| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K071077 |
05/18/2007 |
.DECIMAL APERTURE |
.DECIMAL, INC. |
DANIEL BENNETT |
| K071078 |
05/22/2007 |
.DECIMAL RANGE COMPENSATOR |
.DECIMAL, INC. |
DANIEL BENNETT |
| DEN060009 |
05/08/2007 |
3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR |
3M COMPANY |
DIANNE GIBBS |
| K070956 |
05/22/2007 |
SEA2 SELF ETCH ADHESIVE |
3M ESPE DENTAL PRODUCTS |
KAREN O'MALLEY |
| K062979 |
05/30/2007 |
THYROSAMPLER |
ACD MEDICAL INNOVATION CORP. |
Kevin Walls |
| K070289 |
05/04/2007 |
ACQUASEAL BENZ |
ACQUAMED TECHNOLOGIES, INC. |
HUGH PALMER |
| K070396 |
05/22/2007 |
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
| K071014 |
05/24/2007 |
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR |
ADVANCED STERILIZATION PRODUCTS |
YOGI SHAH |
| K070642 |
05/07/2007 |
AERONEB PROFESSIONAL NEBULIZER SYSTEM |
AEROGEN (IRELAND) LTD |
FRANK ENRIGHT |
| K071162 |
05/08/2007 |
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS |
AGFA HEALTHCARE CORP. |
JEFFERY A JEDLICKA |
| K063545 |
05/07/2007 |
MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE |
ALFA SCIENTIFIC DESIGNS, INC. |
DAITING RONG |
| K070120 |
05/03/2007 |
AUTOVENT MODEL 4000 |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K062826 |
05/22/2007 |
AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS |
ALPHA-OMEGA SERVICES, INC. |
BOB A BOBNETT |
| K062823 |
05/29/2007 |
AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES |
ALPHA-OMEGA SERVICES, INC. |
BOB A ROBNETT |
| K062825 |
05/22/2007 |
AOS MARKER SEEDS |
ALPHA-OMEGA SERVICES, INC. |
BOB A ROBNETT |
| K070681 |
05/04/2007 |
NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM |
ALPHATEC SPINE, INC. |
PAULA MORGAN |
| K063668 |
05/18/2007 |
ROC LUMBAR SYSTEM |
ALPHATEC SPINE, INC. |
PAULA MORGAN |
| K071185 |
05/30/2007 |
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE |
AMBU A/S |
SANJAY PARIKH |
| K070993 |
05/09/2007 |
TOPAS SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
SARAH PETERSON |
| K061257 |
05/04/2007 |
DBEST HCG PANEL TEST KIT |
AMERITEK USA, INC. |
K C YEE |
| K070829 |
05/09/2007 |
SYNEPIX 4600 DETECTOR |
ANALOGIC CORPORATION |
DONALD J SHERRATT |
| K061943 |
05/25/2007 |
ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM |
ANATOMICA AB |
MARCOS VELEZ-DURAN |
| K070615 |
05/04/2007 |
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K071206 |
05/31/2007 |
ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE |
APATECH LTD. |
CANDACE F CEDERMAN |
| K070990 |
05/18/2007 |
APEX MEDICAL MOBINEB, 9R-027 SERIES |
APEX MEDICAL CORP. |
ALAN CHANG |
| K070609 |
05/04/2007 |
APEX MEDICAL XT1 CPAP, MODEL 9S-005 |
APEX MEDICAL CORP. |
ALAN CHANG |
| K070651 |
05/30/2007 |
ARAGON SURGICAL LAPCAP |
ARAGON SURGICAL INC. |
ALAN CURTIS |
| K062525 |
05/16/2007 |
REPROCESSED LIGASURE VESSEL SEALER/DIVIDER |
ASCENT HEALTHCARE SOLUTIONS |
MOIRA BARTON |
| K070755 |
05/08/2007 |
INTERWORKS |
AVREO, INC. |
NANCY BUTCHER |
| K070831 |
05/22/2007 |
VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION |
BARCOVIEW MIS EDINBURGH |
NEIL PHILLIPS |
| K070726 |
05/02/2007 |
NIO COLOR 3MP AND MDNC 3120 |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
LIEVEN DE WANDEL |
| K071095 |
05/18/2007 |
ASPIRA PLEURAL DRAINAGE SYSTEM |
BARD ACCESS SYSTEMS, INC. |
JIHYUN KIM |
| K071222 |
05/25/2007 |
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K070626 |
05/04/2007 |
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT |
BECKMAN COULTER, INC. |
TARA VIVIANI |
| K063318 |
05/03/2007 |
