| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K110131 |
01/21/2011 |
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE |
3M ESPE DENTAL PRODUCTS |
GINGER CANTOR |
| K083894 |
01/18/2011 |
ALIF SPINAL TRUSS INTERBODY FUSION DEVICE |
4-WEB SPINE, LLC |
RICHARD JANSEN |
| K102861 |
01/13/2011 |
SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) |
A PLUS INTERNATIONAL, INC. |
SOLOMON CHEN |
| K102617 |
01/10/2011 |
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K101216 |
01/14/2011 |
AUDIT MICROCV PROTEIN LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K111267 |
11/08/2011 |
CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) |
ABBCONCISE OPTICAL GROUP, LLC |
MARTIN DALSINGH |
| K111882 |
11/07/2011 |
LAMINAR FLOW PHACO TIPS |
ABBOTT MEDICAL OPTICS INC |
ROSANNE M YETEMIAN |
| K112957 |
11/08/2011 |
HI-TORQUE POWERTURN |
ABBOTT VASCULAR-CARDIAC THERAPIES |
KAY SETZER |
| K103110 |
01/10/2011 |
MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER |
ABBOTT VASCULAR-CARDIAC THERAPIES |
SUZANNE REDMAN |
| K100591 |
01/24/2011 |
SORBACT |
ABIGO MEDICAL AB |
CONSTANCE BUNDY |
| K100577 |
01/06/2011 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
KERI YEN |
| K112273 |
11/22/2011 |
ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR |
ACCUMED HEALTHCARE (SHANGHAI) INC. |
CYNTHIA (CINDY) GREEN |
| K112270 |
11/22/2011 |
ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR |
ACCUMED HEALTHCARE (SHANGHAI) INC. |
CYNTHIA (CINDY) GREEN |
| K100823 |
01/24/2011 |
WOUND PRO APEX |
ACCURO MEDICAL PRODUCTS LLC |
TODD HUBBARD |
| K110765 |
11/04/2011 |
FXA (TM) |
ACES GMBH |
FRANK T TRAUTWEIN |
| K111930 |
11/08/2011 |
ACKERMANN EUROPCLIP |
ACKERMANN INSTRUMENTE GMBH |
KAREN E WARDEN, PHD |
| K101371 |
01/07/2011 |
ON CALL PLUS DIABETES MONITORING SOFTWARE |
ACON LABORATORIES, INC. |
RICHARD LENART |
| K113063 |
11/10/2011 |
CT-GUIDE NEEDLE GUIDANCE SYSTEM |
ACTIVIEWS LTD |
JOHN J SMITH |
| K112111 |
11/14/2011 |
ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR |
ACUMED LLC |
LINO TSAI |
| K102998 |
01/04/2011 |
CONGRUENT BONE PLATE SYSTEM |
ACUMED LLC |
ED BOEHMER |
| K103043 |
01/07/2011 |
COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH |
ADAPTA MEDICAL, INC |
NEIL BURRIS |
| K103533 |
01/19/2011 |
ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
JULIE GLENDRANGE |
| K102884 |
01/28/2011 |
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR |
ADVANCED STERILIZATION PRODUCTS |
KEVIN CORRIGAN |
| K110004 |
01/26/2011 |
ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS |
JONATHAN KAHAN |
| K112551 |
11/21/2011 |
S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K102304 |
01/07/2011 |
BREEZE C MODEL C (3W), BREEZE C (4W) |
AFIKIM ELECTRIC VEHICLES |
AVNER FISHBEIN |
| K101454 |
01/28/2011 |
MAMMAPRINT |
AGENDIA |
Guido Brink |
| K103597 |
01/03/2011 |
DX-D 100 |
AGFA HEALTHCARE N.V. |
PHIL CUSCUNA |
| K103058 |
11/10/2011 |
MULTIFUNCTION KEITO |
AGUIFLAI IBERICA S.L. |
XAVIER CASALS |
| K102857 |
01/14/2011 |
AHWON'S IPL SYSTEM |
AHWON MEDI INSTRUMENT CO., LTD |
YOUNG CHI |
| K102338 |
01/12/2011 |
BREATHSCN PRO |
Akers Biosciences, Inc. |
BARBARA A BAGBY |
| K103616 |
01/25/2011 |
PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER |
AKTINA MEDICAL PHYSICS CORP. |
TONY SPACCAROTELLA |
| K112425 |
11/21/2011 |
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE |
ALCON MANUFACTURING, LTD. |
MARTIN A KAUFMAN |
| K103610 |
01/06/2011 |
CLEARVIEW EXACT II INFLUENZA A & B TEST |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
Anne Jepson |
| K102806 |
01/05/2011 |
NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS |
ALLERGAN MEDICAL |
MICAH SCHLOSS |
| K112361 |
11/30/2011 |
ALAMO C |
ALLIANCE PARTNERS, LLC |
JENNIFER PALINCHIK |
| K103036 |
01/10/2011 |
ALLOFUSE PLUS |
ALLOSOURCE, INC. |
PAMELA VETTER |
| K103501 |
01/14/2011 |
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES |
ALMA LASERS, INC. |
TATIANA EPSTEIN |
| K101147 |
01/21/2011 |
MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM |
ALMA LASERS, INC. |
TATIANA EPSTEIN |
| K110170 |
11/28/2011 |
RAPTOR FACET FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
OLGA LEWIS |
| K103252 |
01/10/2011 |
CAMLOG VARIO SR ABUTMENTS |
ALTATEC GMBH |
LINDA SCHULZ |
| K110962 |
11/18/2011 |
AMBU ASCOPE 2 |
AMBU A/S |
SANJAY PARIKH |
| K102824 |
01/28/2011 |
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC |
AMBU A/S |
SANJAY PARIKH |
| K113046 |
11/10/2011 |
AMEDITECH IMMUTEST MILTI-DRUG SCREEN |
AMEDITECH, INC. |
Greg Cerra |
| K103157 |
01/24/2011 |
DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE |
ANGSTROM MFG., INC. |
CHRIS CARRON |
| K101588 |
01/07/2011 |
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL |
APOLLO SPINE, INC. |
CHRISTINE SANTAGATE |
| K102121 |
01/12/2011 |
ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR |
APOLLO SPINE, INC. |
CHRISTINE SANTAGATE |
| DEN100026 |
11/21/2011 |
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE |
APTUS ENDOSYSTEMS, INC. |
BURT GOODSON |
| K113263 |
11/14/2011 |
ARGES IMAGING CONTRAST SPRAY |
ARGES IMAGING, INC |
Rebecca K Pine |
| K111356 |
11/09/2011 |
ASIMANAGER - AT |
ARLINGTON SCIENTIFIC, INC. |
DAVID BINKS |
| K113110 |
11/09/2011 |
AXERA ACCESS SYSTEM |
ARSTASIS, INC. |
DEBRA COGAN |
| K101823 |
01/07/2011 |
ARTHREX SWIVELOCK ANCHORS |
ARTHREX, INC. |
SALLY FOUST |
| K103060 |
01/05/2011 |
ARTHREX TIBIAL GRAFTBOLT |
ARTHREX, INC. |
COURTNEY SMITH |
| K112278 |
11/04/2011 |
ASCENSION NUGRIP CMC IMPLANT |
ASCENSION ORTHOPEDIC |
BRADLEY W STRASSER |
| K111600 |
11/15/2011 |
REPROCESSED HAND ACTIVATE SEALER/DIVIDER |
ASCENT HEALTHCARE SOLUTIONS |
RAMONA KULIK |
| K102226 |
01/04/2011 |
DUAL INCU I |
ATOM MEDICAL CORPORATION |
TSUYOSHI SUGINO |
| K102227 |
01/21/2011 |
INFA WARMER I |
ATOM MEDICAL CORPORATION |
TSUYOSHI SUGINO |
| K113112 |
11/17/2011 |
CLEARWAY RX NB CATHETER |
ATRIUM MEDICAL CORP. |
MEGAN MCCAGH |
| K112488 |
11/23/2011 |
HOTDOG PATIENT WARMING SYSTEM |
AUGUSTINE BIOMEDICAL & DESIGN, LLC |
WENDY NELSON |
| K112636 |
11/26/2011 |
CYTOGUARD(TM) CLOSED LUER CONNECTOR |
B. BRAUN MEDICAL, INC. |
ANGELA J CARAVELLA |
| K103470 |
01/11/2011 |
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 |
| K102594 |
01/19/2011 |
IO-FLEX CATHETER |
BAXANO, INC. |
EDWARD J SINCLAIR |
| K112603 |
11/04/2011 |
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
CINDY MCGUIRE |
| K113241 |
11/28/2011 |
BD EMERALD SINGLE USE, HYPODERMIC SYRINGE |
BECTON DICKINSON |
KARA MCKEE |
| K102520 |
01/06/2011 |
BD NEXIVA CLOSED IV CATHETER SYSTEM |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
JUSTICE ALDER |
| K112639 |
11/16/2011 |
THE BELMONT BUDDY LITE FLUID WARMER |
BELMONT INSTRUMENT CORP. |
URAIWAN P LABADINI |
| K103031 |
11/10/2011 |
BMR FACE |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K093678 |
01/13/2011 |
PLATELIA ASPERGILLUS EIA MODEL 62793 |
BIO-RAD |
CHRISTOPHER BENTSEN |
| K103691 |
11/03/2011 |
BIOHORIZONS ABUTMENTS FOR ZIMMER |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K103291 |
11/04/2011 |
BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K110619 |
11/23/2011 |
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS |
BIOKIT S.A. |
JOAN GUIXER |
| K112299 |
11/03/2011 |
ENDOVASCULAR LASER VEIN SYSTEM KIT |
BIOLITEC MEDICAL DEVICES, INC |
HARRY HAYES |
| K112186 |
11/08/2011 |
FIBER DISK AND BLOCK |
BIOLOREN SRL |
ANDREA RATTI |
| K100613 |
01/05/2011 |
BIOMED WOUND CLEANSER |
BIOMED LABORATORIES, INC |
DONALD G WHITE |
| K110106 |
11/30/2011 |
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K111216 |
11/18/2011 |
OSSEOTITE 2 DENTAL IMPLANTS |
BIOMET 3I, INC. |
MARTHA I GARAY |
| K101336 |
01/14/2011 |
E1 AVANTAGE HEAD |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K103755 |
01/21/2011 |
