| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K100756 |
03/17/2010 |
MALTA |
3M ESPE AG DENTAL PRODUCTS |
DESI SOEGIARTO |
| K100647 |
03/08/2010 |
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 |
| K100718 |
03/12/2010 |
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 |
AALTO SCIENTIFIC LTD. |
BRANDON J PEREZ |
| K100750 |
03/16/2010 |
AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K100716 |
03/12/2010 |
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K100715 |
03/12/2010 |
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 |
AALTO SCIENTIFIC LTD. |
BRANDON J PEREZ |
| K100591 |
03/02/2010 |
SORBACT |
ABIGO MEDICAL AB |
CONSTANCE BUNDY |
| K100577 |
03/01/2010 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
KERI YEN |
| K100823 |
03/24/2010 |
WOUND PRO APEX |
ACCURO MEDICAL PRODUCTS LLC |
TODD HUBBARD |
| K100623 |
03/04/2010 |
AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS |
LISA M BOYLE |
| K100802 |
03/22/2010 |
AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
LISA M BOYLE |
| K100876 |
03/30/2010 |
AESCULAP MONOMAX ABSORBABLE SUTURE |
AESCULAP, INC. |
KATHY A RACOSKY |
| K100685 |
03/10/2010 |
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
CHERYL ALLEN |
| K100746 |
03/16/2010 |
FIBER ONE |
AMERICAN MEDICAL SYSTEMS |
DARLENE CROCKETT-BILLIG |
| K100807 |
03/22/2010 |
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 |
AMERICAN MEDICAL SYSTEMS, INC. |
DONNA SEMLAK |
| K100572 |
03/01/2010 |
VERSACLOSE, MODEL VC-200-01 |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K100747 |
03/16/2010 |
CONTREX PLUS LOW CONTROL SOLUTION |
APEX BIO TECHNOLOGY CORP |
THOMAS Y.S. SHEN |
| K100635 |
03/05/2010 |
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 |
ARROW INTL., INC. |
TRACY MADDOCK |
| K100615 |
03/04/2010 |
ARSTASIS ACCESS SYSTEM |
ARSTASIS, INC. |
SU-MIEN CHONG |
| K100652 |
03/08/2010 |
ACL TIGHTROPE |
ARTHREX, INC. |
GEENA AUGUSTINE |
| K100578 |
03/01/2010 |
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K100743 |
03/16/2010 |
ATLAS SPINE PIVOTING SYSTEM |
ATLAS SPINE INC. |
JEANNETTE G DAILEY |
| K100640 |
03/05/2010 |
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 |
B. BRAUN MEDICAL, INC. |
MATTHEW HOMA |
| K100607 |
03/03/2010 |
COULTER 4C-EX 300 CELL CONTROL |
BECKMAN COULTER, INC. |
LOURDES COBA |
| K100790 |
03/22/2010 |
COULTER LIN-X LINEARITY CONTROL, MODEL A81196 |
BECKMAN COULTER, INC. |
LOURDES M COBA |
| K100775 |
03/18/2010 |
BD INTIMA II CLOSED IV CATHETER |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
| K100722 |
03/15/2010 |
TELAVANCIN 30 UG, BBL SENSI-DISC |
Becton, Dickinson and Company |
JANINE SPAFFORD |
| K100740 |
03/16/2010 |
MD2000B VITAL SIGN MONITOR, MODEL MD2000B |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
DIANA HONG |
| K100622 |
03/04/2010 |
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 |
BELIMED SAUTER AG |
HANS STADLER |
| K100700 |
03/12/2010 |
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES |
BENLAN, INC. |
CHERYL BROWN |
| K100565 |
03/01/2010 |
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 |
BIO-DETEK, INC. |
ROBERT MORSE |
| K100556 |
03/01/2010 |
SLENDERTONE FLEX MAX, MODEL 517 US |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K100589 |
