FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K071077 |
04/17/2007 |
.DECIMAL APERTURE |
.DECIMAL, INC. |
DANIEL BENNETT |
K071078 |
04/17/2007 |
.DECIMAL RANGE COMPENSATOR |
.DECIMAL, INC. |
DANIEL BENNETT |
K071131 |
04/23/2007 |
UNO |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
K070956 |
04/05/2007 |
SEA2 SELF ETCH ADHESIVE |
3M ESPE DENTAL PRODUCTS |
KAREN O'MALLEY |
K070984 |
04/06/2007 |
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS |
ABBOTT DIABETES CARE INC. |
MARIA E TREJO |
K071174 |
04/27/2007 |
PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS |
ABBOTT SPINE, INC. |
ZARA OAKES |
K070943 |
04/04/2007 |
B-SCAN PLUS |
ACCUTOME ULTRASOUND, INC. |
Jeffrey Wright |
K070929 |
04/03/2007 |
ACON U120 URINE ANALYZER, MODEL U111-101 |
ACON LABORATORIES, INC. |
MARTIN O'CONNOR |
K071014 |
04/10/2007 |
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR |
ADVANCED STERILIZATION PRODUCTS |
YOGI SHAH |
K071120 |
04/20/2007 |
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999 |
AEMED, INC. |
RALPH JUGO |
K070981 |
04/06/2007 |
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) |
AESCULAP IMPLANT SYSTEMS, INC. |
Lisa Boyle |
K071125 |
04/23/2007 |
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 |
K071162 |
04/26/2007 |
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS |
AGFA HEALTHCARE CORP. |
JEFFERY A JEDLICKA |
K071165 |
04/26/2007 |
ISCALERT SENSOR SYSTEM |
ALERTIS MEDICAL AS |
CONSTANCE G BUNDY |
K070965 |
04/05/2007 |
ALICIA MENSTRUAL CUP |
ALICIA INTERNATIONAL PTY LTD. |
TOM STONE |
K070924 |
04/03/2007 |
FLEXGUARD |
ALLMED SYSTEMS INC. |
PETER ALLEN |
K071186 |
04/30/2007 |
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE |
AMBU A/S |
SANJAY PARIKH |
K071185 |
04/30/2007 |
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE |
AMBU A/S |
SANJAY PARIKH |
K071164 |
04/26/2007 |
LIFE+CEL BATTERY |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
ALEX HENDERSON |
K070993 |
04/09/2007 |
TOPAS SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
SARAH PETERSON |
K071195 |
04/30/2007 |
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 |
ANI-KAL II, LLC |
GERBAIL T KRISHNAMURTHY, MD |
K071128 |
04/23/2007 |
SCANSCOPE XT SYSTEM |
APERIO TECHNOLOGIES |
PERRY JOHNSTON |
K070990 |
04/09/2007 |
APEX MEDICAL MOBINEB, 9R-027 SERIES |
APEX MEDICAL CORP. |
ALAN CHANG |
K070921 |
04/02/2007 |
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG |
APPLIED DNA TECHNOLOGIES, INC. |
Feng-Yu Lee |
K071030 |
04/11/2007 |
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC |
APPLIED DNA TECHNOLOGIES, INC. |
Feng-Yu Lee |
K071111 |
04/20/2007 |
NON-ABSORBABLE SILK SUTURE |
ARROW INTL., INC. |
KARL J NITTINGER |
K071177 |
04/27/2007 |
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW |
ARTHREX, INC. |
MARIELA CABARCAS |
K071032 |
04/11/2007 |
ARTHREX UNIVERS II SHOULDER PROSTHESIS |
ARTHREX, INC. |
NANCY HOFT |
K071176 |
04/27/2007 |
MODIFICATION TO: ARTHREX INTERFERENCE SCREW |
ARTHREX, INC. |
ANN WATERHOUSE, RAC |
K070958 |
04/05/2007 |
MODIFICATION TO ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K070945 |
04/04/2007 |
ASAHI PTCA GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K071064 |
