| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K071852 |
08/29/2007 |
AAP APS SYSTEM |
AAP IMPLANTATE AG |
MARC SEEGERS |
| K071531 |
08/22/2007 |
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
ACCURAY INCORPORATED |
ANNE SCHLAGENHAFT |
| K071944 |
08/09/2007 |
ACUMED SMALL BONE LOCKING SYSTEM II |
ACUMED LLC |
ED BOEHMER |
| K070158 |
08/23/2007 |
R-PORT LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
TANYA KAVANAGH |
| K070981 |
08/21/2007 |
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) |
AESCULAP IMPLANT SYSTEMS, INC. |
Lisa Boyle |
| K071699 |
08/15/2007 |
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 |
AGA MEDICAL CORP. |
JODI L RAUS |
| K071682 |
08/15/2007 |
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) |
ALARA, INC. |
ROBERT LUNDBERG |
| K062865 |
08/23/2007 |
SMALL VOLUME SYRINGE |
ALCON LABORATORIES |
SEAN P GRIFFIN |
| K072285 |
08/30/2007 |
ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD J CEHOVSKY |
| K071380 |
08/20/2007 |
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM |
ALPHATEC SPINE, INC. |
PAULA MORGAN |
| K072234 |
08/23/2007 |
THERMOGARD XP THERMAL REGULATION SYSTEM |
ALSIUS CORP. |
KENNETH A COLLINS |
| K071213 |
08/10/2007 |
CAMLOG LOGFIT PROSTHETIC SYSTEM |
ALTATEC GMBH |
FLOYD G LARSON |
| K063323 |
08/15/2007 |
SPECTROLYSE PAI-1, MODEL 101201 |
AMERICAN DIAGNOSTICA, INC. |
DAVID TEICHER |
| K071902 |
08/24/2007 |
AMS MINIARC SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
BRAD ONSTAD |
| K072196 |
08/27/2007 |
ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K071959 |
08/01/2007 |
ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K063771 |
08/09/2007 |
GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM |
ARKRAY Factory USA, Inc. |
TOM SPEIKERS |
| K071538 |
08/30/2007 |
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER |
ARROW INTERNATIONAL, INC. |
KIRSTEN STOWELL |
| K071032 |
08/20/2007 |
ARTHREX UNIVERS II SHOULDER PROSTHESIS |
ARTHREX, INC. |
NANCY HOFT |
| K071978 |
08/15/2007 |
MINI TIGHTROPE FT REPAIR KIT |
ARTHREX, INC. |
SALLY FOUST |
| K071176 |
08/03/2007 |
MODIFICATION TO: ARTHREX INTERFERENCE SCREW |
ARTHREX, INC. |
ANN WATERHOUSE, RAC |
| K072089 |
08/17/2007 |
ARTHROCARE SPINEWAND |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K071709 |
08/07/2007 |
ARTHROCARE SYSTEM 12000 |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K071963 |
08/07/2007 |
MODIFICATION TO: ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K071374 |
08/02/2007 |
OPUS TWINLOCK KNOTLESS FIXATION DEVICE |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K070034 |
08/17/2007 |
REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES |
ASCENT HEALTHCARE SOLUTIONS |
KATIE BRAY |
| K070036 |
08/17/2007 |
REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES |
ASCENT HEALTHCARE SOLUTIONS |
KATIE BRAY |
| K071451 |
08/01/2007 |
TATTOOSTAR Y |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K070795 |
08/31/2007 |
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM |
ATCOR MEDICAL PTY. LTD |
EVAN P PHELPS |
| K071923 |
08/14/2007 |
PTFE FLIXENE GRADUATED WALL GRAFT |
ATRIUM MEDICAL CORP. |
KAREN HALL |
| K071459 |
08/16/2007 |
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES |
B. BRAUN MEDICAL, INC. |
CHRISTINE FORD |
| K071518 |
08/17/2007 |
DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
SUSAN OLINGER |
| K071793 |
08/03/2007 |
CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR |
BARTON MEDICAL CORP. |
LAWRENCE W SWOL |
| K071266 |
08/15/2007 |
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS |
BAUSCH & LOMB, INC. |
MICHAEL A SANTALUCIA |
| K071043 |
08/02/2007 |
