| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K091911 |
07/21/2009 |
BOLUS COMPENSATOR |
.DECIMAL, INC. |
DANIEL L BENNETT |
| K083903 |
07/15/2009 |
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 |
3M COMPANY |
JIZHONG JIN |
| K083377 |
07/27/2009 |
ACCUPEN |
ACCUTOME ULTRASOUND, INC. |
BRIAN T.S. BARRETT |
| K083419 |
07/16/2009 |
ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 |
ACTHERM, INC. |
RICHARD HSIEH |
| K083354 |
07/20/2009 |
FLORASEAL, MODEL FS350D |
ADHEZION BIOMEDICAL |
RICHARD JONES |
| K091013 |
07/30/2009 |
SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND |
ADVANCED MEDICAL SOLUTIONS LIMITED |
CLAIRE RYAN |
| K091993 |
07/31/2009 |
RAPID PROGRAMMER, VERSION 3.3.0 |
ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.) |
MIA M WARE |
| K083074 |
07/24/2009 |
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT |
ADVANDX, INC. |
PAULA E BULGER |
| K083004 |
07/02/2009 |
MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
Lisa Boyle |
| K091793 |
07/09/2009 |
AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 |
AGA MEDICAL CORP. |
DIANE CARROLL |
| K083761 |
07/22/2009 |
ALATECH POWDER FREE LATEX EXAMINATION GLOVE |
ALATECH HEALTHCARE, LLC. |
NEIL ANDERSON |
| K083812 |
07/09/2009 |
REFRESH OPTIVE LENS COMFORT REWETTING DROPS |
ALLERGAN, INC. |
BEVERLEY D VENUTI |
| K091219 |
07/09/2009 |
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM |
ALLEZ SPINE, LLC |
HARTMUT LOCH |
| K090779 |
07/07/2009 |
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
CHERYL ALLEN |
| K091189 |
07/08/2009 |
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
PAULA MORGAN |
| K091242 |
07/06/2009 |
BANTAM |
ALTIMATE MEDICAL, INC. |
CAROLL L MARTIN |
| K092086 |
07/30/2009 |
AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 |
AMERX HEALTH CARE CORP. |
ART W SIMONETTI, LPN |
| K091997 |
07/30/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K092045 |
07/30/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K091500 |
07/31/2009 |
MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K091966 |
07/30/2009 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 |
ANGIOSCORE, INC. |
KIMBERLEY KLINE |
| K083686 |
07/02/2009 |
BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES |
ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. |
BIAN WEI QIANG |
| K090850 |
07/30/2009 |
ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE |
APATECH LTD. |
CANDACE F CEDERMAN |
| K090738 |
07/27/2009 |
THERMOFLO HCH, THERMOFLO FILTER |
ARC MEDICAL, INC. |
PAUL DRYDEN |
| K091854 |
07/02/2009 |
BIS CLICK SENSOR/CABLE |
ASPECT MEDICAL SYSTEMS, INC. |
VIKRAM VERMA |
| K091783 |
07/07/2009 |
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM |
AVANTIS MEDICAL SYSTEMS, INC. |
AMRITA SETHI |
| K091285 |
07/28/2009 |
AL T LASER, MODEL AVI HPLL-12 |
AVICENNA LASER TECHNOLOGY, INC. |
BRUCE COREN |
| K083222 |
07/31/2009 |
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
Claire Dora |
| K090838 |
07/20/2009 |
STIMULUS/DISSECTION INSTRUMENTS |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K083689 |
07/01/2009 |
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM |
B. BRAUN MEDICAL, INC. |
LINDA MORGAN |
| K091274 |
07/14/2009 |
CORONIS 5MP HD, MODEL MDMG 5121 |
BARCO NV |
LIEVEN DE WANDEL |
| K090967 |
07/31/2009 |
BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 |
BD Biosciences |
Katy Campbell |
| K091153 |
07/13/2009 |
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
| K091377 |
07/02/2009 |
BD FLU+ SYRINGE |
BECTON DICKINSON & CO. |
EILEEN HILLER |
| K091670 |
07/01/2009 |
BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER |
BECTON DICKINSON & CO. |
JUSTICE ALDER |
| K090434 |
07/06/2009 |
BECE PRESS |
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO |
MICHAEL ESSLER |
| K090599 |
07/20/2009 |
MD300K1 PULSE OXIMETER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
YAJING LI |
| K091855 |
07/01/2009 |
THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 |
BELMONT INSTRUMENT CORP. |
URAIWAN LABADINI |
| K090389 |
07/14/2009 |
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM |
BESTGEN BIOTECH CORP. |
JEN KE-MIN |
| K083105 |
07/24/2009 |
KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K090847 |
07/01/2009 |
PLATELIA TOXO IGM KIT MODEL 26211 |
Bio-Rad Laboratories |
PRIYA BONDRE |
| K090699 |
07/27/2009 |
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 |
BIO-RAD LABORATORIES, INC. |
JACKIE H BUCKLEY |
| K091922 |
07/14/2009 |
WATERLASE C100, MODEL 7100104 |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOIU |
| K091024 |
07/17/2009 |
CHROMID MRSA AGAR, MODEL: REF 43 841 |
BIOMERIEUX, INC. |
Nancy Weaver |
| K091058 |
07/22/2009 |
ADKINS STRUT |
BIOMET MICROFIXATION, INC. |
KIM REED |
| K091067 |
07/14/2009 |
5.5 POLARIS SPINAL SYSTEM |
BIOMET SPINE |
VIVIAN KELLY |
| K091558 |
07/17/2009 |
BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM |
BIOPTICS, INC. |
CARLOS REYES |
| K090554 |
07/02/2009 |
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
STACEY A STRAND |
| K091816 |
07/01/2009 |
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM |
Boston Scientific Corporation |
JANIS TARANTO |
| K082982 |
07/20/2009 |
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES |
BREATHE TECHNOLOGIES, INC. |
CRAIG COOMBS |
| K083094 |
07/07/2009 |
STREAMER POLYMER GUIDEWIRE |
BRIVANT, LTD. |
TOMAS FUREY |
| K090851 |
07/02/2009 |
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) |
BYRNE MEDICAL INC. |
JENNIFER JAMES |
| K090735 |
07/06/2009 |
C.T.M. MOBILITY SCOOTER, HS-528 |
C.T.M. HOMECARE PRODUCT, INC. |
LINDA J BOVARD |
| K091418 |
07/06/2009 |
C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION |
C.T.M. HOMECARE PRODUCT, INC. |
LINDA BOVARD |
| K091300 |
07/23/2009 |
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 |
CAO GROUP, INC. |
ROBERT LARSON |
| K091308 |
07/09/2009 |
ALARIS PC UNIT, MODELS 8000 AND 8015 |
CARDINAL HEALTH 303, INC. |
Michelle J Badal |
| K090211 |
07/01/2009 |
INFLATABLE BONE TAMP |
CARDINAL HEALTH, INC. |
SHARON NICHOLS |
| K091889 |
07/20/2009 |
DRX-EVOLUTION, MODEL VX3733-SYS |
CARESTREAM HEALTH, INC. |
CAROLYN WAGNER |
| K091380 |
07/30/2009 |
CORDCAP |
CENTRIX, INC. |
JOHN DISCKO |
| K091109 |
07/09/2009 |
XPERT C. DIFFICILE |
CEPHEID |
RUSSEL K ENNS |
| K082629 |
07/01/2009 |
S12X WITH ESAX OPTION |
CHATTEN ASSOCIATES, INC. |
JOHN B CHATTEN |
| K083913 |
07/31/2009 |
CHESSON LABS LIQUID BANDAGE |
CHESSON LABORATORY ASSOCIATES, INC. |
SCOTT E NEUVILLE |
| K090646 |
07/23/2009 |
CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 |
CHEST M.I., INC. |
JEAN ASQUITH |
| K091179 |
07/16/2009 |
MONACO RTP SYSTEM, VMAT OPTION |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K091961 |
07/30/2009 |
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K091355 |
07/22/2009 |
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 |
CONMED ENDOSCOPIC TECHNOLOGIES, INC. |
KAREN PROVENCHER |
| K090688 |
07/10/2009 |
COOK UROLOGICAL GRAFT |
COOK BIOTECH, INC. |
MARY A FADERAN |
| K090709 |
07/07/2009 |
CORTEX DENTAL IMPLANT SYSTEM |
CORTEX DENTAL IMPLANTS INDUSTRIES, LTD |
BENNY AZARY |
| K091900 |
07/16/2009 |
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