04/16/2007 |
ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA |
ASCENSION ORTHOPEDICS, INC. |
GLEN NEALLY |
K071095 |
04/18/2007 |
ASPIRA PLEURAL DRAINAGE SYSTEM |
BARD ACCESS SYSTEMS, INC. |
JIHYUN KIM |
K071043 |
04/12/2007 |
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES |
BAUSCH & LOMB, INC. |
DEBRA KETCHUM |
K071141 |
04/24/2007 |
BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 |
BD Biosciences |
NOBUKO NAKAJIMA |
K071143 |
04/24/2007 |
BD TRITEST CD3/CD4/CD45, MODEL 340383 |
BD Biosciences |
NOBUKO NAKAJIMA |
K071026 |
04/11/2007 |
BD GENEOHM STAPHSR ASSAY |
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) |
RAYMOND BOULE |
K071002 |
04/09/2007 |
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT |
BECKMAN COULTER, INC. |
TARA VIVIANI |
K071091 |
04/18/2007 |
MODIFICATION TO BILOK SCREW |
BIOCOMPOSITES LTD. |
SIMON FITZER |
K071115 |
04/20/2007 |
MODIFICATION TO BILOK ST SCREW |
BIOCOMPOSITES LTD. |
SIMON FITZER |
K071121 |
04/20/2007 |
TRIBONE 80 |
BIOMATLANTE |
ADELINE FILLIATRE |
K071146 |
04/24/2007 |
VIDAS B.R.A.H.M.S. PCT ASSAY |
BIOMERIEUX, INC. |
NIKITA S MAPP |
K070961 |
04/05/2007 |
BIOMERIX SURGICAL MESH, MODEL: RCR-01 |
BIOMERIX CORPORATION |
CHRISTINA L KICHULA |
K070955 |
04/05/2007 |
ACID ETCHED LAG SCREWS |
BIOMET ORTHOPEDICS, INC. |
BECKEY EARL |
K071053 |
04/13/2007 |
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD |
BIOMET, INC. |
BECKY EARL |
K070901 |
04/02/2007 |
MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM |
BIOPLATE, INC. |
JESUS T FARINAS |
K071004 |
04/09/2007 |
OSTEOCRETE BONE VOID FILLER |
BONE SOLUTIONS, INC. |
CHRISTINE EMANUEL |
K070951 |
04/04/2007 |
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS |
BOSTON SCIENTIFIC |
BRIAN PARK |
K071042 |
04/12/2007 |
POLARCATH PERIPHERAL DILATATION SYSTEM |
BOSTON SCIENTIFIC CORP. |
MONICA MORRISON |
K071066 |
04/16/2007 |
SPYCATCH STONE RETRIEVAL BASKET |
BOSTON SCIENTIFIC CORP. |
NEIL KELLY |
K071011 |
04/10/2007 |
MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER |
BRAEMAR, INC. |
DARREN DERSHEM |
K070996 |
04/09/2007 |
4 FR SINGLE LUMEN (SL) POWERPICC CATHETER |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
K071086 |
04/17/2007 |
RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 |
CALGARY SCIENTIFIC, INC. |
PIERRE LEMIRE |
K071108 |
04/19/2007 |
TEXIUM SYRINGE |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
K070968 |
04/05/2007 |
CHOY COMPRESSION FRAME |
CHOY MEDICAL TECHNOLOGIES, INC. |
JONATHAN S KAHAN |
K071196 |
04/30/2007 |
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS |
COEUR, INC. |
DEBRA F MANNING |
K070939 |
04/04/2007 |
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM |
COLOPLAST MANUFACTURING US, LLC |
REBEKA STOLTMAN |
K071100 |
04/19/2007 |
AMNISCREEN HOME DETECTION LINER KIT |
COMMON SENSE, LTD. |
NATASHA LESKOVSEK |
K071172 |
04/27/2007 |
MODIFIED MERCI RETRIEVER, MODEL 90060 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
K071050 |
04/13/2007 |
GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM |
COOLSYSTEMS, INC. |
MARIANNE BALDWIN |
K071189 |
04/30/2007 |
CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER |
CORDIS EUROPA, N.V. |
