| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K103434 |
11/23/2010 |
3B FLEX-LITE |
3B PRODUCTS, LLC |
ALBERT ALEXANDER LUCIO |
| K103310 |
11/10/2010 |
CRYONIZE TM |
3JT ENTERPRISES LLC |
ANTHONY GOLDBOSS |
| K100235 |
01/26/2010 |
FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE |
3M COMPANY |
SCOTT ERICKSON |
| K103277 |
11/05/2010 |
3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER |
3M COMPANY-3M HEALTH CARE |
SUZANNE LEUNG |
| K103491 |
11/26/2010 |
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM |
A JOHNSON & JOHNSON COMPANY |
FRANK S JURCZAK |
| K100145 |
01/19/2010 |
A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 |
A&E BIOCERAMIC CO., LTD. |
MARZ CHIU |
| K103403 |
11/19/2010 |
MULTICONSTITUENT CALIBRATOR |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K100015 |
01/04/2010 |
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 |
ABBOTT MOLECULAR, INC. |
PAMELA L SWATKOWSKI |
| K103471 |
11/24/2010 |
UBM PLUS |
ACCUTOME, INC. |
BRIAN T.S. BARRETT |
| K103387 |
11/18/2010 |
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL |
ACON LABORATORIES, INC. |
RICHARD LENART |
| K103298 |
11/08/2010 |
ACAM 5 AUDIOMETER SYSTEM |
ACOUSTICON GMBH |
Maureen Garner |
| K103499 |
11/29/2010 |
A SCOPE |
ACTIVE SIGNAL TECHNOLOGIES, INC. |
HARVEY KNAUSS |
| K100123 |
01/15/2010 |
ACUMED WRIST ARTHRODESIS PLATE SYSTEM |
ACUMED LLC |
LINO TSAI |
| K103513 |
11/30/2010 |
LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
JULIE GLENDRANGE |
| K103362 |
11/17/2010 |
AOI CRANIAL HELMET |
ADVANCED ORTHOPRO INC. |
MOHAMAD MANSOORI |
| K103218 |
11/01/2010 |
STERRAD CHEMICAL INDICATOR STRIP |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K103222 |
11/01/2010 |
STERRAD CYCLESURE BIOLOGICAL INDICATOR |
ADVANCED STERILIZATION PRODUCTS |
YOGI SHAH |
| K103219 |
11/01/2010 |
STERRAD SEALSURE CHEMICAL INDICATOR TAPE |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K103210 |
11/01/2010 |
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K100037 |
01/06/2010 |
ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD |
ADVANCED VERTEBRAL SOLUTIONS, LLC |
MIKE DUGERY |
| K100121 |
01/15/2010 |
MODEL 300157 CPAP SYSTEM |
AEIOMED, INC. |
DARIN BUSCH |
| K100147 |
01/19/2010 |
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
Lisa Boyle |
| K103284 |
11/05/2010 |
LAMINOPLASY PLATING SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
LISA M BOYLE |
| K100243 |
01/27/2010 |
QUINTEX CERVICAL PLATING SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
Lisa Boyle |
| K100133 |
01/19/2010 |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 |
AIRSTRIP TECHNOLOGIES, LP |
WILLIAM CAMERON POWELL |
| K103445 |
11/24/2010 |
ALACER SURGICAL SCAFFOLD |
ALACER BIOMEDICAL INC |
CONNIE GARRISON |
| K100051 |
01/08/2010 |
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) |
ALFA SCIENTIFIC DESIGNS, INC. |
NASISHU WANG |
| K103501 |
11/29/2010 |
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES |
ALMA LASERS, INC. |
TATIANA EPSTEIN |
| K100001 |
01/04/2010 |
MOBIVISION |
ALMANA MEDICAL IMAGING |
DANIEL KAMM, P.E. |
| K103205 |
11/01/2010 |
BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
OLGA LEWIS |
| K100138 |
01/19/2010 |
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
CHERYL ALLEN |
| K103252 |
11/03/2010 |
CAMLOG VARIO SR ABUTMENTS |
ALTATEC GMBH |
LINDA SCHULZ |
| K100129 |
01/19/2010 |
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X |
AMBU A/S |
SANJAY PARIKH |
| K100108 |
01/14/2010 |
AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K100265 |
01/29/2010 |
DIAMOND ANTERIOR CERVICAL PLATE SYSTEM |
AMENDIA, INC. |
TIM LUSBY |
| K100014 |
01/04/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K100199 |
01/22/2010 |
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K100120 |
01/15/2010 |
ALEXIS ORTHOPAEDIC WOUND RETRACTOR |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
| K103282 |
11/05/2010 |
LAPAROSCOPIC DISSECTOR |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
| K100215 |
01/25/2010 |
ARCHIMED REMEDY CERVICAL PLATE |
ARCHIMED, INC. |
BARRY AIKEN |
| K103421 |
11/22/2010 |
ARSTASIS DILATOR ADAPTER |
ARSTASIS, INC. |
DEBRA COGAN |
| K100221 |
01/26/2010 |
INTELLIWAVE3 |
ART OPTICAL CONTACT LENS, INC. |
MARTIN DALSING |
| K103466 |
11/24/2010 |
ARTHREX UNIVERS II SHOULDER PROSTHESIS |
ARTHREX, INC. |
SALLY FOUST, RAC |
| K100176 |
01/21/2010 |
ASCENSION ANKLE FUSION PLATE SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K100254 |
01/28/2010 |
REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER |
ASCENT HEALTHCARE SOLUTIONS |
AMANDA BABCOCK |
| K100080 |
01/12/2010 |
REPROCESSED TROCARS, MODEL B5LT AND CB5LT |
ASCENT HEALTHCARE SOLUTIONS |
MOIRA BARTON-VARTY |
| K103399 |
11/19/2010 |
GENERAL DENISTRY MOTOR |
ASEPTICO, INC. |
CHERIE TREGONING |
| K103495 |
11/29/2010 |
ASICO SOFTIP INJECTOR SYSTEM |
ASICO LLC |
RAVI NALLAKRISHNAN |
| K103251 |
11/03/2010 |
DUOCENTRIC REVERSED |
ASTON MEDICAL |
CATHERINE GLOSTER |
| K103317 |
11/10/2010 |
RESUSCITATION UNIT 105 |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
| K100076 |
01/12/2010 |
ATRIUM C-QUR OVT MESH |
ATRIUM MEDICAL CORP. |
Jacqueline Emery |
| K100016 |
01/04/2010 |
AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7 |
AVITA CORPORATION |
JENNIFER REICH |
| K103412 |
11/22/2010 |
AXIOM FASCIAL CLOSURE SYSTEM |
AXIOM TECHNOLOGY PARTNERS, LLC |
RICHARD RUSH |
| K100241 |
01/27/2010 |
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 |
B. BRAUN MEDICAL, INC. |
LISA GIAQUINTO |
| K103470 |
11/26/2010 |
PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP |
B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD |
CHU XIAOAN |
| K103367 |
11/16/2010 |
SEEKER CROSSING SUPPORT CATHETER |
BARD PERIPHERAL VASCULAR, INC. |
CANDACE WADE |
| K103245 |
11/02/2010 |
CELSTAT |
BAXTER HEALTHCARE CORP. |
SAMUEL MATHEW |
| K100010 |
01/04/2010 |
HDL CHOLESTEROL (HDLX) ASSAY |
BECKMAN COULTER, INC. |
Yvette Lloyd |
| K103373 |
11/17/2010 |
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 |
BECKMAN COULTER, INC. |
Yvette Lloyd |
| K100209 |
01/25/2010 |
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY |
BECTON DICKINSON & CO. |
PASQUALE AMATO |
| K100005 |
01/04/2010 |
BD PEN NEEDLE |
BECTON, DICKINSON AND CO. |
James Haynes |
| K100203 |
01/25/2010 |
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K100092 |
01/13/2010 |
CORVUS RADIATION THERAPY PLANNING SYSTEM |
BEST NOMOS |
CHI PALKO |
| K103230 |
11/01/2010 |
AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION |
BESTGEN BIOTECH CORP. |
STEVEN SHEN |
| K103280 |
11/05/2010 |
BHDENTAL IMPLANT SYSTEM |
BHDENTAL LTD |
EILAT EZRA |
| K100246 |
01/27/2010 |
MAX-IF1000 |
BIO PROTECH, INC. |
JUDY BURTON |
| K100150 |
01/19/2010 |
CERAMICS2IN1 |
BIODENTA SWISS AG |
DAVID EILER |
| K100162 |
01/20/2010 |
MULTIPLE PRIVATE LABEL |
BIOGREEN YIELDS SDN.BHD |
TIONG CHIONG KIENG |
| K103291 |
11/08/2010 |
BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K100155 |
01/20/2010 |
TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM |
BIOMEDICAL SYSTEMS CORP. |
MICHAEL KROEHNKE |
| K100048 |
01/08/2010 |
E1 ANTIOXIDANT INFUSED TECHNOLOGY |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K103393 |
11/19/2010 |
POLARIS SPINAL SYSTEM |
BIOMET SPINE |
VIVIAN KELLY |
| K100114 |
01/15/2010 |
FAT CONCENTRATION SYSTEM |
BIOMET, INC. |
LONNIE WITHAM |
| K103343 |
11/15/2010 |
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) |
BIONESS INC. |
ADELE SHOUSTAL |
| K100264 |
01/28/2010 |
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 |
BIONIX DEVELOPMENT CORP. |
JAMES HUTTNER |
| K103514 |
11/30/2010 |
PRO-V COAT |
BISCO, INC. |
Michelle Schiltz-Taing |
| K100044 |
01/08/2010 |
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY |
BLACKSTONE |
WHITNEY TORNING |
| K103355 |
11/16/2010 |
GDC 360 DETEACHABLE COIL |
BOSTON SCIENTIFIC CORP. |
RHODA M SANTOS |
| K103426 |
11/22/2010 |
LITE PELVIC FLOOR REPAIR KITS |
BOSTON SCIENTIFIC CORP. |
MICHELLE BERRY |
| K100078 |
01/12/2010 |
MODIFIED STRAIGHT FIRE LASER FIBER |
BOSTON SCIENTIFIC CORP. |
JANET A MCGRATH |
| K100038 |
01/07/2010 |
DISPOSABLE REFLECTIVE MARKER SPHERES |
BRAINLAB, AG |
ALEXANDER SCHWIERSCH |
| K103246 |
11/03/2010 |
IPLAN RT |
BRAINLAB, AG |
ALEXANDER SCHWIERSCH |
| K103227 |
11/01/2010 |
ORATECT ORAL FLUID DRUG SCREEN DEVICES |
BRANAN MEDICAL CORPORATION |
HUIYING WANG |
| K103345 |
11/15/2010 |
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) |
BREATHE TECHNOLOGIES, INC. |
JOSEPH CIPILLONE |
| K103377 |
11/17/2010 |
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 |
BRIVANT, LTD. |
TOMAS FUREY |
| K103459 |
11/24/2010 |
VASCUTRAK PTA DILATATION CATHETER |
C. R. BARD, INC. |
CANDACE WADE |
| K103359 |
11/16/2010 |
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) |
C.R. BARD, INC. |
CINDY MOSS |
| K100229 |
01/26/2010 |
VENTRIO HERNIA PATCH |
C.R. BARD, INC. |
MICHELLE GODIN |
| K103418 |
11/22/2010 |
DESARA MINI |
CALDERA MEDICAL, INC. |
VICKI GAIL |
| K100266 |
01/29/2010 |
ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 |
CAMNTECH, LTD |
HOWARD SMITH |
| K100143 |
01/19/2010 |
PILOT DIODE LASER, MODEL 002-00139 |
CAO GROUP, INC. |
ROBERT LARSEN |
| K103249 |
11/03/2010 |
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
| K103334 |
11/15/2010 |
CARDIO MED |
CARDIO MEDICAL PRODUCTS, INC. |
NICK MENDISE |
| K100008 |
01/04/2010 |
CARDO MEDICAL CERAMIC HIP SYSTEM |
CARDO MEDICAL, INC |
DAVE LAMB |
| K103211 |
11/01/2010 |
AVEA VENTILATOR |
CAREFUSION |
FAROKH ETEMADIEH |
| K100094 |
01/13/2010 |
CARESTREAM IMAGE SUITE |
CARESTREAM HEATLH, INC. |
JOHN PARDO |
| K100035 |
01/06/2010 |
MODEL VISULAS 532S LASER WITH THE VITE OPTION |
CARL ZEISS MEDITEC AG |
JUDITH A BRIMACOMBE |
| K100253 |
01/28/2010 |
VISUMAX LASER KERATOME |
CARL ZEISS MEDITEC AG |
JUDITH A BRIMACOMBE |
| K103472 |
11/24/2010 |
NUFACE PLUS |
Carol Cole Company |
BOB DUFFY |
| K103410 |
11/22/2010 |
NEOPAP SYSTEM |
CHILDRENS MEDICAL VENTURES LLC |
SCOTT WRIGHT |
| K103215 |
11/01/2010 |
CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT |
CIANNA MEDICAL |
GARY MOCNIK |
| K100055 |
01/08/2010 |
BLOOD PRESSURE METER, MODEL CH-609 |
CITIZEN SYSTEMS JAPAN CO., LTD. |
NATHAN A BEAVER |
| K103461 |
11/24/2010 |
COLGATE DESENSITIZING DENTAL CREAM |
COLGATE-PALMOLIVE CO. |
CHARLES P IRELAND |
| K100156 |
01/20/2010 |
COLLAGEN DENTAL MEMBRANE V |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K100218 |
01/26/2010 |
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM |
COLOPLAST A/S |
REBEKA STOLTMAN |
| K103254 |
11/03/2010 |
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE |
COLOPLAST A/S |
BRIAN SCHMIDT |
| K100047 |
01/08/2010 |
SUREFIT DUAL DISPERSIVE ELECTRODE |
CONMED CORPORATION |
SHAWN RIEDEL |
| K103431 |
11/23/2010 |
COREN TOTAL HIP SYSTEM |
CORENTEC CO., LTD |
KEVIN A THOMAS |
| K103518 |
11/30/2010 |
TRINITY ACETABULAR SYSTEM |
CORIN U.S.A. |
LUCINDA GERBER, BA (HONS) |
| K100267 |
01/29/2010 |
FLEXIMARC, MODEL CM-0.9-2-10-GG-L |
CORTEX MANUFACTURING, INC. |
ANDREW JONES |
| K103407 |
11/19/2010 |
COTRONIC DIGITAL THERMOMETER |
COTRONIC MANUFACTURING |
YAN DUR LIN |
| K103253 |
11/03/2010 |
SILS PORT |
COVIDEN (FORMERLY REGISTERED AS US SURGICAL, A DIV |
TIM M LOHNES |
| K103263 |
11/04/2010 |
ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
FRANK GIANELLI |
