FDA 510(k) Applications Received During August, 2007

FDA 510(k) Number Submission Date Device Name Applicant Contact
K072163 08/06/2007 HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 3A HEALTH CARE S.R.L. MAUREEN O'CONNELL
K072174 08/06/2007 INSUCOZI INSULIN VIAL COVER 41 INDUSTRIES LLC DANIEL LAFAVER
K072411 08/27/2007 AAP BONE PLATES AND SCREW IMPLANTS AAP IMPLANTATE AG MARC SEEGERS
K072460 08/31/2007 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE ABBOTT VASCULAR, INC. MICHELE WALZ
K072354 08/22/2007 GUIDEWIRE, MODEL G-V220-3527S AND OTHERS ACCELLENT INC. KARL STEINECK
K072309 08/17/2007 MICROLUX/BLU ADDENT, INC. JOSHUA FRIEDMAN, DDS
K072252 08/13/2007 VEINOPLUS NEUROMUSCULAR STIMULATOR ADREM TECHNOLOGY SARL NORMAN F ESTRIN
K072462 08/31/2007 WIDE SPACED QUATTRODE LEADS ADVANCED NEUROMODULATION SYSTEMS MIA M WARE
K072167 08/06/2007 COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE ADVANCED VASCULAR DYNAMICS HERBERT J SEMLER
K072359 08/22/2007 AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C AEARO COMPANY ANN L PHILLIPS
K072357 08/22/2007 NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM AFP IMAGING CORP. MARY MCNAMARA-CULLINANE
K072313 08/17/2007 AMPLATZER TORQVUE DELIVERY SYSTEM AGA MEDICAL CORP. PATRICIA A LAFORTE
K072413 08/28/2007 MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM AGAMATRIX CONNIE HERTEL
K072185 08/06/2007 AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 AIRISTAR TECHNOLOGIES, LLC DANIEL KAMM
K072356 08/22/2007 S-TEST CA ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. DAVID SLAVIN
K072143 08/02/2007 S40 CLINICAL ANALYZER, S TEST ALB ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. DAVID SLAVIN
K072142 08/02/2007 S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. DAVID SLAVIN
K072140 08/02/2007 S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. DAVID SLAVIN
K072141 08/02/2007 S40 CLINICAL ANALYZER, S TEST IP, S TEST UA ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. DAVID SLAVIN
K072214 08/09/2007 PORTABLE VENTILATOR, MODEL EPV-100 ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K072182 08/06/2007 ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 ALMA LASERS LTD. ANNE WORDEN
K072258 08/14/2007 BI-RADS COMPANION ALMEN LABORATORIES, INC. ROGER H SCHNEIDER
K072285 08/16/2007 ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K072234 08/10/2007 THERMOGARD XP THERMAL REGULATION SYSTEM ALSIUS CORP. KENNETH A COLLINS
K072196 08/07/2007 ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K072375 08/23/2007 SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET ANGIODYNAMICS, INC. BRIAN KUNST
K072225 08/10/2007 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. MELINDA SWANSON
K072378 08/24/2007 PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 ARTHREX, INC. ANN WATERHOUSE
K072431 08/29/2007 ASAHI PTCA GUIDE WIRE, X-TREME ASAHI INTECC CO., LTD. YOSHI TERAI
K072316 08/17/2007 PRECIOUS PLUS GUIDE CATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K072286 08/16/2007 BIS EEG VISTA MONITOR SYSTEM AND BISX ASPECT MEDICAL SYSTEMS, INC. VIKRAM VERMA
K072426 08/29/2007 ATLAS SPINE PEDICLE SCREW SYSTEM ATLAS SPINE LLC JEANETTE G DAILEY
K072137 08/02/2007 AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB AVITA CORPORATION JENNIFER REICH
K072409 08/27/2007 AFINION ACR AND ACR CONTROL AXIS-SHIELD POC AS JORUNN GREVIE LOLLAND
K072247 08/13/2007 STERICAN HYPODERMIC NEEDLES B. BRAUN MEDICAL, INC. CHRISTINE FORD
K072283 08/16/2007 DORADO PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. GENEVIEVE BALUTOWSKI
K072274 08/15/2007 MAJOR III BLOOD GLUCOSE MONITORING SYSTEM BESTGEN BIOTECH CORP. JEN KE-MIN