HARM HOVINGA |
K070918 |
04/02/2007 |
4DDOME |
COUSIN BIOTECH |
PAUL DRYDEN |
K071148 |
04/24/2007 |
ATLAS IMPLANT SYSTEM |
COWELL MEDI CO., LTD. |
CHANG D KYU |
K071076 |
04/16/2007 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K071142 |
04/24/2007 |
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM |
DATEX-OHMEDA |
DAN KOSEDNAR |
K071158 |
04/25/2007 |
AURALAY PIT & FISSURE SEALANT |
DENALI CORPORATION |
JAN G STANNARD |
K070925 |
04/03/2007 |
MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
K071135 |
04/23/2007 |
DEPUY CI HIP INSTRUMENTATION |
DEPUY ORTHOPAEDICS, INC. |
NATALIE S HECK |
K071016 |
04/10/2007 |
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
DEPUY ORTHOPAEDICS, INC. |
KATHY HARRIS |
K071059 |
04/16/2007 |
DEPUY SPA POROUS COATED PROXIMAL SLEEVE |
DEPUY ORTHOPAEDICS, INC. |
KATHY HARRIS |
K071117 |
04/20/2007 |
MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS |
DEPUY ORTHOPAEDICS, INC. |
Natalie Heck |
K070994 |
04/09/2007 |
EAGLE + ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
FRANK S JURCZAK |
K071039 |
04/12/2007 |
MISSION OLYMPUS AU ISE CALIBRATORS |
DIAMOND DIAGNOSTICS, INC. |
KATHRYN THORSEN |
K071168 |
04/27/2007 |
THE PORTABLE ANSISCOPE |
DYANSYS, INC. |
MICHAEL A DANIEL |
K071080 |
04/17/2007 |
ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M |
E SURGICAL, LLC |
HANS J RICHTER |
K071166 |
04/26/2007 |
UNIWEB, VERSION 5.0 |
ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) |
ANDY YEW |
K071103 |
04/19/2007 |
HABIB HEXABLATE |
EMCISION, LTD. |
NAGY HABIB |
K071180 |
04/30/2007 |
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 |
ENGINEERED MEDICAL SOLUTIONS CO. LLC |
WILLIAM G MCLAIN |
K071028 |
04/11/2007 |
VIEWMATE SYSTEM |
EP MEDSYSTEMS |
LARRY PICCIANO |
K070903 |
04/02/2007 |
MYLAB40 |
ESAOTE EUROPE B.V. |
CARRI GRAHAM |
K070917 |
04/02/2007 |
FEEL-JECT INSULIN SYRINGE |
FEEL TECH |
DANIEL KAMM |
K071104 |
04/19/2007 |
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM |
FLIER'S QUALITY WATER SYSTEMS INC |
JAMES FLIER |
K070920 |
04/02/2007 |
FUJI IP CASSETTE TYPE PC |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
DEBBIE PEACOCK |
K071079 |
04/17/2007 |
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 |
GAMBRO BCT, INC. |
PATTI L ARNDT |
K071020 |
04/10/2007 |
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE |
GE HEALTHCARE |
JOEL KENT |
K071175 |
04/27/2007 |
OHMEDA MEDICAL GIRAFFE OMNIBED |
GE HEALTHCARE |
AGATA SMIEJA |
K071097 |
04/18/2007 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
ADRIENNE LENZ |
K071073 |
04/16/2007 |
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KAREN M LUNDE |
K071153 |
04/25/2007 |
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
K071187 |
04/30/2007 |
MICROFUSE BONE VOID FILLER |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
K071022 |
04/11/2007 |
POWDER-FREE VINYL EXAMINATION GLOVES |
GLORMED COLOMBIA S.A. |
SAM KAO |
K070966 |
04/05/2007 |
GSO GS1 SPINAL SYSTEM |
GOLD STANDARD ORTHOPAEDICS, LLC |
DAVID BAUGHMAN |
K071119 |
04/20/2007 |
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) |
GX CORPORATION SDN BHD |
FOO KHON PU |
K071194 |
04/30/2007 |