| K103303 |
11/09/2010 |
CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE |
CROSSTEX INTERNATIONAL, INC. |
RICHARD M ORMSBEE |
| K100045 |
01/08/2010 |
OCTO |
DALIM SURGNET CORPORATION |
PETER CHUNG |
| K103321 |
11/12/2010 |
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES |
DANA PRODUCTS, INC. |
HARRY BALA |
| K103371 |
11/17/2010 |
COUDE/ OR TIEMANN |
DEGANIA SILICONE, LTD. |
ZOYA LEE |
| K103220 |
11/01/2010 |
VOYAGER PERITONEAL DIALYSIS SYSTEM |
DEKA RESEARCH & DEVELOPMENT CORP. |
ROGER A LEROUX |
| K103329 |
11/12/2010 |
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION |
DELBIO INCORPORATION |
NICKY PAN |
| K103244 |
11/02/2010 |
QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K100012 |
01/04/2010 |
GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
Ruth Forstadt |
| K100238 |
01/27/2010 |
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K103408 |
11/19/2010 |
POSTERIOR LATERAL PLATES |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K100070 |
01/11/2010 |
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER ROGERS |
| K100247 |
01/27/2010 |
DETAX IMPLANTLINK SEMI |
DETAX GMBH & CO. KG |
DAGMAR MAESER |
| K103364 |
11/16/2010 |
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL |
DIAMOND DIAGNOSTICS, INC |
LIANN VOO |
| K100042 |
01/08/2010 |
DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM |
DIFUSION TECHNOLOGIES |
JAMI HAFIZ |
| K100100 |
01/12/2010 |
DIO STEADY EXTERNAL IMPLANT SYSTEM |
DIO CORPORATION |
TIMOTHY LEE |
| K100020 |
01/05/2010 |
DX SERIES FINGER SENSOR |
DIXTAL MEDICAL INC. |
ROBERT SCHIFFMAN |
| K103285 |
11/08/2010 |
DIXTAL DZ-4100 SERIES PULSE OXIMETER |
DIXTAL MEDICAL, INC. |
ROBERT H SCHIFFMAN |
| K100062 |
01/11/2010 |
INFILTRATION KIT |
DMG USA, INC. |
PAMELA PAPINEAU |
| K100248 |
01/27/2010 |
DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S |
DRFP LTD |
DAGMAR MAESER |
| K100220 |
01/26/2010 |
POLARIS SPINAL SYSTEM |
EBI, L.P. |
SHIKHA GOLA |
| K103290 |
11/08/2010 |
EDLEN IMAGING - GEMINI DUSB |
EDLEN IMAGING LLC |
FELIX HOVSEPIAN |
| K103520 |
11/30/2010 |
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING |
EDWARDS LIFESCIENCES, LLC. |
DARYL RICHARDSON |
| K103288 |
11/08/2010 |
DEKA SYNCHRO FT |
EL.EN. ELECTRONIC ENGINEERING SPA |
PAOLO PERUZZI |
| K100115 |
01/15/2010 |
XVI R4.5 |
ELEKTA LTD. |
ANDREW HEDGES |
| K100230 |
01/26/2010 |
SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V |
ELEME MEDICAL, INC. |
William McGrail |
| K100071 |
01/11/2010 |
EMCOOLSPAD |
EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG |
MICHAEL KUEHLING |
| K103223 |
11/01/2010 |
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS |
ENCORE MEDICAL, L.P. |
ALBERT E ALONSO |
| K103208 |
11/01/2010 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K100224 |
01/26/2010 |
ESTECH COBRA BIPOLSR II |
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH |
TAMER IBRAHIM |
| K103213 |
11/01/2010 |
FINESS ENDOSCOPE STERILIZATION TRAY |
Entellus Medical, Inc. |
KAREN E PETERSON |
| K103235 |
11/02/2010 |
ERBEFLO 2 DISPOSABLE TUBING SYSTEM |
ERBE USA, INC. |
JOHN TARTAL |
| K100017 |
01/04/2010 |
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM |
EUROIMMUN US INC |
KATHRYN KOHL |
| K103322 |
11/12/2010 |
EVERCROSS 0.035 OTW PTA DILATION CATHETER |
EV3 INC |
DAVID WORRELL, MS, RAC |
| K100063 |
01/11/2010 |
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL |
EV3 INC |
Laura Heaton |
| K103419 |
11/22/2010 |
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM |
EXACTECH, INC. |
PATRICK HUGHES |
| K100269 |
01/29/2010 |
NOVATION CROWN CUP GXL LINERS |
EXACTECH, INC. |
GRAHAM L CUTHBERT |
| K100126 |
01/19/2010 |
STELLATE GRIDVIEW |
EXCEL-TECH LTD. (XLTEK) |
GOLDY SINGH |
| K100011 |
01/04/2010 |
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM |
FISHER & PAYKEL HEALTHCARE, LTD. |
ROBERT PETRY |
| K103336 |
11/15/2010 |
MPS450 MULTIPARAMETER SIMULATOR |
FLUKE BIOMEDICAL |
JOHN NELSON |
| K100148 |
01/19/2010 |
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 |
FOCUS DIAGNOSTICS, INC. |
TARA VIVIANI |
| K100205 |
01/25/2010 |
FRONTIER DEVICES NEURO SYSTEM |
FOLSOM METAL PRODUCTS, INC. |
DON PETERSON |
| K103465 |
11/24/2010 |
SYNAPSE 3D CARDIAC TOOLS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
DEBBIE PEACOCK |
| K103450 |
11/24/2010 |
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE |
FUJIREBIO DIAGNOSTICS, INC |
KENT PRUETT |
| K103358 |
11/16/2010 |
ROMA (HE4 EIA + ARCHITECT CA 125 II) |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA L DICKSON |
| K103234 |
11/02/2010 |
GC AADVA BO AC ABUTMENTS |
GC AMERICA, INC. |
CARL JENKINS |
| K103330 |
11/12/2010 |
BRIVO MR355, OPTIMA MR360 |
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
RUOQIAN LIU |
| K103335 |
11/15/2010 |
GEM OPTION FOR 1.5 MRI SYSTEMS |
GE HEALTHCARE |
MICHAEL S PRETO |
| K103458 |
11/23/2010 |
VIEWPOINT 6 |
GE HEALTHCARE |
NICOLE LANDREVILLE |
| K103365 |
11/17/2010 |
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A |
GE HEALTHCARE COILS (USA INSTRUMENTS INC.) |
MICHAEL S PRETO |
| K103327 |
11/12/2010 |
DISCOVERY MR750W 3.0T |
GE HEALTHCARE JAPAN CORPORATION |
TORU SHIMIZU |
| K103411 |
11/22/2010 |
IDEAL IQ SOFTWARE OPTION |
GE MEDICAL SYSTEMS |
TRACEY FOX |
| K103432 |
11/23/2010 |
UNITY NETWORK ID |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC |
ROBERT CASARSA |
| K103238 |
11/02/2010 |
1.5T OPTIMA MR430S |
GE MEDICAL SYSTEMS, LLC |
NORMA LEMAY |
| K103448 |
11/24/2010 |
BRIVO XR385 |
GE MEDICAL SYSTEMS, LLC |
JOHN L SCHMIDT |
| K103476 |
11/24/2010 |
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX |
GE MEDICAL SYSTEMS, LLC |
NIDHI CHAUDHARY |
| K103480 |