TAPERLOC COMPLETE, SIZE 5 AND 6 |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K111908 |
11/29/2011 |
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM |
BIOMET MICROFIXATION, INC. |
KIM REED |
| K101894 |
01/21/2011 |
HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT |
BIOREMEDI THERAPEUTIC SYSTEMS, INC |
NORMAN F ESTRIN |
| K103746 |
01/21/2011 |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K112050 |
11/18/2011 |
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER |
BIOSENSE WEBSTER, INC. |
MARINA GUEVREKIAN |
| K112118 |
11/17/2011 |
DREAMBOND |
BISCO, INC. |
Michelle Schiltz-Taing |
| K110426 |
11/02/2011 |
DYNA-EXTOR II |
BK MEDITECH CO., LTD. |
ELAINE DUNCAN |
| K111593 |
11/18/2011 |
GUARDIAN INFLATABLE BONE EXPANDER SYSTEM |
BM KOREA CO., LTD. |
RONALD D ARKIN |
| K112697 |
11/30/2011 |
CHARGER PTA BALLON DILATATION CATHETER |
BOSTON SCIENTIFIC |
GLENN JACQUES |
| K112303 |
11/09/2011 |
RUBICON SUPPORT CATHETER |
BOSTON SCIENTIFIC |
GLENN JACQUES |
| K110030 |
01/12/2011 |
EXPECT ENDOSCOPIC ASPIRATION NEEDLE |
BOSTON SCIENTIFIC CORP. |
ASHLEY PYLE |
| K102336 |
01/24/2011 |
RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE |
Boston Scientific Corporation |
ASHLEY PYLE |
| K111648 |
11/03/2011 |
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR |
BRACCO DIAGNOSTIC, INC. |
TRACEY ALEXANDER |
| K102165 |
01/19/2011 |
STERILE SALINE SOLUTION |
CACHET PHARMACEUTICALS PVT. LTD. |
SHIVKUMAR AGRAWAL |
| K101016 |
01/28/2011 |
ANS SYSTEM |
CAIRD TECHNOLOGY |
JAMES H BROWN |
| K103418 |
11/30/2011 |
DESARA MINI |
CALDERA MEDICAL, INC. |
VICKI GAIL |
| K112768 |
11/18/2011 |
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING |
CALYPSO MEDICAL TECHNOLOGIES INC |
MARCIA PAGE |
| K103160 |
01/06/2011 |
NUPRO MODEL 13016901 |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K103334 |
01/18/2011 |
CARDIO MED |
CARDIO MEDICAL PRODUCTS, INC. |
NICK MENDISE |
| K103159 |
01/11/2011 |
CARDIO MED MODEL A102, H104, O101, P103, AND Z100 |
CARDIO MEDICAL PRODUCTS, INC. |
NICK MENDISE |
| K103064 |
01/10/2011 |
AVAMAX VERTEBRAL BALLOON |
CAREFUSION |
JOY GREIDANUS |
| K101643 |
01/26/2011 |
MODEL LTV 1100 VENTILATOR |
CAREFUSION |
MONTHER ABUSHABAN |
| K102792 |
01/26/2011 |
DISPOSABLE BLOOD PRESSURE CUF |
CAREMATE MEDICAL DEVICE CO., LTD |
LEE FU |
| K112321 |
11/10/2011 |
CS 1200 |
CARESTREAM HEALTH,INC. |
DANIEL HOEFER |
| K103472 |
11/07/2011 |
NUFACE PLUS |
Carol Cole Company |
BOB DUFFY |
| K112985 |
11/09/2011 |
CATHETER CONNECTIONS' DUALCAP DUO |
CATHETER CONNECTIONS, INC. |
DONALD D SOLOMON |
| K103820 |
11/03/2011 |
REPROBONE DENTAL GRAFTING MATERIAL |
CERAMISYS LTD |
HILLARD W WELCH |
| K110554 |
11/02/2011 |
BIOCERAMIC ORBITAL IMPLANT, ORBTEX |
CERAMISYS LTD. |
HILLARD W WELCH |
| K103047 |
01/05/2011 |
CERETENE SOLUBLE IMPLANT MATERIAL |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K111690 |
11/22/2011 |
DEVINE SPINAL SYSTEM |
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K103166 |
01/25/2011 |
CHEETAH RELIANT |
CHEETAH MEDICAL INC. |
Rhona Shanker |
| K102203 |
01/20/2011 |
CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS |
CHEMTRON BIOTECH, INC. |
Jane Zhang |
| K102756 |
11/29/2011 |
SURECORE BIOPSY DEVICE |
CHEST INNOVATIONS INC |
SALMAAN HAMEED |
| K113212 |
11/16/2011 |
DENTAL LASER THERAPY SYSTEM |
CHINA DAHENG GROUP, INC. |
Diana Hong |
| K110605 |
11/23/2011 |
ROM PLUS |
CLINICAL INNOVATIONS, LLC |
DEAN WALLACE |
| K102077 |
01/14/2011 |
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM |
CMA MICRODIALYSIS AB |
NANCY BLANCO |
| K102589 |
01/14/2011 |
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER |
Codman & Shurtleff, Inc. |
SHARON MCDERMOTT |
| K103254 |
01/31/2011 |
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE |
COLOPLAST A/S |
BRIAN SCHMIDT |
| K112168 |
11/21/2011 |
COMPONEER |
COLTENE/WHALEDENT AG |
MARK VAN METER |
| K102940 |