K072294 08/16/2007 SYSTEM-MINI, MODELS: 390, E30 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K072358 08/22/2007 BIOPLEX VASCULITIS KIT Bio-Rad Laboratories PRIYA BONDRE
K072306 08/17/2007 BIOXTRA MOISTURIZING GEL BIO-X HEALTHCARE S.A. EMALEE MURPHY
K072127 08/02/2007 DOMINATOR BIOCOMPOSITES LTD. SIMON FITZER
K072389 08/24/2007 MODIFICATION TO HYPERQ SYSTEM BIOLOGICAL SIGNAL PROCESSING, LTD. GEORGE J HATTUB
K072138 08/02/2007 VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 BIOMERIEUX, INC. NIKITA S MAPP
K072363 08/23/2007 NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX BIOMET 3I, INC. DIANA TAYLOR
K072161 08/06/2007 BIOMET FEMORAL LOCKING NAIL SYSTEM BIOMET MANUFACTURING CORP. BECKY EARL
K072336 08/20/2007 REGENEREX POROUS TITANIUM SLEEVE AUGMENTS BIOMET MANUFACTURING CORP. BECKY EARL
K072330 08/20/2007 CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM BIOMET, INC. PAULA DEMING
K072298 08/17/2007 BIOPRO MEMORY STAPLE, MODELS 18062-18073 BIOPRO, INC. DAVID MRAK
K072344 08/21/2007 APL MEDICAL SYSTEM BIOS S.R.L. ALDO CASALINO
K072202 08/08/2007 CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) BIOSENSE WEBSTER, INC. NATALIE BENNINGTON
K072321 08/20/2007 BIOFLEX BIOSPINE CO., LTD. JUSTIN EGGLETON
K072329 08/20/2007 SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED BIOTRONIK, INC. Jon Brumbaugh
K072123 08/02/2007 HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE BIOWAVE CORPORATION MARY MCNAMARA-CULLINANE
K072436 08/30/2007 MEGA SPINE SYSTEM BK MEDITECH CO., LTD. HENRY YANG
K072124 08/02/2007 BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES BLACK & BLACK SURGICAL, INC. NORMAN M BLACK, III
K072453 08/31/2007 CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T BRYMILL CORP. STEPHEN WILLIAMS
K072230 08/10/2007 POWERPICC SOLO C.R. BARD, INC. LYNN M KIRCHOFF
K072215 08/09/2007 TITANIUM POWERPORT ISP IMPLANTED PORT C.R. BARD, INC. SUSAN D SCOTT
K072456 08/31/2007 DESARA MESH SLING, MODEL CAL-DS01 CALDERA MEDICAL, INC. CHRISTINE EMANUEL
K072119 08/01/2007 AIRLIFE NEBULIZER CAP Cardinal Health SHARON NICHOLS
K072133 08/02/2007 AVAFLEX VERTEBRAL AUGMENTATION NEEDLE CARDINAL HEALTH, INC. SHARON NICHOLS
K072297 08/17/2007 BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM CARDIVA MEDICAL, INC. KIT CARIQUITAN
K072260 08/14/2007 NUFACE, MODEL NU-4003 Carol Cole Company HOWARD ASHER
K072245 08/13/2007 EMULATE ADVANCED CAVEX HOLLAND B.V. RICHARD WOORTMAN
K072210 08/09/2007 CHISON, MODEL 8300 CHISON MEDICAL IMAGING CO., LTD. Diana Hong
K072402 08/27/2007 FLEX-STAR V CMP INDUSTRIES LLC. DEVON O HOWE
K072326 08/20/2007 OSTAPEK VBR SYSTEM CO-LIGNE AG DAVID SCHLERF
K072397 08/27/2007 SYNOSS SYNTHETIC BONE GRAFT MATERIAL COLLAGEN MATRIX, INC. PEGGY HANSEN
K072201 08/08/2007 COMPUMEDICS SOMTE PSG RECORDING SYSTEM COMPUMEDICS LIMITED GORDON FERGUSON
K072368 08/23/2007 CONFORMIS METAL BACKED TIBIAL COMPONENT CONFORMIS, INC. MICHAEL SHARP
K072291 08/16/2007 CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR CONMED LINVATEC JON WARD
K072148 08/03/2007 CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER COOK, INC. SUSANNE GALIN
K072240 08/13/2007 GUNTHER TULIP VENA CAVA FILTER COOK, INC. MOLLY BUSENBARK
K072229 08/10/2007 MONOSWIFT CP MEDICAL BETSY CORTELLONI
K072422 08/28/2007 CYBERWAND STERILE PADS, MODEL: CW-RBPBX CYBERSONICS, INC. WILLIAM A STOLL
K072381 08/24/2007 SOFTPAP CERVICAL CELL COLLECTOR CYTOCORE, INC. RICHARD DOMANIK
K072219 08/10/2007 CYTOPHIL TISSUE MARKER CYTOPHIL INC Greg Johnson
K072435 08/30/2007 DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H DADE BEHRING, INC. KATHLEEN ENNIS
K072304 08/17/2007 FIBRINOGEN CALIBRATOR KIT DADE BEHRING, INC. RADAMES RIESGO
K072147 08/03/2007 DEN TEK COMFORT FIT NIGHTGUARD DEN TEK ORAL CARE, INC. HOWARD HOLSTEIN, ESQ.