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES |
BAUSCH & LOMB, INC. |
DEBRA KETCHUM |
| K070163 |
08/03/2007 |
SWABBABLE CAP, MODEL 60205 |
BAXA CORP. |
KIMBERLY ZIZIK |
| K071623 |
08/20/2007 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML |
BECTON, DICKINSON & CO. |
VICKI K WHITLEY |
| K070371 |
08/13/2007 |
FINGERTIP PULSE OXIMETER MD300C |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K062854 |
08/06/2007 |
BENZ-G 4X HIOXIFILCON D |
BENZ RESEARCH AND DEVELOPMENT CORP. |
ARTHUR J WARD |
| K072127 |
08/31/2007 |
DOMINATOR |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K071952 |
08/14/2007 |
GRAFTLOCK SCREW, ST SCREW |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K072106 |
08/30/2007 |
150W CERALAS D 980NM DIODE LASER |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K071551 |
08/30/2007 |
QUICKBRIDGE TM CYLINDER AND CAP |
BIOMET 3I, INC. |
DIANA TAYLOR |
| K071377 |
08/06/2007 |
POLARIS BE RODS |
BIOMET SPINE |
DEBRA BING |
| K070389 |
08/09/2007 |
PEEK KNOTLESS ANCHORS |
BIOMET SPORTS MEDICINE, INC. |
SUSAN ALEXANDER |
| K071863 |
08/31/2007 |
ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) |
BIORETEC LTD |
MARI RUOTSALAINEN |
| K071328 |
08/31/2007 |
VISUALASE THERMAL THERAPY SYSTEM |
BIOTEX, INC. |
MATTHEW FOX |
| K070002 |
08/17/2007 |
BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER |
BOSTONSCIENTIFIC |
NICHOLAS CONDAKES |
| K070201 |
08/01/2007 |
BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 |
C.R. BARD, INC. |
MICHELLE GUDITH |
| K071469 |
08/15/2007 |
INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM |
CANDELA CORP. |
JEFFREY ROBERTS |
| K071648 |
08/22/2007 |
EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS |
CANTERBURY SCIENTIFIC LTD. |
MAURICE OWEN |
| K072119 |
08/10/2007 |
AIRLIFE NEBULIZER CAP |
Cardinal Health |
SHARON NICHOLS |
| K071350 |
08/22/2007 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
MICHAEL J KALLOK |
| K071427 |
08/30/2007 |
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS |
CARDIOVASCULAR SYSTEMS, INC. |
CINDY SETUM |
| K072210 |
08/24/2007 |
CHISON, MODEL 8300 |
CHISON MEDICAL IMAGING CO., LTD. |
Diana Hong |
| K070627 |
08/02/2007 |
OPACIDEN SOLUTION |
CIDEN TECHNOLOGIES LLC |
LISA S JONES |
| K071496 |
08/15/2007 |
ICATH, STERILESURE |
COLORADO CATHETER COMPANY, INC. |
DOUG WILSON |
| K071172 |
08/22/2007 |
MODIFIED MERCI RETRIEVER, MODEL 90060 |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K070376 |
08/20/2007 |
CONMED LINVATEC 300W XENON LIGHT SOURCE |
CONMED LINVATEC |
ELIZABETH M PAUL |
| K070780 |
08/21/2007 |
CONMED LINVATEC XO BUTTON |
CONMED LINVATEC |
JOY LOVETT |
| K071461 |
08/21/2007 |
MODEL 300D HOME OXYGEN LIQUEFIER |
COPD PARTNERS, INC. |
PAUL DRYDEN |
| K071520 |
08/10/2007 |
RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X |
CORE ESSENCE ORTHOPAEDICS, LLC |
SHAWN T HUXEL |
| K071477 |
08/15/2007 |
REVERTO 55 AND 37 SHAPE MEMORY STAPLES |
CORE ESSENCE ORTHOPAEDICS, LLC |
SHAWN T HUXEL |
| K070918 |
08/22/2007 |
4DDOME |
COUSIN BIOTECH |
PAUL DRYDEN |
| K070272 |
08/03/2007 |
NEUROPORT ELECTRODE |
CYBERKINETICS NEUROTECHNOLOGY SYSTEMS, INC. |
Gary Syring |
| K071767 |
08/04/2007 |
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A |
DADE BEHRING, INC. |
PAMELA A JURGA |
| K071811 |
08/24/2007 |
ETOH FLEX REAGENT CARTRIDGE (DF22) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K071317 |
08/20/2007 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K071316 |
08/20/2007 |
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K071247 |
08/08/2007 |
N LATEX RF KIT |
DADE BEHRING, INC. |
HELEN LEE |
| K071834 |
08/17/2007 |
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
