAIR MATRIX |
CRYOLIFE, INC. |
BRYAN BROSSEAU |
| K101601 |
09/23/2010 |
AFFIRM DO DIODE LASER |
CYNOSURE, INC. |
ANTHONY BURNS |
| K101611 |
09/29/2010 |
RELAY POWER WHEELCHAIR |
DALTON INSTRUMENT CORP. |
JENNIFER YU |
| K101551 |
09/09/2010 |
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M |
DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD. |
LEON LU |
| K094049 |
09/10/2010 |
STLASE DIODE LASER |
DENTAL PHOTONICS, INC |
Marcy Moore |
| K100391 |
09/29/2010 |
DEPUY UNIVERSAL GRIPTION TF CONES |
DEPUY ORTHOPAEDICS, INC. |
DAWN SINCLAIR, MA |
| K101710 |
09/28/2010 |
LUXATEMP ULTRA /STAR |
DMG USA, INC. |
PAMELA PAPINEAU |
| K092977 |
09/29/2010 |
EBERLE SHAVER SYSTEM ACCESSORIES |
EFS EBERLE FEINWERKTECHNISCHE SYSTEME |
GERALD GOIGITZER |
| K102368 |
09/07/2010 |
NON-ABLATIVE WRINKLE TREATMENT HANDPIECE |
ELLMAN INT'L INC. |
JONATHAN ACHENBACH |
| K093723 |
09/08/2010 |
EMS MINIMASTER LED |
EMS ELECTRO MEDICAL SYSTEMS SA |
CYNTHIA J.M. NOLTE |
| K091956 |
09/28/2010 |
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 |
ENCORE MEDICAL, L.P. |
ELIZABETH ONDERLINDE |
| K093901 |
09/10/2010 |
SURGICAL FACE MASK |
EPARD PROTECTIVE PRODUCTS, LTD |
DARREN REEVES |
| K092734 |
09/20/2010 |
E-LIGHT LINE |
ESPANSIONE MARKETING S.P.A |
GUIDO BONAPACE |
| K091969 |
09/02/2010 |
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) |
EUROIMMUN US INC |
KATHRYN KOHL |
| K092736 |
09/02/2010 |
EUROIMMUN ANTI-M2-3E ELISA (IGG) |
EUROIMMUN US INC |
KATHRYN KOHL |
| K100017 |
09/13/2010 |
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM |
EUROIMMUN US INC |
KATHRYN KOHL |
| K101689 |
09/20/2010 |
EMM EQUIPMENT COVER-POLYTHYLENE |
EXACT MEDICAL MANUFACTURING, INC |
ROBERT O DEAN |
| K101688 |
09/20/2010 |
EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 |
EXACT MEDICAL MANUFACTURING, INC |
ROBERT O DEAN |
| K101593 |
09/03/2010 |
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL |
EXACT MEDICAL MANUFACTURING, INC |
ROBERT O DEAN |
| K093430 |
09/02/2010 |
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. |
EXACTECH, INC. |
GRAHAM CUTHBERT |
| K101761 |
09/21/2010 |
EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 |
EXACTECH, INC. |
DARRELL KASSNER |
| K102260 |
09/24/2010 |
FDI GLUCOSE CONTROL SOLUTIONS |
FUJIREBIO DIAGNOSTICS, INC |
KENT PRUETT |
| K101420 |
09/17/2010 |
GC FUJI TEMP |
GC AMERICA, INC. |
MARK HEISS |
| K093694 |
09/20/2010 |
GERATHERM UNIQUERESC |
GERATHERM MEDICAL AG |
ANDREA PECSI |
| K101200 |
09/30/2010 |
PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE |
GIVEN IMAGING LTD. |
Tim Thomas |
| K101477 |
09/28/2010 |
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH |
GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) |
WENDY MCMANUS |
| K101694 |
09/08/2010 |
HANDHELD PULSE OXIMETER MODEL M800 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Diana Hong |
| K102040 |
09/24/2010 |
PATIENT MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
ANA HONG |
| K100971 |
09/27/2010 |
ATEK SURGICAL GOWNS |
HANGZHOU ATEK MEDICAL & TEXTILE CO., LTD |