K072342 08/21/2007 SULTAN TOOTH ROOT DESENSITIZER DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K072423 08/29/2007 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K072385 08/24/2007 HEARTEVENT, MODEL AT DIAGNOSTIC DEVICES PTY LTD HARRY PLATT
K072270 08/15/2007 DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) DIAZYME LABORATORIES CHARLES YU
K072395 08/27/2007 DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS DIAZYME LABORATORIES CHARLES YU
K072292 08/16/2007 NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS DIMA ITALIA SRL LEWIS WARD
K072290 08/16/2007 PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS DIMA ITALIA SRL LEWIS WARD
K072412 08/27/2007 OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 DRAGER MEDICAL AG & CO. KGAA KATHY ANDERSON
K072353 08/22/2007 PORTABLE ECSCOPE DYANSYS CORP SRINI NAGESHWAR
K072146 08/03/2007 EMS PIEZON MASTER SURGERY E.M.S. ELECTRO MEDICAL SYSTEMS S.A. SUSAN BONAPACE
K072399 08/27/2007 DEL SOL RED LIGHT THERAPY SYSTEM EDGE SYSTEMS, INC. GARY MOCNIK
K072159 08/06/2007 SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER EL.EN. ELECTRONIC ENGINEERING SPA ANDREA TOZZI
K072383 08/24/2007 HABIB ENDOBLATE EMCISION, LTD. NAGY HABIB
K072126 08/02/2007 HABIB VESEAL EMCISION, LTD. NAGY HABIB
K072154 08/03/2007 FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM ENCORE MEDICAL, L.P. TEFFANY HUTTO
K072248 08/13/2007 VIAPEEL PEELABLE INTRODUCER ENPATH MEDICAL, INC. PATRICE STROMBERG
K072302 08/17/2007 ENTELLUS MEDICAL RS-SERIES SYSTEM Entellus Medical, Inc. TOM RESSEMANN
K072404 08/27/2007 ERBE ERBEJET 2 SYSTEM ERBE USA, INC. JOHN TARTAL
K072206 08/08/2007 ERCHONIA EML LASER ERCHONIA MEDICAL, INC. Kevin Walls
K072231 08/10/2007 THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) ESM TECHNOLOGIES, LLC. CLIFF TRIBUS
K072355 08/22/2007 OSSIFUSE BONE SUBSTITUTE MATERIAL ETEX CORP. PAMELA W ADAMS
K072203 08/08/2007 HARMONIC 10CM COMBINATION HOOK BLADE ETHICON ENDO-SURGERY, LLC ELIZABETH MILLER
K072301 08/17/2007 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 EV3 INC. David Worrell
K072114 08/01/2007 IMPULSE 6000D/7000DP FLUKE BIOMEDICAL COLLEEN BOSWELL
K072293 08/16/2007 FOSSA URETERAL OPEN STENTS FOSSA MEDICAL, INC. GLORIA KOLB
K072232 08/10/2007 GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K072425 08/29/2007 JNE IMPLANT SYSTEM GC AMERICA, INC. CARL JENKINS
K072439 08/30/2007 GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA JAMES P RASKOB
K072224 08/10/2007 ZIP'R PC GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD. JUNNATA CHANG
K072458 08/31/2007 GBI TSH NEONATAL SCREENING KIT GOLDEN BRIDGE INTERNATIONAL, INC. XIAOPING ZHANG
K072320 08/20/2007 GREINER VACUETTE QUICKSHIELD COMPLETE GREINER BIO-ONE NORTH AMERICA, INC. Judi Smith
K072191 08/06/2007 CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM GVI TECHNOLOGY PARTNERS KEVIN M MURROCK
K072444 08/06/2007 WELLGRAFT PE I GWOWEI TECHNOLOGY CO., LTD. JENNIFER REICH
K072170 08/06/2007 WELLGRAFT PE II GWOWEI TECHNOLOGY CO., LTD. JENNIFER REICH
K072432 08/29/2007 F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE HAND BIOMECHANICS LAB, INC. JEFF WOODHOUSE
K072256 08/13/2007 HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL HILL LABORATORIES CO. BRADY ALLER