| K072147 |
08/30/2007 |
DEN TEK COMFORT FIT NIGHTGUARD |
DEN TEK ORAL CARE, INC. |
HOWARD HOLSTEIN, ESQ. |
| K072052 |
08/08/2007 |
OSTEOGRAF/D-300 |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K072056 |
08/06/2007 |
OSTEOGRAF/D-700 |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K072057 |
08/06/2007 |
OSTEOGRAF/LD-300 |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K072058 |
08/03/2007 |
MODIFICATION TO: OSTEOGRAF/N-700 |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K071481 |
08/09/2007 |
HEALIX ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
Ruth Forstadt |
| K070267 |
08/17/2007 |
DEPUY GCK TIBIAL COMPONENTS |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K071417 |
08/02/2007 |
DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K071860 |
08/01/2007 |
MODIFICATION TO: VIPER SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K070206 |
08/30/2007 |
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 |
DIAGNOSTIC HYBRIDS, INC. |
GAIL GOODRUM |
| K071039 |
08/08/2007 |
MISSION OLYMPUS AU ISE CALIBRATORS |
DIAMOND DIAGNOSTICS, INC. |
KATHRYN THORSEN |
| K071299 |
08/31/2007 |
IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP |
DIGITAL HEALTHCARE, LTD. |
GERRY SKEWS |
| K070117 |
08/06/2007 |
SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC |
DOLOMITE BIOTECH SDN BHD |
TIMOTHY LIEW |
| K072353 |
08/30/2007 |
PORTABLE ECSCOPE |
DYANSYS CORP |
SRINI NAGESHWAR |
| K071168 |
08/31/2007 |
THE PORTABLE ANSISCOPE |
DYANSYS, INC. |
MICHAEL A DANIEL |
| K071080 |
08/31/2007 |
ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M |
E SURGICAL, LLC |
HANS J RICHTER |
| K071722 |
08/10/2007 |
DEEP BLUE |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
CYNTHIA J.M. NOLTE |
| K063620 |
08/06/2007 |
EKOS MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K071933 |
08/10/2007 |
ENDOWAVE INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K063453 |
08/30/2007 |
VERTEFIX PEDICLE SCREW SPINAL SYSTEM |
ELITE SURGICAL SUPPLIES (PTY) LTD. |
CHARISE DE BARRIOS |
| K060980 |
08/16/2007 |
VENDYS MODEL 5000 B/BC |
ENDOTHELIX, INC. |
DOUGLAS BLAKELY |
| K071996 |
08/03/2007 |
MYLAB30, MODEL 7300 |
ESAOTE S.P.A. |
Allison Scott |
| K070151 |
08/15/2007 |
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER |
ETHICON ENDO-SURGERY, LLC |
KIMBERLY SHOEMAKER |
| K071320 |
08/17/2007 |
EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 |
EVERLIFE MEDICAL EQUIPMENT CO., LTD. |
JEN KE-MIN |
| K071738 |
08/15/2007 |
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER |
EXACTECH, INC. |
AMNON TALMOR |
| K071775 |
08/07/2007 |
DASH |
EZSURGICAL |
Kevin Walls |
| K063447 |
08/16/2007 |
INSIGHT DISCOVERY |
FASSTECH |
LEE BRODY |
| K070209 |
08/08/2007 |
FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR |
FEGO PRECISION INDUSTRIAL CO; LTD |
JENNIFER REICH |
| K070135 |
08/16/2007 |
VITRIFREEZE MEDIUM; VITRITHAW MEDIUM |
FERTI PRO N.V. |
GRACE HOLLAND |
| K071858 |
08/31/2007 |
DENTAL MATRIX BAND |
FLY CAST TECHNOLOGIES, INC. |
MICHELE H VOVOLKA |
| K070820 |
08/01/2007 |
ARCHITECT TACROLIMUS: MODEL 1L77 |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA DICKSON |
| K071079 |
08/02/2007 |
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 |
GAMBRO BCT, INC. |
PATTI L ARNDT |
| K071674 |
08/09/2007 |
GC-ZIRCONIA |
GC AMERICA, INC. |
TERRY L JORITZ-LYONS |
| K071828 |
08/06/2007 |
LULLABY |
GE HEALTHCARE CLINICAL SYSTEMS |
THALIA BRINE |
| K071985 |
08/17/2007 |
GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K072075 |
08/29/2007 |
MODIFICATION TO GE LOGIQ A3 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K071274 |