RAPHAEL COLOR ASV VENTILATOR |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
K071149 |
04/24/2007 |
HRI 6500, 6600 AND 6700 SERIES V2MASKS |
HANS RUDOLPH, INC. |
KEVIN RUDOLPH |
K071018 |
04/10/2007 |
MONARCH NASAL IMPLANT |
HANSON MEDICAL, INC. |
GERALD HANSON |
K071006 |
04/09/2007 |
HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
K071005 |
04/09/2007 |
HEARTWAY LIGHTWEIGHT POWER CHAIR, P15 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
K071007 |
04/09/2007 |
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
K071150 |
04/25/2007 |
TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR MAESER |
K070963 |
04/05/2007 |
REUNION HA FRACTURE STEM |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
K071082 |
04/17/2007 |
STRYKER MODULAR HIP SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
K071092 |
04/18/2007 |
ASNIS MICRO CANNULATED SCREW |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K070948 |
04/04/2007 |
HSINER NEBULIZER BOTTLE |
HSINER |
TOM SHANKS |
K070975 |
04/06/2007 |
SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES |
HU-FRIEDY MFG. CO., INC |
KEITH DUNN |
K070979 |
04/06/2007 |
PULL TAB SQUEEZE FLUSH |
ICU MEDICAL, INC |
TRACY BEST |
K071188 |
04/30/2007 |
MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
K071099 |
04/19/2007 |
NEURO II-SE, MODELS: OR-DR-OR, OR-MB |
IMRIS, INC. |
THOMAS M TSAKERIS |
K070998 |
04/09/2007 |
INION BIORESTORE |
INION OY |
KATI MARTTINEN |
K070904 |
04/02/2007 |
ANTLIA II SUCTION PUMP SYSTEM |
INNOVATIVE THERAPIES, INC. |
JUDITH HARBOUR |
K070927 |
04/03/2007 |
HEMOSIL D-DIMER HS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K071035 |
04/12/2007 |
IFS BONE FIXATION DEVICES |
INTERNAL FIXATION SYSTEMS, INC. |
STEVE HERNANDEZ |
K071000 |
04/09/2007 |
MYRIAN |
INTRASENSE |
NICOLAS CLARY |
K070947 |
04/04/2007 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
K071118 |
04/20/2007 |
GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE |
IVES EEG SOLUTIONS, INC. |
JOHN R IVES |
K071190 |
04/30/2007 |
ROOT ZX II |
J. MORITA USA, INC. |
ROBERT A SILVERMAN |
K071070 |
04/16/2007 |
OLYMPUS DENTAL IMPLANT SYSTEM |
KEYSTONE DENTAL, INC. |
FLOYD G LARSON |
K071067 |
04/16/2007 |
BACTRACK LCD ALCOHOL DETECTOR |
KHN SOLUTIONS, LLC |
DANIEL KAMM |
K071181 |
04/30/2007 |
DIRECT DIGITIZER, REGIUS MODEL 110 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSEL MUNVES |
K071169 |
04/27/2007 |
CLEARFIL MAJESTY POSTERIOR PLT |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
K071192 |
04/30/2007 |
BLUGOO HD |
LANCER ORTHODONTICS, INC. |
GRACE HOLLAND |
K070995 |
04/09/2007 |
ARX-LINK CROSS CONNECTOR |
LIFE SPINE |
REBECCA M BROOKS |
K070974 |
04/06/2007 |
LIGHT RELIEF, MODEL LR150, LR200 |
LIGHT RELIEF, LLC |
LAURIE MCLAUGHLIN |
K071088 |
04/18/2007 |
LIFE LATCH SHARPS & BIOHAZARD CONTAINER |
M&M INDUSTRIES, INC. |
NORMAN F ESTRIN |
K071047 |
04/13/2007 |
MASIMO PATIENT SAFETY NET |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
K071024 |
04/11/2007 |
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS |
MASIMO CORPORATION |
JAMES J CRONIN |
K071094 |
04/18/2007 |
MODIFICATION TO SOLAR GI |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
KARIN OGINK-SOMHORST |
K071133 |
04/23/2007 |