01/20/2011 |
VASCOPRESS SEQUENTIAL DVT PUMP |
COMPRESSION THERAPY CONCEPTS |
LEONARD NASS |
| K112838 |
11/10/2011 |
VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS |
COMPRESSION THERAPY CONCEPTS, INC. |
LEONARD NASS |
| K103117 |
01/07/2011 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA S SHAH |
| K102927 |
01/26/2011 |
CONSENSUS KNEE SYSTEM |
Consensus Orthopedics, Inc |
MATTHEW HULL |
| K112205 |
11/16/2011 |
SNORERX 9.0 |
CONSUMER HEALTH PRODUCTS, INC |
GARY MOCNIK |
| K112185 |
11/02/2011 |
FOURSNARE VASCULAR RETRIEVAL SNARE |
COOK, INC. |
MOLLY BUSENBARK |
| K111716 |
11/10/2011 |
KNOTLESS SUTURE FIXATION SYSTEM |
CORE ESSENCE ORTHOPAEDICS |
JEFF MILLER |
| K102506 |
01/12/2011 |
MIXED MEDIA MARKER |
CORTEX MANUFACTURING, INC. |
ANDREW JONES |
| K102872 |
01/12/2011 |
OSBONE DENTAL |
CURASAN AG |
CYNTHIA J NOLTE |
| K102822 |
01/10/2011 |
IMPLANT-ONE SYSTEM |
CUSTOM DENTAL IMPLANTS INC |
KAREN E WARDEN |
| K111901 |
11/09/2011 |
ASA 'MPHI FAMILY DIODE LASER |
CYNOSURE, INC. |
ANTHONY BURNS |
| K100891 |
01/13/2011 |
DANA EMULATING INDICATOR |
DANA PRODUCTS, INC. |
HARRY BALA |
| K112152 |
11/09/2011 |
CERCON HT |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K102298 |
01/07/2011 |
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K103133 |
01/18/2011 |
VEPER SYSTEM, EXPEDIUM SYSTEM |
DEPUY SPINE, INC. |
EUGENE BANG |
| K112220 |
11/22/2011 |
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL |
DEVILBISS HEALTHCARE LLC |
JAMES P FROEHLICH |
| K101853 |
01/03/2011 |
PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 |
DIADEXUS, INC. |
NINA PELED |
| K093101 |
01/21/2011 |
MAGO 4S |
DIAMEDIX CORP. |
Glenn Gerstenfeld |
| K102959 |
01/14/2011 |
PROLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC. |
LIANN VOO |
| K103529 |
01/21/2011 |
LIAISON XL ANALYZER MODEL 10050 |
DIASORIN, INC. |
Mari Meyer |
| K101741 |
01/25/2011 |
DIATRON PICTUS 400 |
DIATRON GROUP |
JIM SCHEPP |
| K102432 |
01/14/2011 |
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, |
DIAZYME LABORATORIES |
Abhijit Datta |
| K101614 |
01/13/2011 |
HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 |
DM SYSTEMS, INCORPORATED |
MICHAEL ZMUDA |
| K102836 |
01/13/2011 |
BONASIL A+ IMPRESSION MATERIALS |
DMP LTD |
DIMITRIS PRANTSIDIS |
| K100794 |
01/25/2011 |
FLUORCANASITE DENTAL CERAMIC |
DR SARAH POLLINGTON |
JUDY BURTON |
| K102524 |
11/03/2011 |
FUTURA |
DR. OLIVER WENKER, M.D., M.B.A. |
COURTLAND IMEL |
| K111655 |
11/30/2011 |
FLAATZ 760 |
DRTECH CORP. |
CHOUL-WOO SHIN |
| K103176 |
01/26/2011 |
FREQUENCER |
DYMEDSO INC. |
Jean Bigoney |
| K100358 |
01/06/2011 |
CENTRAL MONITORING SYSTEM |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K102140 |
01/13/2011 |
FETAL MONITORS, MODELS F2 AND F3 |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K112354 |
11/30/2011 |
5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K103288 |
01/31/2011 |
DEKA SYNCHRO FT |
EL.EN. ELECTRONIC ENGINEERING SPA |
PAOLO PERUZZI |
| K101904 |
01/12/2011 |
SMARTXIDE 50 HS/MS |
EL.EN. ELECTRONIC ENGINEERING SPA |
PAOLO PERUZZI |
| K111960 |
11/18/2011 |
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS |
ELITECHGROUP |
DEBRA K HUTSON |
| K102698 |
01/05/2011 |
PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE |
ELLMAN INT'L INC. |
JONATHAN ACHENBACH |
| K103068 |
01/14/2011 |
KING COBRA ANTERIOR CERVICAL PLATE |
EMINENT SPINE |
KAREN E WARDEN |
| K103208 |
01/31/2011 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K112069 |
11/15/2011 |
RSP GLENOID BASEPLATE POROUS COATED |
ENCORE MEDICAL, L.P. |
WILLIAM GARZON |
| K103152 |
01/07/2011 |
6250 ULTRASOUND SYTEMS |
ESAOTE, S.P.A. |
Allison Scott |
| K112033 |
11/08/2011 |
ENSEAL G2 TISSUS SEALERS |
ETHICON ENDO-SUGERY, LLC |
DONOVAN MAY |
| K103618 |
01/05/2011 |
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM |
EV3 INC |
BRENDA JOHNSON |
| K102870 |
01/21/2011 |