K072279 08/16/2007 MAGNETIC RESONANCE DIAGNOSTIC DEVICE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K072369 08/23/2007 EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM HMD BIOMEDICAL LLC MERRELL SHYE
K072272 08/15/2007 HONEYWELL HOMMED CENTRAL STATION 4.0 HONEYWELL HOMMED, LLC MICHAEL LEIGH
K072115 08/01/2007 ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H HORIBA ABX OLIVIER DUCAMP
K072221 08/10/2007 MODIFICATION TO TRIATHLON TS KNEE SYSTEM HOWMEDICA OSTEONICS CORP. TIFFANI ROGERS
K072446 08/30/2007 MOBIL-O-GRAPH NG 24 H ABP-CONTROL I.E.M. GMBH GUENTER GINSBERG
K072382 08/24/2007 MODEL I-2000 MONITOR INFINITE BIOMEDICAL TECHNOLOGIES MANAN HATHI
K072379 08/24/2007 MPS OXIPORT AND MPS OXIPORT PLUS INNERSPACE, INC. DON BOBO
K072120 08/01/2007 PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE INNOVATIVE SPINAL TECHNOLOGIES INC GINA YEH
K072207 08/08/2007 DURAGEN XS DURAL REGENERATION MATRIX INTEGRA LIFESCIENCES CORP. PETER ALLAN
K072113 08/01/2007 INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 INTEGRA LIFESCIENCES CORP. DIANA M BORDON
K072208 08/08/2007 MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS INTEGRA LIFESCIENCES CORPORATION HELDER A SOUSA
K072454 08/31/2007 INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K072254 08/14/2007 VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM INTERACOUSTICS A/S DANIEL EGGAN
K072130 08/02/2007 PTFE PEEL AWAY MICROINTRODUCER INTROMED PHIL TRIOLO
K072211 08/09/2007 INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K072338 08/20/2007 CERVITEC PLUS IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K072325 08/20/2007 BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 JAWON MEDICAL CO., LTD. Won-Hee Park
K072152 08/03/2007 JUNIPER CLN1 DERMAL COOLING DEVICE JUNIPER MEDICAL INC. DONALD V JOHNSON
K072216 08/09/2007 KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 KAPP SURGICAL INSTRUMENT, INC. ALBERT N SANTILLI
K072387 08/24/2007 KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE CHEN
K072410 08/27/2007 KSEA CLEARVISION II, MODEL 40334120 KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K072262 08/15/2007 GENTLERAY 980 DIODE LASER SYSTEM KAVO AMERICA JOHN MILLER
K072384 08/24/2007 MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE KENSEY NASH CORP. JENNIFER J BOSLEY
K072195 08/07/2007 THROMCAT THROMBECTOMY CATHETER SYSTEM KENSEY NASH CORP. CINDY R VARUGHESE
K072250 08/13/2007 SUPERCABLE GRIP AND PLATE SYSTEM KINAMED, INC. VINEET K SARIN
K072135 08/02/2007 KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K072132 08/02/2007 LDR SPINE ROI-T SYSTEM LDR SPINE USA JAMES BURROWS
K072233 08/10/2007 SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS LEONHARD LANG GMBH ELAINE DUNCAN
K072241 08/13/2007 PRIMACONNEX CAD/CAM ABUTMENT SYSTEM LIFECORE BIOMEDICAL, INC. JUDITH MEDLOCK-HAYES
K072414 08/28/2007 CRYOSTAT LIL DRUG STORE PRODUCTS, INC. PATRICIA L MILLER
K072246 08/13/2007 VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 MAINE STANDARDS CO. HOLLY CRESSMAN
K072172 08/06/2007 JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE MAQUET CARDIOPULMONARY AG KATRIN SCHWENGLENKS
K072190 08/06/2007 ORTHO-WRAP BIORESORBABLE SHEET MAST BIOSURGERY KENNETH K KLEINHENZ
K072360 08/22/2007 K-Y BRAND INTRIGUE INTENSE WARMING SENSATION MCNEIL-PPC, INC. NADER FOTOUHU, PH.D.