APEXNRG-BLUE ELECTRONIC APEX LOCATOR |
MEDICNRG LTD. |
GEORGE J HATTUB |
K071167 |
04/26/2007 |
FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 |
MEDIGROUP, INC. |
JOHN A NAVIS |
K071033 |
04/12/2007 |
T2 XVBR SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
K071101 |
04/19/2007 |
TRU RSV |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
K071019 |
04/10/2007 |
DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES |
MESURE TECHNOLOGY CO.,LTD. |
JOHN CHEN |
K070897 |
04/02/2007 |
BONEMEDIK, AND BONEMEDIK-S |
META BIOMED CO., LTD. |
TAE-HOON KIM |
K071137 |
04/24/2007 |
SONICATOR PLUS 940, MODEL ME940 |
METTLER ELECTRONICS CORP. |
ROB FLEMING |
K071085 |
04/17/2007 |
E3-80 PORTABLE ECG RECORDER & ANALYZER |
MICRO-STAR INTERNATIONAL CO., LTD. |
ALBUM D TSAI |
K070934 |
04/03/2007 |
PANOSOL II TRU-BLU, MODEL UBL-417 |
NATIONAL BIOLOGICAL CORP. |
GEORGE KRINER |
K070899 |
04/02/2007 |
PURITAN BENNETT LEGENDAIR XL2 |
NELLCOR PURITAN BENNETT |
JAMES BONDS |
K071154 |
04/25/2007 |
SUPERSTAR 0.35T MRI SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
|
K071147 |
04/24/2007 |
NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM |
NEXA ORTHOPEDICS, INC. |
MARY MCNAMARA-CULLINANE |
K071058 |
04/16/2007 |
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
K071081 |
04/17/2007 |
CONTACT LENS CASE |
NINGBO KAIDA RUBBER AND PLASTIC TECHNOLOGY CO., LT |
Diana Hong |
K071145 |
04/24/2007 |
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
K071182 |
04/30/2007 |
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K070960 |
04/05/2007 |
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K071056 |
04/16/2007 |
NEUTROPHASE WOUND CLEANSER |
NOVABAY PHARMACEUTICALS |
LUANA STAIGER |
K071037 |
04/12/2007 |
SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000 |
NOVADAQ TECHNOLOGIES, INC. |
ALLISON MANNERS |
K071191 |
04/30/2007 |
NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT |
NOVARTIS NUTRITION CORP. |
|
K070937 |
04/04/2007 |
MULTIPLE BRAND MALE LATEX CONDOM |
NULATEX SDN. BHD. |
KIM L LEE |
K070983 |
04/06/2007 |
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K070926 |
04/03/2007 |
ELECTRODE/EXTENSION CABLES, MODELS ATAR |
Oscor Inc. |
MILA DOSKOCIL |
K071173 |
04/27/2007 |
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D |
OSSUR AMERICANS (FORMERLY THE JEROME GROUP) |
BERNIE TATRO |
K071105 |
04/19/2007 |
OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM |
OSTEOMED L.P. |
DAWN D TINDALL |
K070985 |
04/06/2007 |
AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC |
OSYPKA MEDICAL, INC. |
MARKUS OSYPKA |
K071178 |
04/27/2007 |
OTOMEDICS SOFT TYMPANOSTOMY TUBE |
OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD. |
AHAVA STEIN |
K071152 |
04/25/2007 |
PALOMAR ERBIUM HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
SHARON TIMBERLAKE, RAC, CCRA |
K071063 |
04/16/2007 |
LINASYS |
PATHFINDER THERAPEUTICS, INC. |
JAMES D STEFANSIC |
K071065 |
04/16/2007 |
ORTHADAPT BIOIMPLANT |
PEGASUS BIOLOGICS, INC. |
PAMELA MISAJON |
K070970 |
04/06/2007 |
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F |
PENUMBRA, INC. |
THERESA BRANDNER-ALLEN |
K070973 |
04/06/2007 |