MONOLISA ANTI-HAV EIA |
Bio-Rad Laboratories |
MANUELA KAUL |
| K063319 |
05/03/2007 |
MONOLISA ANTI-HAV IGM EIA |
Bio-Rad Laboratories |
MANUELA KAUL |
| K070452 |
05/07/2007 |
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU |
BIO-RAD LABORATORIES, INC. |
JACKIE H BUCKLEY |
| K071091 |
05/17/2007 |
MODIFICATION TO BILOK SCREW |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K071115 |
05/17/2007 |
MODIFICATION TO BILOK ST SCREW |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K061323 |
05/23/2007 |
MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM |
BIOINFERA, INC. |
CHAN Q WANG |
| K071295 |
05/16/2007 |
100W CERALAS D 980NM DIODE LASER |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K061385 |
05/30/2007 |
OSSTAPLE, OSSPLATE, OSSFORCE |
BIOMEDICAL ENTERPRISES, INC |
W. CASEY FOX |
| K070147 |
05/14/2007 |
INTERGRO ORAL |
BIOMET 3I |
TAMARA J NELSON |
| K070399 |
05/04/2007 |
100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES |
BIOMET MANUFACTURING, INC. |
TRACY B JOHNSON |
| K070823 |
05/07/2007 |
GROWTH CONTROL PLATING SYSTEM |
BIOMET TRAUMA |
SUSAN ALEXANDER |
| K070364 |
05/03/2007 |
100KGY E-POLY MAXROM ACETABULAR LINERS |
BIOMET, INC. |
TRACY BICKEL JOHNSON |
| K070240 |
05/04/2007 |
CARTO XP EP NAVIGATION SYSTEM, VERSION 9 |
BIOSENSE WEBSTER, INC. |
NEELU MEDHEKAR |
| K070242 |
05/15/2007 |
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 |
BIOSENSE WEBSTER, INC. |
NEELU MEDHEKAR |
| K070324 |
05/03/2007 |
IPC-BOOT |
C-BOOT LTD. |
AVI ABRAHAM |
| K070996 |
05/08/2007 |
4 FR SINGLE LUMEN (SL) POWERPICC CATHETER |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
| K071204 |
05/18/2007 |
SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 |
C.R. BARD, INC. |
KIMBERLY GEISLER |
| K070235 |
05/18/2007 |
BODYGUARD PAIN MANAGER INFUSION SYSTEM |
CAESAREA MEDICAL ELECTRONICS LTD. |
SHLOMI DINES |
| K070070 |
05/25/2007 |
ASCENT DENTAL CLEANSER |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K071108 |
05/24/2007 |
TEXIUM SYRINGE |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
| K070740 |
05/07/2007 |
CHAD THERAPEUTICS BONSAI MODEL 800 |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
| K063269 |
05/23/2007 |
5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC |
CHI LIN TECHNOLOGY CO., LTD. |
JUDY LIN |
| K070054 |
05/04/2007 |
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST |
CHURCH & DWIGHT CO., INC. |
CYNTHIA DAVIDSON |
| K071355 |
05/24/2007 |
SMARTSPONGE SYSTEM |
CLEARCOUNT MEDICAL SOLUTIONS, INC. |
STEVEN FLECK |
| K070741 |
05/04/2007 |
CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K070814 |
05/30/2007 |
MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP |
CONFLUENT SURGICAL,INC |
KRISTINE BURKE |
| K070628 |
05/01/2007 |
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. |
CONTAMAC LTD. |
MARTIN DALSING |
| K063742 |
05/08/2007 |
RESONANCE METALLIC URETERAL STENT |
COOK IRELAND LTD |
SINEAD BURKE |
| K071189 |
05/16/2007 |
CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER |
CORDIS EUROPA, N.V. |
HARM HOVINGA |
| K062025 |
05/29/2007 |
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 |
CORGENIX, INC. |
KIMBERLY N HASSLER |
| K070893 |
05/01/2007 |
CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 |
CSA MEDICAL, INC. |
JENNIFER CARTLEDGE |
| K062572 |
05/11/2007 |
CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE |
CUSTOM SCIENTIFIC |
PATSY J TRISLER |
| K070860 |
05/11/2007 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K071076 |