K072421 08/28/2007 K-Y BRAND YOURS+MINE MCNEIL-PPC, INC. NADER FOTOUHI
K072249 08/13/2007 EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT MEDICA CORP. FRAN WHITE
K072226 08/10/2007 IMPIX SPACER MEDICREA TECHNOLOGIES J.D. WEBB
K072447 08/31/2007 PENTABORN MEDISCITEC INC. Kevin Walls
K072328 08/20/2007 MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K072155 08/03/2007 PIONEER CATHETER MEDTRONIC INC. CATHERINE PRIESTLEY
K072315 08/20/2007 MIDAS REX CURVED BUR MEDTRONIC POWERED SURGICAL SOLUTIONS JEFFREY HENDERSON
K072429 08/29/2007 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K072265 08/15/2007 PROGENIX DMB PUTTY MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K072317 08/20/2007 MODIFICATION TO:TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. LEE GRANT
K072372 08/23/2007 PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE MEGO AFEK AHAVA STEIN
K072205 08/08/2007 VISAGE PACS/CS, RELEASE VERSION 5.0 MERCURY COMPUTER SYSTEMS, INC Martin Gabler
K072251 08/13/2007 MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM MERETE MEDICAL GMBH DONNA COLEMAN
K072197 08/07/2007 POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR METACURE SURGICAL GLOVES SDN BHD AZMAN ISMAIL
K072200 08/08/2007 STIMLAB MICROPACE PTY. LTD. MICHAEL CEJNAR
K072173 08/06/2007 MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K072255 08/13/2007 MINRAD INC. NASAL SCAVENGING CIRCUIT MINRAD, INC. JOHN MCNEIMEY
K072288 08/16/2007 PATHFAST D-DIMER MITSUBISHI KAGAKU IATRON HELEN LANDICHO
K072189 08/06/2007 PATHFAST NTPROBNP AND D-DIMER TESTS MITSUBISHI KAGAKU IATRON HELEN LANDICHO
K072438 08/30/2007 MEDICAL MAGGOTS, CREATURE COMFORTS MONARCH LABS, LLC. RONALD S SHERMAN
K072257 08/13/2007 MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL MORE DIAGNOSTICS JAMES W SNIPES
K072125 08/02/2007 ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT NDO SURGICAL, INC. JOHN J VOZELLA
K072116 08/01/2007 SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM NEUROSPINE INNOVATIONS AND SOLUTIONS RICHARD JANSEN
K072424 08/29/2007 COOLTOUCH, MODEL LC215,COOLLIPO NEW STAR LASERS, INC. NATALIE VOLLRATH
K072259 08/14/2007 OPHTHALMOSCOPE F-10 NIDEK CO., LTD. PAUL SUMNER
K072217 08/09/2007 ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M NIHON KOHDEN AMERICA, INC. JACK COGGAN
K072129 08/02/2007 NOBELACTIVE ZIRCONIA ABUTMENT NOBEL BIOCARE AB HERBERT CRANE
K072222 08/10/2007 SPY FLUORESCENT IMAGING SYSTEM NOVADAQ TECHNOLOGIES, INC. ALLISON MANNERS
K072362 08/22/2007 NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG NOVALUNG GMBH ROSINA ROBINSON
K072150 08/03/2007 DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL NOVOCOL, INC. STEVE RUDOLPH
K072445 08/30/2007 INTEGRATED BRACHYTHERAPY UNIT - DIGITAL NUCLETRON CORP. LISA DIMMICK
K072343 08/21/2007 NEUROVISION JJB SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K072339 08/20/2007 NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K072420 08/28/2007 MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE OCEANIC MEDICAL PRODUCTS, INC. HOWARD HOLSTEIN, ESQ
K072157 08/03/2007 MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) OHMEDA MEDICAL AGATA SMIEJA
K072295 08/16/2007 CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE ORIDION CAPNOGRAPHY, INC. RACHEL WEISSBROD
K072443 08/30/2007 VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY Ortho-Clinical Diagnostics, Inc. MARLENE HANNA