QUANTUM SPINAL SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
K070928 |
04/03/2007 |
CERAMIC BALL HEADS, 28, 32 AND 36 MM |
PLUS ORTHOPEDICS AG |
PAMELA J WEAGRAFF |
K070950 |
04/04/2007 |
LIFT CHAIR, MODEL C5 |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS J SCHAPPERT |
K070997 |
04/09/2007 |
DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX |
PRO-MED INSTRUMENTS GMBH |
EDGAR SCHUELE |
K070931 |
04/03/2007 |
MODEL PMT850 |
PROMEDTEK, INC. |
DIANE MANDELL |
K070976 |
04/06/2007 |
RII INFRARED EAR THERMOMETER, MODEL TH01BN |
RADIANT INNOVATION INC. |
FRANK LIN |
K071008 |
04/09/2007 |
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM |
RADIANT MEDICAL |
SCOTT A WILSON |
K070954 |
04/05/2007 |
PATIENTGALLERY IMAGING SOFTWARE |
RASTER BUILDERS, INC. |
DAVID L STARK |
K071023 |
04/11/2007 |
REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C |
REACH SURGICAL, INC |
RICH GRANT |
K071013 |
04/10/2007 |
REDSENSE |
REDSENSE MEDICAL AB |
CONSTANCE G BUNDY |
K070907 |
04/02/2007 |
INTERSON USB ULTRASOUND PROBE SYSTEM |
REGULATORY MANAGEMENT SERVICES |
GARY J ALLSEBROOK |
K071051 |
04/13/2007 |
FRAXEL III SR LASER SYSTEM AND ACCESSORIES |
RELIANT TECHNOLOGIES, INC. |
HEATHER MACFALLS |
K071171 |
04/27/2007 |
VPAP AUTO WITH H3I |
RESMED LTD. |
DAVID D'CRUZ |
K071113 |
04/20/2007 |
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 |
RESTORATIVE THERAPIES INC. |
ANDREW BARRISKILL |
K070999 |
04/09/2007 |
BC (BODY COMPOSITION SOFTWARE) |
RJL SYSTEMS, INC. |
BARRY CALLAHAN |
K071041 |
04/12/2007 |
COAGUCHEK XS PLUS SYSTEM |
Roche Diagnostics |
THERESA BUSH |
K071048 |
04/13/2007 |
RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 |
RUBICOR MEDICAL, INC. |
ROBERT J CHIN |
K071109 |
04/18/2007 |
SACS EEG WORKSTATION A7 |
SACS MEDICAL AB |
SHEILA RAMERMAN |
K071093 |
04/18/2007 |
SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202 |
SAN SHIH ELECTRICAL ENTERPRISE CO., LTD. |
Ke-Min Jen |
K070933 |
04/03/2007 |
LOWTOP PEDICLE SCREW SYSTEM |
SANACOR |
MICHAEL ENSIGN |
K070915 |
04/02/2007 |
SAPIMED DISPOSABLE SIGMOIDOSCOPE |
SAPIMED S.P.A. |
E J SMITH |
K070913 |
04/02/2007 |
SELF-LIGHT DISPOSABLE ANOSCOPE |
SAPIMED S.P.A. |
E J SMITH |
K071010 |
04/09/2007 |
TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS |
SCHUTZ-DENTAL GMBH |
MICHAEL WIERZ |
K071155 |
04/25/2007 |
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER |
SCIENCE FOR BIOMATERIALS |
DENIS CLEMENT |
K070987 |
04/06/2007 |
SENTINEL LITHIUM ASSAY |
SENTINEL CH SPA |
FABIO ROTA |
K070971 |
04/06/2007 |
MODIFICATION TO SENTINEL CLIN CHEM CAL |
SENTINEL CH. SRL |
FABIO ROTA |
K071060 |
04/16/2007 |
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) |
SGMP CO., LTD. |
JANNA P TUCKER |
K071072 |
04/16/2007 |
SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE |
SHANGHAI CHINA STAR CORP |
ROMIL RAMBHIA |
K070982 |
04/06/2007 |
CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
BOB LEIKER |
K070988 |
04/06/2007 |
SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) |
SHINCHANG MEDICAL CO., LTD. |
JAN J FRANK |
K071074 |
04/16/2007 |
MYKRES SPINAL SYSTEM |
SHOWA IKA KOHGYO CO.,LTD. |
FLOYD G LARSON |
K071114 |
04/20/2007 |
SYNGO IMAGING (VERSION V30) |
SIEMENS AG, MEDICAL SOLUTIONS |