REBECCA RONNER |
| K090054 |
07/29/2009 |
ATLAS IMPLANT SYSTEM - WIDE PLUS |
COWELLMEDI CO., LTD |
JUNG BAE BANG |
| K082849 |
07/16/2009 |
SILENT SLEEP |
CRANIOFACIAL PAIN CENTER OF IDAHO |
JAMISON R SPENCER |
| K091482 |
07/06/2009 |
HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 |
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
JIUGUANG (JOE) SONG |
| K090007 |
07/24/2009 |
JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 |
DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. |
QING WANG |
| K091834 |
07/15/2009 |
PASSPORT V MONITOR, MODEL 0998-00-6100 |
DATASCOPE CORP., PATIENT MONITORING DIVISION |
KATHLEEN KRAMER |
| K090256 |
07/06/2009 |
POWER STANDING DANI |
DAVISMADE, INC. |
DANIEL DAVIS |
| K092030 |
07/24/2009 |
ELATION MB METAL REINFORCED PLASTIC BRACKET |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K091751 |
07/14/2009 |
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP |
DEPUY ORTHOPAEDICS, INC. |
DAWN SINCLAIR |
| K092122 |
07/27/2009 |
GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K091294 |
07/24/2009 |
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K091760 |
07/20/2009 |
DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) |
DERMAPORT, INC |
JENNIFER HESSEL |
| K083712 |
07/10/2009 |
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS |
DIPURE, LLC. |
TIM MARCO |
| K091700 |
07/09/2009 |
AIRCAST VENAFLOW ELITE SYSTEM |
DJO, LLC |
CHRISTINE OTIS |
| K091747 |
07/01/2009 |
FLAATZ 500 |
DRTECH CORP. |
BEOM-JIN MOON |
| K091397 |
07/08/2009 |
ECSCOPE 200 |
DYANSYS, INC. |
SRINI NAGESHWAR |
| K090203 |
07/30/2009 |
5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS |
EBI, L.P. |
VIVIAN KELLY |
| K090523 |
07/01/2009 |
POLARIS SPINAL SYSTEM |
EBI, L.P. |
VIVIAN KELLY |
| K091513 |
07/24/2009 |
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K081998 |
07/09/2009 |
H-WAVE SPORT |
ELECTRONIC WAVEFORM LABORATORY, INC. |
RYAN P HEANEY |
| K090972 |
07/20/2009 |
LEKSELL GAMMAPLAN |
ELEKTA INSTRUMENT AB |
ANDERS SKOGLUND |
| K091832 |
07/22/2009 |
ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER |
ENDOGASTRIC SOLUTIONS, INC. |
STEVE HOFFMAN |
| K083461 |
07/24/2009 |
IMAGINE TC SKIN THERAPY SYSTEM |
ENDYMION MEDICAL LTD |
YORAM LEVY |
| K091681 |
07/08/2009 |
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) |
Entellus Medical, Inc. |
DEBORAH I NEYMARK |
| K090438 |
07/24/2009 |
REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR |
ENVITEC-WISMAR GMBH |
STEPHEN GORSKI |
| K090867 |
07/30/2009 |
AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 |
EP DYNAMICS, INC. |
ALBERT REGO |
| K091229 |
07/31/2009 |
GLUCOMANAGER DATA MANAGEMENT SOFTWARE |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K091054 |
07/27/2009 |
WALK400H |
ET MEDICAL DEVICES SPA |
LUIGO BUCCHI |
| K083052 |
07/28/2009 |
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) |
EUROIMMUN US INC |
KATHRYN KOHL |
| K083670 |
07/23/2009 |
UNIVERSAL, AESTHETICA, NATEA, NATURA |
EUROTEKNIKA |
EMMANUEL MONTINI |
| K091596 |
07/02/2009 |
EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST |
EVALVE INC |
CINDY MORROW |
| K083870 |
07/30/2009 |
EXSALT SD7 WOUND DRESSING |
EXCITON TECHNOLOGIES INC. |
SANDRA REIS |
| K091577 |
07/24/2009 |
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM |
EXTREMITY MEDICAL LLC |
JAMY GANNOE |
| K091163 |
07/22/2009 |
PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST |
FIAB SPA |
ALBERTO CALABRO |
| K091723 |
07/06/2009 |
FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5 |
FREEDOM SCIENCES, LLC |
EDWARD A KROLL |