K072440 08/30/2007 VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) Ortho-Clinical Diagnostics, Inc. MARLENE HANNA
K072175 08/06/2007 TITANIUM HIP TOOL LOCKING PLATE ORTHOPEDIC SCIENCES, INC JAMES K BRANNON
K072184 08/06/2007 VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE ORTHOVITA, INC. GINA M NAGVAJARA
K072213 08/09/2007 PERIMETRICS PERIOMETER PERIMETRICS, INC. ALBERT REGO
K072427 08/29/2007 SIGMA SERIES HYPERBARIC CHAMBER PERRY BAROMEDICAL CORP. JOHN CROCKER
K072300 08/17/2007 POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM PERUSAHAAN PELINDUNG GETAH (M) SDN BHD THOMAS N TILLOTSON
K072391 08/24/2007 PFM PICC PFM MEDICAL, INC SALVADORE PALOMARES
K072393 08/27/2007 ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 PHADIA US INC. MARTIN R MANN
K072149 08/03/2007 ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 PHADIA US INC. MARTIN MANN
K072459 08/31/2007 OMNILUX NEW-U PHOTO THERAPEUTICS, INC. SUE DARCY
K072228 08/10/2007 SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) PINNACLE CO., LTD. DAVID DING
K072227 08/10/2007 VINYL EXAMINATION GLOVE POWDER FREE PINNACLE CO., LTD. DAVID DING
K072223 08/10/2007 VINYL EXAMINATION GLOVE, POWDERED PINNACLE CO., LTD. DAVID DING
K072299 08/17/2007 POWRSYRINGE ASPIRATOR PINYONS MEDICAL TECHNOLOGY, INC. SHAWN P FOJTIK
K072318 08/20/2007 POWRSYRINGE INJECTOR PINYONS MEDICAL TECHNOLOGY, INC. SHAWN P FOJTIK
K072345 08/21/2007 POWRSYRINGE MONITOR PINYONS MEDICAL TECHNOLOGY, INC. SHAWN P FOJTIK
K072187 08/06/2007 PIONEER LOWTOP SPINAL ROD SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K072244 08/13/2007 PLANMECA PROONE PLANMECA OY LARS MORING
K072376 08/24/2007 PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS PLAYTEX PRODUCTS, INC. KEITH EDGETT
K072269 08/15/2007 ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 POSSIS MEDICAL, INC. MIKE BURNSIDE
K072267 08/15/2007 TOTAL HIP SURGETICS NAVIGATION SYSTEM PRAXIM SA JIHANE ZEMMOURI
K072348 08/21/2007 PRECISION OXYGEN CONCENTRATOR PRECISION MEDICAL, INC. JAMES PARKER
K072165 08/06/2007 VICTORY THREE WHEEL SCOOTER, MODEL: SC610 PRIDE MOBILITY PRODUCTS CORP. THOMAS J SCHAPPERT
K072261 08/14/2007 FINESSE SYSTEM PRIMAEVA MEDICAL, INC. SEVRINA CIUCCI
K072364 08/22/2007 PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES PULSION MEDICAL SYSTEMS AG Jamie Sulley
K072264 08/15/2007 FASTPACK HCG IMMUNOASSAY Qualigen, Inc. MICHAEL S POIRIER
K072268 08/15/2007 HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S R & D SYSTEMS, INC. NANCY C RING
K072331 08/20/2007 RADIANCY MISTRAL DEVICE RADIANCY (ISRAEL) LTD. ZVI LADIN
K072109 08/01/2007 STATMAP, MODEL 7200 RAMSEY MEDICAL, INC. DARRYL PARMET
K072242 08/13/2007 COR ANALYZER II, MODEL V1.7 RCADIA MEDICAL IMAGING LTD. DAN LAOR
K072238 08/13/2007 BIOSET XCH REGENERATION TECHNOLOGIES, INC. TRAVIS AROLA
K072327 08/20/2007 CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON REGENERATION TECHNOLOGIES, INC. Lisa Simpson
K072194 08/07/2007 RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 RENU MEDICAL, INC. BRUCE PIERSON
K072450 08/31/2007 ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 RESPIRONICS CALIFORNIA, INC. MARA CALER
K072418 08/28/2007 OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER RESPIRONICS NEW JERSEY, INC. Lauren Ziegler
K072398 08/27/2007 RT300-S AND RT300-SP FES CYCLE ERGOMETER RESTORATIVE THERAPIES INC. ANDREW BARRISKILL
K072394 08/27/2007 PORTRAIT STAND-OFF RHYTEC INCORPORATED Robert Zoletti