03/02/2010 |
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS |
BIO-RAD |
FRAN WHITE |
| K100727 |
03/15/2010 |
LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK |
BIO-RAD, DIAGNOSTICS GRP. |
SUZANNE PARSONS |
| K100847 |
03/25/2010 |
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 |
BIOCOMPATIBLES, INC. |
WAYNE W RICHARDSON |
| K100726 |
03/15/2010 |
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM |
BIOLITEC, INC. |
HARRY HAYES |
| K100613 |
03/04/2010 |
BIOMED WOUND CLEANSER |
BIOMED LABORATORIES, INC |
DONALD G WHITE |
| K100724 |
03/15/2010 |
OSSEOTITE II MODEL XIFOSSXXX |
BIOMET 3I, INC. |
JOSE E CABRERA |
| K100805 |
03/22/2010 |
GALLERY LAMINOPLASTY FIXATION SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
SHIKHA GOLA |
| K100691 |
03/10/2010 |
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 |
BIONIX DEVELOPMENT CORP. |
JAMES HUTTNER |
| K100761 |
03/17/2010 |
BIOPRO POLAR HEAD |
BIOPRO, INC. |
DAVID MRAK |
| K100560 |
03/01/2010 |
EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 |
Biotest Medical Corp. |
MAGGIE CHU |
| K100701 |
03/12/2010 |
SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 |
Biotest Medical Corp. |
MAGGIE CHU |
| K100885 |
03/30/2010 |
FETAL MONITOR MODEL: BT-200T |
BISTOS CO., LTD. |
YOUNG CHI |
| K100614 |
03/04/2010 |
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES |
BLACKSTONE MEDICAL, INC. |
DARLA CHEW |
| K100742 |
03/16/2010 |
EXACTECH GPS |
BLUE ORTHO |
ANTHONY BOYER |
| K100785 |
03/19/2010 |
BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES |
BONART CO. LTD. |
ERIC L ONG |
| K100892 |
03/31/2010 |
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX |
BOSTON SCIENTIFIC CORP. |
Scott Sepple |
| K100663 |
03/08/2010 |
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 |
Boston Scientific Corporation |
DEBBIE MCINTIRE |
| K100712 |
03/12/2010 |
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE |
Boston Scientific Corporation |
ASHLEY PYLE |
| K100843 |
03/25/2010 |
ABREU, MODEL 700 |
BRAIN TUNNELGENIX TECHNOLOGIES CORP |
DANIEL KAMM |
| K100786 |
03/19/2010 |
MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX |
BSD MEDICAL CORP. |
DIXIE TOOLSON SELLS |
| K100698 |
03/11/2010 |
STCC |
CARDINAL SPINE, LLC |
DAVID J COLLETTE |
| K100714 |
03/12/2010 |
CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 |
CEDARS-SINAI MEDICAL CENTER |
DAVID R DILLS |
| K100822 |
03/23/2010 |
XPERT MRSA/SA NASAL ASSAY |
CEPHEID |
RUSSEL K ENNS |
| K100723 |
03/15/2010 |
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 |
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. |
CHARLIE MACK |
| K100721 |
03/15/2010 |
LOCKING BONE SCREW MODEL HCQ04, HCZ04 |
CHANGZHOU ORTHMAR MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K100767 |
03/18/2010 |
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM |
CHURCH & DWIGHT CO., INC. |
JOSEPH CICCONE |
| K100695 |
03/11/2010 |
COLLADENTAL BARRIER |
COLLAMATRIX, INC |
DENNIS J. N. SEAH |
| K100878 |
03/30/2010 |
SELF CATH CATHETER |
COLOPLAST MANUFACTURING US, LLC |
BRIAN SCHMIDT |
| K100703 |
03/12/2010 |
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS |
COMED CO., LTD |
BRANDON CHOI |
| K100686 |