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
| K112097 |
11/21/2011 |
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
| K111474 |
11/02/2011 |
BINGO PRO |
FORUM ENGINEERING TECHNOLOGIES (96) LTD. |
YULIYA YUTKEVICH |
| K103550 |
01/04/2011 |
YOBOSHI DENTAL UNIT |
FOSHAM YOBOSHI MEDICAL EQUIPMENT CO., LTD |
SABRINA WEI |
| K101693 |
01/05/2011 |
GAUNYING INFRARED LAMP MODEL IL50 |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
GUENTER GINSBERG |
| K102833 |
11/18/2011 |
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS |
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD |
Diana Hong |
| K111645 |
11/09/2011 |
FD TENS 2050 OR SLIDE TENS MODEL FD2050 |
FUJI DYNAMICS LTD |
CHING KONG (FELIX) LEE |
| K103465 |
01/31/2011 |
SYNAPSE 3D CARDIAC TOOLS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
DEBBIE PEACOCK |
| K103450 |
01/25/2011 |
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE |
FUJIREBIO DIAGNOSTICS, INC |
KENT PRUETT |
| K103073 |
01/03/2011 |
SUPER CHAIR FOR KIDS BY ORION |
FUTURE MOBILITY HEALTHCARE INC. |
ABDULSAMAD PANCHBHAYA |
| K111097 |
11/09/2011 |
HUMELOCK CEMENTED SHOULDER PROSTHESIS |
FX SOLUTIONS |
CHERYL HASTINGS |
| K103070 |
01/12/2011 |
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + |
G SURGICAL CO., LTD. |
DONALD GRAFTON |
| K100585 |
01/20/2011 |
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 |
GAYMAR INDUSTRIES, INC. |
BRIAN L ORWAT |
| K101346 |
01/27/2011 |
GC ORAL MOISTURIZING GEL |
GC AMERICA, INC. |
MARK HEISS |
| K103365 |
01/12/2011 |
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 |
| K112570 |
11/30/2011 |
CENTRICITY CARDIO IMAGING |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
JOHN MANARIK |
| K103182 |
01/14/2011 |
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
GENORAY CO., LTD. |
JAE KIM |
| K092963 |
01/14/2011 |
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 |
GENX INTL., INC. |
MICHAEL D CECCHI |
| K103088 |
01/14/2011 |
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT |
GIVEN IMAGING LTD. |
Tim Thomas |
| K102293 |
01/05/2011 |
CALIBER SPACER |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K102195 |
01/19/2011 |
SP-FIX SPINOUS PROCESS FIXATION PLATE |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K111290 |
11/18/2011 |
PIEZO BONE SURGERY |
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
CHARLIE MACK |
| K101716 |
01/11/2011 |
HVR PAIN RELIEF DEVICE |
H.V.R., INC. |
JESSANY GARRETT |
| K102775 |
01/21/2011 |
HAMILTON-C2 |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K103803 |
11/23/2011 |
HAMILTON-G5 |
HAMILTON MEDICAL AG |
FREDERIKE BRUEHSCHWEIN |
| K110276 |
11/09/2011 |
POWERPRESS UNIT |
HANURI DISTRIBUTION, INC |
JUNG HYUN MOON |
| K102613 |
01/13/2011 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
HEBEI FAVOR PLASTIC CO., LTD |
CHU XIAOAN |
| K113129 |
11/08/2011 |
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) |
HEIDELBERG ENGINEERING GMBH |
GERHARD ZINSER |
| K103512 |
01/07/2011 |
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM |
HOLOGIC, INC. |
GAIL YAEKER-DAUNI |
| K103788 |
11/08/2011 |
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT |
HORIBA ABX SAS |
CAROLINE FERRER |
| K103046 |
01/10/2011 |
HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE |
HOSMAN INTERNATIONAL CO., LTD |
JEN KE-MIN |
| K103224 |
01/07/2011 |
HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING |
HOSPIRA, INC. |
KAREN KEENER |
| K102561 |
01/25/2011 |
ORTHODONTIC CERAMIC BRACKET |
HT CO., LTD. |
JERRY CHOI |
| K102664 |
01/28/2011 |
HEMA SCREEN ER |
IMMUNOSTICS, INC. |
RICHARD M PEOPLES |
| K100811 |
11/04/2011 |
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 |
IMPEDIMED LIMITED |
ALDEN KAY |
| K103021 |
11/04/2011 |
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K102047 |
11/01/2011 |
LCI OPTION FOR INNOCOR |
INNOVISION A/S |
H. CARL JENKINS |
