| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K063526 |
06/29/2007 |
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER |
A-M SYSTEMS, INC. |
JAY MANSOUR |
| K063753 |
06/20/2007 |
GFX NERVE ABLATION SYSTEM |
ACI, INC. |
CLAY ANSELMO |
| K070490 |
06/20/2007 |
CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) |
ADVANCED CIRCULATORY SYSTEMS, INC. |
PAUL DRYDEN |
| K062878 |
06/27/2007 |
EZPACS, VERSION 3.0 |
ADVANCED IMAGING SOLUTIONS, LLC |
RAY HASHEMI |
| K070444 |
06/14/2007 |
AOS TIBIAL NAIL |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
PAUL DONER |
| K071220 |
06/01/2007 |
COLUMBUS TOTAL KNEE SYSTEM AS |
AESCULAP IMPLANT SYSTEMS, INC. |
MATTHEW M HULL |
| K071125 |
06/18/2007 |
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 |
AGA MEDICAL CORP. |
JODI L RAUS |
| K070675 |
06/22/2007 |
MAMMAPRINT |
AGENDIA BV |
Guido Brink |
| K071297 |
06/22/2007 |
IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) |
AGFA HEALTHCARE CORP. |
TOM HOLBROOK |
| K070660 |
06/21/2007 |
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
MAJID PAJOUH |
| K070460 |
06/11/2007 |
ALLEZ SPINE CROSS CONNECTORS |
ALLEZ SPINE, LLC |
HARTMUT LOCH |
| K070924 |
06/21/2007 |
FLEXGUARD |
ALLMED SYSTEMS INC. |
PETER ALLEN |
| K070891 |
06/11/2007 |
ALTIVA CLASSIC ACP SYSTEM |
ALTIVA CORP. |
JOHN KAPITAN |
| K071430 |
06/21/2007 |
SYNERAD OMNI, MODELS AN6255 AND AN6265 |
ANALOGIC CORP. |
DONALD J SHERRATT |
| K070613 |
06/29/2007 |
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K070610 |
06/21/2007 |
SKATER BILIARY CATHETER |
ANGIOTECH |
TRUDY ESTRIDGE |
| K071195 |
06/20/2007 |
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 |
ANI-KAL II, LLC |
GERBAIL T KRISHNAMURTHY, MD |
| K070921 |
06/29/2007 |
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG |
APPLIED DNA TECHNOLOGIES, INC. |
Feng-Yu Lee |
| K071030 |
06/29/2007 |
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC |
APPLIED DNA TECHNOLOGIES, INC. |
Feng-Yu Lee |
| K070426 |
06/29/2007 |
SILHOUETTE, MODEL 1000.01 |
ARANZ MEDICAL LIMITED |
SHANE GOODWIN |
| K071177 |
06/29/2007 |
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW |
ARTHREX, INC. |
MARIELA CABARCAS |
| K061954 |
06/01/2007 |
ARTELON CMC SPACER ARTHRO |
ARTIMPLANT AB |
RUSSELL PAGANO |
| K061956 |
06/07/2007 |
ARTELON STT SPACER |
ARTIMPLANT AB |
RUSSELL PAGANO |
| K062885 |
06/13/2007 |
STRIDE MICROCATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K071064 |
06/22/2007 |
ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA |
ASCENSION ORTHOPEDICS, INC. |
GLEN NEALLY |
| K070572 |
06/26/2007 |
ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM |
ASH ACCESS TECHNOLOGY, INC. |
ROLAND WINGER |
| K062613 |
06/18/2007 |
BIS EEG MONITOR VIEW |
ASPECT MEDICAL SYSTEMS, INC. |
VIKRAM VERMA |
| K070833 |
06/22/2007 |
ATLANTIS ABUTMENT FOR ASTRA IMPLANT |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K071497 |
06/29/2007 |
ATLAS SPINE VERTEBRAL BODY REPLACEMENT |
ATLAS SPINE INC. |
JEANNETTE G DAILEY |
| K063282 |
06/20/2007 |
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET |
B. BRAUN MEDICAL, INC. |
REBECCA STOLARICK |
| K070533 |
06/21/2007 |
BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS |
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
;EYRE Z HERNANDO |