03/10/2010 |
CONMED MACROLYTE DISPERSIVE ELECTRODE |
CONMED CORPORATION |
SHAWN RIEDEL |
| K100799 |
03/22/2010 |
FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 |
CONTRACT MEDICAL INTL. GMBH |
JAN KLOBOUCNIK |
| K100879 |
03/30/2010 |
CONTRALCO |
CONTRALCO |
CAMILLE D THORNTON |
| K100850 |
03/26/2010 |
COWELL IMPLANT SYSTEM |
COWELLMEDI CO., LTD |
JOYCE BANG |
| K100841 |
03/25/2010 |
BONEOPTIMIZER |
CURASAN AG |
CYNTHIA J.M. NOLTE, PH.D. |
| K100633 |
03/05/2010 |
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 |
D B ORTHODONTICS LTD |
ANNA DYSON |
| K100628 |
03/05/2010 |
PLASMALUXLS |
DAAVLIN DISTRIBUTING CO. |
MICHELE THIEL |
| K100891 |
03/31/2010 |
DANA EMULATING INDICATOR |
DANA PRODUCTS, INC. |
HARRY BALA |
| K100806 |
03/22/2010 |
DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM |
DELBIO INCORPORATION |
NICKY PAN |
| K100638 |
03/05/2010 |
VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
SUSAN KAGAN |
| K100838 |
03/24/2010 |
ERGO IMAGING SYSTEM |
DIGIRAD CORP. |
Joel Tuckey |
| K100765 |
03/17/2010 |
FIXPINE II SYSTEM |
DIO MEDICAL CO., LTD. |
JOYCE BANG |
| K100895 |
03/31/2010 |
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) |
DIPPED PRODUCTS LIMITED |
W.S.E.F. FERNANDO |
| K100704 |
03/12/2010 |
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE |
DISETRONIC MEDICAL SYSTEMS AG |
Scott Thiel |
| K100794 |
03/22/2010 |
FLUORCANASITE DENTAL CERAMIC |
DR SARAH POLLINGTON |
JUDY BURTON |
| K100749 |
03/16/2010 |
FREQUENCER MODEL V2X |
DYMEDSO INC. |
Jean Bigoney |
| K100595 |
03/02/2010 |
ECLERIS MICROSTAR COLPOSCOPE |
Ecleris USA |
RAYMOND J KELLY IV |
| K100797 |
03/22/2010 |
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS |
EDAN INSTRUMENTS, INC. |
JIGAR SHAH |
| K100709 |
03/12/2010 |
EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M |
EDWARDS LIFESCIENCES, LLC. |
PATRICIA MILBANK, JD |
| K100739 |
03/16/2010 |
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 |
EDWARDS LIFESCIENCES, LLC. |
PATRICIA MILBANK |
| K100711 |
03/12/2010 |
SUCTION IRRIGATION ELECTRODES AND ADAPTERS |
ENCISION, INC. |
JUDITH V KING |
| K100900 |
03/31/2010 |
MOTIVATION KNEE SYSTEM |
ENCORE MEDICAL, L.P. |
ELIZABETH ONDERLINDE |
| K100741 |
03/16/2010 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K100670 |
03/09/2010 |
S-SCAN, MODEL 9800020010 |
ESAOTE, S.P.A. |
Allison Scott |
| K100883 |
03/30/2010 |
CARRIGEN |
ETEX CORP. |
CHRISTOPHER KLACZYK |
| K100597 |
03/02/2010 |
HARMONIC FOCUS SHEARS |
ETHICON ENDO-SURGERY, LLC |
MARCIA ARENTZ |
| K100789 |
03/22/2010 |
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST |
EVALVE INC |
KARUNA VELUSAMY |
| K100580 |
03/02/2010 |
EXSALT WOUND DRESSING |
EXCITON TECHNOLOGIES INC. |
JOHN SIMON |
| K100662 |
03/08/2010 |
FEMVUE CORNUAL BALLOON CATHETER |
FEMASYS INC. |
LISA PEACOCK |
| K100837 |
03/24/2010 |
PACENTRIC CONNECT, TRAVELER AND WEB |
FIMREITE SOFTWARE AS |
SVEIN FIMREITE |
| K100753 |
03/17/2010 |
FLIGHT 60 VENTILATOR, MODEL F-60 |
FLIGHT MEDICAL LTD. |
SHOSHANA FRIEDMAN |
| K100881 |
03/30/2010 |
SYNAPSE OBLIQUUS MIP/MPR/FUSION |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
PETER ALTMAN |
| K100762 |
03/17/2010 |
FLAT PANEL DETECTOR, MODEL FDR D-EVO |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