05/21/2007 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K070529 |
05/08/2007 |
AFF (MARK I) VOLUMETRIC INFUSION PUMP |
DEFINITIVE MEDICAL TECHNOLOGIES, LTD. |
BOAZ BARTOV |
| K070124 |
05/23/2007 |
GASTROSTOMY REPLACEMENT TUBE, MODEL 253 |
DEGANIA SILICONE, LTD. |
ZOYA LEE |
| K070693 |
05/09/2007 |
AURAVUE PIT & FISSURE SEALANT |
DENALI CORPORATION |
JAN G STANNARD |
| K070702 |
05/10/2007 |
FUSION RESIN CEMENT AND CORE KIT |
DENALI CORPORATION |
JAN G STANNARD |
| K070307 |
05/02/2007 |
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K070925 |
05/02/2007 |
MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K071135 |
05/23/2007 |
DEPUY CI HIP INSTRUMENTATION |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
| K071117 |
05/18/2007 |
MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS |
DEPUY ORTHOPAEDICS, INC. |
Natalie Heck |
| K070994 |
05/09/2007 |
EAGLE + ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
FRANK S JURCZAK |
| K070568 |
05/25/2007 |
DIO PROTEM IMPLANT SYSTEM |
DIO DEPARTMENT DSI, INC. |
KENNY LIM |
| K070536 |
05/21/2007 |
MEDILAS D FAMILY LASERS |
DORNIER MEDTECH AMERICA, INC. |
Tim Thomas |
| K070692 |
05/30/2007 |
DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK |
DUKAL CORPORATION |
PATRICK J LAMB |
| K062724 |
05/11/2007 |
ACCUPULSE PULSE OXIMETER |
EAGLE MEDICAL EQUIPMENT CO. |
JAMES A DUNNING |
| K070427 |
05/14/2007 |
DUPEL TRANSPORT IONTOPHORESIS SYSTEM |
EMPI |
SANDRA WALROD |
| K070050 |
05/23/2007 |
VITALITY HIP SYSTEM MODEL#420 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K070193 |
05/02/2007 |
ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES |
ENVITEC-WISMAR GMBH |
STEPHEN GORSKI |
| K071028 |
05/01/2007 |
VIEWMATE SYSTEM |
EP MEDSYSTEMS |
LARRY PICCIANO |
| K070494 |
05/01/2007 |
EPI-C PLUS |
ESPANSIONE MARKETING SPA |
GUIDO BONAPACE |
| K070887 |
05/25/2007 |
ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) |
ETHICON ENDO-SURGERY, LLC |
DENNIS HAHN |
| K070763 |
05/22/2007 |
EUROIMMUN ANA IFA: HEP-20-10 |
EUROIMMUN US LLC |
KATHRYN KOHL |
| K070239 |
05/25/2007 |
MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM |
EXIR PHARMACEUTICAL CO. |
ERICA LI |
| K062563 |
05/18/2007 |
FEMTEN CERVICAL TENACULUM |
FEM SUITE, L.L.C. |
CARL YOUNGMANN |
| K063363 |
05/07/2007 |
FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE |
FLEXICATH LTD. |
AHAVA STEIN |
| K070920 |
05/22/2007 |
FUJI IP CASSETTE TYPE PC |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
DEBBIE PEACOCK |
| K070393 |
05/04/2007 |
LAGWIRE SYSTEM |
FXDEVICES |
RICH LIPSCHUTZ |
| K070840 |
05/15/2007 |
GVC-100 |
GC AMERICA, INC. |
TERRY L JORITZ-LYONS |
| K071073 |
05/11/2007 |
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KAREN M LUNDE |
| K063042 |
05/30/2007 |
CARDIOMEM CM 3000-12BT |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
SID MATHUR |
| K070475 |
05/07/2007 |
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K052480 |
05/02/2007 |
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH |
HANSEN MEDICAL, INC. |
NINA PELED |
| K071018 |
05/25/2007 |
MONARCH NASAL IMPLANT |
HANSON MEDICAL, INC. |
GERALD HANSON |
| K071006 |
05/21/2007 |
HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
| K071005 |
05/22/2007 |
HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
| K070593 |
05/07/2007 |
TRACKRECORD DATA MANAGEMENT SOFTWARE |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K070861 |
05/15/2007 |
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
HONG XIN RUBBER PRODUCTS CO., LTD |
KATHY LIU |
| K063104 |
05/16/2007 |