| K071543 |
06/29/2007 |
HALO360' COAGULATION CATHETER |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
| K071141 |
06/06/2007 |
BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 |
BD Biosciences |
NOBUKO NAKAJIMA |
| K071143 |
06/06/2007 |
BD TRITEST CD3/CD4/CD45, MODEL 340383 |
BD Biosciences |
NOBUKO NAKAJIMA |
| K071002 |
06/21/2007 |
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT |
BECKMAN COULTER, INC. |
TARA VIVIANI |
| K071280 |
06/01/2007 |
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS |
BECKMAN COULTER, INC. |
TARA M VIVIANI |
| K071277 |
06/01/2007 |
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS |
BECKMAN COULTER, INC. |
TARA M VIVIANI |
| K071283 |
06/01/2007 |
SYNCHRON SYSTEMS CREATININE REAGENT |
BECKMAN COULTER, INC. |
TARA M VIVIANI |
| K070654 |
06/08/2007 |
HYPERTHERMIA PUMP |
BELMONT INSTRUMENT CORP. |
URAIWAN P LABADINI |
| K070819 |
06/25/2007 |
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, |
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI |
JACKIE H BUCKLEY |
| K071319 |
06/26/2007 |
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 |
BIO-RAD, DIAGNOSTICS GRP. |
MARIA ZEBALLOS |
| K070810 |
06/08/2007 |
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) |
BIOKIT S.A. |
JOAN GUIXER |
| K063232 |
06/19/2007 |
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 |
BIOKIT S.A. |
JOAN GUIXER |
| K062558 |
06/20/2007 |
MESOSFOL SURGICAL FILM |
BIOMET MANUFACTURING CORP. |
ERIKA MARTIN |
| K070864 |
06/01/2007 |
BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER |
BIOMET OSTEOBIOLOGICS |
PALANISWAMY VIJAY |
| K063393 |
06/25/2007 |
SMALL STATURE SPACERS |
BIOMET SPINE |
SUSAN ALEXANDER |
| K071053 |
06/29/2007 |
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD |
BIOMET, INC. |
BECKY EARL |
| K070901 |
06/15/2007 |
MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM |
BIOPLATE, INC. |
JESUS T FARINAS |
| K070951 |
06/04/2007 |
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS |
BOSTON SCIENTIFIC |
BRIAN PARK |
| K071042 |
06/13/2007 |
POLARCATH PERIPHERAL DILATATION SYSTEM |
BOSTON SCIENTIFIC CORP. |
MONICA MORRISON |
| K071066 |
06/29/2007 |
SPYCATCH STONE RETRIEVAL BASKET |
BOSTON SCIENTIFIC CORP. |
NEIL KELLY |
| K071086 |
06/01/2007 |
RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 |
CALGARY SCIENTIFIC, INC. |
PIERRE LEMIRE |
| K070524 |
06/22/2007 |
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM |
CAMBRIDGE SENSORS LIMITED |
WARREN REEVES |
| K071396 |
06/28/2007 |
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS |
CAPINTEC, INC. |
MARY ANNE DELL |
| K070647 |
06/22/2007 |
TRIFLEX SELECT |
CARDINAL HEALTH, INC. |
AMY HOYD |
| K070380 |
06/08/2007 |
PORTACLAMP FLEX |
CARDIO LIFE RESEARCH, S.A. |
WILLIAM GREENROSE |
| K070425 |
06/11/2007 |
VITALSTIM EXPERIA |
CHATTANOOGA GROUP |
MICHAEL TREAS |
| K070939 |
06/01/2007 |
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM |
COLOPLAST MANUFACTURING US, LLC |
REBEKA STOLTMAN |
| K071050 |
06/29/2007 |
GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM |
COOLSYSTEMS, INC. |
MARIANNE BALDWIN |
| K063106 |
06/11/2007 |
REVOIS IMPLANT SYSTEM |
CURASAN AG |
ERIC WEICHERT |
| K070281 |
06/11/2007 |
ISSYS LP SPINAL FIXATION SYSTEM |
CUSTOM SPINE, INC. |