Glen Feye |
| K093834 |
09/29/2010 |
CRIT-LINE ANEMIA MANAGEMENT SOFTWARE |
HEMA METRICS, LLC |
TERRY LANIER |
| K101617 |
09/07/2010 |
FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL |
HERAEUS KULZER, LLC |
CHERYL ZIMMERMAN |
| K094003 |
09/17/2010 |
REVIVATOR |
HERSILL, S.L. |
ANA MARIA ROMERO |
| K102098 |
09/27/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
HONG DI PLASTIC PRODUCTS CO, LTD. |
JIE LIU |
| K101435 |
09/15/2010 |
IMIX PANORAD AND SOMARAD |
IMIX ADR FINLAND OY |
DANIEL KAMM, P.E. |
| K100992 |
09/24/2010 |
NEURALMAS |
INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") |
SUSAN D GOLDSTEIN-FALK |
| K102266 |
09/24/2010 |
ISOLED AC-POWERED LED HEADLIGHT SYSTEM |
ISOLUX LLC |
NIKOLAUS ANDREOULAKIS |
| K101373 |
09/15/2010 |
EMBRACE |
IZI MEDICAL PRODUCTS INC. |
HELEN SHAFER |
| K093137 |
09/28/2010 |
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL |
KAMIYA BIOMEDICAL CO. |
SHAWN KAPLAN |
| K100657 |
09/17/2010 |
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
MARGARET MARSH |
| K100899 |
09/13/2010 |
OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
RON WARREN |
| K102032 |
09/08/2010 |
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS |
KIMBERLY-CLARK CORP. |
LESTER F PADILLA |
| K100793 |
09/22/2010 |
UROSTATION 3D PROSTATE SUITE |
KOELIS |
CECILE DESMULIE |
| K102442 |
09/10/2010 |
E.S.O. (ELECTRO SENSOR OXI) |
L.D. TECHNOLOGY, LLC |
ALBERT MAAREK |
| K102036 |
09/28/2010 |
DOCTOR SURGERY DIODE LASERS FAMILY |
LAMBDA S.P.A. |
BOSCHI ALESSANDRO |
| K102265 |
09/29/2010 |
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM |
LDR SPINE USA |
BECKINAM NOWATZKE |
| K101740 |
09/20/2010 |
ALBOSURE POLYESTER VASCULAR PATCH |
LEMAITRE VASCULAR, INC. |
VIC ZHANG |
| K102136 |
09/27/2010 |
VESSEL GUARDIAN |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K101573 |
09/23/2010 |
ACCUSCULPT II LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K101771 |
09/20/2010 |
RELINE-IT MODEL RELINE-IT |
MAJESTIC DRUG CO., INC. |
ROGER S MASTRONY |
| K101157 |
09/17/2010 |
E-BASIC SINGLE BREAST PUMP |
MAPA GMBH |
SHEILA W PICKERING |
| K101426 |
09/15/2010 |
CEROS TCP GRANULES |
MATHYS LTD |
LINDA SCHULZ |
| K102437 |
09/24/2010 |
GMK REVISION KNEE SYSTEM |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K101791 |
09/23/2010 |
ROSA SURGICAL DEVICE |
MEDTECH SAS |
BERTIN NAHUM |
| K102176 |
09/01/2010 |
FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 |
MEDTRONIC CRYOCATH LP |
KARI LAHTI |
| K101885 |
09/09/2010 |
MEDTRONIC C315 DELIVERY CATHETER |
MEDTRONIC INC. |
BRUCE BACKLUND |
| K101186 |
09/03/2010 |
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG |
MEDTRONIC PERFUSION SYSTEMS |
CARALEE WALTON |
| K091445 |
09/27/2010 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K101772 |
09/30/2010 |
TSRH(R) SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LILA JOE |
| K102273 |
09/07/2010 |
MERIT BIPOLAR COAGULATION PROBE |
MERIT MEDICAL SYSTEMS, INC. |
DAN W LINDSAY |
| K102178 |
09/02/2010 |
EASY TOUCH |