08/24/2007 |
GSO GS1 SPACER |
GOLD STANDARD ORTHOPEDICS LLC |
DAVID BAUGHMAN |
| K071908 |
08/23/2007 |
DOCTOR'S LIGHT LED DENTAL CURING LIGHT |
GOOD DOCTORS CO., LTD. |
IAN P GORDON |
| K070419 |
08/31/2007 |
OPACIDEN OPA REAGENT STRIPS |
HACH COMPANY |
DAVID A MORRIS |
| K070630 |
08/31/2007 |
HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE |
HEALTH LINE INTERNATIONAL CORPORATION (HLIC) |
DENICE WROE |
| K072104 |
08/17/2007 |
HEARTWAY POWER MOBILITY SCOOTER, PF6 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
HSIANG-PIN HUANG |
| K071519 |
08/06/2007 |
HEMCON CHITOFLEX-SURGICAL DRESSING |
HEMCON, INC. |
KEVIN HAWKINS |
| K071207 |
08/07/2007 |
MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES |
HIGH MOMENTUM SDN BHD |
HUE K FAH |
| K071806 |
08/28/2007 |
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS THISTLETHWAITE |
| K071991 |
08/15/2007 |
MODIFICATION TO SCORPIO NRG KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
PATRICIA SETTI-LAPERCH |
| K071894 |
08/16/2007 |
XEBRA DICOM IMAGE BROWSER |
HX TECHNOLOGIES, INC. |
CARL ALLETTO |
| K071470 |
08/31/2007 |
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX |
IMPLANTECH ASSOCIATES INC. |
STEPHEN MEADE |
| K071464 |
08/03/2007 |
INION HEXALON BIODEGRADABLE ACL/PCL SCREW |
INION OY |
KATI MARTTINEN |
| K071225 |
08/31/2007 |
INNOVASA STAT*SEAL TOPICAL HEMOSTAT |
INNOVASA, INC. |
Roberta Hines |
| K071943 |
08/10/2007 |
SERENITY PRO PSF SYSTEM |
INOLASE 2002, LTD. |
GEORGE J HATTUB |
| K072071 |
08/15/2007 |
STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
| K070549 |
08/31/2007 |
STRAUMANN P.004 RC GOLD ABUTMENT |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
| K071771 |
08/02/2007 |
INSTRUMED RETRACTORS |
INSTRUMED INTERNATIONAL, INC. |
MICHAEL MASSONG |
| K070005 |
08/15/2007 |
HEMOSIL RECOMBIPLASTIN 2G |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K072207 |
08/23/2007 |
DURAGEN XS DURAL REGENERATION MATRIX |
INTEGRA LIFESCIENCES CORP. |
PETER ALLAN |
| K071505 |
08/06/2007 |
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
JON CAPAROTTA |
| K071669 |
08/17/2007 |
INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP |
INTEGRA RADIONICS, INC. |
KEVIN J O'CONNELL |
| K071035 |
08/13/2007 |
IFS BONE FIXATION DEVICES |
INTERNAL FIXATION SYSTEMS, INC. |
STEVE HERNANDEZ |
| K071637 |
08/03/2007 |
INTRINSIC THERAPEUTICS FIXATION STAPLE |
INTRINSIC THERAPEUTICS INCORPORATED |
KRISHNA UPPUGONDURI |
| K061880 |
08/15/2007 |
ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC |
ISOTIS NV |
ELAINE SCHUTTE |
| K071848 |
08/30/2007 |
IPS INLINE POM SYSTEM |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K071636 |
08/09/2007 |
CODIAGNOSTIX (R) 5.72 |
IVS SOLUTIONS AG |
FRANK STOCKMANN |
| K071190 |
08/17/2007 |
ROOT ZX II |
J. MORITA USA, INC. |
ROBERT A SILVERMAN |
| K071884 |
08/09/2007 |
BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 |
JAWON MEDICAL CO., LTD. |
Won-Hee Park |
| K071857 |
08/08/2007 |
DELTA SPINAL FUSION SYSTEM |
JEMO SPINE, LLC |
PATRICK MOORE |
| K071710 |
08/14/2007 |
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) |
JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. |
DAGMAR OETTE |
| K071530 |
08/24/2007 |
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE CHEN |
| K070579 |
08/30/2007 |
STORZ SLX-F2 STORM TOUCH |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
| K072195 |
08/23/2007 |
THROMCAT THROMBECTOMY CATHETER SYSTEM |
KENSEY NASH CORP. |
CINDY R VARUGHESE |
| K070360 |
08/07/2007 |
KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 |
KIRWAN SURGICAL PRODUCTS, INC. |
KEVIN P PRARIO |
| K070828 |
08/15/2007 |
KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