| K091727 |
07/06/2009 |
MEDICAL TREATMENT CHAIR, T400, T500,T600 |
FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD. |
RAM KAMATH |
| K091388 |
07/22/2009 |
GCUC-505 |
GC AMERICA, INC. |
MARK HEISS |
| K091594 |
07/29/2009 |
HEART-EXERCISE |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH |
PATRICIA TAIGE |
| K083421 |
07/24/2009 |
MR-TOUCH OPTION |
GE MEDICAL SYSTEMS, LLC |
Daniel Biank |
| K091536 |
07/17/2009 |
OPTIMA MR450W |
GE MEDICAL SYSTEMS, LLC |
MARK STAUFFER |
| K083131 |
07/30/2009 |
MEDOS HILITE RESERVOIR, MODEL: 4030 |
GISH BIOMEDICAL, INC. |
JANET PEETS |
| K091405 |
07/29/2009 |
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT |
GIVEN IMAGING LTD. |
Tim Thomas |
| K081923 |
07/01/2009 |
ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD |
GLAXOSMITHKLINE CONSUMER HEALTHCARE |
ZINATARA A MANJI |
| K090952 |
07/14/2009 |
ZYFUSE FACET FIXATION SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K091519 |
07/28/2009 |
HAEMOBAND MULTI-LIGATOR |
HAEMOBAND SURGICAL LTD. |
PAUL DRYDEN |
| K091881 |
07/01/2009 |
RPL/CPL VERTICAL PLATFORM LIFTS |
HARMAR SUMMIT LLC |
KEVIN KAMINSKI |
| K091390 |
07/30/2009 |
HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 |
HDC S.R.L. |
GUIDO BONAPACE |
| K081603 |
07/24/2009 |
DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 |
HEARTFORCE MEDICAL, INC. |
ARTHUR WARD |
| K091690 |
07/28/2009 |
SHARP CHUTE |
HEATHROW SCIENTIFIC, LLC |
PETE HADJIS |
| K091491 |
07/31/2009 |
HERO VASCULAR ACCESS DEVICE |
HEMOSPHERE INC |
W. ALLEN PUTNAM |
| K091494 |
07/31/2009 |
FLEXITIME FLOW |
HERAEUS KULZER, INC. |
CHERYL ZIMMERMAN |
| K083183 |
07/16/2009 |
AKLARUS PHOTOTHERAPY SYSTEM |
HILL LABORATORIES CO. |
BRADY ALLER |
| K091378 |
07/02/2009 |
MAMMOSITE II RADIATION THERAPY SYSTEM |
HOLOGIC, INC. |
JENNIFER SULLIVAN |
| K091185 |
07/24/2009 |
70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER |
HSINER CO., LTD. |
TOM SHANKS |
| K090285 |
07/15/2009 |
SONICAID FM820 AND FM830 ENCORE |
HUNTLEIGH HEALTHCARE LTD. |
GRAHAM BOOTH |
| K091687 |
07/07/2009 |
PACSMATE, MODEL MMD-4300C/MMD-4300CX |
IEI TECHNOLOGY CORP. |
JENNIFER REICH |
| K091021 |
07/15/2009 |
MODIFICATION TO MEDICOMPASS CONNECT |
IMETRIKUS, INC. |
MICHAEL ACOSTA |
| K090579 |
07/07/2009 |
SMARTSCREENER-PLUS2 |
INTELLIGENT HEARING SYSTEMS |
EDWARD MISKIEL |
| K090406 |
07/22/2009 |
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE |
INTERACOUSTICS AS |
HANNE NIELSEN |
| K091075 |
07/21/2009 |
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM |
IRHYTHM TECHNOLOGIES, INC. |
MICHAEL RIGHTER |
| K090941 |
07/17/2009 |
ADHESE ONE F |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K091985 |
07/24/2009 |
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE |
IVY BIOMEDICAL SYSTEMS, INC. |
DICK LISTRO |
| K091141 |
07/24/2009 |
THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS |
KNIT-RITE, INC. |
JEFFREY C DALBEY |
| K091683 |
07/02/2009 |
KOWA VX-10 A |
KOWA CO. LTD. |
AKIHIRO FUJITA |
| K090830 |
07/21/2009 |
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP |
LABORIE MEDICAL TECHNOLOGIES, LTD. |
BARBARA MORNET |
| K091088 |
07/14/2009 |
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM |
LDR SPINE USA |
NOAH BARTSCH |
| K090879 |
07/23/2009 |
INSUFLOW CO2IONSHIELD |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K090320 |
07/22/2009 |
CONQUEST SPINAL SYSTEM |
LIFE SPINE |
MURALI AUDIPUDY |
| K090766 |
07/23/2009 |
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER |
LIFELOC TECHNOLOGIES, INC. |
MARK LARY |
| K090844 |
07/30/2009 |
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