MHC MEDICAL PRODUCTS |
DANIEL KAMM |
| K102004 |
09/10/2010 |
ENDEAVOUR MONITORING SYSTEM |
MINDRAY DS USA, INC. |
RUSSELL OLSEN |
| K102173 |
09/13/2010 |
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 |
MOLDEX/METRIC, INC. |
MARK MEINECKE |
| K100029 |
09/15/2010 |
MEPILEX BORDER AG DRESSING |
MOLNLYCKE HEALTH CARE |
STEVEN DOWDLEY |
| K102021 |
09/17/2010 |
CRYO-TOUCH II |
MYOSCIENCE INC |
TRACEY HENRY |
| K101326 |
09/02/2010 |
NMI IC |
NAVILYST MEDICAL, INC. |
NICHOLAS CONDAKES |
| K101729 |
09/23/2010 |
NEOWIRE PTA/PTCA GUIDEWIRE |
NEO METRICS, INC. |
GENE CHAMPEAU |
| K101783 |
09/13/2010 |
COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE |
NEW STAR LASERS, INC. |
NATALIE R VOLLRATH |
| K101803 |
09/08/2010 |
NEWPORT E360 VENTILATOR |
NEWPORT MEDICAL INSTRUMENTS, INC. |
TOM COLONNA |
| K091952 |
09/10/2010 |
ACTA VESSEL OCCLUSION SYSTEM (VOS) |
NFOCUS NEUROMEDICAL, INC. |
BOB O'HOLLA |
| K101380 |
09/13/2010 |
RXPEAKFLOW |
NOBLE MARKETING |
LAURA LYONS |
| K101860 |
09/01/2010 |
NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT |
NovaBone Products, LLC |
DAVID M GALSSER |
| K101976 |
09/14/2010 |
INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET |
OMNI LIFE SCIENCE, INC. |
RADHIKA PONDICHERRY |
| K101994 |
09/28/2010 |
APEX KNEE MODULAR TIBIA SYSTEM |
OMNLIFE SCIENCE |
RADHIKA TAUNTON |
| K102492 |
09/30/2010 |
P200MAAF |
OPTOS PLC |
HOWARD M HOLSTEIN |
| K101505 |
09/15/2010 |
RTVUE MODEL RTVUE 100 |
OPTOVUE, INC. |
JOHN TALARICO |
| K101676 |
09/13/2010 |
CLEARARCH |
ORMCO CORP. |
Wendy Garman |
| K101812 |
09/27/2010 |
CONSTRUX MINI PEEK SPACER SYSTEM |
ORTHOFIX INC. |
RUSSELL JOHNSON |
| K102156 |
09/30/2010 |
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K101962 |
09/27/2010 |
MINI MAXLOCK EXTREME PLATING SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K091618 |
09/27/2010 |
VITOMATRIX |
ORTHOVITA, INC. |
DEBORAH L JACKSON |
| K102438 |
09/30/2010 |
PRIMALOK FACET FIXATION SYSTEM |
OSTEOMED L.P. |
KAREN E WARDEN |
| K101524 |
09/29/2010 |
C2000 POWERED WHEELCHAIR |
OTTO BOCK HEALTH CARE, LP |
WILLIAM KABITZ |
| K101506 |
09/01/2010 |
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
| K101532 |
09/01/2010 |
NESSI OTC SPACER |
PHARMACARIBE |
PAUL DRYDEN |
| K102495 |
09/30/2010 |
M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 |
PHILIPS MEDICAL SYSTEMS |
THERESA POOLE |
| K101311 |
09/30/2010 |
EP NAVIGATOR R3 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN HARMER |
| K100550 |
09/28/2010 |
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC |
POLYMEDCO, INC. |
HELEN LANDICHO |
| K101630 |
09/07/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE |
PT. SMART GLOVE INDONESIA |
CHO SOW FONG |
| K101918 |
09/24/2010 |
QUICKVUE RSV 10 |
QUIDEL CORP. |
JENNIFER S HANKARD |
| K102118 |
09/08/2010 |
SNORE GUARD ADVANCE |
RANIR LLC |
GERARD J PRUD'HOMME |
| K101130 |
09/02/2010 |
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK |
RESPIRONICS, INC. |
ZITA A YURKO |
| K101129 |
09/16/2010 |