| K070826 |
08/15/2007 |
KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
| K072027 |
08/20/2007 |
FORU KV10HB |
KWANG YANG MOTOR CO., LTD. |
JUNNATA CHANG |
| K071685 |
08/06/2007 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
LANGFANG HUILONG PLASTIC PRODUCT CO., LTD. |
CHU XIAOAN |
| K071686 |
08/22/2007 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
LANGFANG HUILONG PLASTIC PRODUCT CO., LTD. |
CHU XIAOAN |
| K071633 |
08/15/2007 |
LANX DEFORMITY SYSTEM |
LANX, LLC |
JANICE HOGAN |
| K070341 |
08/08/2007 |
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM |
LDR SPINE USA |
JAMES BURROWS |
| K072132 |
08/30/2007 |
LDR SPINE ROI-T SYSTEM |
LDR SPINE USA |
JAMES BURROWS |
| K071367 |
08/29/2007 |
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 |
LEMAITRE VASCULAR, INC. |
MINNIE MILDWOFF |
| K072037 |
08/08/2007 |
CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML |
LIFE-SHIELD PRODUCTS, INC |
ROSINA ROBINSON |
| K071751 |
08/27/2007 |
LIFESYNC ADAPTER, MODEL LS-302 |
LIFESYNC CORPORATION |
DIANE SUDDUTH |
| K071761 |
08/03/2007 |
LLOYD LINDEN, MODEL E04 |
LLOYD LINDEN, INC. |
JUNNATA CHANG |
| K061828 |
08/24/2007 |
LORENZ BIOTECH APTIVA, VERSION 2.13 |
LORENZ BIOTECH S.P.A. |
ROSINA ROBINSON |
| K071529 |
08/10/2007 |
XTRACT CATHETER SYSTEM |
LUMEN BIOMEDICAL, INC. |
MARIA E BRITTLE |
| K062974 |
08/13/2007 |
TESLA NIBP |
MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH |
ROBERT N CLARK |
| K072172 |
08/31/2007 |
JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENGLENKS |
| K070625 |
08/01/2007 |
PELVIMESH / HERMESH 7 |
MARKETING SOLUTIONS INC. |
LORENA TRABUCCO |
| K063607 |
08/23/2007 |
SPINEASSIST SYSTEM |
MAZOR SURGICAL TECHNOLOGIES LTD. |
AHAVA STEIN |
| K070057 |
08/30/2007 |
EASYRA CLINICAL CHEMISTRY ANALYZER |
MEDICA CORP. |
Photios Makris |
| K072079 |
08/14/2007 |
IGUIDE SYSTEM |
MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA |
MICHAEL WOLFF |
| K071094 |
08/13/2007 |
MODIFICATION TO SOLAR GI |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
KARIN OGINK-SOMHORST |
| K072040 |
08/03/2007 |
C-JAWS CERVICAL COMPRESSIVE MINI FRAME |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K071167 |
08/31/2007 |
FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 |
MEDIGROUP, INC. |
JOHN A NAVIS |
| K071960 |
08/03/2007 |
MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 |
MEDITECH KFT. |
BENNY ARAZY |
| K071341 |
08/03/2007 |
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 |
MEDIVANCE, INC. |
LYNNE ARONSON |
| K063836 |
08/16/2007 |
RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K071033 |
08/14/2007 |
T2 XVBR SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
| K072205 |
08/29/2007 |
VISAGE PACS/CS, RELEASE VERSION 5.0 |
MERCURY COMPUTER SYSTEMS, INC |
Martin Gabler |
| K071548 |
08/21/2007 |
WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED |
MERZ DENTAL GMBH |
RICHARD G HUNTER |
| K071137 |
08/01/2007 |
SONICATOR PLUS 940, MODEL ME940 |
METTLER ELECTRONICS CORP. |
ROB FLEMING |
| K070023 |
08/15/2007 |
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100 |
MICROSURGEON, INC. |
DUDLEY HARRIS |
| K063671 |
08/16/2007 |
REBOUND HRD |
MINNESOTA MEDICAL DEVELOPMENT, INC. |
ELAINE DUNCAN |
| K071298 |
08/08/2007 |
HF JUNIOR HEMOFILTER |
MINNTECH CORP. |
LYNN LUEDERS |
| K072047 |
08/29/2007 |
MHI-TM2000 LINEAR ACCELERATOR SYSTEM |
MITSUBISHI HEAVY INDUSTRIES, LTD. |
TAKASHI YAMAKAWA |
| K063066 |
08/03/2007 |
AXIS-V MONOCHROME 5 MP DISPLAY |
NATIONAL DISPLAY SYSTEMS |
RON HANSON |
| K070622 |
08/14/2007 |
NEOGUIDE ENDOSCOPY SYSTEM |
NEOGUIDE SYSTEMS, INC. |
JORGE L PORRAS |
| K071308 |