11/26/2010 |
THORACIC VCAR |
GE MEDICAL SYSTEMS, LLC |
STEPHEN SLAVENS |
| K103489 |
11/26/2010 |
GE VEO RECONSTRUCTION OPTION |
GENERAL ELECTRIC CO. |
ANDREW J MENDEN |
| K103485 |
11/26/2010 |
SENOGRAPH DS, SENOGRAPH ESSENSTIAL |
GENERAL ELECTRIC COMPANY |
STEVEN KACHELMEYER |
| K100090 |
01/12/2010 |
IMPLANTABLE CLIP |
GENICON |
GARY HABERLAND |
| K103425 |
11/22/2010 |
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM |
GENORAY AMERICA INC. |
JAE KIM |
| K103504 |
11/26/2010 |
GETINGE 400HC/500HC SERIES STEAM STERILIZER |
GETINGE SOURCING, LLC |
BARB SMITH |
| K103382 |
11/18/2010 |
INTERCONTINENTAL PLATE-SPACER |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K100046 |
01/08/2010 |
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Diana Hong |
| K100135 |
01/19/2010 |
GDS-DC12 |
GUIDED DELIVERY SYSTEMS |
BONNIE L MCINERNEY |
| K100202 |
01/25/2010 |
SLIT LAMP BO 900, BQ 900, BP900 |
HAAG-STREIT AG |
OSCAR BANZ |
| K103417 |
11/22/2010 |
HALIFAX BIOMEDICAL TANATLUM BEAD SET |
HALIFAX BIOMEDICAL, INC. |
ROBERT A POGGIE, PHD |
| K103340 |
11/15/2010 |
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM |
HARVEST TECHNOLOGIES, CORP. |
JOHN D BONASERA |
| K100103 |
01/13/2010 |
SPECIALTY ASSAYED CONTROL-2 |
HELENA LABORATORIES |
PATRICIA FRANKS |
| K100234 |
01/26/2010 |
HM-LAMP II |
HILLUSA, INC. |
MARIA GUMA |
| K100273 |
01/29/2010 |
INSTAFLO BOWEL CATHETER SYSTEM KIT |
HOLLISTER, INC. |
BENJAMIN LICHTENWALNER |
| K103512 |
11/30/2010 |
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM |
HOLOGIC, INC. |
GAIL YAEKER-DAUNI |
| K103265 |
11/04/2010 |
NHANES WHOLE BODY DXA REFERENCE DATABASE |
HOLOGIC, INC. |
CHRISTINA HURTON |
| K103385 |
11/18/2010 |
SECURVIEW DX DIAGNOSTIC WORKSTATION |
HOLOGIC, INC. |
GAIL YAEKER-DAUNIS |
| K103224 |
11/01/2010 |
HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING |
HOSPIRA, INC. |
KAREN KEENER |
| K103344 |
11/15/2010 |
INFUSION SETS |
HOSPIRA, INC. |
REBECCA ANDERSEN |
| K103233 |
11/02/2010 |
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT |
HOWMEDICA OSTEONICS CORP |
AVITAL MERL-MARGULIES |
| K100271 |
01/29/2010 |
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES |
HOWMEDICA OSTEONICS CORP. |
MELISSA MATARESE |
| K103278 |
11/05/2010 |
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION |
i-SENS, Inc. |
HYUN JOON OH |
| K103396 |
11/19/2010 |
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION |
i-SENS, Inc. |
STANLEY R GOODMAN |
| K103207 |
11/01/2010 |
JBAIDS Q FEVER DETECTION KIT |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
| K103337 |
11/15/2010 |
MULTIPLE NAME |
IDEAL QUALITY SDN., BHD. |
SH TAN |
| K103325 |
11/12/2010 |
IDS-ISYS INTACT PTH |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
| K103318 |
11/12/2010 |
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR |
IMPACT INSTRUMENTATION, INC. |
SUSAN MCNEVIN |
| K100233 |
01/26/2010 |
SUDOSCAN |
IMPETO MEDICAL |
KYE CHEUNG |
| K103506 |
11/29/2010 |
1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) |
IMRIS, INC. |
THOMAS M TASKERIS |
| K103493 |
11/29/2010 |
HEAD FIATION DEVICE (HFD 100) |
IMRIS, INC. |
THOMAS M TSKERIS |
| K100031 |
01/06/2010 |
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 |
IND DIAGNOSTIC INC. |
JASON PENG |
| K103416 |
11/22/2010 |
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM |
INFIMED, INC. |
JIGAR SHAH |
| K103268 |
11/04/2010 |
OMNI EXPRESS |
INFINIUM MEDICAL |
JOHN OBRIEN |
| K103516 |
11/30/2010 |
AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 |
INOVISE MEDICAL, INC. |
EARL ANDERSON |
| K103392 |
11/19/2010 |
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER |
INOVO, INC. |
MICHAEL T DILDINE |
| K103248 |
11/03/2010 |
INTEGRITY SPINAL CARE SYSTEM |
INTEGRA LIFE SCIENCES |
JAMES J GIBSON |
| K100096 |
01/13/2010 |
LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART |
INTEGRA RADIONICS, INC. |
HELDER A SOUSA |
| K103276 |
11/05/2010 |
INTEL HEALTH GUIDE |
INTEL CORPORATION DIGITAL HEALTH GROUP |
MAUREEN GYLNN |
| K100208 |
01/25/2010 |
IMC SURGICAL DRAPE |
INTERNATIONAL MEDSURG CONNECTION |
PETER KIM |
| K103347 |
11/15/2010 |
CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES |
INTERVASCULAR, SAS |
PHILIPPE BENSIMON |
| K103528 |
11/30/2010 |
IPS EMPRESS DIRECT FLOW |
IVOCLAR VIVADENT, INC. |
DONNA HARTNETT |
| K103391 |
11/19/2010 |
IVOBASE HYBRID, IVOBASE HIGH IMPACT |
IVOCLAR VIVADENT, INC. |
DONNA HARTNETT |
| K103379 |
11/17/2010 |
TELIO CS INLAY & TELIO CS ONLAY |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
| K100098 |
01/13/2010 |
PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE |
JM SYSTEM CO., LTD. |
KEVIN WALLS, RAC |
| K103490 |
11/26/2010 |
EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM |
JOHNSON & JOHNSON |
KEVIN STEVENS |
| K103488 |
11/26/2010 |
CONCORDE BULLET CAGE SYSTEM |
JOHNSON AND JOHNSON |
KEVIN G STEVENS |
| K103232 |
11/02/2010 |
CASPIAN SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K100061 |
01/11/2010 |
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX |
K2M, INC. |
RICHARD W WOODS |
| K103440 |
11/23/2010 |
EVEREST SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K103308 |
11/09/2010 |
AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL HAGAN |
| K103467 |
11/24/2010 |
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SHIVEN GANDHI |
| K103351 |
11/16/2010 |
DMC COMPOSITE 2 |
KERR CORPORATION |
Wendy Garman |
| K100083 |
01/12/2010 |
ESTHETICA |
KERR CORPORATION |
Wendy Garman |
| K103311 |
11/10/2010 |
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS |
KIMBERLY CLARK CORPORATION |
CHERYL SANZARE |
| K103406 |
11/19/2010 |