K072437 08/23/2007 ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET Roche Diagnostics KAY TAYLOR
K072181 08/06/2007 MINI LED AUTOFOCUS SATELEC STEVE SALESKY
K072463 08/31/2007 SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM SATYRNE MEDICAL SCOTT LOVALD
K072374 08/23/2007 COMPASS SCANDITRONIX WELLHOFER GMBH MARTIN AROLD
K072134 08/02/2007 SCHICK COMPUTED ORAL RADIOLOGY SYSTEM SCHICK TECHNOLOGIES, INC. DANIEL MITCHELL
K072406 08/27/2007 NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) SGMP CO., LTD. JANNA P TUCKER
K072400 08/27/2007 NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES SGMP CO., LTD. JANNA P TUCKER
K072403 08/27/2007 NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS) SGMP CO., LTD. JANNA P TUCKER
K072164 08/06/2007 DC-6 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD LI DONGLING
K072235 08/10/2007 PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K072346 08/21/2007 PM-7000 PATIENT MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K072334 08/20/2007 SIALO DRAIN SIALO TECHNOLOGY, LTD. AHAVA STEIN
K072204 08/08/2007 ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS PHILIP LIU
K072266 08/15/2007 ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHEILA PICKERING
K072237 08/13/2007 MAGNETOM VERIO SIEMENS MEDICAL SOLUTIONS USA, INC. JUDITH CAMPBELL
K072392 08/27/2007 OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. KIM RENDON
K072365 08/23/2007 SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI ROBERT LAWRENCE
K072198 08/07/2007 X-VOID, SPIDER SINTEA BIOTECH, INC. GUSTAVO A RIOS
K072212 08/09/2007 JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE SMITH & NEPHEW, INC. DAVID HENLEY
K072417 08/28/2007 SMITH & NEPHEW MIS HIP STEM SMITH & NEPHEW, INC. RISHI SINHA
K072322 08/20/2007 ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS SMITH & NEPHEW, INC. JULIE ACKER
K072419 08/28/2007 ADVANTIV SAFETY I.V. CATHETER SMITHS MEDICAL ASD, INC. BARBARA LAW
K072144 08/02/2007 CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR SMITHS MEDICAL MD, INC. PHIL NEURURER
K072308 08/17/2007 D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED SORIN GROUP ITALIA S.R.L. BARRY SALL
K072131 08/02/2007 M3 MONITOR SPECTRUM MEDICAL LTD STEVE TURNER
K072289 08/16/2007 SPINEFRONTIER DORADO VBR SPINEFRONTIER, INC. TOM CARLSON
K072236 08/10/2007 DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT SSL AMERICAS CHRIS ROBINSON
K072169 08/06/2007 DUREX SYNTHETIC POLYISOPRENE MALE CONDOM SSL AMERICAS, INC. CHRIS ROBINSON
K072278 08/16/2007 BRK TRANSSEPTAL NEEDLE ST. JUDE MEDICAL Laura Moen-Ftacek
K072158 08/03/2007 AQUA PURE DEIONIZER EXCHANGE SERVICE STAUBACH BARROR WATER SYSTEMS, INC. JARROD J STAUBACH
K072371 08/23/2007 ODYSSEY WORKSTATION STEREOTAXIS, INC. DENNIS POZZO
K072408 08/27/2007 EMU-GRAPH EMULATOR, MODEL CI 131 STERITEC PRODUCTS MFG. CO., INC. LINDA NELSON
K072151 08/03/2007 P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS STRAUMANN USA PAIGE SWEENEY
K072271 08/15/2007 STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE STRYKER CORP. BECKY DITTY
K072118 08/01/2007 STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT STRYKER CORP. JEAN SHEPPARD
K072153 08/03/2007 QUICKIE QX MANUAL FOLDING WHEELCHAIR SUNRISE MEDICAL, INC. JOSEPH E OLSAVSKY
K072415 08/28/2007 STALIF (TM) C SURGICRAFT LTD. DONALD W GUTHNER
K072370 08/23/2007 SURGICRAFT SURGICAL MESH SYSTEM SURGICRAFT LTD. DONALD GUTHNER
K072177 08/06/2007 ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM SURGRX, INC. LINDA OLESON