08/16/2007 |
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
| K072217 |
08/30/2007 |
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K072060 |
08/17/2007 |
QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K071370 |
08/03/2007 |
NOBELACTIVE INTERNAL CONNECTION IMPLANT |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K063190 |
08/21/2007 |
SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC |
NOBLE FIBER TECHNOLOGIES, INC. |
PATRICIA DAVIDSON |
| K071415 |
08/08/2007 |
DIGITAL PULSE OXIMETER, MODEL 7500FO |
NONIN MEDICAL, INC. |
LORI M ROTH |
| K071329 |
08/08/2007 |
NUVASIVE HELIX ACP SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K071435 |
08/06/2007 |
NUVASIVE OCT SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K071263 |
08/24/2007 |
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K071606 |
08/31/2007 |
BIOSIGN CENTRAL STATION |
OBS MEDICAL |
WAYNE NETHERCUTT |
| K072157 |
08/27/2007 |
MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) |
OHMEDA MEDICAL |
AGATA SMIEJA |
| K070708 |
08/21/2007 |
OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 |
OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH |
STEPHANIE G SCHWARTZ |
| K062489 |
08/15/2007 |
APEX HCLA ACETABULAR CUP LINERS |
OMNILIFE SCIENCE |
EDWARD CHEAL |
| K071555 |
08/30/2007 |
FORTAGEN ORAL MEMBRANE |
ORGANOGENESIS, INC. |
PATRICK R BILBO |
| K072175 |
08/21/2007 |
TITANIUM HIP TOOL LOCKING PLATE |
ORTHOPEDIC SCIENCES, INC |
JAMES K BRANNON |
| K071500 |
08/10/2007 |
NANO-BOND II ADHESIVE SYSTEM |
PENTRON CLINICAL TECHNOLOGIES |
FLOYD G LARSON |
| K070970 |
08/17/2007 |
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F |
PENUMBRA, INC. |
THERESA BRANDNER-ALLEN |
| K071281 |
08/03/2007 |
UNIRING - ANNULOPLASTY RING WITH SIZERS |
PETERS SURGICAL |
ROBERT RENAULT |
| K071846 |
08/30/2007 |
MODIFICATION TO EZ HUBER SAFETY INFUSION SET |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K071913 |
08/24/2007 |
IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 |
PHADIA AB |
KARL-ERIK BACKLUND |
| K070623 |
08/31/2007 |
PHARMAPAC LUBRICATING JELLY |
PHARMAPAC LLC |
TOM OTTO |
| K070185 |
08/21/2007 |
TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 |
PHAROS LIFE CORPORATION |
PHIL CUSCUNA |
| K071564 |
08/31/2007 |
MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 |
PHILIPS MEDICAL SYSTEMS |
RICK SCHUL |
| K072070 |
08/10/2007 |
PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
| K070020 |
08/16/2007 |
COMCASET-P SAFETY IV CATHETER |
PITANGO MEDICAL LTD |
BEN LEVIN |
| K070928 |
08/01/2007 |
CERAMIC BALL HEADS, 28, 32 AND 36 MM |
PLUS ORTHOPEDICS AG |
PAMELA J WEAGRAFF |
| K071756 |
08/15/2007 |
ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE |
POINTE CONCEPTION MEDICAL, INC |
WILLIAM C HAACK |
| K071335 |
08/08/2007 |
MEDPOR ATTRACTOR IMPLANT |
POREX SURGICAL, INC. |
JERRI L DAVIS |
| K071336 |
08/24/2007 |
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 |
POSSIS MEDICAL, INC. |
FRANK B FREEDMAN |
| K071404 |
08/17/2007 |
SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE |
POWER PRODUCTS, INC.-SPLINTEK |
MALANIE HASEK |
| K072165 |
08/17/2007 |
VICTORY THREE WHEEL SCOOTER, MODEL: SC610 |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS J SCHAPPERT |
| K071949 |
08/01/2007 |
VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740 |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS J SCHAPPERT |
| K071138 |
08/15/2007 |
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM |
PROSURG, INC. |
ASHVIN DESAI |
| K070594 |
08/01/2007 |
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 |
PULMONETIC SYSTEMS, INC. |
ROBERT C SAMEC |
| K072010 |