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS |
KIMBERLY-CLARK CORP. |
DAVID M LEE |
| K103348 |
11/15/2010 |
DIGIVIEW 250 |
KUB TECHNOLOGIES, INC |
VIKRAM BUTANI |
| K103414 |
11/22/2010 |
VENUS CERVICAL SPINAL FIXATION SYSTEM |
L&K BIOMED CO.,LTD. |
SUN YI LEE |
| K103498 |
11/29/2010 |
LAKONG ULTRASONIC SCALER |
LAKONG MEDICAL DEVICE COMPANY, LTD |
DANNY WANG |
| K100191 |
01/22/2010 |
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
LANX, INC. |
ANDREW LAMBORNE |
| K103237 |
11/02/2010 |
LANX SPINAL SYSTEM |
LANX, INC. |
DAMON BELLONI |
| K100116 |
01/15/2010 |
LASERTOUCHONE (OTC) |
LASER HEALTH TECHNOLOGIES, LLC |
PATSY J TRISLER |
| K103356 |
11/16/2010 |
PRUITT CAROTID KIT |
LEMAITRE VASCULAR, INC. |
VIC ZHANG |
| K103368 |
11/17/2010 |
HAIRMAX LASERCOMB |
LEXINGTON INTERNATIONAL, LLC |
CASPER E ULDRIKS ESQ. |
| K103423 |
11/22/2010 |
MIS ANTERIOR CERVICAL PLATING SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K103302 |
11/09/2010 |
STEMPRO MSC SFM |
LIFE TECHNOLOGIES CORPORATION |
KELLI TANZELLA |
| K103357 |
11/16/2010 |
LIFEBRIDGE |
LIFEBRIDGE MEDIZINTECHNIK AG |
KATHLEEN JOHNSON |
| K103214 |
11/01/2010 |
M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 |
LIFELINE SYSTEMS, INC. |
CARLOS O ACOSTA |
| K100184 |
01/21/2010 |
FUSTAR STEERABLE INTRODUCERS |
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
Diana Hong |
| K103217 |
11/01/2010 |
LITE-MED LM-9200 ELMA |
LITE-MED INC |
WALT HSU |
| K103511 |
11/30/2010 |
LITECURE THERAPY SYSTEM |
LITECURE, LLC |
LIANG LU |
| K100213 |
01/25/2010 |
LUMANOSITY CELEBRITY, MODEL 204 |
LUMANOSITY, INC |
JEFF PROVISSIERO |
| K100228 |
01/26/2010 |
VERSAPULSE MODEL P20 LASER SYSTEM |
LUMENIS, INC. |
DOUG STANTE |
| K103455 |
11/23/2010 |
SPECTRA LASER SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
| K103271 |
11/05/2010 |
MSC LIPID CONTROL |
MAINE STANDARDS CO. |
HOLLY CRESSMAN |
| K100053 |
01/08/2010 |
MATTIOLI PULSE TWO/THREE PLUS FAMILY |
MATTIOLI ENGINEERING CORP. |
GIANFRANCO BERNABEI |
| K103352 |
11/16/2010 |
VERSAFITCUP CC TRIO |
MEDACTA INTERNATIONAL |
NATALIE J KENNEL |
| K103332 |
11/12/2010 |
APTUS ULNA PLATES |
MEDARTIS AG |
KEVIN A THOMAS |
| K100056 |
01/08/2010 |
MEDCOM RT-VIEWER SYSTEM |
MEDCOM GMBH |
STEFAN WALTER |
| K100217 |
01/25/2010 |
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 |
MEDIANA CO., LTD. |
CHARLIE MACK |
| K100225 |
01/26/2010 |
PULSE OXIMETER MODEL P10 |
MEDIANA CO., LTD. |
CHARLIE MACK |
| K100187 |
01/22/2010 |
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT |
MEDICA CORP. |
Photios Makris |
| K103507 |
11/29/2010 |
MEDICAL VISORS MV100 |
MEDICAL VISORS, INC |
BRAIN HUGHES |
| K103397 |
11/19/2010 |
ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYEONG-MI PARK |
| K100186 |
01/22/2010 |
MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
MARK JOB |
| K103375 |
11/16/2010 |
PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL |
MEDTEK DEVICES, INC. |
GREG PEPE |
| K100023 |
01/05/2010 |
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM |
MEDTOX DIAGNOSTICS, INC. |
PHILLIP HARTZOG |
| K103314 |
11/10/2010 |
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL |
MEDTRONIC INC. |
JEFFREY L KOLL |
| K103313 |
11/10/2010 |
HEPARIN ASSAY CONTROLS |
MEDTRONIC INC. |
JEFFREY L KOLL |
| K103386 |
11/18/2010 |
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS |
MEDTRONIC INC. |
ANU GAUR |
| K100274 |
01/29/2010 |
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L |
MEDTRONIC INC. |
CARALEE WALTON |
| K103464 |
11/24/2010 |
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER |
MEDTRONIC INC. |
HEATHER MOROSE |
| K100175 |
01/21/2010 |
CLYDESDALE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
JUSTINE VIERA |
| K100214 |
01/25/2010 |
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K103231 |
11/01/2010 |
KYPHON INFLATION SYRINGE |
MEDTRONIC SPINE LLC |
HETAL JAWAHAR THAKKER |
| K103272 |
11/05/2010 |
ZENIUS SPINAL SYSTEM |
MEDYSSEY CO., LTD. |
PATRICK MOORE |
| K103427 |
11/22/2010 |
MOBILEECG SYSTEM |
MEMTEC CORP. |
DENNIS GARBOSKI |
| K100244 |
01/27/2010 |
METRO SOFT |
METRO OPTICS OF AUSTIN, INC. |
MARTIN DAISING |
| K103474 |
11/26/2010 |
ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) |
MICERIUM S.P.A. |
SSA CARLA TAZZER |
| K100144 |
01/19/2010 |
THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS |
MICROGENICS CORP. |
LISA CHARTER |
| K100130 |
01/19/2010 |
PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 |
MITSUBISHI CHEMICAL MEDIENCE CO |
Judi Smith |
| K100029 |
01/06/2010 |
MEPILEX BORDER AG DRESSING |
MOLNLYCKE HEALTH CARE |
STEVEN DOWDLEY |
| K100127 |
01/19/2010 |
ELI 230 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
CHARLES MORREALE |
| K100237 |
01/26/2010 |
DIALYSATE METER, MODEL D-6 |
MYRON L COMPANY |
RICHARD JAMES SPAHL |
| K103209 |
11/01/2010 |
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) |
NANOSPHERE, INC. |
GREGORY W SHIPP |
| K103354 |
11/16/2010 |
EBONY PTA .035 PERIPHERAL DILATATION CATHETER |
NATEC MEDICAL LTD |
E.J. Smith |
| K103353 |
11/16/2010 |
MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
| K100195 |
01/22/2010 |
NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X |
NDS SURGICAL IMAGING |
JIM LENG |
| K103342 |
11/15/2010 |
3.0T METAFLEXCOIL |
NEOCOIL, LLC |
BRIAN BROWN |
| K103338 |
11/15/2010 |
COOLTOUCH |
NEW STAR LASERS, INC. |
NATALIE R VOLLRATH |
| K103515 |
11/30/2010 |
EQUAL DOSE |
NUCLETRON CORPORATION |
MANAL YOUSOF |
| K100043 |
01/08/2010 |
COROENT XLR STANDALONE SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K103264 |
11/04/2010 |
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELL KLUESNER, MS, RAC |
| K103478 |
11/26/2010 |