| K112945 |
11/03/2011 |
ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM |
INRAD INC. |
RYAN GOOSEN |
| K102584 |
01/14/2011 |
IMC HYPODERMIC NEEDLE |
INTERNATIONAL MEDSURG CONNECTION |
PETER KIM |
| K112601 |
11/09/2011 |
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER |
INTRICON DATRIX CORPORATION |
TANYA O'BRIEN |
| K103149 |
01/03/2011 |
1.5T 16-CHANNEL HAND-WRIST COIL |
INVIVO CORPORATION |
ELIZABETH WHEELER |
| K102651 |
01/12/2011 |
ISCREEN VISION SCREENER |
ISCREEN VISION, INC. |
BUCK BROWN |
| K103778 |
01/26/2011 |
LEFORTE NEURO SYSTEM BONE PLATE |
JEIL MEDICAL CORPORATION |
PAUL SUMNER |
| K101945 |
01/26/2011 |
NEODENT IMPLANT SYSTEM |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
LINDA K SCHULZ |
| K111748 |
11/23/2011 |
RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A |
JOY LONG |
JOY LONG |
| K103232 |
01/13/2011 |
CASPIAN SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K103800 |
01/26/2011 |
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS |
KAZ USA, INC (A SUBSIDIARY OF KAZ INC) |
RAJ KASBEKAR |
| K103351 |
01/20/2011 |
DMC COMPOSITE 2 |
KERR CORPORATION |
Wendy Garman |
| K102621 |
01/28/2011 |
SOLSTICE |
KERR CORPORATION |
Wendy Garman |
| K113279 |
11/14/2011 |
IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT |
KETTENBACH GMBH & CO KG |
SIMONE MATUSCHKA |
| K092025 |
01/27/2011 |
FLUID FILLED TEETHER - GEL |
KIDS II |
BOB COUGHLIN |
| K113036 |
11/02/2011 |
U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS |
KIMBERLY-CLARK CORPORATION |
LORI BARR |
| K102834 |
01/12/2011 |
ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) |
KINAMED INCORPORATED |
ANTHONY ROSE |
| K101136 |
01/28/2011 |
FISIO CHAMBER SPACE |
KOO(SHANGHAI)INDUSTRIES CO., LTD. |
PAUL DRYDEN |
| K101628 |
01/26/2011 |
KOWA NONMYD WX |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
| K111982 |
11/17/2011 |
CLEARFIL DC CORE PLUS |
KURARAY AMERICA, INC. |
KIYOYUKI ARIKAWA |
| K102590 |
01/13/2011 |
FLEBOSET DOUBLE |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K102864 |
01/14/2011 |
84E SERIES SINGLE PLY WRAPPER |
LAC MAC, LTD. |
JEFFREY O STULL |
| K112381 |
11/03/2011 |
HI TORQUE CONNECT GUIDEWIRE |
LAKE REGION MEDICAL |
KENNY WALSH |
| K112397 |
11/04/2011 |
ORTHO-JET CRYSTAL |
LANG DENTAL MFG. CO., INC. |
DAVID LANG |
| K103080 |
01/19/2011 |
ALBOGRAFT VASCULAR PROSTHESIS |
LEMAITRE VASCULAR, INC. |
ANDREW HODGKINSON |
| K112357 |
11/10/2011 |
VESSEL GUARDIAN |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K103547 |
11/03/2011 |
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM |
LIGHTMED CORP. |
JOCELYN LIU |
| K101263 |
01/28/2011 |
LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, |
LIMA-LTO S.P.A. |
CHERYL HASTINGS |
| K113139 |
11/22/2011 |
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K112965 |
11/02/2011 |
NANO SUTURE ANCHOR |
LINVATEC CORPORATION D/B/A CONMED LINVATEC |
ASHLEA RICCI |
| K103511 |
01/25/2011 |
LITECURE THERAPY SYSTEM |
LITECURE, LLC |
LIANG LU |
| K100610 |
01/20/2011 |
LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K103271 |
01/25/2011 |
MSC LIPID CONTROL |
MAINE STANDARDS CO. |
HOLLY CRESSMAN |
| K101446 |
01/20/2011 |
EMERALD SPINAL SYSTEM |
MAZOR SURGICAL TECHNOLOGIES LTD. |
JUSTIN EGGLETON |
| K102218 |
01/24/2011 |
COMPACT PIEZO P2K, POWERCARE |
MECTRON S.P.A. |
ROGER GRAY |
| K103332 |
01/24/2011 |
APTUS ULNA PLATES |
MEDARTIS AG |
KEVIN A THOMAS |
| K110424 |
11/30/2011 |
DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL |
MEDCOMP (MEDICAL COMPONENTS) |
JEAN CALLOW |
| K103017 |
01/20/2011 |
MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE |
MEDERI THERAPEUTICS INC. |
CURT RAYMOND |
| K110612 |
11/08/2011 |
FM20 |
MEDIANA CO., LTD. |
AMY KIM |
| K112190 |
11/09/2011 |
PATIENT MONITOR |
MEDIANA CO., LTD. |
CHARLIE MACK |
| K100829 |
01/14/2011 |
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 |