FOX MEDICAL DIODE LASER SYSTEM 810NM |
HOWARD INSTRUMENTS, INC. |
JACK HOWARD |
| K070963 |
05/04/2007 |
REUNION HA FRACTURE STEM |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
| K070885 |
05/16/2007 |
UNIVERSAL TAPER DELTA FEMORAL HEAD |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
| K071092 |
05/11/2007 |
ASNIS MICRO CANNULATED SCREW |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K070883 |
05/11/2007 |
DURACON X3 CS TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP. |
FRANCISCO HARO |
| K071188 |
05/21/2007 |
MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
| K071099 |
05/22/2007 |
NEURO II-SE, MODELS: OR-DR-OR, OR-MB |
IMRIS, INC. |
THOMAS M TSAKERIS |
| K070801 |
05/24/2007 |
IMM HYPODERMIC NEEDLE SET |
INNOVATIVE MEDICAL MANUFACTURING CO. |
JOSEPH J CHANG |
| K071301 |
05/24/2007 |
ANTLIA I WOUND IRRIGATION SYSTEM |
INNOVATIVE THERAPIES, INC. |
JUDITH HARBOUR |
| K070724 |
05/16/2007 |
IOS EXTERNAL FIXATOR, MODEL 2-0-0 |
INTELLIGENT ORTHOPAEDICS LTD |
Neil McLachlan |
| K062149 |
05/31/2007 |
SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES |
INTERNATIONAL BUSINESS STRATEGIES |
BILL ROETTGER |
| K071000 |
05/14/2007 |
MYRIAN |
INTRASENSE |
NICOLAS CLARY |
| K070646 |
05/11/2007 |
ADHESE ONE |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K070074 |
05/31/2007 |
LUBRINA, MODEL HIM-1 |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K070234 |
05/22/2007 |
JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS |
JMS NORTH AMERICA CORP. |
SWEE CHEAU CHONG |
| K070229 |
05/03/2007 |
RANGE SPINAL SYSTEM |
K2M, INC. |
RICHARD W WOODS |
| K070830 |
05/08/2007 |
MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) |
KAREX INDUSTRIES SDN BHD |
LENG KIAN GOH |
| K070716 |
05/31/2007 |
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
| K070827 |
05/22/2007 |
KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE CHEN |
| K070752 |
05/01/2007 |
KSEA MINIATURE ENDOSCOPE, MODEL 11565 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL K DIZOL |
| K070353 |
05/02/2007 |
KELSEY INTERSITITAL LASER THERAPY SYSTEM |
KELSEY, INC. |
PAUL KETTERIDGE |
| K071181 |
05/30/2007 |
DIRECT DIGITIZER, REGIUS MODEL 110 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSEL MUNVES |
| K062096 |
05/07/2007 |
KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST |
KOREAMEDICO CO. LTD. |
KIM YOUNG-YONG |
| K071338 |
05/29/2007 |
FLEX ARM RETRACTOR SYSTEM |
KOROS USA, INC. |
GABRIEL KOROS |
| K070331 |
05/04/2007 |
UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES |
LABORIE MEDICAL TECHNOLOGIES |
BARBARA MORNET |
| K063802 |
05/07/2007 |
LENSTEC LC INJECTION SYSTEM |
LENSTEC, INC. |
JIMMY CHACKO |
| K070974 |
05/24/2007 |
LIGHT RELIEF, MODEL LR150, LR200 |
LIGHT RELIEF, LLC |
LAURIE MCLAUGHLIN |
| K070825 |
05/25/2007 |
LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR |
LITTLE DOCTOR (SHANGHAI) ELECTRONIC MANUFACTURING |
David Zhang |
| K071231 |
05/17/2007 |
EDAC QUANTIFIER |
LUNA INNOVATIONS, INC. |
KRISTINE RICHARDSON |
| K070557 |
05/23/2007 |
MP 719 |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K070003 |
05/15/2007 |
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) |
MEDCOMP |
JEAN CALLOW |
| K070868 |
05/15/2007 |
LMS-LUNG/TRACK |
MEDIAN TECHNOLOGIES |
CHAS BURR |
| K070821 |
05/10/2007 |
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE |
MEDTEXX MANUFACTURING SDN. BHD. |
OOI LOON SENG |
| K070286 |
05/22/2007 |
BIO-CONSOLE, MODEL 560 |
Medtronic |
CHERYL NORTON |
| K070527 |
05/04/2007 |