DEBBIE PEACOCK |
| K100831 |
03/24/2010 |
CYFRA 21-1 EIA MODEL 211-10 |
FUJIREBIO DIAGNOSTICS, INC |
STACEY DOLAN |
| K100585 |
03/02/2010 |
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 |
GAYMAR INDUSTRIES, INC. |
BRIAN L ORWAT |
| K100757 |
03/17/2010 |
TILOCK PEDICLE SCREW SYSTEM |
GENESYS SPINE |
JOSH KAUFMANN |
| K100563 |
03/01/2010 |
GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA |
GEON CORPORATION |
JENNIFER REICH |
| K100788 |
03/22/2010 |
COCR RODS |
GLOBUS MEDICAL INC. |
KELLY BAKER |
| K100839 |
03/24/2010 |
BARIREP |
GORBEC PHARMACEUTICAL SERVICES, INC. |
MATTHEW POPP |
| K100896 |
03/31/2010 |
GYRUS ACMI HALO PKS CUTTING FORCEPS |
GYRUS ACMI, INC. |
LORRAINE CALZETTA |
| K100816 |
03/23/2010 |
PK SUPERPULSE SYSEM GENERATOR MODEL 744000 |
GYRUS ACMI, INC. |
GRAHAM A.L. BAILLIE |
| K100731 |
03/15/2010 |
BOSWORTH AIR POLISHER |
HARRY J. BOSWORTH CO. |
GARY CHUVEN |
| K100620 |
03/04/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 |
HARVARD MEDICAL DEVICES LTD. |
MARTIN MA |
| K100745 |
03/16/2010 |
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM |
HOANA MEDICAL, INC. |
Cindy Green |
| K100692 |
03/10/2010 |
DIGITAL SPOT MAMMOGRAPHY SYSTEM |
HOLOGIC, INC. |
GAIL YAEKER-DAUNIS |
| K100840 |
03/24/2010 |
EMBO PLUS EMBOLECTOMY CATHETER |
HOTSPUR TECHNOLOGIES |
Eric Ankerud |
| K100842 |
03/25/2010 |
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM |
HOTSPUR TECHNOLOGIES |
Eric Ankerud |
| K100884 |
03/30/2010 |
STRYKER KNIFELIGHT |
HOWMEDICA OSTEONICS CORP. |
AVITAL MERL-MARGULIES |
| K100734 |
03/15/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
HUANFU PLASTIC PRODUCTS LIMITED |
CHU XIAOAN |
| K100702 |
03/12/2010 |
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 |
| K100576 |
03/01/2010 |
HIGH PRESSURE SETS-400 PSI |
ICU MEDICAL, INC. |
TRACY BEST |
| K100811 |
03/22/2010 |
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 |
IMPEDIMED LIMITED |
ALDEN KAY |
| K100660 |
03/08/2010 |
INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 |
INNOCHIPS TECHNOLOGY CO., LTD. |
BRANDON CHOI |
| K100574 |
03/01/2010 |
COLLEXA |
INNOCOLL PHARMACEUTICALS |
AARON WYSE |
| K100559 |
03/01/2010 |
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
INTERLACE MEDICAL INC. |
John Vozella |
| K100846 |
03/25/2010 |
IMC SURGICAL FACE MASK |
INTERNATIONAL MEDSURG CONNECTION |
PETER KIM |
| K100624 |
03/04/2010 |
INVENDO C20 COLONOSCOPY SYSTEM |
INVENDO MEDICAL GBMH |
OLIVER V RUEPPRECHT |
| K100766 |
03/17/2010 |
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN B REISS |
| K100590 |
03/02/2010 |
EDGE CO2 LASER SYSTEM |
JM SYSTEM CO., LTD. |
SU-GUN LEE |
| K100857 |
03/26/2010 |
FUSION MEDICAL RING LOCK SYSTEM |
JOHN J RICCIO |
JOHN RICCIO |
| K100851 |
03/26/2010 |
RANGE SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K100773 |
03/18/2010 |
KAI SPOT MODEL KMS 200 |
KAI MEDICAL, INC. |
ROBERT NAKATA |
| K100720 |
03/15/2010 |
K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING |
KAWASUMI LABORATORIES, INC. |
SUZAN ONEL |
| K100821 |
03/23/2010 |
PREVENA INCISION MANAGEMENT SYSTEM |
KCI USA, INC. |
MARGARET MARSH |
| K100657 |
03/08/2010 |
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 |