RICHARD JANSEN |
| K070853 |
06/13/2007 |
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K071268 |
06/26/2007 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K071142 |
06/06/2007 |
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM |
DATEX-OHMEDA |
DAN KOSEDNAR |
| K071158 |
06/05/2007 |
AURALAY PIT & FISSURE SEALANT |
DENALI CORPORATION |
JAN G STANNARD |
| K070869 |
06/15/2007 |
PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 |
DENTALEZ, INC. |
WILLIAM GUSCOTT |
| K071257 |
06/29/2007 |
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K070849 |
06/26/2007 |
DEPUY GCK FEMORAL AND TIBIAL COMPONENTS |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K071495 |
06/29/2007 |
EXPEDIUM 4.5MM SPINE SYSTEM |
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY |
CHRISTOPHER KLACZYK |
| K070760 |
06/07/2007 |
POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE |
DERMA CARE PLUS PRODUCTS LLC |
JOSEPH NEUSER |
| K070351 |
06/29/2007 |
SPACE 360 DELIVERY SYSTEM |
DFINE, INC. |
ROBERT POSER |
| K070383 |
06/22/2007 |
ENZYMATIC CREATININE ASSAY (265 SERIES) |
DIAGNOSTIC CHEMICALS LTD. |
DEBBIE M MURRAY |
| K070566 |
06/04/2007 |
INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL |
Draeger Medical Systems, Inc. |
MARK KIERAS |
| K071378 |
06/13/2007 |
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES |
E-Z-EM, INC. |
STEVEN HARTMAN |
| K070320 |
06/07/2007 |
EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 |
EDWARDS LIFESCIENCES SERVICES GMBH |
NEIL R ARMSTRONG |
| K071103 |
06/27/2007 |
HABIB HEXABLATE |
EMCISION, LTD. |
NAGY HABIB |
| K071180 |
06/20/2007 |
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 |
ENGINEERED MEDICAL SOLUTIONS CO. LLC |
WILLIAM G MCLAIN |
| K062630 |
06/28/2007 |
OSSIPRO BONE SUBSTITUTE MATERIAL |
ETEX CORP. |
FRANCES A FLORENCE |
| K070198 |
06/13/2007 |
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 |
ETHICON ENDO-SURGERY, LLC |
WENDY TURNER |
| K071249 |
06/05/2007 |
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV |
ETHICON, INC. |
PATRICE NAPODA |
| K070880 |
06/07/2007 |
ER35 ERO-SCAN PRO HEARING TEST SYSTEM |
ETYMOTIC RESEARCH, INC. |
CAMPBELL L TUSKEY |
| K061239 |
06/28/2007 |
EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT |
EUROIMMUN US LLC |
KATHRYN KOHL |
| K070890 |
06/29/2007 |
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 |
EVERLIFE MEDICAL EQUIPMENT CO., LTD. |
Ke-Min Jen |
| K063685 |
06/07/2007 |
OPTECURE; OPTECURE + CCC |
EXACTECH, INC. |
MARITZA ELIAS |
| K070917 |
06/20/2007 |
FEEL-JECT INSULIN SYRINGE |
FEEL TECH |
DANIEL KAMM |
| K062484 |
06/08/2007 |
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS |
FLAEM NUOVA S.P.A. |
MAUREEN O'CONNELL |
| K070617 |
06/14/2007 |
CANNULATED SCREW |
FOURNITURES HOSPITALIERES INDUSTRIE |
PATRICIA DONNARD |
| K071387 |
06/15/2007 |
FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET C KAY |
| K070815 |
06/20/2007 |
THD |
G.F. S.R.L. |
MAUREEN O'CONNELL |
| K071020 |
06/18/2007 |
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE |
GE HEALTHCARE |
JOEL KENT |
| K071570 |
06/27/2007 |
GE LUNAR BODY COMPOSITION SOFTWARE |
GE MEDICAL SYSTEMS LUNAR |
JAMES P RASKOB |
| K071352 |
06/29/2007 |
CERADRILL |
GEBR. BRASSELER GMBH & CO. KG |
OLAF BRAND |
| K071523 |
06/26/2007 |