ARCUATE VERTEBRAL AUGMENTATION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
| K070562 |
05/18/2007 |
EZ PLUS IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
DAE K CHANG |
| K070441 |
05/08/2007 |
METASURG SUBTALAR IMPLANT |
METASURG |
LARRY WEATHERFORD |
| K070456 |
05/24/2007 |
MICRUS COURIER ENZO MICROCATHETER 0.017 |
MICRUS ENDOVASCULAR CORPORATION |
R. MICHAEL CROMPTON |
| K070313 |
05/11/2007 |
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
MISONIX, INC. |
RONALD R MANNA |
| K070347 |
05/11/2007 |
ALLOFIX PUSH-IN ANCHOR |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY L BENNEWITZ |
| K062731 |
05/01/2007 |
ULTRASONIC SCALER, VARIOS 560 |
NAKANISHI, INC. |
NORIMASA KANEKO |
| K070934 |
05/22/2007 |
PANOSOL II TRU-BLU, MODEL UBL-417 |
NATIONAL BIOLOGICAL CORP. |
GEORGE KRINER |
| K070408 |
05/25/2007 |
DURAMAX REUSABLE OXIMETRY SENSOR |
NELLCOR PURITAN BENNETT, INC. |
JAMES BONDS |
| K071311 |
05/22/2007 |
NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL |
NEOCOIL |
BRIAN BROWN |
| K070416 |
05/29/2007 |
NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP |
NEOFORCE GROUP, INC. |
MARY STANIEWICZ |
| K062943 |
05/09/2007 |
POLYSMITH SLEEP SYSTEM, MODEL NTI5498 |
NEUROTRONICS, INC. |
JENNIFER LAINE |
| K071154 |
05/10/2007 |
SUPERSTAR 0.35T MRI SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
|
| K063693 |
05/11/2007 |
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST |
NEW BAY BIORESEARCH CO. LTD. |
RODRIGO BERLIE |
| K070688 |
05/18/2007 |
NEXFIX COMPRESSION STAPLE |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K071081 |
05/01/2007 |
CONTACT LENS CASE |
NINGBO KAIDA RUBBER AND PLASTIC TECHNOLOGY CO., LT |
Diana Hong |
| K063752 |
05/04/2007 |
LIFESENSE, MODEL LS1-9R |
NONIN MEDICAL, INC. |
LORI M ROTH |
| K070014 |
05/25/2007 |
AUTO DETECT FOR TELAHEART DR200/E-A |
NORTHEAST MONITORING, INC. |
JOSEPH AZARY |
| K070068 |
05/07/2007 |
NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD,PHD |
| K071037 |
05/10/2007 |
SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
| K071267 |
05/18/2007 |
PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN |
NOVAMIN TECHNOLOGY, INC. |
ROBERT G ROTHFRITZ |
| K070047 |
05/18/2007 |
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH |
NUNC A/S |
JANA S HELLMANN |
| K070834 |
05/18/2007 |
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) |
OMEGA MEDICAL IMAGING, INC. |
JAMES A PRINCEHORN |
| K070575 |
05/29/2007 |
EVICEL APPLICATION DEVICE |
OMRIX BIOPHARMACEUTICALS LTD. |
DAVID NAKAR |
| K063690 |
05/09/2007 |
COLIN PRESS MATE, MODEL BP S510 |
OMRON HEALTHCARE, INC. |
RANNDY KELLOGG |
| K063454 |
05/09/2007 |
POGS, MODEL 33C |
ON SITE GAS SYSTEMS, INC. |
GUY HATCH |
| K062171 |
05/25/2007 |
EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES |
ORTHO DEVELOPMENT CORP. |
JOHANNE YOUNG |
| K071216 |
05/25/2007 |
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
| K071215 |
05/25/2007 |
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
| K071243 |
05/23/2007 |
METAL HEMI IMPLANT |
ORTHOPRO LLC |
J.D. WEBB |
| K071173 |
05/25/2007 |
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D |
OSSUR AMERICANS (FORMERLY THE JEROME GROUP) |
BERNIE TATRO |
| K062192 |
05/24/2007 |
OSTIAL PRO STENT POSITIONING SYSTEM |
OSTIAL SOLUTIONS, LLC |
MICHAEL J BILLIG |
| K070318 |
05/11/2007 |
SKIPPI POWERED WHEELCHAIR FOR CHILDREN |
OTTO BOCK HEALTHCARE, LP |
SHANNON TUFVANDER |
| K071152 |
05/25/2007 |
PALOMAR ERBIUM HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
SHARON TIMBERLAKE, RAC, CCRA |
| K070637 |