03/31/2010 |
OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
RON WARREN |
| K100803 |
03/22/2010 |
OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 |
KEYMED, INC. |
RONALD WARREN |
| K100793 |
03/22/2010 |
UROSTATION 3D PROSTATE SUITE |
KOELIS |
CECILE DESMULIE |
| K100706 |
03/12/2010 |
VENUS BASIC SPINAL FIXATION SYSTEM |
L & K BIOMED CO., LTD |
HEE KYEONG JOO |
| K100653 |
03/08/2010 |
JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD |
LANG DENTAL MFG. CO., INC. |
DAVID LANG |
| K100888 |
03/30/2010 |
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM |
LANX, INC. |
WILLIAM SANDUL |
| K100575 |
03/01/2010 |
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM |
LDR SPINE USA |
NOAH BARTSCH |
| K100616 |
03/04/2010 |
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 |
LIFE TECHNOLOGIES CORPORATION |
KELLI TANZELLA |
| K100858 |
03/26/2010 |
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, |
LIMA-LTO S.P.A. |
CHERYL HASTINGS |
| K100593 |
03/02/2010 |
SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME |
LSI SOLUTIONS, INC. |
PETER SPATH |
| K100610 |
03/03/2010 |
LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K100567 |
03/01/2010 |
PEARL DIABETES MANAGEMENT SYSTEM |
M2 GROUP HOLDINGS, INC. |
NAGHMEH NOURI |
| K100617 |
03/04/2010 |
MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K100673 |
03/09/2010 |
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 |
MEDICA CORP. |
Photios Makris |
| K100829 |
03/24/2010 |
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 |
MEDICA CORP. |
Photios Makris |
| K100874 |
03/30/2010 |
LIPOSONIX SYSTEM, MODEL 1 P00XXXX |
MEDICIS TECHNOLOGIES CORPORATION |
JONATHAN KAHAN |
| K100798 |
03/22/2010 |
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C |
MEDRAD, INC. |
SUSAN LYNN FELIX |
| K100693 |
03/11/2010 |
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING |
MEDTRADE PRODUCTS LIMITED |
JONATHAN D RANFIELD |
| K100631 |
03/05/2010 |
AFFIITY CP CENTRIFUGAL BLOOD PUMP |
MEDTRONIC INC. |
SUE FIDLER |
| K100646 |
03/05/2010 |
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE |
MEDTRONIC INC. |
JEFFREY L KOLL |
| K100645 |
03/05/2010 |
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE |
MEDTRONIC INC. |
JESSICA SIXBERRY |
| K100779 |
03/19/2010 |
SUSTAIN SPACE MAINTENANCE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MICHELLE OBENAUER |
| K100677 |
03/10/2010 |
LYMPHA PRESS 201MAX, MODEL 201MAX |
MEGO AFEK AC LTD |
AHAVA STEIN |
| K100818 |
03/23/2010 |
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 |
MERIDIAN BIOSCIENCE, INC. |
Michelle L Smith |
| K100569 |
03/01/2010 |
MERIT EMBOLECTOMY CATHETER MODEL ASAP100 |
MERIT MEDICAL SYSTEMS, INC. |
LINDSAY MARTIN |
| K100763 |
03/17/2010 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K100754 |
03/17/2010 |
GRAFT DELIVERY SYSTEM MODEL SA-6115 |
MICROMEDICS, INC. |
THOMAS A LOPAC |
| K100596 |
03/02/2010 |
CRYOPETTE |
MID-ATLANTIC DIAGNOSTICS, INC. |
ELISA D HARVEY |
| K100683 |
03/10/2010 |
NEUROLINK IP MODEL: PK1117 |
NATUS MEDICAL INCORPORATED |
GOLDY SINGH |
| K100625 |
03/04/2010 |
REALEYE MODEL VCPS |
NAVOTEK MEDICAL LTD |
STEVEN B DATLOF, M.D., J.D. |
| K100665 |
03/08/2010 |
MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX |
NEEDLETECH PRODUCTS, INC. |
RICK TRIPP |
| K100668 |
03/09/2010 |
NEMA-ST, MODEL V1.0.2 |
NERVOMATRIX LTD |
DAN LAOR |
| K100744 |
03/16/2010 |
CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 |
NEUWAVE MEDICAL, INC |
DANIEL KOSEDNAR |
| K100602 |
03/03/2010 |
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K100671 |
03/09/2010 |
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
| K100584 |
03/02/2010 |
EVIS EXERAII 180 SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY A KLUESNER |
| K100555 |
03/01/2010 |
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK |
OMNI LIFE SCIENCE, INC. |
RADHIKA PONDICHERRY |
| K100819 |
03/23/2010 |
THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER |
ONSET MEDICAL CORPORATION |
JOSEPH BISHOP |
| K100644 |
03/05/2010 |
OPTOS LIMITED PANORAMIC 200CAF |
OPTOS PLC |
HOWARD M HOLSTEIN |
| K100861 |
03/26/2010 |
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 |
OPTOVUE, INC. |
Azimun Jamal |
| K100875 |
03/30/2010 |
CEROX, MODEL 321OF |
OR-NIM MEDICAL LTD. |
MICHAL BALBERG |
| K100618 |
03/04/2010 |
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K100599 |
03/03/2010 |
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
| K100833 |
03/24/2010 |
SYLE SMARTIP |
OSSPRAY LTD |
DAVID GREENSPAN |
| K100815 |
03/23/2010 |
OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 |
OXYPULSE |
JAMES A DUNNING |
| K100661 |
03/08/2010 |
EARPROBE |
PATH MEDICAL GMBH |
KURT RENTEL |
| K100598 |
03/03/2010 |
PENRITH ELETTRA ULTRASOUND SYSTEM |
PENRITH CORPORATION |
LAWRENCE ENGLE |
| K100826 |
03/24/2010 |
PENUMBRA CATHERER 025 |
PENUMBRA, INC. |
SETH A SCHULMAN |
| K100769 |
03/18/2010 |
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 |
PENUMBRA, INC. |
MICHAELA MAHL |
| K100862 |
03/29/2010 |
BODYFLOW P2CH |
PHYSIOMED ELEKTROMEDIZIN AG |
BIRGIT SCHMID |
| K100708 |
03/12/2010 |
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES |
PIONEER SURGICAL TECHNOLOGY |
EMILY M DOWNS |
| K100854 |
03/26/2010 |
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 |
PREMIUM PLUS INTERNATIONAL LIMITED |
DENNIS NG |
| K100817 |
03/19/2010 |
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG, PH.D. |
| K100781 |
03/19/2010 |
OBSIDIAN CERAMIC BLOCKS |
PRISMATIK DENTALCRAFT, INC. |
KEITH ALLRED |
| K100801 |
03/22/2010 |
PUMA MODEL VERSION 1.0 |
PROWESS, INC. |
RACHEL SCARANO |
| K100813 |
03/23/2010 |
QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB |
PULSE BIOMEDICAL, INC. |
SALEEM HASAN |
| K100558 |
03/01/2010 |
QUANTA DIODE LASER SYSTEM |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K100678 |
03/10/2010 |
SUPRA SCAN DELIVERY SYSTEM |
QUANTEL MEDICAL |
PATRICK QUERO |
| K100777 |
03/18/2010 |
ABL837 FLEX ANALYZER |
RADIOMETER MEDICAL APS |
ROWENA JANSSON |
| K100733 |
03/15/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
RAYEN SAFETY PRODUCTS LIMITED |
CHU XIAOAN |
| K100735 |
03/15/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
RAYU PLASTIC PRODUCTS LIMITED |
CHU XIAOAN |
| K100606 |
03/03/2010 |
VATEA ENDONTIC IRRIGATION SYSTEM |
REDENT NOVA LTD |
JONATHAN S KAHAN |
| K100641 |
03/05/2010 |
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) |