MEDICA CORP. |
Photios Makris |
| K111005 |
11/15/2011 |
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL |
MEDICA CORP. |
Photios Makris |
| K112210 |
11/22/2011 |
FRAXION |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
MICHAEL WOLFF |
| K103530 |
11/21/2011 |
SPIRODOC |
MEDICAL INTERNATIONAL RESEARCH USA, INC. |
ED KOHERE |
| K103805 |
01/25/2011 |
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE |
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD |
DAVID ELLIS |
| K102285 |
01/03/2011 |
KRYSTALRAD (ATAL8) |
MEDICATECH USA |
JOHN ROSS |
| K102284 |
01/03/2011 |
KRYSTALRAD 560 (FLAATZ 560) |
MEDICATECH USA |
JOHN ROSS |
| K112132 |
11/18/2011 |
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM |
MEDICATECH USA |
DANIEL KAMM |
| K112493 |
11/21/2011 |
PASS LP SPINAL SYSTEM |
MEDICREA INTERNATIONAL |
J.D. WEBB |
| K103722 |
01/05/2011 |
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
PARK KYEONG-MI |
| K102996 |
01/13/2011 |
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR |
MEDIVATORS REPROCESSING SYSTEMS |
LYNN LUEDERS |
| K111955 |
11/16/2011 |
MEDLINE PNEUMOPERITONEUM NEEDLE |
MEDLINE, INDUSTRIES, INC. |
MATT CLAUSEN |
| K112724 |
11/21/2011 |
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM |
MEDOS INTERNATIONAL SARL |
EUGENE BANG |
| K101354 |
01/21/2011 |
FETCH 2 ASPIRATION CATHETER MODEL 109400-001 |
MEDRAD INTERVENTIONAL/POSSIS |
Doug Atkins |
| K110560 |
11/18/2011 |
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K112444 |
11/15/2011 |
ANATOMIC PEEK CERVICAL FUSION SYSTEM |
MEDTRONIC SOFAMOR DANCK USA, INC. |
BECKY RONNER |
| K110562 |
11/09/2011 |
TELAMON PEEK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA |
REGINA HOLMES |
| K113174 |
11/21/2011 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRIS MCKEE |
| K112405 |
11/21/2011 |
CLYDESDALES SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
JULIE BASSETT |
| K102886 |
01/26/2011 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
LEE GRANT |
| K103231 |
01/24/2011 |
KYPHON INFLATION SYRINGE |
MEDTRONIC SPINE LLC |
HETAL JAWAHAR THAKKER |
| K110955 |
11/22/2011 |
ANYRIDGE INTERNAL IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
APRIL LEE |
| K112197 |
11/17/2011 |
MEMOMETAL INTRA-MEDULLARY BONE FASTENER |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
| K110738 |
11/03/2011 |
THERMO SCIENTIFIC MAS OMNI-CORE |
Microgenics Corporation |
LISA CHARTER |
| K103780 |
01/26/2011 |
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K112380 |
11/22/2011 |
CLEARVISION |
MIDMARK CORP. |
LISA BARTAKOVICS |
| K111066 |
11/22/2011 |
MIGRA TAB, QUICKSPLINT MIGRAINE |
MIGRATHERAPY LLC |
BRADLEY ELI |
| K110715 |
11/04/2011 |
INTERDRY SILVER |
MILLIKEN HEALTHCARE PRODUCTS, LLC |
BRIAN J LINDSAY |
| K103141 |
01/21/2011 |
LOW ADHERENT AFM AG DRESSINGS |
MILLIKEN HEALTHCARE PRODUCTS, LLC |
RONALD S WARREN, RAC |
| K103715 |
01/20/2011 |
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE |
MIRADOR BIOMEDICAL, INC. |
JUSTIN HULVERSHORN |
| K103014 |
01/28/2011 |
MIRADRY SYSTEM |
MIRAMAR LABS, INC. |
Kathy O'Shaughnessy |
| K113234 |
11/17/2011 |
MOBCARDIO SYSTEM |
MOBHEALTH INCORPORATION |
PATRICIA LIN |
| K102153 |
01/20/2011 |
MOBIUS ULTRASOUND IMAGING SYSTEM |
MOBISANTE, INC. |
SAILESH CHUTANI |
| K110040 |
01/26/2011 |
OMNIVISION |
MODERN MODULE INC |
SAMUEL KOH |
| K102827 |
11/02/2011 |
MEDICAL MAGGOTS, LESOC |
MONARCH LABS, LLC. |
RONALD SHERMAN |
| K112282 |
11/04/2011 |
M VISUM ALERT ALARM MANAGEMENT SYSTEM |
MVISUM, INC. |
PRAVEEN DALA |
| K102369 |
01/31/2011 |
PICCOLO COMPOSITE NAILING SYSTEM |
N.M.B. MEDICAL APPLICATIONS, LTD. |
YAEL RUBIN |
| K103209 |
01/10/2011 |
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) |
NANOSPHERE, INC. |
GREGORY W SHIPP |
| K110442 |
11/09/2011 |
NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM |
NANOVIS, LLC |
KEVIN A THOMAS, PHD |
| K103353 |