MARIE LIN |
| K090802 |
07/07/2009 |
TIGRT MLC, TIGRT DMLC |
LINATECH, LLC |
JONATHAN YAO |
| K090893 |
07/15/2009 |
TIGRT TPS |
LINATECH, LLC |
JONATHAN YAO |
| K091236 |
07/30/2009 |
MANTRA COMBO, MODEL MECS 320 |
MANTRA INTL. (HK) LTD. |
BRENT REIDER |
| K083719 |
07/30/2009 |
LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K091057 |
07/09/2009 |
MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K090165 |
07/09/2009 |
RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K091474 |
07/09/2009 |
EASY.TOUCH INSULIN SYRINGE |
MASTERS HEALTHCARE, LLC. |
DANIEL KAMM |
| K090988 |
07/10/2009 |
GMK TOTAL KNEE SYSTEM |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K090983 |
07/01/2009 |
APTUS 2.0/2.3 FOUR CORNER FUSION PLATE |
MEDARTIS AG |
KEVIN A THOMAS |
| K091479 |
07/13/2009 |
APTUS FOOT SYSTEM |
MEDARTIS AG |
LINDA SCHULZ |
| K091586 |
07/23/2009 |
VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN |
MEDCOMP |
JEAN CALLOW |
| K090734 |
07/17/2009 |
EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES |
MEDICA CORP. |
Photios Makris |
| K083658 |
07/07/2009 |
PACS PLUS 5TH EDITION |
MEDICAL STANDARD CO., LTD. |
BRANDON CHOI |
| K092023 |
07/28/2009 |
NAVIJECT SUB2-1P, MODEL: LP604430 |
MEDICEL AG |
GEORGE MYERS |
| K083810 |
07/31/2009 |
PASS LP SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K090245 |
07/23/2009 |
SOLO INSULIN PATCH PUMP |
MEDINGO LTD. |
ARAVA HACOHEN |
| K092159 |
07/28/2009 |
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
SHIM KYUNG-AM |
| K090707 |
07/15/2009 |
TALOS INTERVERTEBRAL BODY FUSION DEVICE |
MEDITECH ADVISORS, LLC |
JANET M WEBB |
| K091454 |
07/24/2009 |
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM |
MEDTOX DIAGNOSTICS, INC. |
PHILLIP HARTZOG |
| K091442 |
07/15/2009 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
BRAD SHEALS |
| K091882 |
07/08/2009 |
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM |
MICROVENTION, INC. |
Naomi Gong |
| K091866 |
07/20/2009 |
PROGENY VANTAGE PANORAMIC X-RAY SYSTEM |
MIDMARK |
ALAN KREMA |
| K090670 |
07/07/2009 |
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER |
MIDMARK CORP. |
GARY BENNING |
| K090792 |
07/06/2009 |
MITAKA UNIARM |
MITAKA KOHKI CO., LTD. |
MAXWELL STURGIS |
| K091180 |
07/14/2009 |
MINITAPE URETHRAL SLING |
MPATHY MEDICAL DEVICES, LTD. |
CAROLINE STRETTON |
| K091178 |
07/31/2009 |
MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
YVONNE FERNANDEZ |
| K083294 |
07/24/2009 |
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST |
NANOSPHERE, INC |
GREGORT W SHIPP |
| K091645 |
07/21/2009 |
GOLD ANCHOR |
NASLUND MEDICAL AB |
TOMAS NASLUND |
| K090527 |
07/14/2009 |
SINUS QUICK IT SYSTEM |
NEOBIOTECH CO., LTD. |
JUNG BAE BANG |
| K090825 |
07/16/2009 |
SQ IS SYSTEM |
NEOBIOTECH CO., LTD. |
EUGENE BANG |
| K083154 |
07/10/2009 |
NEWDEAL HALLU LOCK PLATE SYSTEM |
NEWDEAL SAS |
JUDITH O'GRADY |
| K091788 |
07/29/2009 |
PANTA NAIL (DIA. 10MM), PANTA NAIL XL |
NEWDEAL SAS |
JUDITH O'GRADY |
| K090918 |
07/30/2009 |
NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER |
NFOCUS NEUROMEDICAL, INC. |
BOB FOUNDS |
| K091515 |
07/09/2009 |
SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
JOHN FENGLER |
| K091422 |
07/30/2009 |
NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) |
NOVAPRO CO., LTD. |
ZHENZHONG CHENG |
| K091421 |
07/23/2009 |
NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED) |
NOVAPRO CO., LTD. |
ZHENZHONG CHENG |
| K090981 |
07/02/2009 |
MODIFICATION TO: NUVASIVE SPHERX SYSTEM |
NUVASIVE, INC. |
HAN FAN |
| K091502 |
07/22/2009 |
NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
HAN FAN |
| K083594 |
07/21/2009 |
EZ HSG CATHETER.FOAMSEAL CATHETER |
OBG PRODUCTS |
AL MUZZAMMEL |
| K091444 |
07/20/2009 |
PERFSCAPE |
OLEA MEDICAL |
NEAL KOLBER |
| K090210 |
07/29/2009 |
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K091403 |
07/29/2009 |
MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY |
ONCOLOGY TECH, LLC |
SEAN COMER |
| K091829 |
07/28/2009 |
PLS PORTABLE LIGHT SOURCE |
OPTIM, INC. |
ROBERT KRUPA |
| K091666 |
07/15/2009 |
PASCAL PHOTOCOAGULATOR, PASCAL-US |
OPTIMEDICA CORPORATION |
DARLENE CROCKETT-BILLIG |
| K090587 |
07/17/2009 |
STARLIGHT |
ORTHOMERICA PRODUCTS, INC. |
ALAN T SANDIFER |
| K090901 |
07/06/2009 |
ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 |
OSMETECH MOLECULAR DIAGNOSTICS |
ROBERT S DICHECK |
| K090522 |
07/02/2009 |
OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM |
OSTEOMED L.P. |
ALMA RELJA |
| K090996 |
07/29/2009 |
PONTO PRO |
OTICON MEDICAL AB |
KAROLIN ISBERG |
| K090829 |
07/21/2009 |
PARI PEP S |
PARI RESPIRATORY EQUIPMENT, INC. |
MICHAEL JUDGE |
| K090485 |
07/22/2009 |
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 |
PERCUTANEOUS SYSTEMS, INCORPORATED |
THOMAS LAWSON |
| K083130 |
07/09/2009 |
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 |
PERKINELMER, INC. |
KAY A TAYLOR |
| K091804 |
07/17/2009 |
CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS |
PHILIPS ULTRASOUND, INC. |
ROB BUTLER |
| K091197 |
07/29/2009 |
PLANMECA PROSENSOR |
PLANMECA OY |
BOB PIENKOWSKI |
| K090733 |
07/28/2009 |
PMT HALO SYSTEM |
PMT CORP. |
ERIC CAILLE |
| K091296 |
07/17/2009 |
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 |
POLYMAP WIRELESS |
PIERRE LANDAU |
| K091392 |
07/30/2009 |
TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK |
POU YU BIOTECHNOLOGY CO., LTD. |
DANIEL TSAO |
| K091693 |
07/30/2009 |
TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK |
POU YU BIOTECHNOLOGY CO., LTD. |
DANIEL TSAO |
| K092088 |
07/16/2009 |
VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713 |
PRIDE MOBILITY PRODUCTS CORP. |
KIMBERLY BLAKE |
| K082620 |
07/08/2009 |
ONCE-A-DAY VERTOS TEST PACK |
PROPPER MFG. CO., INC. |
MARIAN M SCHUMAN |
| K091258 |
07/24/2009 |
EXTRAFIX EXTERNAL FIXATION SYSTEM |
QFX TECHNOLOGIES, INC. |
MARCOS VELEZ-DURAN |
| K091909 |
07/09/2009 |
LITHO LASER SYSTEM |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K091719 |
07/30/2009 |
NEOSALUS LOTION |
QUINNOVA PHARMACEUTICALS |
SHAHBAZ KHAN |
| K091517 |
07/14/2009 |
RALCO, MODEL R225 ACS |
RALCO S.R.L. |
DANIEL KAMM |
| K091792 |
07/08/2009 |
REST ASSURED GENERATION II DENTAL PROTECTOR |
RANIR CORPORATION |
JEFF FISHER |
| K091459 |
07/28/2009 |
PHILIPS NM3 MONITOR, MODEL 7900 |
RESPIRONICS NOVAMETRIX LLC |
KEVIN MADER |
| K091028 |
07/23/2009 |
OMNI 5 TOTAL O2 DELIVERY SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
| K091235 |
07/24/2009 |
RAMP RSV ASSAY |
RESPONSE BIOMEDICAL CORP. |
KEN PILGRIM |
| K091563 |
07/30/2009 |
RECRUIT MICROCATHETER |
REVERSE MEDICAL CORPORATION |
AMY ESKINA |
| K090541 |
07/02/2009 |
ELECSYS PRECICONTROL UNIVERSAL |
Roche Diagnostics |
GAIL SAUERS |
| K080380 |
07/23/2009 |
SAS INFLUENZA A & B TEST |
SA SCIENTIFIC, INC. |
ROBBI PERRY |
| K090477 |
07/27/2009 |
ALPINE PEDICLE SCREW SYSTEM |
SANACOR |
MICHAEL ENSIGN |
| K091252 |
07/22/2009 |
IMPLANT CENTER 2 |
SATELEC |
RICK ROSATI |
| K090937 |
07/24/2009 |
E-STATIS 40 SYSTEM |
SCICAN LTD. |
BRENDA MURPHY |
| K090812 |
07/30/2009 |
THERAFORM STANDARD/SHEET |
SEWON CELLONTECH CO., LTD. |
JUNG BAE BANG |
| K090194 |
07/07/2009 |