RELIEVANT MEDSYSTEMS |
ADAM SAVAKUS |
| K100772 |
03/18/2010 |
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) |
RESMED LTD. |
DAVID D'CRUZ |
| K100611 |
03/03/2010 |
RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) |
RIVERSTONE RESOURCES SDN. BHD. |
CHONG CHU MEE |
| K100603 |
03/03/2010 |
RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) |
RIVERSTONE RESOURCES SDN. BHD. |
CHONG CHU MEE |
| K100810 |
03/22/2010 |
ELECSYS C-PEPTIDE CALCHECK 5 |
Roche Diagnostics |
KELLY ADAMS |
| K100594 |
03/02/2010 |
ELECSYS TROPONIN I CALCHECK 5 |
Roche Diagnostics |
Sarah Baumann |
| K100853 |
03/26/2010 |
COBAS 8000 MODULAR SERIES ANALYZER |
ROCHE DIAGNOSTICS CORP. |
ANGELO PEREIRA |
| K100893 |
03/31/2010 |
CHEVEUX DIODE LASER SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
| K100604 |
03/03/2010 |
OTIS -C PLUS |
SCIENCES ET BIO MATERIAUX (SBM) |
DENIS CLEMENT |
| K100626 |
03/05/2010 |
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
Diana Hong |
| K100830 |
03/24/2010 |
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K100699 |
03/11/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG STAR PLASTIC CO., LTD |
CHU XIAOAN |
| K100697 |
03/11/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD |
CHU XIAOAN |
| K100637 |
03/05/2010 |
SYNGO.CT CORONARY ANALYSIS |
SIEMENS AG, MEDICAL SOLUTIONS |
RALF HOFMANN |
| K100778 |
03/19/2010 |
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE T MARINELLI |
| K100619 |
03/04/2010 |
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 |
SIEMENS MEDICAL SOLUTIONS USA INC. |
ELAINE CHANG |
| K100795 |
03/22/2010 |
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
| K100897 |
03/31/2010 |
LEGION POROUS + HA TIBIAL BASEPLATES |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K100787 |
03/19/2010 |
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT |
SMITH & NEPHEW, INC. |
LAURA D REYNOLDS |
| K100736 |
03/15/2010 |
KIRSCHNER AND GUIDE WIRES |
SMT SCHILLING METALLTECHNIK GMBH |
ANDRE WEINGERL |
| K100649 |
03/08/2010 |
SOUNDBITE HEARING SYSTEM BY SONITUS |
SONITUS MEDICAL INC |
ROBERT J CHIN |
| K100605 |
03/03/2010 |
MIS SYSTEM |
SPINE WAVE, INC. |
DENISE DUCHENE |
| K100710 |
03/12/2010 |
ROLL-X GUIDEWIRE |
ST. JUDE MEDICAL |
Jennifer Zwiefelhofer |
| K100707 |
03/12/2010 |
REPROCESSED PINS |
STERILMED, INC. |
GARRETT AHLBORG |
| K100852 |
03/26/2010 |
STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 |
STRYKER COMMUNICATIONS |
ALMA RELJA |
| K100865 |
03/29/2010 |
AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX |
STRYKER SPINE |
KIMBERLY S LANE |
| K100737 |
03/15/2010 |
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K100836 |
03/24/2010 |
CLEARPOINT SYSTEM |
SURGIVISION, INC. |
JOHN J SMITH M.D., J.D. |
| K100824 |
03/24/2010 |
MECHANICAL WHEELCHAIR, MODEL DS 202-S |
SUZHOU KD MEDICAL |
JACOB CHANG |
| K100855 |
03/26/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K100856 |
03/26/2010 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K100849 |
03/26/2010 |
SYNC-RX SYSTEM, MODEL AS00010 |
SYNC-RX LTD |
A ANSELMO |
| K100776 |
03/18/2010 |
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM |
SYNTHES (USA) |
KARL J NITTINGER |
| K100634 |
03/05/2010 |
SYNTHES MATRIX SYSTEM |