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750 |
GENEXEL-SEIN, INC. |
JAY MANSOUR |
| K062883 |
06/13/2007 |
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR |
GEREONICS, INC. |
GERALD ROST |
| K071153 |
06/11/2007 |
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K071506 |
06/28/2007 |
ECHELON SPECTROSCOPY PACKAGE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K060434 |
06/05/2007 |
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL |
HORIBA ABX |
TIM LAWTON |
| K062737 |
06/12/2007 |
CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER |
HORIBA ABX |
TIM LAWTON |
| K070095 |
06/01/2007 |
TRIATHLON TS KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
| K070975 |
06/21/2007 |
SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES |
HU-FRIEDY MFG. CO., INC |
KEITH DUNN |
| K070633 |
06/05/2007 |
GENIE, MODEL CH-200 |
ICU MEDICAL, INC |
TRACY BEST |
| K071408 |
06/13/2007 |
X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
| K071409 |
06/08/2007 |
X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
| K071403 |
06/11/2007 |
X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHAN SAMARAPPULI |
| K071402 |
06/08/2007 |
X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
| K071401 |
06/22/2007 |
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
| K062636 |
06/01/2007 |
OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS |
IMPLANT INNOVATIONS, INC. |
JACQUELYN A HUGHES |
| K062541 |
06/07/2007 |
CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS |
INNOVA VISION INC. |
JENNIFER REICH |
| K063818 |
06/20/2007 |
QUANTA PLEX CELIAC IGA PROFILE |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| DEN060002 |
06/13/2007 |
INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM |
INRANGE SYSTEMS, INC. |
CHRISTOPHER E BOSSI |
| K070744 |
06/29/2007 |
NARROW NECK TEMPORARY COPING |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
| K071458 |
06/13/2007 |
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS |
INTEGRA LIFESCIENCES CORPORATION |
DONNA WALLACE |
| K070696 |
06/29/2007 |
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) |
INTERACOUSTICS A/S |
DANIEL EGGAN |
| DEN070006 |
06/13/2007 |
BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX |
INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX |
Anne Jepson |
| K070491 |
06/21/2007 |
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 |
K-JUMP HEALTH CO., LTD. |
DANIEL WANG |
| K063740 |
06/07/2007 |
V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 |
KCI USA, INC. |
MARGARET MARSH |
| K063692 |
06/07/2007 |
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 |
KCI USA, INC. |
MARGARET MARSH |
| K071237 |
06/01/2007 |
COPIOS BONE VOID FILLER SPONGE AND PASTE |
KENSEY NASH CORP. |
JENNIFER J BOSLEY |
| K070395 |
06/07/2007 |
KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
| K071436 |
06/27/2007 |
REGIUS UNITEA |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K071233 |
06/20/2007 |
XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM |
KUB TECHNOLOGIES, INC |
JOSEPH M AZARY |
| K071169 |
06/20/2007 |
CLEARFIL MAJESTY POSTERIOR PLT |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
| K071192 |
06/22/2007 |
BLUGOO HD |
LANCER ORTHODONTICS, INC. |
GRACE HOLLAND |
| K070995 |