SINGLE USE BILIARY DRAINAGE STENT V |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K103312 |
11/10/2010 |
UPD-Y0003 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY KLUESNER |
| K100102 |
01/13/2010 |
CS-SERIES-FP |
OMEGA MEDICAL IMAGING, INC. |
James Princehorn |
| K100151 |
01/19/2010 |
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) |
OMNLIFE SCIENCE |
Robert Zoletti |
| K103475 |
11/24/2010 |
SPINEANALYER MODEL SAPOC |
OPTASIA MEDICAL |
ANTHONY HOLMES |
| K100194 |
01/22/2010 |
OPTICAL INTEGRITY LASERGUARD FIBERS |
OPTICAL INTEGRITY, INC. |
RONALD E BOWMAN |
| K100019 |
01/05/2010 |
PASCAL STREAMLINE PHOTOCOAGULATOR |
OPTIMEDICA CORPORATION |
DARLENE CROCKETT-BILLING |
| K103266 |
11/04/2010 |
ISTAND |
OPTOVUE, INC. |
JOHN J TALARICO |
| K103384 |
11/18/2010 |
ESCALADE ACETABULAR CUP SYSTEM |
ORTHO DEVELOPMENT |
TOM HAUETER |
| K100240 |
01/27/2010 |
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K100245 |
01/27/2010 |
HS/HG PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K100270 |
01/29/2010 |
ARTISAN AESTHETIC SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
SHARON TIMBERLAKE, MSHS, RAC, CC |
| K100164 |
01/20/2010 |
MR INSPIRE WITH EXTENDED KIT |
PARAMED SRL |
JOE OUELLETTE |
| K103305 |
11/09/2010 |
PENUMBRA EMBOLIZATION COIL SYSTEM |
PENUMBRA, INC. |
SETH A SCHULMAN |
| K100101 |
01/13/2010 |
GSP NEONATALGALT KIT, MODEL 3303-001U |
PERKINELMER, INC. |
KAY TAYLOR |
| K103477 |
11/26/2010 |
PERMOBIL M300 / M400 |
PERMOBIL AB |
JAN ASTROM |
| K103295 |
11/08/2010 |
QUICKSCREEN COCAINE 150 SCREENING TEST |
PHAMATECH INC. |
CARL MONGIOVI |
| K103415 |
11/22/2010 |
TANDA MAX |
PHAROS LIFE CORPORATION |
GORDON WEHNER |
| K100099 |
01/13/2010 |
ORAL/ENTERAL SYRINGES |
PHILIPS CHILDREN'S MEDICAL VENTURES |
LISA CASAVANT |
| K103483 |
11/26/2010 |
INGENUITY TF PET/MR |
PHILIPS HEALTHCARE (CLEVELAND) |
EDUARD TOEREK |
| K100272 |
01/29/2010 |
INTELLIVUE CLINICAL INFORMATION PORTFOLIO |
PHILIPS MEDICAL SYSTEMS |
TERESA SCHMIDT |
| K100104 |
01/13/2010 |
HYBERNITE RAINOUT CONTROL SYSTEM |
PLASTIFLEX GROUP NV |
WILLIAM GREENROSE |
| K103349 |
11/16/2010 |
BACKSTOP CATHETER |
PLUROMED, INC. |
JAMES WILKIE |
| K103269 |
11/04/2010 |
PATCHASSIST LARGE |
POLYTOUCH MEDICAL LTD |
LEO BASTA |
| K103339 |
11/15/2010 |
TDS ABUTMENT FOR FRIADENT XIVE |
POU YU BIOTECHNOLOGY CO., LTD. |
DANIEL TSAO |
| K103324 |
11/12/2010 |
PRECISION LIQUID OXYGEN SYSTEM |
PRECISION MEDICAL, INC. |
JAMES PARKER |
| K100124 |
01/19/2010 |
FASTX STERNAL INTRAOSSEOUS DEVICE |
PYNG MEDICAL CORP. |
MAYA BUTTERFIELD |
| K100050 |
01/08/2010 |
R & D SYSTEMS XERET HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
NANCY RING |
| K100169 |
01/20/2010 |
DURASPAN HEMODIALYSIS LONG-TERM CATHETER |
R4 VASCULAR, INC. |
LAURIE LEWANDOWSKI |
| K100084 |
01/12/2010 |
MULTI FRAME WHEELCHAIR |
R82 A/S |
KIRK MACKENZIE |
| K103206 |
11/01/2010 |
RAUMEDIC- ICP-MONITORING SYSTEM |
RAUMEDIC AG |
REINER THIEM |
| K103242 |
11/02/2010 |
REDSENSE-ALARM UNIT AND SENSOR |
REDSENSE MEDICAL AB |
CONSTANCE G BUNDY |
| K103395 |
11/19/2010 |
PERFORMAX TOTAL FACE MASK |
RESPIRONICS, INC. |
MICHELLE BRINKER |
| K103428 |
11/22/2010 |
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS |
RESTORATION ROBOTICS, INC |
KIT CARIQUITAN |
| K103370 |
11/17/2010 |
RT200 |
RESTORATIVE THERAPIES INC. |
ANDREW BARRISKILL |
| K103366 |
11/16/2010 |
RT600 |
RESTORATIVE THERAPIES INC. |
SCOTT SIMCOX |
| K103200 |
11/01/2010 |
PROPEP DELIVERY DEVICE |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES M MEWBORNE |
| K100226 |
01/25/2010 |
WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H) |
RIO FLEXON TECHNOLOGY CO., LTD. |
CHI-HUNG LIAO |
| K103449 |
11/23/2010 |
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS |
RIVERPOINT MEDICAL |
DOUG ROWLEY |
| K100006 |
01/04/2010 |
HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED |
RIVERPOINT MEDICAL |
DOUG ROWLEY |
| K103402 |
11/19/2010 |
ELECSYS DHEA-S CALCHECK 5 |
Roche Diagnostics |
KELLY C O'MAINE ADAMS |
| K103221 |
11/01/2010 |
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 |
Roche Diagnostics |
KELLY C O'MAINE ADAMS |
| K093867 |
01/05/2010 |
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A |
Roche Diagnostics |
MICHELLE LEE NEFF |
| K100227 |
01/26/2010 |
SAS FLUALERT A&B, SAS INFLUENZA A TEST |
SA SCIENTIFIC, INC. |
ROBBI PERRY |
| K100192 |
01/22/2010 |
STRONG DENTAL HANDPIECES |
SAESHIN PRECISION CO., LTD. |
Y.S. LEE |
| K100212 |
01/25/2010 |
DENTACENTER/EXPEDITION, MODEL SAF-430 |
SAFARI DENTAL, INC. |
ANDRE MATHIEU |
| K100139 |
01/19/2010 |
SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 |
SAFELIFE CORP. |
ALBERT REGO |
| K100173 |
01/21/2010 |
IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT |
SAINATH INTELLECTUAL PROPERTIES, LLC |
CHRISTOPHER PARADIES |
| K100182 |
01/21/2010 |
SALVIN DENTAL SPECIALTIES FIXATION SCREW |
SALVIN DENTAL SPECIALTIES, INC. |
ROBERT SALVIN |
| K103297 |
11/08/2010 |
REDONDO-L |
SEASPINE, INC. |
ETHEL BERNAL |
| K100268 |
01/29/2010 |
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER |
SECHRIST INDUSTRIES, INC. |
VICTOR ARELLANO |
| K103274 |
11/05/2010 |
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING |
SENTINELLE MEDICAL, INC. |
CAMERON PIRON |
| K100113 |
01/14/2010 |
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 |
SENTINELLE MEDICAL, INC. |
JOAN MEDLEY |
| K103376 |
11/17/2010 |
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL |
SEPPIM S.A.S. |
DEBRA K HUTSON |
| K100263 |
01/28/2010 |
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS |
SEPPIM S.A.S. |
DEBRA K HUTSON |
| K100211 |
01/25/2010 |
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA |
SHEN WEI (USA), INC. |
BELLE CHOU |
| K100117 |
01/15/2010 |
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
ZHIGANG ZHAO |
| K100079 |
01/12/2010 |
DIGITAL ULTRASOUND SCANNER |
SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD |
Diana Hong |
| K103346 |
11/15/2010 |
DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY |
SHERPA KOREA |
RAYMOND KELLY |
| K103360 |
11/16/2010 |
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL |
SIEMENS CORP. |
ROSE T MARINELLI |
| K100200 |
01/25/2010 |
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 |
SIEMENS HEALTHCARE DIAGNOSTICS |
KIRA GORDON |
| K103429 |
11/22/2010 |
BIOGRAPH MMR |
SIEMENS MEDICAL SOLUTIONS USA INC. |
ALAINE MEDIO |
| K100141 |
01/19/2010 |
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K103424 |
11/22/2010 |
SAFIRE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALICIA BUSTOS-JUERGENSEN |
| K103275 |
11/05/2010 |
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALICIA BUSTOS-JUERGENSEN |
| K100152 |
01/19/2010 |
SIRONA CAD/CAM SYSTEM |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K100185 |
01/22/2010 |
SLEEP APP |
SLEEP MEDICINE NETWORK, INC. |
RICHARD MOORE |
| K100160 |
01/20/2010 |
ZZOMA POSITIONAL SLEEPER MODEL 001 |
SLEEP SPECIALISTS, LLC |
HOWARD MANN |
| K103409 |
11/22/2010 |
ALLERGEAZE R CLEAR |
SMARTPRACTICE |
KIM SULLIVAN |
| K103309 |
11/10/2010 |
OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS |
SMITH & NEPHEW ENDOSCOPY, INC. |
KATHLEEN SOLOMON |
| K100159 |
01/20/2010 |
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
CHRISTINA FLORES |
| K100197 |
01/22/2010 |
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS |
SMITH & NEPHEW, INC. |
GINO BROOKS |
| K103256 |
11/03/2010 |
SMITH & NEPHEW SMF HIP STEM |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
| K100107 |
01/14/2010 |
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 |
SMITH & NEPHEW, INC. |
REGINA HOLMES |
| K103389 |
11/18/2010 |
TRUCLEAR INCISOR PLUS BLADE 2.9 |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K100204 |
01/25/2010 |
SONALIS |
SMITH ASSOCIATES |
E J SMITH |
| K103204 |
11/01/2010 |
SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY |
SOLARC SYSTEMS INC. |
BRUCE ELLIOTT |
| K100077 |
01/12/2010 |
NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 |
SOLARIS MEDICAL TECHNOLOGY, INC. |
RACHEL CHENG |
| K100112 |
01/14/2010 |
SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
CARLOS GONZALEZ |
| K100252 |
01/28/2010 |
MASTER-VU A-SCAN, MV4500 |
SONOMED, INC. |
CHARLES O'NEAL |
| K100193 |
01/22/2010 |
OTOMAG BONE CONDUCTION HEARING SYSTEM |
SOPHONO, INC |
Mary Armstrong |
| K103469 |
11/24/2010 |
STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K103468 |
11/24/2010 |
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K103202 |
11/01/2010 |
PREASSEMBLED SURGICAL WASH SET |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K103383 |
11/18/2010 |
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM |
SPARTEK MEDICAL, INC. |
HENRY KLYCE |
| K103369 |
11/17/2010 |
VAULT ALIF SYSTEM |
SPINAL USA |
LINDA POLK |
| K100122 |
01/15/2010 |
MODIFICATION TO CAPSURE PS SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K103505 |
11/29/2010 |
ALTUM ANTERIOR CERVICAL PLATE |
SPINECRAFT LLC |
AMI AKALLAL-ASAAD |
| K103250 |
11/03/2010 |
CPS DIRECT SL II SLITTABLE OUTER CATHETER |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
COLLEEN CANAN |
| K100236 |
01/26/2010 |
STAIR SYSTEMS PACS & DICOM VIEWER |
STAIR SYSTEMS, INC. |
JAMES W MONROE |
| K103226 |
11/01/2010 |
STERILIZATION MATS |
STERIS Corporation |
ROBERT F SULLIVAN |
| K100049 |
01/08/2010 |
SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT |
STERIS CORPORATION |
ROBERT SULLIVAN |
| K103331 |
11/12/2010 |
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES |
STERIS Corporation |
ROBERT F SULLIVAN |
| K103479 |
11/26/2010 |
NOVEL TAPERED HIP STEM |
STRYKER CORP |
ESTELA CELI |
| K103400 |
11/19/2010 |
FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP |
STRYKER CORPORATION |
LILIAN ECKERT |
| K103292 |
11/08/2010 |
TRIO TRAUMA SPINAL SYSTEM |
STRYKER CORPORATION |
CURTIS TRUESDALE |
| K100242 |
01/27/2010 |
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
NISHITH DESAI |
| K100257 |
01/28/2010 |
VLOC9ABSORBABLE WOUND CLOSURE DEVICE |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
JENNIFER BRENNAN |
| K100109 |
01/14/2010 |
LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE |
SURGICAL INNOVATIONS PLC |
MIKE WHITE |
| K100180 |
01/21/2010 |
SURGIQUEST ANCHORPORT SIL KIT |
SURGIQUEST, INC. |
KOUROSH AZARBARZIN |
| K103243 |
11/01/2010 |
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM |
SYNTHES (USA) |
CHRISTOPHER HACK |
| K103287 |
11/01/2010 |
SYNTHES 6.0 COCR AND CPT TI-3 RODS |
SYNTHES SPINE |
ELIZABETH KIERZEK |
| K100089 |
01/12/2010 |
SYNTHES T-PAL SPACER |
SYNTHES SPINE |
HEATHER GUERIN |
| K103320 |
11/12/2010 |
SYNTHES XRL |
SYNTHES SPINE CO.LP |
HEATHER GUERIN |
| K103487 |
11/26/2010 |
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST |
TaiDoc Technology Corporation |
TELING HSU |
| K100232 |
01/26/2010 |
LUMINESSE ZR BLANKS |
TALLADIUM, INC. |
EDWARD HARMS |
| K100074 |
01/11/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K100075 |
01/11/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) |
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K100057 |
01/08/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
TANGSHAN KANGYUAN GLOVE CO., LTD. |
CHU XIAOAN |
| K100059 |
01/08/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) |
TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K100058 |