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK |
RESPIRONICS, INC. |
ZITA A YURKO |
| K102267 |
09/10/2010 |
ELECSYS FERRITIN CALCHECK 5 |
Roche Diagnostics |
Sarah Baumann |
| K102016 |
09/01/2010 |
PRECICONTROL CLINCHEM MULTI 1 AND 2 |
Roche Diagnostics |
PATRICK J STIMART |
| K101456 |
09/08/2010 |
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM |
Roche Diagnostics |
Susan Hollandbeck |
| K101203 |
09/10/2010 |
TINA-QUANT ALBUMIN GEN 2 |
Roche Diagnostics |
KATHIE J GOODWIN |
| K100853 |
09/09/2010 |
COBAS 8000 MODULAR SERIES ANALYZER |
ROCHE DIAGNOSTICS CORP. |
ANGELO PEREIRA |
| K101054 |
09/03/2010 |
ROMIAPEX MODEL A-15 |
ROMIDAN LTD |
EITAN MARGALIT |
| K101496 |
09/14/2010 |
CABLECAP MODEL: WLF, STZ, ACM |
SENSORMED |
WILLIAM MILAM |
| K093883 |
09/20/2010 |
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- |
SEPPIM S.A.S. |
DEBRA K HUTSON |
| K101646 |
09/08/2010 |
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR |
SGMP CO., LTD. |
JANNA P TUCKER |
| K101039 |
09/20/2010 |
SHIMADZU COLLIMATOR R-300 |
SHIMADZU CORP. |
DON KARLE |
| K093107 |
09/30/2010 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K101425 |
09/10/2010 |
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES |
SIEMENS HEALTHCARE DIAGNOSTICS |
Elisabeth Warriner |
| K101550 |
09/03/2010 |
BIOGRAPH MCT FAMILY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K102017 |
09/20/2010 |
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K101869 |
09/29/2010 |
PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) |
SILMET LTD. |
SHARON CHAPLIK |
| K091467 |
09/17/2010 |
BABY QUASAR |
SILVER BAY, LLC |
DANIEL KAMM, P.E. |
| K092551 |
09/14/2010 |
SMITH & NEPHEW INSTRUMENT TRAYS |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
CHRISTINA FLORES |
| K100795 |
09/02/2010 |
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
| K100787 |
09/17/2010 |
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT |
SMITH & NEPHEW, INC. |
LAURA D REYNOLDS |
| K093047 |
09/27/2010 |
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
| K100736 |
09/10/2010 |
KIRSCHNER AND GUIDE WIRES |
SMT SCHILLING METALLTECHNIK GMBH |
ANDRE WEINGERL |
| K102219 |
09/24/2010 |
SOCORRO SMI TUNNEL RELEASE DEVICE |
SOCORRO MEDICAL, INC. |
ED DIAO |
| K100112 |
09/28/2010 |
SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
CARLOS GONZALEZ |
| K101337 |
09/30/2010 |
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM |
SONOSCAPE COMPANY LIMITED |
Diana Hong |
| K102090 |
09/30/2010 |
SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM |
SPINE SMITH PARTNERS L.P. |
LAURA LEBOEUF |
| K101288 |
09/10/2010 |
STAXX XD SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K102020 |
09/01/2010 |
VEGA SPAN SPINOUS PROCESS PLATE SYSTEM |
SPINEFRONTIER, INC. |
JOHN SULLIVAN |
| K101883 |
09/07/2010 |
6F ENGAGE/ENGAGE TR INTRODUCER |
ST. JUDE MEDICAL |
VENKATA DAMARAJU |
| K101697 |
09/22/2010 |
ENSITE VERISMO SEGMENTATION TOOL V.2.0 |
ST. JUDE MEDICAL |
KRIS MILLER |
| K101968 |
09/15/2010 |
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A |