05/01/2007 |
FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K071065 |
05/04/2007 |
ORTHADAPT BIOIMPLANT |
PEGASUS BIOLOGICS, INC. |
PAMELA MISAJON |
| K070807 |
05/23/2007 |
CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES |
PEPIN MFG., INC. |
Gary Syring |
| K063137 |
05/01/2007 |
PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000 |
PHARMASMART, INC. |
IAN GORDON |
| K070715 |
05/07/2007 |
NASOPORE EAR |
Polyganics BV |
JAN NIEUWENHUIS |
| K070363 |
05/11/2007 |
FETCH ASPIRATION CATHETER |
POSSIS MEDICAL, INC. |
FRANK B FREEDMAN |
| K070997 |
05/16/2007 |
DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX |
PRO-MED INSTRUMENTS GMBH |
EDGAR SCHUELE |
| K063494 |
05/21/2007 |
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS |
PRO-MED INSTRUMENTS GMBH |
EDGAR SCHUELE |
| K063202 |
05/02/2007 |
PRODERMA LIQUID BANDAGE |
PROCUREMENT TECHNOLOGY SYSTEMS, LLC |
WILLIAM J GRISWOLD |
| K070931 |
05/24/2007 |
MODEL PMT850 |
PROMEDTEK, INC. |
DIANE MANDELL |
| K070862 |
05/30/2007 |
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE) |
PURTECH CLEANROOM PRODUCTS CO., LTD. |
KATHY LIU |
| K071008 |
05/09/2007 |
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM |
RADIANT MEDICAL |
SCOTT A WILSON |
| K063584 |
05/09/2007 |
STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 |
REGENERATION TECHNOLOGIES, INC. |
Lisa Simpson |
| K070284 |
05/17/2007 |
FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) |
RELIANT TECHNOLOGIES, INC. |
HEATHER MACFALLS |
| K070739 |
05/25/2007 |
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 |
RENAL SOLUTIONS INC. |
DAVID J VANELLA |
| K063661 |
05/25/2007 |
RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 |
RENU MEDICAL, INC. |
BRUCE PIERSON |
| K070328 |
05/08/2007 |
BIPAP SYNCHRONY WITH AVAPS |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K070180 |
05/18/2007 |
WALLABY 4 |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K071041 |
05/11/2007 |
COAGUCHEK XS PLUS SYSTEM |
Roche Diagnostics |
THERESA BUSH |
| K070585 |
05/25/2007 |
ACCU-CHEK PERFORMA SYSTEM |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K062395 |
05/09/2007 |
ACCU-CHEK SMART PIX |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K071048 |
05/15/2007 |
RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 |
RUBICOR MEDICAL, INC. |
ROBERT J CHIN |
| K070388 |
05/02/2007 |
PROFILE MULTI-PLATFORM SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K062784 |
05/04/2007 |
SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405) |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
PAUL WARE |
| K071229 |
05/18/2007 |
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY |
SENORX, INC. |
EBEN GORDON |
| K070086 |
05/10/2007 |
SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR |
SENSACARE LTD. |
STEVEN CHANG |
| K070971 |
05/23/2007 |
MODIFICATION TO SENTINEL CLIN CHEM CAL |
SENTINEL CH. SRL |
FABIO ROTA |
| K063634 |
05/11/2007 |
RTR SYRINGE |
SEPTODONT |
WAYNE H MATELSKI |
| K070645 |
05/17/2007 |
SERADYN QMS TOPIRAMATE |
SERADYN INC. |
JACK ROGERS |
| K070982 |
05/02/2007 |
CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
BOB LEIKER |
| K063743 |
05/24/2007 |
RHYTHM TOUCH Q 2-WAY |
SHOCKIM ENTERPRISES, LTD. |
NICOLAAS C BESSELING |
| K071114 |
05/22/2007 |
SYNGO IMAGING (VERSION V30) |
SIEMENS AG, MEDICAL SOLUTIONS |
EVA REITER |
| K071017 |
05/02/2007 |
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
DEBORAH L MORRIS |
| K071068 |
05/14/2007 |
BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CRISTIN WETHERBEE |