01/08/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K100183 |
01/21/2010 |
MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER |
TANITA CORP. |
TOSHISHIKO ISHIKAWA |
| K100024 |
01/05/2010 |
TECO DIAGNOSTICS UTI DETECTION STRIPS |
TECO DIAGNOSTICS |
KC CHEN |
| K100261 |
01/28/2010 |
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K103433 |
11/24/2010 |
F20 |
TEKNIMED SA |
J.D. WEBB |
| K100179 |
01/21/2010 |
SPAPLUS |
THE BINDING SITE GROUP, LTD. |
JAY GELLER |
| K103228 |
11/02/2010 |
PARAMOUNT R IBF DEVICE |
THEKEN SPINE LLC |
DALE DAVISON |
| K103319 |
11/12/2010 |
I-SEED |
THERAGENICS CORP. |
BESTY CORTELLONI |
| K103247 |
11/03/2010 |
VASCUCOMP |
THERMOTEK, INC. |
NIRAN BALACHANDRAN |
| K100172 |
01/21/2010 |
TOKUYAMA SHIELD FORCE |
TOKUYAMA DENTAL CORPORATION |
KEITH BARRITT |
| K100207 |
01/25/2010 |
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F |
TOPCON CORP. |
TAKAO SUGAWARA |
| K100142 |
01/19/2010 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
TORNIER |
SEVERIEN BONNETON |
| K103262 |
11/04/2010 |
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM |
TORNIER, INC. |
HOWARD L SCHRAYER |
| K100067 |
01/11/2010 |
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K100210 |
01/25/2010 |
TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T |
TRANS1 INCORPORATED |
CHERYL WAGONER |
| K103456 |
11/24/2010 |
THE SENSITITRE AIM |
TREK DIAGNOSTIC SYSTEMS |
CYNTHIA C KNAPP |
| K100287 |
01/29/2010 |
JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 |
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND |
ROBERT E MILLER |
| K103510 |
11/29/2010 |
UNIMAX SPECIMEN RETRIEVAL SYSTEM |
UNIMAX MEDICAL SYSTEMS, INC. |
MICHAEL LEE |
| K103509 |
11/29/2010 |
UNIMAX SUCTION IRRIGATION SET |
UNIMAX MEDICAL SYSTEMS, INC. |
MICHAEL LEE |
| K103508 |
11/29/2010 |
UNMIAX LAPAROSCOPIC INSTRUMENT |
UNIMAX MEDICAL SYSTEMS, INC. |
MICHAEL LEE |
| K103497 |
11/29/2010 |
CERAMIC FEMORAL HEAD |
UNITED ORTHOPEDIC CORP. |
FANG-YUAN HO |
| K100081 |
01/12/2010 |
ENTEROSCOPY OVERTUBE, MODEL 00712140 |
UNITED STATES ENDOSCOPY GROUP, INC. |
BOB BISHUI |
| K103239 |
11/02/2010 |
IRRIGATION SYSTEM |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K103326 |
11/12/2010 |
MULTIPLE BIOPSY SYSTEM |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K103437 |
11/23/2010 |
US ENDOSCOPY CYTOLOGY BRUSH |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K100251 |
01/28/2010 |
G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 |
USGI MEDICAL |
MARY L MOONEY |
| K103316 |
11/10/2010 |
FLOWREST |
VAPOTHERM, INC. |
GREGORY A WHITNEY |
| K103394 |
11/19/2010 |
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
VY TRAN |
| K103405 |
11/19/2010 |
PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH |
VASCULAR SOLUTIONS, INC. |
MATT NIENSTEDT |
| K100093 |
01/13/2010 |
VSI TORQUE DEVICE |
VASCULAR SOLUTIONS, INC. |
JENNIFER RUETHER |
| K103283 |
11/05/2010 |
PHYSIOFLOW ENDURO |
VASOCOM, INC. |
JAMES GUNNERSON |
| K103260 |
11/04/2010 |
VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE |
VASONOVA INC. |
KIM TOMPKINS |
| K103255 |
11/03/2010 |
VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET |
VASONOVA INC. |
KIM TOMPKINS, RN, MBA |
| K103502 |
11/29/2010 |
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 |
VERIDEX, LLC |
SARAH MCMANUS |
| K100095 |
01/13/2010 |
CENTRAL VISION ANALYZER MODEL 1000 |
VIMETRICS,LLC. |
STEPHEN H H SINCLAIR,MD |
| DEN100013 |
11/05/2010 |
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50 |
VIOGUARD |
CRAIG RANTA |
| K100125 |
01/19/2010 |
VISION SCIENCES FLEXIBLE ENT SCOPE |
VISION-SCIENCES, INC. |
LILLIAN QUINTERO |
| K100060 |
01/11/2010 |
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 |
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD |
MELITA LAMBIRIS |
| K100163 |
01/20/2010 |
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX |
VYGON CORP. |
CINDY VARUGHESE |
| K103500 |
11/29/2010 |
GORE EMBOLIC FILTER |
W.L. GORE & ASSOCIATES,INC |
MICHELLE A WELLS |
| K103484 |
11/26/2010 |
GSP NEONATAL THYROXINE (T4) |
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. |
SUSAN K HAMANN |
| K100066 |
01/11/2010 |
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 |
WELLDOC, INC |
MALINDA PEEPLES |
| K103212 |
11/01/2010 |
ROUGHRIDER |
WHIRLWIND WHEELCHAIR INTERNATIONAL |
MARC KRIZACK |
| K100258 |
01/28/2010 |
ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 |
WICKIMED SUPPLY LIMITED |
KIPSON FUNG |
| K103494 |
11/29/2010 |
ZENOSTAR MAGIC GLAZE |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K100146 |
01/19/2010 |
EVOLVE EPS ORTHOLOC |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| K103374 |
11/17/2010 |
INBONE TOTAL ANKLE SYSTEM MODEL 200347902 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELSEY LEE |
| K100137 |
01/19/2010 |
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MEGAN MCCAGH |
| K100154 |
01/20/2010 |
FIXCET SPINAL FACET SCREW SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K100250 |
01/27/2010 |
XCERAM |
XCERAMUSA |
DANIEL KAMM |
| K100040 |
01/07/2010 |
BIOHARNESS |
ZEPHYR TECHNOLOGY CORPORATION |
CODE CUBITT |
| K103363 |
11/17/2010 |
ZEUS ELISA HSV GC-I IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K103404 |
11/19/2010 |
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM |
ZIMMER GMBH |
JASON HECKAMAN |
| K100111 |
01/14/2010 |
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM |
ZIMMER INC. |
ANTHONY FRANCALANICA, RAC |
| K103517 |
11/30/2010 |
TRABECULAR METAL FEMORAL CONE AUGMENTS |
ZIMMER TRABECULAR METAL TECHNOLOGY, INC. |
JUDITH ROSEN |
| K103473 |
11/24/2010 |
ZOLL RESCUENET EPCR MODEL RESCUENET EPCR |
ZOLL MEDICAL CORPORATION |
CHARLES W KOLIFRATH |