SYNTHES (USA) |
AMNON TALMOR |
| K100676 |
03/10/2010 |
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL |
SYNTHES (USA) |
KARL J NITTINGER |
| K100887 |
03/30/2010 |
VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY |
T.A.G. MEDICAL PRODUCTS |
GEORGE J HATTUB |
| K100732 |
03/15/2010 |
FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 |
TaiDoc Technology Corporation |
NICKY PAN |
| K100658 |
03/08/2010 |
U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
NICKY PAN |
| K100694 |
03/11/2010 |
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN |
TEKMEDIC (M) SDN BHD |
PATRICK LEONG |
| K100588 |
03/02/2010 |
HUMAN IGA2 KIT FOR USE ON THE SPAPLUS |
THE BINDING SITE GROUP LTD |
JAY GELLER |
| K100800 |
03/22/2010 |
TIDI FACEMASK |
TIDI PRODUCTS, LLC |
DION BRANDT |
| K100889 |
03/31/2010 |
ENDOSKELETON TC |
TITAN SPINE, LLC |
JOHN J SMITH |
| K100562 |
03/01/2010 |
LATITUDE ELBOW PROSTHESIS |
TORNIER, INC. |
BRAHIM HADRI |
| K100784 |
03/19/2010 |
UC-CARE NAVIGO SYTEM |
UC-CARE LTD. |
JOHN KAHAN |
| K100812 |
03/23/2010 |
ULTICARE DISPOSABLE PEN NEEDLES |
ULTIMED, INC. |
MARY BETH HENDERSON |
| K100752 |
03/17/2010 |
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K100780 |
03/19/2010 |
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA |
UNILENE S.A.C. |
KEVIN WALLS, RAC |
| K100669 |
03/09/2010 |
CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES |
US MEDICAL INNOVATIONS LLC |
KRISTA OAKES |
| K100890 |
03/31/2010 |
VARIAN HIGH ENERGY LINEAR ACCELERATOR |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K100586 |
03/02/2010 |
VENUS FREEZE SYSTEM |
VENUS CONCEPT LTD |
YORAM LEVY |
| K100684 |
03/10/2010 |
CELLTRACKS AUTOPREP SYSTEM MODEL:9541 |
VERIDEX, LLC |
SARAH MCMANUS |
| K100687 |
03/10/2010 |
VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 |
VITALOGRAPH(IRELAND) LTD. |
TOM J HEALY |
| K100600 |
03/03/2010 |
PROSTHODONTIC SCREWDRIVER , MODEL IA-400 |
W & H DENTALWERK BUERMOOS GMBH |
JOHANN G SCHARL |
| K100682 |
03/10/2010 |
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U |
WALLAC OY |
KAY TAYLOR |
| K100820 |
03/23/2010 |
WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM |
WENZEL SPINE |
SOURABH MISHRA |
| K100656 |
03/08/2010 |
COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) |
WONJIN MULSAN CO., LTD. |
BRANDON CHOI |
| K100630 |
03/05/2010 |
G-FORCE PEEK SUTURE ANCHOR SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELLEN HILLS |
| K100579 |
03/02/2010 |
G-FORCE TI SUTURE ANCHOR SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELLEN HILLS |
| K100886 |
03/30/2010 |
INBONE II TOTAL ANKLE REPLACEMENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| K100866 |
03/29/2010 |
PROFEMUR HIP SYSTEM MODULAR NECKS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
GREGORY NEAL |
| K100728 |
03/15/2010 |
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K100845 |
03/25/2010 |
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES |
ZIMMER SPINE, INC |
DAVID PADGETT, RAC (US) |
| K100654 |
03/08/2010 |
ZOLL PROPAQ MD |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
PAUL DIAS |
| K100705 |
03/12/2010 |
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 |
ZYNO MEDICAL LLC |
CHAOYOUNG LEE |