EVA REITER |
K071017 |
04/10/2007 |
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
DEBORAH L MORRIS |
K071068 |
04/16/2007 |
BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CRISTIN WETHERBEE |
K071179 |
04/27/2007 |
NORAS OR HEAD HOLDER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
K071015 |
04/10/2007 |
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY RENDON |
K071036 |
04/12/2007 |
MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
MARTINA VOGT |
K071170 |
04/27/2007 |
POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
K070908 |
04/02/2007 |
SMITH & NEPHEW KINSA RC SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
DEANA BOUSHELL |
K071071 |
04/16/2007 |
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS |
SMITH & NEPHEW, INC. |
RISHI SINHA |
K071160 |
04/26/2007 |
REFLECTION, TANDEM UNIPOLAR |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
K071134 |
04/23/2007 |
SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM |
SONOSITE,INC. |
DAINA L GRAHAM |
K071061 |
04/16/2007 |
ABSORBATACK AND APPLICATOR |
SORBX, LLC |
MARY LEE WILLETS |
K071156 |
04/25/2007 |
SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER |
SOUNMED, INC. |
JHOANA LORES |
K070905 |
04/02/2007 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
SOUTHERN IMPLANTS, INC. |
GRETA M HOLS |
K071161 |
04/26/2007 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
SOUTHERN IMPLANTS, INC. |
GRETA M HOLS |
K071151 |
04/25/2007 |
TENSION BAND ANTERIOR SPINAL SYSTEM |
SPINAL INSTRUMENTATION SIMPLIFICATION SYSTEMS LLC |
KAREN E WARDEN |
K070922 |
04/02/2007 |
MODIFICATION TO SPINAL USA VBR SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
K070902 |
04/02/2007 |
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 |
ST. JUDE MEDICAL |
KAREN J MCKELVEY |
K070911 |
04/02/2007 |
STD MED PRIMO PORT |
STD MED, INC. |
PAMELA PAPINEAU |
K071029 |
04/11/2007 |
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) |
STEREOTAXIS, INC. |
DENNIS POZZO |
K070930 |
04/03/2007 |
REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS |
STERILMED, INC. |
DENNIS TOUSSAINT |
K071087 |
04/17/2007 |
VIS-U-ALL II HEAT-SEAL POUCH AND TUBING |
STERIS Corporation |
JOHN R SCOVILLE |
K071157 |
04/25/2007 |
STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS |
Stryker Endoscopy |
JEFF SEMONE |
K070935 |
04/03/2007 |
T.B.R. ZIRCONNECT |
SUDIMPLANT SA |
DIDIER SAILHAN |
K070896 |
04/02/2007 |
ENSEAL PTC TISSUE SEALING DEVICE |
SURGRX, INC. |
LINDA OLESON |
K071184 |
04/30/2007 |
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K071046 |
04/13/2007 |
SYNTHES CHRONOS COMPOSITE |
SYNTHES (USA) |
JEFFREY DOW |
K070946 |
04/04/2007 |
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K070910 |
04/02/2007 |
SYSMEX MODEL UF1000I |
SYSMEX AMERICA, INC. |
NINA M GAMPERLING |
K070941 |
04/04/2007 |
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 |
TaiDoc Technology Corporation |
ERICA LI |
K071075 |
04/16/2007 |
TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A |
TERUMO CORP. |
YOSHIAKI NAGURA |
K070900 |
04/02/2007 |
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K070962 |
04/05/2007 |