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR |
SHEN WEI (USA), INC. |
BELLE CHOU |
| K091941 |
07/09/2009 |
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
TAN CHUANBIN |
| K091523 |
07/09/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG CENTURY PLASTIC CO., LTD |
CHU XIAOAN |
| K091429 |
07/22/2009 |
VINYL POWDER FREE EXAMINATION GLOVE |
SHUN DA (XINGHUA) CO., LTD |
ZHANG YAN |
| K091383 |
07/22/2009 |
VINYL POWDER FREE EXAMINATION GLOVE |
SHUN TONG CO., LTD |
CHEE HOONG TAN |
| K091384 |
07/20/2009 |
VINYL POWDERED EXAMINATION GLOVE |
SHUN TONG CO., LTD |
CHEE HOONG TAN |
| K092013 |
07/17/2009 |
SYNGO VOLUME PERFUSION-CT BODY |
SIEMENS AG, MEDICAL SOLUTIONS |
|
| K091264 |
07/22/2009 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 |
SIEMENS HEALTHCARE DIAGNOSTICS |
SHANNON POPSON |
| K082848 |
07/24/2009 |
NUBIC AND RABEA DEVICES |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN |
| K082871 |
07/09/2009 |
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM |
SIS LTD. SURGICAL INSTRUMENT SYSTEMS |
Kevin Walls |
| K090935 |
07/01/2009 |
MINIME PEDIATRIC MASK |
SLEEPNET CORPORATION |
PAUL DRYDEN |
| K091147 |
07/27/2009 |
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K083113 |
07/22/2009 |
ACTICOAT FLEX 7 DRESSING |
SMITH & NEPHEW, INC. |
TERRY MCMAHON |
| K092015 |
07/30/2009 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K091470 |
07/09/2009 |
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 |
SMITH & NEPHEW, INC. |
LAURA KREJCI |
| K091627 |
07/02/2009 |
SMITH & NEPHEW INSTRUMENT TRAYS |
SMITH & NEPHEW, INC. |
CHRISTINA FLORES |
| K090955 |
07/16/2009 |
SMITH & NEPHEW RF CANNULATE |
SMITH & NEPHEW, INC. |
MASON W ROBBINS |
| K091224 |
07/09/2009 |
OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K091007 |
07/02/2009 |
AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K091008 |
07/15/2009 |
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K090655 |
07/14/2009 |
PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 |
SOURCE-RAY, INC. |
RAY MANEZ |
| K083334 |
07/30/2009 |
ELASTO-GEL MANUKA HONEY WOUND DRESSING |
SOUTHWEST TECHNOLOGIES, INC. |
EDWARD STOUT |
| K091299 |
07/01/2009 |
SPECTRANETICS TURBO-TANDEM SYSTEM |
SPECTRANETICS CORP. |
GRACIE MURGUIA |
| K091908 |
07/10/2009 |
M3 MONITOR |
SPECTRUM MEDICAL LTD |
STEVE TURNER |
| K091110 |
07/24/2009 |
SPINAL EDGE TITAN PEDICLE SCREW SYSTEM |
SPINAL EDGE, LLC |
CHRISTINA VACCA |
| K091587 |
07/01/2009 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K091044 |
07/09/2009 |
SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM |
SPINAL USA |
JEFFEREY JOHNSON |
| K082093 |
07/29/2009 |
BULLSEYE BILIARY STENT SYSTEM |
SQUAREONE |
Eric Ankerud |
| K090613 |
07/01/2009 |
CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
COLLEEN CANAN |
| K091858 |
07/01/2009 |
PINNACLE STAIR WAY LIFT |
SUMMIT HARMAR, LLC |
EDWARD KROL |
| K090336 |
07/01/2009 |
SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS |
SUNMAX ENTERPRISE SHANGHAI CO. LTD. |
JIGAR SHAH |
| K091689 |
07/10/2009 |
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM |
SYNTHES (USA) |
STACEY BONNELL |
| K090949 |
07/31/2009 |
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS |
SYNTHES (USA) |
KARL J NITTINGER |
| K091159 |
07/10/2009 |
SYNTHES ORACLE PLATE |
SYNTHES SPINE |
STACEY BONNELL |
| K091694 |
07/07/2009 |
MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) |
T.A.G. MEDICAL PRODUCTS |
GEORGIE J HATTUB |
| K090188 |
07/13/2009 |
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K082647 |
07/22/2009 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN DAR PLASTIC & RUBBER PRODUCTS CO. LTD. |