| K071015 |
05/10/2007 |
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY RENDON |
| K071314 |
05/22/2007 |
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MARTINA VOGT |
| K071036 |
05/16/2007 |
MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
MARTINA VOGT |
| K063806 |
05/17/2007 |
SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED |
SLEEPNET CORPORATION |
PAUL CHIESA |
| K070793 |
05/30/2007 |
SBI DISTAL RADIUS VOLAR PLATING SYSTEM |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
| K070908 |
05/16/2007 |
SMITH & NEPHEW KINSA RC SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
DEANA BOUSHELL |
| K070565 |
05/18/2007 |
COFIELD TOTAL SHOULDER SYSTEM |
SMITH & NEPHEW, INC. |
MARLON D RIDLEY |
| K070116 |
05/23/2007 |
POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE |
SMITHS MEDICAL MD, INC. |
PHIL NEURURER |
| K071134 |
05/08/2007 |
SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM |
SONOSITE,INC. |
DAINA L GRAHAM |
| K071061 |
05/16/2007 |
ABSORBATACK AND APPLICATOR |
SORBX, LLC |
MARY LEE WILLETS |
| K070905 |
05/24/2007 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
SOUTHERN IMPLANTS, INC. |
GRETA M HOLS |
| K063764 |
05/16/2007 |
SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM |
SOUTHERN SPINE, LLC |
JULIE STEPHENS |
| K070595 |
05/24/2007 |
SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR |
SPSMEDICAL SUPPLY CORP. |
GARY SOCOLA |
| K063638 |
05/11/2007 |
MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 |
ST. JUDE MEDICAL |
SHANNON SPRINGER |
| K070902 |
05/01/2007 |
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 |
ST. JUDE MEDICAL |
KAREN J MCKELVEY |
| K063789 |
05/10/2007 |
WN SYNOCTA GOLD ABUTMENT |
STRAUMANN USA |
ELAINE ALAN |
| K063480 |
05/22/2007 |
STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750 |
STRYKER CORP. |
JEAN SHEPPARD |
| K070368 |
05/04/2007 |
TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM |
STRYKER CORP. |
SIMONA VOIC |
| K070758 |
05/16/2007 |
STRYKER PEEK ZIP SUTURE ANCHOR |
Stryker Endoscopy |
ERICA A WALTERS |
| K070457 |
05/16/2007 |
SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB |
SUN SCIENTIFIC LLC |
JOSEPH AZARY |
| K070750 |
05/02/2007 |
247 BP DEVICE |
SUNTECH MEDICAL, INC. |
CHUCK SETZER |
| K063680 |
05/09/2007 |
SHARPOINT PDO (POLYDIOXANONE) SUTURES |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K070678 |
05/02/2007 |
DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST |
SWISSRAY INTERNATIONAL, INC. |
JOHN MONAHAN |
| K070327 |
05/25/2007 |
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K063489 |
05/23/2007 |
STRYKER INTRADISCAL RF GENERATOR |
SYNERGETICS, INC. |
DAN REGAN |
| K070843 |
05/02/2007 |
SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K070910 |
05/25/2007 |
SYSMEX MODEL UF1000I |
SYSMEX AMERICA, INC. |
NINA M GAMPERLING |
| K070713 |
05/02/2007 |
IMPLANT LOCATION SOFTWARE-T |
TACTILE TECHNOLOGIES, LTD. |
URIEL WEINSTEIN |
| K070561 |
05/25/2007 |
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES |
TELEFLEX MEDICAL |
LORI HAYS |
| K071075 |
05/25/2007 |
TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A |
TERUMO CORP. |
YOSHIAKI NAGURA |
| K070264 |
05/29/2007 |
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K070362 |
05/07/2007 |
SURFLO WINGED INFUSION SET |
TERUMO EUROPE N.V. |
M J AERTS |
| K070547 |
05/25/2007 |
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K062475 |
05/09/2007 |
LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM |
THE LARYNGEAL MASK CO.,LTD. |