08/07/2007 |
QUANTUM DIREX SYSTEM |
QUANTUM MEDICAL IMAGING, LLC. |
MARK CAMIRAND |
| K072096 |
08/20/2007 |
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 |
R & D SYSTEMS, INC. |
NANCY C RING |
| K071361 |
08/20/2007 |
R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005 |
R4 VASCULAR, INC. |
MICHAEL SARAJIAN |
| K070338 |
08/28/2007 |
RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS |
RAINBOW COMMUNICATIONS, INC |
LEON E JEW |
| K071509 |
08/08/2007 |
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K071422 |
08/22/2007 |
15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K071492 |
08/28/2007 |
FIRSTVIEW |
RIVERAIN MEDICAL GROUP,LLC |
JENNIFER STEINKE |
| K070999 |
08/02/2007 |
BC (BODY COMPOSITION SOFTWARE) |
RJL SYSTEMS, INC. |
BARRY CALLAHAN |
| K071953 |
08/08/2007 |
RTX3370 |
RTX HEALTHCARE A/S |
NIELS O ANDERSON |
| K070913 |
08/10/2007 |
SELF-LIGHT DISPOSABLE ANOSCOPE |
SAPIMED S.P.A. |
E J SMITH |
| K071424 |
08/24/2007 |
PMAX NEWTRON XS |
SATELEC-ACTEON GROUP |
STEVE SALESKY |
| K071010 |
08/24/2007 |
TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS |
SCHUTZ-DENTAL GMBH |
MICHAEL WIERZ |
| K063310 |
08/02/2007 |
TRUEFIELD ANALYZER |
SEEING MACHINES LIMITED |
ALAN DONALD |
| K071584 |
08/31/2007 |
OASIS RELEASE 1.0 |
SEGAMI CORPORATION |
PHILIPPE BRIANDET |
| K070987 |
08/02/2007 |
SENTINEL LITHIUM ASSAY |
SENTINEL CH SPA |
FABIO ROTA |
| K071072 |
08/30/2007 |
SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE |
SHANGHAI CHINA STAR CORP |
ROMIL RAMBHIA |
| K072006 |
08/31/2007 |
DAR-9400F |
SHIMADZU CORP. |
DON KARLE |
| K070988 |
08/23/2007 |
SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) |
SHINCHANG MEDICAL CO., LTD. |
JAN J FRANK |
| K071742 |
08/15/2007 |
BEAUTIFIL II |
SHOFU DENTAL CORP. |
DAVID MORAIS |
| K070727 |
08/03/2007 |
ADVIA CHEMISTRY ENZYMATIC CREATININE_2 |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
PHILIP LIU |
| K072266 |
08/29/2007 |
ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHEILA PICKERING |
| K062623 |
08/22/2007 |
AXIOM LUMINOS DRF |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY JOHNSON |
| K071925 |
08/14/2007 |
MAGNETOM ESSENZA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K071656 |
08/27/2007 |
SBI ARTFIX |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
| K071549 |
08/07/2007 |
SBI RHEAD PLATING SYSTEM |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
| K071479 |
08/02/2007 |
SBI STAFIX |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
| K071540 |
08/08/2007 |
SBI TITANIUM THREADED PIN |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
| K063635 |
08/29/2007 |
SBI FOREFOOT SET |
SMALL BONE INNOVATIONS, INC. |
ROBERT HOEHN |
| K071586 |
08/17/2007 |
BIORAPTOR 2.3 PK SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
JULIE ACKER |
| K063835 |
08/03/2007 |
ALLEVYN AG DRESSING |
SMITH & NEPHEW, INC. |
TERRY MCMAHON |
| K071790 |
08/17/2007 |
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K071563 |
08/08/2007 |
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K071269 |
08/01/2007 |
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM |
SMITHS MEDICAL ASD, INC. |
BARBARA LAW |
| K071785 |
08/02/2007 |
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
| K071327 |
08/10/2007 |
MEMO 3D SEMIRIGID ANNULOPLASTY RING |
SORIN BIOMEDICA CARDIO S.R.L. |
HEATHER CRAWFORD |
| K071392 |
08/03/2007 |
PXS-810, PODIATRY X-RAY SYSTEM |
SOURCE-RAY, INC. |
RAY MANEZ |
| K072131 |
08/17/2007 |
M3 MONITOR |
SPECTRUM MEDICAL LTD |
STEVE TURNER |
| K071438 |
08/21/2007 |
PSS SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
| K072012 |
08/22/2007 |
REFLEXION SPIRAL VARIABLE RADIUS CATHETER |
