| 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 |