K072307 08/17/2007 QUANTITATIVE NEUROQ 3.0 SYNTERMED, INC. KENNETH TRAIN
K072253 08/14/2007 SYNFIX-LR SPACER SYNTHES SPINE CO.LP SUSAN LEWANDOWSKI
K072434 08/29/2007 SYNTHES OC FUSION AND SYNAPSE SYSTEMS SYNTHES SPINE CO.LP SUSAN LEWANDOWSKI
K072273 08/15/2007 BELMONT QUOLIS 5000 SERIES DENTAL UNIT TAKARA BELMONT USA, INC. ROBERT SCHIFF
K072108 08/01/2007 MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES TECNIMED S.R.L. MARIA F GRIFFIN
K072166 08/06/2007 CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER THE BINDING SITE JAY GELLER
K072407 08/27/2007 BODYFORM THORACIC FIXATION SYSTEM THEKEN SPINE LLC DALE DAVISON
K072296 08/17/2007 POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 THERAGENICS CORP. BETSY CORTELLONI
K072311 08/17/2007 TILITE AERO X TISPORT, LLC RICHARD S FORMAN
K072441 08/30/2007 EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM TYSON BIORESEARCH, INC. WEN-HAI TSAI
K072156 08/03/2007 OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER USCI IRELAND MAUREEN O'CONNELL
K072405 08/27/2007 USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE USGI MEDICAL MARY LOU MOONEY
K072117 08/01/2007 THROMBIX PATCH THROMBIN HEMOSTASIS PATCH VASCULAR SOLUTIONS, INC. JAMES CHAPMAN
K072332 08/20/2007 VARI-LASE WIRE FIBER VASCULAR SOLUTIONS, INC. DEBORAH NEYMARK
K072323 08/20/2007 MASTERSCREEN & OXYCON CPX VIASYS HEALTHCARE GMBH Yvette Lloyd
K072171 08/06/2007 GATECT-RT VISION RT LIMITED ROBERT J MORTON, M.S.
K072180 08/06/2007 VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM VISION-SCIENCES, INC. PAMELA PAPINEAU
K072449 08/31/2007 CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS WELCH ALLYN, INC. JOHN SAWYER
K072168 08/06/2007 OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 WELL-LIFE HEALTHCARE LIMITED JENNY HSIEH
K072220 08/10/2007 PEDI CO2 EASY Westmed, Inc. DALE BICKLEY
K072136 08/02/2007 ULTRASONIC NEBULISER MODEL 2010 WILFRED KROMKER GMBH STEPHEN GORSKI
K072367 08/23/2007 REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K072337 08/20/2007 WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A WU'S TECH CO., LTD. Ke-Min Jen
K072282 08/16/2007 CAPLESS LI PEDICLE SCREW SYSTEM X-SPINE SYSTEMS, INC. DAVID KIRSCHMAN
K072276 08/15/2007 SUBDERMAL NEEDLE ELECTRODES XIAN FRIENDSHIP ELECTRONICS CO.,LTD. CHU XIAOAN
K072401 08/27/2007 DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR XUZHOU FULL SUN MEDICAL PRODUCTS LTD. HSUN-HUI HUANG
K072377 08/24/2007 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR XUZHOU FULL SUN MEDICAL PRODUCTS LTD. HSUN-HUI HUANG
K072314 08/17/2007 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR XUZHOU FULL SUN MEDICAL PRODUCTS LTD. HSUN- HUI HUANG
K072178 08/06/2007 ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. EWA NADOLCZAK
K072145 08/02/2007 MEDICAL GLOVE SERIES ZHANJIANG JIALI GLOVE PRODUCTS CO., LTD Diana Hong
K072183 08/06/2007 ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600 ZIMMER SPINE, INC. TIM CRABTREE
K072281 08/16/2007 NEXGEN PROLONG ALL-POLY PATELLA ZIMMER, INC. BRANDON HIPSHER
K072160 08/06/2007 NEXGEN TRABECULAR METAL TIBIAL TRAY ZIMMER, INC. BRANDON HIPSHER
K072121 08/01/2007 TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER ZIMMER, INC. PATRICIA JENKS
K072430 08/29/2007 ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE ZOLL MEDICAL CORPORATION SEAN REYNOLDS


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