ST. JUDE MEDICAL |
Laura Moen-Ftacek |
| K070911 |
08/10/2007 |
STD MED PRIMO PORT |
STD MED, INC. |
PAMELA PAPINEAU |
| K071029 |
08/24/2007 |
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) |
STEREOTAXIS, INC. |
DENNIS POZZO |
| K071628 |
08/10/2007 |
STRYKER EXTERNAL FIXATION SYSTEM |
STRYKER CMF |
TENNILLE FOLK |
| K071373 |
08/27/2007 |
STRYKER SPINE XIA III SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K072028 |
08/03/2007 |
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM |
SURGICAL SPECIALTIES CORP. |
LOIS SMART |
| K071989 |
08/06/2007 |
QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL |
SURGICAL SPECIALTIES CORP. |
KEVIN BENTLEY |
| K071703 |
08/22/2007 |
ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC |
SWISS AMERICAN PRODUCTS, INC. |
ERIC LUO |
| K071872 |
08/22/2007 |
VELASHAPE |
SYNERON MEDICAL LTD. |
YONI IGER |
| K071476 |
08/24/2007 |
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP |
SYNTHES (USA) |
ANGELA SILVESTRI |
| K071245 |
08/02/2007 |
TALON AND REVERE |
TALON ACRYLICS, INC. |
SHERMAN WATSON |
| K072001 |
08/15/2007 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K063729 |
08/21/2007 |
DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 |
TECHNOMED EUROPE |
MAURICE ROOST |
| K072108 |
08/31/2007 |
MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES |
TECNIMED S.R.L. |
MARIA F GRIFFIN |
| K071807 |
08/06/2007 |
ORTHOMEND SOFT TISSUE MATRIX |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K063759 |
08/15/2007 |
HEATMARKER TIME TEMPERATURE INDICATOR |
TEMPTIME CORPORATION |
RICHARD PHILLIPS |
| K071410 |
08/15/2007 |
ARGEN PEARL BRAND ZIRCONIA |
THE ARGEN CORPORATION |
PAUL CASCONE |
| K070962 |
08/22/2007 |
CORAL PEDICLE SCREW SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K063086 |
08/08/2007 |
TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS |
THERMO ELECTRON OY |
PAIVI SORMUNEN |
| K071126 |
08/16/2007 |
CRYOSEAL FS APPLICATOR SYSTEM |
THERMOGENESIS CORP. |
JOHN CHAPMAN |
| K070787 |
08/24/2007 |
LATITUDE ELBOW PROTHESIS |
TORNIER |
Mireille Lemery |
| K072066 |
08/14/2007 |
1.3M MONOCHROME LCD MONITOR MDL1908A |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K072065 |
08/14/2007 |
20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K071485 |
08/28/2007 |
TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 |
TPC ADVANCED TECHNOLOGY, INC. |
SCOTT BECKLEY |
| K071936 |
08/23/2007 |
WOUNDSTAT, MODEL TC1001 |
TRAUMACURE INC. |
CAMPBELL HUTTON |
| K071822 |
08/20/2007 |
URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 |
UROPLASTY, INC. |
LISA GALLATIN |
| K071992 |
08/15/2007 |
HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K071873 |
08/09/2007 |
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K070938 |
08/06/2007 |
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT |
VASCULAR SOLUTIONS, INC. |
JAMES CHAPMAN |
| K071753 |
08/14/2007 |
MASTERSCREEN PNEUMO & MASTERSCOPE |
VIASYS HEALTHCARE GMBH |
Yvette Lloyd |
| K071903 |
08/02/2007 |
ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K072088 |
08/29/2007 |
FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K072073 |
08/29/2007 |
VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR |
VISION-SCIENCES, INC. |
PAMELA PAPINEAU |
| K070661 |
08/29/2007 |
VITALCOR FEATHERWEIGHT VASCULAR CLAMPS |
VITALCOR, INC. |
DANIEL KAMM |
| K071660 |
08/31/2007 |
VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 |
VOLCANO CORPORATION |
JENNIFER MOTTO |
| K072220 |
08/23/2007 |
PEDI CO2 EASY |
Westmed, Inc. |
DALE BICKLEY |
| K070754 |
08/31/2007 |
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JENNIFER P HARAKAL |