CHU XIAOAN |
| K090479 |
07/07/2009 |
TANITA BODY COMPOSITION ANALYZER, MODEL SC-331 |
TANITA CORPORATION OF AMERICA |
TOSHIHIKO ISHIKAWA |
| K083614 |
07/27/2009 |
SONOLITH I-SYS LITHOTRIPER |
TECHNOMED MEDICAL SYSTEMS, SA |
LYNETTE L HOWARD |
| K083242 |
07/29/2009 |
NEUROSIGN AVALANCHE MOTOR NERVE MONITOR |
THE MAGSTIM COMPANY LTD. |
ANWEN EVANS |
| K091617 |
07/17/2009 |
QMS LIDOCAINE CALIBRATORS, MODEL 0374678 |
Thermo Fisher Scientific |
JACK ROGERS |
| K090154 |
07/27/2009 |
SPI DENTAL IMPLANT INICELL |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| K070385 |
07/31/2009 |
TI-TAMED SPINAL SYSTEM |
TI-TAMED (PTY) LTD |
SANDRA MORTIMER |
| K091580 |
07/24/2009 |
PICA WHOLE BODY MRI SYSTEM |
TIME MEDICAL LIMITED |
Diana Hong |
| K090582 |
07/02/2009 |
CALCANEAL FRACTURE PLATE SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K092054 |
07/29/2009 |
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON |
TOSAMA D.D. |
ANTONIJA VIDENSEK |
| K092179 |
07/29/2009 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
|
| K090902 |
07/22/2009 |
SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 |
TRANSENTERIX, INC. |
TAMMY CARREA |
| K083912 |
07/15/2009 |
TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS |
TREU-INSTRUMENTE GMBH |
FRANZ MENEAN |
| K091156 |
07/15/2009 |
TRIMED STERILE PRODUCT |
TRIMED, INC. |
KELLI ANDERSON |
| K083896 |
07/02/2009 |
DESTINY MAX COAGULATION ANALYZER |
TRINITY BIOTECH |
Bonnie B DeJoy |
| K090828 |
07/28/2009 |
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES |
ULTRAWIN SDN BHD |
MAH SIEW HOE |
| K090612 |
07/24/2009 |
BENACEL |
UNICARE BIOMEDICAL |
STAN YANG |
| K083704 |
07/14/2009 |
NUTRAC PELVATOR, MODEL PEL 200 |
VERITY SCIENTIFIC LTD. |
BRENT REIDER |
| K091988 |
07/30/2009 |
MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 |
VERTEBRAL TECHNOLOGIES, INC. |
SURESH GHAI |
| K092081 |
07/21/2009 |
QXLINK |
VIEWORKS CO., LTD. |
CHARLIE MACK |
| K090221 |
07/01/2009 |
REACTION SYSTEM |
VIORA LTD. |
JOSEF LUZON |
| K090817 |
07/23/2009 |
IONOLUX |
VOCO GMBH |
M.TH. PLAUMANN |
| K091894 |
07/23/2009 |
TEMPORARY C&B COMPOSITE |
VOCO GMBH |
T. GERKENSMEIER |
| K091304 |
07/02/2009 |
VORTEX CANNULA |
VORTEX MEDICAL INC |
CHERYL BLAKE |
| K090954 |
07/30/2009 |
ATLAS WOUND MATRIX |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN M BELANEY |
| K090857 |
07/14/2009 |
VALOR ANKLE FUSION NAIL SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELLEN HILLS |
| K083409 |
07/29/2009 |
POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K083410 |
07/31/2009 |
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K083408 |
07/31/2009 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K090224 |
07/30/2009 |
FORTEX PEDICLE SCREW SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K090914 |
07/16/2009 |
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E |
XOFT, INC. |
STEVE LIN |
| K091796 |
07/31/2009 |
SOFTLASE PRO, ORTHOLASE AND HYGIENELASE |
ZAP LASERS, LLC |
JAY GOBLE |
| K091663 |
07/27/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. |
CHU XIAOAN |
| K091662 |
07/30/2009 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. |
CHU XIAOAN |
| K091661 |
07/27/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZHANG JIA GANG HUAYUAN PLASTIC CO. LTD. |
CHU XIAOAN |
| K091431 |
07/08/2009 |
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES |
ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD. |
JOHN ZHAO |
| K091190 |
07/30/2009 |
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 |
ZIMMER SPINE, INC |
HEATHER CRAWFORD |