ST. JUDE MEDICAL |
SUSAN ENGELSON |
| K102462 |
09/21/2010 |
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K100442 |
09/07/2010 |
FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM |
SURGICAL INNOVATIONS GROUP PLC |
MIKE WHITE |
| K101536 |
09/15/2010 |
2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM |
SYNTHES (USA) LLC |
LISA GRANEY |
| K102018 |
09/23/2010 |
NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY |
SYNTHES USA PRODUCTS LLC |
JEFFREY L DOW |
| K100421 |
09/27/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN YONKSHUN GLOVE, CO., LTD |
CHU XIAOAN |
| K102230 |
09/10/2010 |
NUGARD NITILE GREY COLOR |
TERANG NUSA SDN BHD |
ROBERT HILL |
| K100455 |
09/03/2010 |
SPAPLUS ANALYZER |
THE BINDING SITE |
JAY GELLER |
| K101310 |
09/02/2010 |
VU APOD INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
Glenn Stiegman |
| K101490 |
09/08/2010 |
FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US |
THERMAGE, INC. |
KRISS FOSS |
| K101015 |
09/23/2010 |
GUIDE CATHETERS AND ACCESSORIES |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| K101868 |
09/07/2010 |
INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K093960 |
09/14/2010 |
ST AIA-PACK CYSTATIN C, MODEL 025217 |
Tosoh BioScience, Inc. |
JUDITH K OGDEN |
| K092794 |
09/13/2010 |
TRANSCORP ACIF SYSTEM |
TRANSCORP, INC. |
ANDREW RODENHOUSE |
| K101375 |
09/15/2010 |
TRIMED X-FIX |
TRIMED, INC. |
KELLI ANDERSON |
| K101906 |
09/17/2010 |
SHAPE TO FIT COMPRESSION WEAR |
TSUNG HAU TECHNOLOGY CO., LTD. |
PEGGY KUO |
| K102430 |
09/10/2010 |
TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET |
TYCO ELECTRONICS CORPORATION |
DENNIS M GILKEY |
| K101245 |
09/17/2010 |
ULTRASEAL ID |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K102011 |
09/03/2010 |
ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K091125 |
09/03/2010 |
CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 |
VERILUX |
RYAN DOUGLAS |
| K101734 |
09/08/2010 |
VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES |
VISIONSCOPE TECHNOLOGIES, LLC |
LIM CHEUNG PH.D |
| K101799 |
09/03/2010 |
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE |
WEAR SAFE (MALAYSIA) SDN. BHD. |
MOHD AZLAN |
| K100969 |
09/20/2010 |
WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N |
WMI ENTERPRISES LLC |
MIKE WILFORD |
| K101977 |
09/14/2010 |
TAPERED SCREW-VENT T IMPLANT |
ZIMMER DENTAL INC. |
JEREMY MARKOVICH |
| K100845 |
09/21/2010 |
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES |
ZIMMER SPINE, INC |
DAVID PADGETT, RAC (US) |
| K101696 |
09/10/2010 |
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM |
ZIMMER, INC. |
STEPHEN G MCKELVEY, MA, RAC |
| K091561 |
09/23/2010 |
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE |
ZOLL MEDICAL CORPORATION |
CHARLES W KOLIFRATH |
| K102174 |
09/15/2010 |
ZOLL PROPAQ M |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
PAUL DIAS |
| K102468 |
09/30/2010 |
ZOLL PROPAQ MD |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
PAUL DIAS |