06/22/2007 |
ARX-LINK CROSS CONNECTOR |
LIFE SPINE |
REBECCA M BROOKS |
| K070560 |
06/11/2007 |
LRTM SURGICAL MESH |
LIFECELL CORP. |
LORRAINE T MONTEMURRO |
| K071047 |
06/08/2007 |
MASIMO PATIENT SAFETY NET |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K071024 |
06/29/2007 |
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS |
MASIMO CORPORATION |
JAMES J CRONIN |
| K071241 |
06/08/2007 |
LMS-LIVER |
MEDIAN TECHNOLOGIES |
CHAS BURR |
| K063376 |
06/25/2007 |
EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER |
MEDICA CORP. |
Photios Makris |
| K063339 |
06/29/2007 |
MEDICK MHM200 PERSONAL HEART MONITOR |
MEDICK HEALTHCARE LTD. |
JAMES W SANDBERG |
| K063681 |
06/29/2007 |
TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE |
MEDILINE ITALIA S.R.L. |
PANTALEONI MAURIZIO |
| K063876 |
06/14/2007 |
MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING |
MEDIVATORS REPROCESSING SYSTEMS |
LYNN LUEDERS |
| K063670 |
06/28/2007 |
MODIFICATIONS TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
| K070288 |
06/18/2007 |
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 |
MEDTRONIC VASCULAR |
SCOTT CUNDY |
| K070648 |
06/29/2007 |
THE INHIBITOR, MODEL 001 |
MELMEDTRONICS, INC. |
DAVID W HOLMES |
| K070159 |
06/21/2007 |
PRELUDE SHEATH INTRODUCER |
MERIT MEDICAL SYSTEMS, INC. |
JERRIE HENDRICKSON |
| K070672 |
06/26/2007 |
MASSAGE MATTRESS VM9100RM |
METEK GMBH |
STEFAN ZIEGENFUB |
| K070656 |
06/15/2007 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
| K071246 |
06/01/2007 |
MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K071611 |
06/28/2007 |
NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL |
NEOCOIL |
BRIAN BROWN |
| K071058 |
06/29/2007 |
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
| K070255 |
06/13/2007 |
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD, PHD |
| K071488 |
06/29/2007 |
REALHAND HIGH DEXTERITY (HD) INSTRUMENTS |
NOVARE SURGICAL SYSTEMS, INC. |
GREGORY MATHISON |
| K063699 |
06/01/2007 |
IMDX SYSTEMS |
NOVX SYSTEMS INC. |
THOMAS TSAKERIS |
| K070835 |
06/04/2007 |
OLYMPUS CK-MB REAGENT |
OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH |
STEPHANIE G SCHWARTZ |
| K070453 |
06/11/2007 |
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL |
OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH |
STEPHANIE G SCHWARTZ |
| K071203 |
06/13/2007 |
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES |
OPTIKEM INTERNATIONAL, INC. |
MARTIN DALSING |
| K070926 |
06/07/2007 |
ELECTRODE/EXTENSION CABLES, MODELS ATAR |
Oscor Inc. |
MILA DOSKOCIL |
| K071178 |
06/22/2007 |
OTOMEDICS SOFT TYMPANOSTOMY TUBE |
OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD. |
AHAVA STEIN |
| K062902 |
06/07/2007 |
PAJUNKS EPILONG SET PEDIATRIC |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K061123 |
06/29/2007 |
PALM ECG RECORDER, MODEL EP-201/202 |
PARAMA-TECH COMPANY., LTD |
RICHARD KEEN |
| K071425 |
06/20/2007 |
UNITE BIOMATRIX |
PEGASUS BIOLOGICS, INC. |
PAMELA MISAJON |
| K070699 |
06/29/2007 |
AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN |
PENTRON CERAMICS, INC. |
MEGAN VERNAK |
| K070666 |
06/20/2007 |
GENESISCS COMPONENT CONCENTRATING SYSTEM |
PERFUSION PARTNERS & ASSOC. INC. |
NANCY LORD MD. ESQ |
| K071426 |
06/13/2007 |
MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
| K070559 |
06/29/2007 |
POLYMAP PWR-08-03 |
POLYMAP WIRELESS |
PIERRE LANDAU |
| K071278 |
06/29/2007 |
EMBRACE DUAL CURE COMPOSITE MATERIALS |
PULPDENT CORPORATION |
KENNETH J BERK |
| K071323 |
06/22/2007 |
POWDERED LATEX EXAMINATION GLOVES |
QUALITY GALLANT SDN. BHD. |
SEAH B HOON |
| K071358 |
06/01/2007 |
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM |
RADIANT MEDICAL |
SCOTT A WILSON |
| K070263 |
06/15/2007 |
APNEALINK |
RESMED GERMANY INC. |
DAVID D'CRUZ |
| K070878 |
06/05/2007 |
DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 |
RG MEDICAL DIAGNOSTICS |
RONALD G LE TOURNEAU |
| K071372 |
06/11/2007 |
MODIFICATION TO: INTERPLATE VBR SYSTEM |
RSB SPINE LLC. |
KAREN WARDEN |
| K061496 |
06/28/2007 |
SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST |
SA SCIENTIFIC LTD. |
RICARDO R MARTINEZ |
| K071109 |
06/07/2007 |
SACS EEG WORKSTATION A7 |
SACS MEDICAL AB |
SHEILA RAMERMAN |
| K070933 |
06/13/2007 |
LOWTOP PEDICLE SCREW SYSTEM |
SANACOR |
MICHAEL ENSIGN |
| K063498 |
06/11/2007 |
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) |
SEBIA |
KAREN ANDERSON |
| K070596 |
06/21/2007 |
TOPICAL APPLICATOR |
SHARN, INC. |
PAUL DRYDEN |
| K063407 |
06/11/2007 |
BC-3200 AUTO HEMATOLOGY ANALYZER |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K070791 |
06/26/2007 |
PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K070639 |
06/15/2007 |
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K071399 |
06/20/2007 |
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 |
SICEL TECHNOLOGIES, INC. |
TAMMY B CARREA |
| K071310 |
06/08/2007 |
SYNGO CT ONCOLOGY SOFTWARE PACKAGE |
SIEMENS AG |
KRISTIN FROWEIN |
| K071462 |
06/05/2007 |
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) |
SIEMENS HEARING INSTRUMENTS, INC. |
JON SCHIRADO |
| K071513 |
06/26/2007 |
INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY |
SIEMENS MEDICAL SOLUTIONS |
RALF HOFMANN |
| K071234 |
06/29/2007 |
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHEILA W PICKERING |
| K071179 |
06/13/2007 |
NORAS OR HEAD HOLDER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K071394 |
06/29/2007 |
MODIFICATION TO:SBI RINGFIX |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
| K070756 |
06/06/2007 |
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM |
SMITH & NEPHEW, INC. |
NICHOLAS TABRIZI |
| K070841 |
06/21/2007 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
SOUTHERN IMPLANTS, INC. |
GRETA M HOLS |
| K070449 |
06/14/2007 |
LUMILOC (TM) SAFETY INTRODUCER NEEDLE |
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. |
Mark Nelson |
| K071433 |
06/28/2007 |
SMS GLUCOSE CONTROL, MODEL 2120059 |
SPECIALTY MEDICAL SUPPLIES |
JOHN C GORMLEY |
| K070303 |
06/22/2007 |
SILICONE TISSUE EXPANDER |
SPECIALTY SURGICAL PRODUCTS |
ANGELA LAWRENCE |
| K071226 |
06/29/2007 |
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 |
SPECTRANETICS CORP. |
MICHAEL K HANDLEY |
| K070417 |
06/05/2007 |
ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 |
ST. JUDE MEDICAL |
Laura Moen-Ftacek |
| K070336 |
06/14/2007 |
STOCKERT NEURO N50, MODEL12267 |
STOCKERT GMBH |
DOMINIKA SCHULER |
| K062112 |
06/04/2007 |
SUNMED FOLEY CATHETERS |
SUNMED, INC. |
ARTHUR WARD |
| K070842 |