CORAL PEDICLE SCREW SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
K071031 |
04/11/2007 |
VU E*POD VERTEBRAL BODY REPLACEMENT |
THEKEN SPINE LLC |
DALE DAVISON |
K071126 |
04/23/2007 |
CRYOSEAL FS APPLICATOR SYSTEM |
THERMOGENESIS CORP. |
JOHN CHAPMAN |
K071057 |
04/16/2007 |
COLONIC & ENEMA NOZZLE |
TILLER MIND BODY, INC. |
HAROLD L JONES |
K071140 |
04/24/2007 |
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 |
TOPSPINS, INC. |
ERIN BUETHE |
K071132 |
04/23/2007 |
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 |
Tosoh BioScience, Inc. |
CHARLES P GILL |
K071027 |
04/11/2007 |
TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE |
TRIBOFILM RESEARCH, INC. |
VINAY SAKHRANI |
K071049 |
04/13/2007 |
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR |
TYCO HEALTHCARE |
WEI ZHAO |
K071106 |
04/19/2007 |
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 |
ULTRADENT PRODUCTS, INC. |
COREY JASEPH |
K071055 |
04/16/2007 |
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 |
ULTRADENT PRODUCTS, INC. |
ROBERT WANG |
K071130 |
04/23/2007 |
HEARTRAK AF |
UNIVERSAL MEDICAL, INC. |
STEVEN ADAMSKY |
K070938 |
04/04/2007 |
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
JAMES CHAPMAN |
K071069 |
04/16/2007 |
MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY |
VIASYS SLEEP SYSTEMS, LLC. |
KEITH BOSECKER |
K071193 |
04/30/2007 |
VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS |
VIDAR SYSTEMS CORP. |
DANIEL KAMM |
K071127 |
04/23/2007 |
FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
K070991 |
04/09/2007 |
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 |
K071199 |
04/30/2007 |
BONALIVE GRANULES |
VIVOXID LTD. |
CONSTANCE G BUNDY |
K071054 |
04/16/2007 |
RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4 |
VOLUME INTERACTIONS PTE LTD |
MICHAEL SIM |
K071183 |
04/30/2007 |
ALLEGRO OCULYZER |
WAVELIGHT AG |
ALEXANDER POPP |
K071163 |
04/26/2007 |
WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603 |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
ECKHARDT ALBERS |
K070964 |
04/05/2007 |
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM |
WELCH ALLYN, INC. |
CHRIS HORACEK |
K070936 |
04/03/2007 |
WELMED HYPODERMIC SYRINGE |
WELMED INC. |
DARREN REEVES |
K071040 |
04/12/2007 |
WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS |
WRIGHT LINEAR PUMP, INC. |
CAROL WRIGHT |
K071201 |
04/30/2007 |
ZEO CE LIGHT & ZEO QUICK PORCELAIN |
XPDENT CORP. |
CARMEN PEREZ |
K071123 |
04/23/2007 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN-HUI HUANG |
K071122 |
04/23/2007 |
DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR |
XUZHOU FULL SUN MEDICAL PRODUCTS LTD. |
HSUN-HUI HUANG |
K071090 |
04/18/2007 |
TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION |
ZIMMER TRABECULAR METAL TECHNOLOGY |
KATHLEEN RUTHERFORD |
K071107 |
04/19/2007 |
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON |
ZIMMER, INC. |
BRANDON HIPSHER |
K070906 |
04/02/2007 |
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS |
ZIMMER, INC. |
MASON W ROBBINS |
K070978 |
04/06/2007 |
ZIMMER SEGMENTAL SYSTEM |
ZIMMER, INC. |
BRANDON HIPSHER |
K071025 |
04/11/2007 |
ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
EILEEN M BOYLE |