FOSTER BOOP |
| K070638 |
05/30/2007 |
THEKEN ATOLL CERVICO-THORACIC SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K070064 |
05/22/2007 |
AMYLASE EPS REAGENT |
Thermo Fisher Scientific |
MELITA LAMBIRIS |
| K070024 |
05/16/2007 |
THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE |
THOR INTERNATIONAL |
M. JOYCE HEINRICH |
| K063873 |
05/23/2007 |
ICARE TONOMETER TA01I |
TIOLAT OY |
NELSON TOBIN |
| K070612 |
05/07/2007 |
TOP-RANK ADHESIVE ELECTRODE |
TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. |
UWE DEGENHARDT |
| K070295 |
05/21/2007 |
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM |
TRINITY ORTHOPEDICS, LLC |
FLOYD G LARSON |
| K071106 |
05/08/2007 |
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 |
ULTRADENT PRODUCTS, INC. |
COREY JASEPH |
| K071055 |
05/03/2007 |
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 |
ULTRADENT PRODUCTS, INC. |
ROBERT WANG |
| K070591 |
05/11/2007 |
REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH |
UNION DENTAL S.A./UNIDESA.ODI |
JOSE LUIS RODRIGUEZ |
| K063611 |
05/23/2007 |
SALINE/ CONTRAST MEDIA INFUSION CATHETER |
UTAH MEDICAL PRODUCTS, INC. |
KEVIN L CORNWELL |
| K070446 |
05/02/2007 |
COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL |
VALLEYLAB,A DIVISION OF TYCO HEALTHCARE GROUP LP |
JULIE ROSS |
| K071217 |
05/17/2007 |
BLADDERSCAN BVI 9400 ULTRASOUND |
VERATHON INCORPORATED |
RUSS GARRISON |
| K070614 |
05/04/2007 |
CORSCREEN |
VIASYS HEALTHCARE GMBH |
DETLEF GROTHEER |
| K062011 |
05/11/2007 |
MODIFICATION TO FLOWSCREEN |
VIASYS HEALTHCARE GMBH |
Yvette Lloyd |
| K070759 |
05/21/2007 |
POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K071193 |
05/30/2007 |
VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS |
VIDAR SYSTEMS CORP. |
DANIEL KAMM |
| K071362 |
05/30/2007 |
VITAL CONNECT 4.1 |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS, MBA,RAC |
| K071331 |
05/25/2007 |
VITREA VERSION 4.0 |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
| K071054 |
05/22/2007 |
RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4 |
VOLUME INTERACTIONS PTE LTD |
MICHAEL SIM |
| K063367 |
05/23/2007 |
45L CORE INSUFFLATOR, MODEL F114 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
| K063868 |
05/25/2007 |
MASSTRAK IMMUNOSUPPRESSANTS KIT |
WATERS CORPORATION |
FRAN WHITE |
| K070964 |
05/18/2007 |
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM |
WELCH ALLYN, INC. |
CHRIS HORACEK |
| K070431 |
05/24/2007 |
WELMED, INC. SURGICAL GOWNS |
WELMED INC. |
Glen Feye |
| K070326 |
05/05/2007 |
NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM |
WIDEMED LTD |
DORIT WINITZ |
| K060968 |
05/15/2007 |
STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW |
WORTHAM LABORATORIES INC |
LEON WORTHAM |
| K071040 |
05/22/2007 |
WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS |
WRIGHT LINEAR PUMP, INC. |
CAROL WRIGHT |
| K070437 |
05/09/2007 |
PRO-DENSE BONE VOID FILLER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN M BELANEY |
| K070473 |
05/23/2007 |
BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX |
ZEN STRONG MEDICAL TECHNOLOGY CO., LTD |
CHENG ROEI-SHENG |
| K070677 |
05/11/2007 |
COLORISE |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K071235 |
05/30/2007 |
ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
| K070382 |
05/30/2007 |
VISTA -S DEVICE |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JENNIFER P HARAKAL |
| K070906 |
05/01/2007 |
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS |
ZIMMER, INC. |
MASON W ROBBINS |