06/07/2007 |
ULCELOOCIN ORAL ULCER PATCH |
SUNSHINE INTERNATIONAL GROUP, INC. |
LIPING HE |
| K071184 |
06/22/2007 |
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K070946 |
06/06/2007 |
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K070573 |
06/08/2007 |
SYNAPSE SYSTEM |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
| K070941 |
06/21/2007 |
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 |
TaiDoc Technology Corporation |
ERICA LI |
| K062372 |
06/21/2007 |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K070786 |
06/28/2007 |
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT |
THEKEN SPINE LLC |
DALE DAVISON |
| K052936 |
06/12/2007 |
THERMAGE THERMACOOL SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K071232 |
06/20/2007 |
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
| K063388 |
06/22/2007 |
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM |
TOPCON CORP. |
JONATHAN S KAHAN |
| K071140 |
06/07/2007 |
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 |
TOPSPINS, INC. |
ERIN BUETHE |
| K063605 |
06/21/2007 |
ST AIA-PACK INTACT PTH ASSAY |
Tosoh BioScience, Inc. |
CHARLES P GILL |
| K061438 |
06/12/2007 |
ULTRAEZ DESENSITIZING GEL |
ULTRADENT PRODUCTS, INC. |
TAMMY LAVERY |
| K071360 |
06/08/2007 |
OPTICAL GUIDANCE PLATFORM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K070372 |
06/01/2007 |
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610 |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
| K070403 |
06/13/2007 |
PRONTO .035 EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
DORALIE POGANSKI |
| K071376 |
06/13/2007 |
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K071069 |
06/12/2007 |
MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY |
VIASYS SLEEP SYSTEMS, LLC. |
KEITH BOSECKER |
| K063768 |
06/27/2007 |
TITANIUM SCALLOPED ABUTMENT |
VIDENT |
ELIZABETH WOLFSEN |
| K070991 |
06/01/2007 |
VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 |
VITA |
ELIZABETH WOLFSEN |
| K070055 |
06/25/2007 |
BONALIVE GRANULES AND BONALIVE PLATES |
VIVOXID LTD. |
CONSTANCE G BUNDY |
| K071386 |
06/05/2007 |
AMARIS/AMARIS FLOW |
VOCO GMBH |
MANFRED THOMAS PLAUMANN |
| K070723 |
06/07/2007 |
FUTURABOND DC/SINGLE DOSE |
VOCO GMBH |
THORSTEN GERKENSMEIER |
| K070770 |
06/29/2007 |
GORE BALLOON SHEATH |
W. L. GORE & ASSOCIATES, INC. |
ALAN CURTIS |
| K071218 |
06/14/2007 |
PROXENON 350, MODEL 902XX |
WELCH ALLYN, INC. |
JOHN E SAWYER |
| K062704 |
06/08/2007 |
STERILIZATION POUCH WITH INDICATORS |
WINNER INDUSTRIES (SHENZHEN) CO., LTD. |
MING XIE |
| K070619 |
06/27/2007 |
POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K070580 |
06/13/2007 |
NASOPHARYNGOSCOPE, BRONCHOSCOPE |
XION GMBH |
ALEXANDER KLIEM |
| K063008 |
06/07/2007 |
HEALTH CHECK KIOSK |
XPEREX CORPORATION |
GEORGE MYERS |
| K071607 |
06/26/2007 |
ASA01 HEAVY DUTY SUCTION PUMP |
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. |
POLO CHEN |
| K071090 |
06/29/2007 |
TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION |
ZIMMER TRABECULAR METAL TECHNOLOGY |
KATHLEEN RUTHERFORD |
| K070695 |
06/07/2007 |
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS |
ZIMMER, INC. |
DALENE BINKLEY |
| K071025 |
06/22/2007 |
ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
EILEEN M BOYLE |