01/14/2011 |
MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
| K113198 |
11/28/2011 |
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML |
NAVILYST MEDICAL, INC. |
MARION W GORDON |
| K100625 |
01/21/2011 |
REALEYE MODEL VCPS |
NAVOTEK MEDICAL LTD |
STEVEN B DATLOF, M.D., J.D. |
| K102649 |
01/06/2011 |
NEOPOP INFANT RESUSCITATOR WITH FLOW METER |
NEOFORCE GROUP, INC. |
MONICA FERRANTE |
| K110989 |
11/03/2011 |
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
| K110077 |
01/28/2011 |
NEUCOLONCARE |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YEUHUI |
| K103338 |
11/01/2011 |
COOLTOUCH |
NEW STAR LASERS, INC. |
NATALIE R VOLLRATH |
| K102925 |
11/10/2011 |
NEXGEN EXPANDABLE CATHETER |
NEXGEN MEDICAL SYSTEMS, INC. |
CRAIG PAGAN |
| K102979 |
01/18/2011 |
NEXGEN PERIPHERAL GUIDE CATHETER |
NEXGEN MEDICAL SYSTEMS, INC. |
CRAIG PAGAN |
| K112359 |
11/08/2011 |
PROW FUSION |
NLT SPINE LTD |
JOHN J SMITH |
| K111487 |
11/10/2011 |
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE |
NORAV MEDICAL CORP. |
BENNY ARAZY |
| K110463 |
11/10/2011 |
PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) |
NORAV MEDICAL LTD. |
BENRY ARAZY |
| K102385 |
01/14/2011 |
NORFOLK MEDICAL NORPORT FAMILY OF PORTS |
NORFOLK MEDICAL PRODUCTS, INC. |
MICHAEL J DALTON |
| K112988 |
11/09/2011 |
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE |
NORTHSTAR HEALTHCARE HOLDINGS LIMITED |
ANTONIO L GIACCIO |
| K112420 |
11/18/2011 |
ONCENTRA PROSTATE 4.0 |
NUCLETRON |
MICHAEL PAUL |
| K102683 |
01/06/2011 |
THE ADDITION |
OB THE-ADDITION, LLC |
Rebecca K Pine |
| K090626 |
01/21/2011 |
ENDOSERTER |
OCULAR SYSTEMS, INC. |
KURT WEBER |
| K112564 |
11/23/2011 |
QUIXIE NEBULIZER |
ODYSSEY MEDICAL TECHNOLOGIES |
DAVID PIPER |
| K111161 |
11/04/2011 |
PERFSCAPE V2.0 |
OLEA MEDICAL |
KRISTI GUSMAN |
| K110294 |
11/18/2011 |
HIGH FLOW INSUFFLATION UNIT UHI-4 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K102379 |
01/05/2011 |
LTF-Y0009; MAJ-YOO41; XOEV-3D1 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY A KLUESNER, M.S. RAC |
| K111087 |
11/29/2011 |
FOUNDATION |
OLYMPUS TERUMO BIOMATERIALS CORPORATION |
PATSY J TRISLER |
| K103032 |
01/14/2011 |
ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ |
OLYMPUS WINTER & IBE GMBH |
STACY ABBATIELLO KLUESNER |
| K102781 |
01/11/2011 |
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS |
OLYMPUS WINTER & IBE GMBH |
STACY ABBATIELLO |
| K102322 |
01/07/2011 |
STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF) |
OMNI SURGICAL, L.P. |
J. D WEBB |
| K103475 |
01/05/2011 |
SPINEANALYER MODEL SAPOC |
OPTASIA MEDICAL |
ANTHONY HOLMES |
| K093280 |
01/07/2011 |
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 |
OPTI MEDICAL SYSTEMS INC. |
LEN OWENS |
| K110221 |
11/01/2011 |
EYE-CEPT STERILE SALINE SOLUTION |
OPTICS LABORATORY, INC |
PATRICIA CHIU |
| K111643 |
11/03/2011 |
OPTO MITRA YELLOW LASER |
OPTO ELECTRONICA SA |
PAULO ANEAS LICHTI |
| K100875 |
01/25/2011 |
CEROX, MODEL 321OF |
OR-NIM MEDICAL LTD. |
MICHAL BALBERG |
| K093595 |
01/04/2011 |
CERAROOT IMPLANT SYSTEM |
ORAL ICEBERG S.L. |
STUART R GOLDMAN |
| K101995 |
01/11/2011 |
CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD |
ORIDION CAPNOGRAPHY, INC. |
RACHEL WEISSBROD |
| K112640 |
11/16/2011 |
HYPERELASTIC WIRE |
ORMCO CORP. |
Wendy Garman |
| K102743 |
01/20/2011 |
ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES |
ORTHO SOLUTIONS LIMITED |
AL LIPPINCOTT |
| K102601 |
01/14/2011 |
ORTHOFLEX ROD |
ORTHO-PRO LLC |
J.D. WEBB |
| K110661 |
11/17/2011 |
ACCELEDENT |
ORTHOACCEL TECHNOLOGIES, INC |
MICHAEL E KAUFMAN |
| K101171 |
01/25/2011 |
ORTHOVITA PEEK SPACER |
ORTHOVITA, INC. |
CATHERINE V MOFFA |
| K090754 |
01/21/2011 |
LIPOCONTROL |
OSYRIS MEDICAL |
BLANDINE BOUVET |
| K112053 |
11/18/2011 |
OBC BONE ANCHORED HEARING SYSTEM |
OTICON MEDICAL AB |
KAROLIN ISBERG JERNBY |
| K101472 |
01/05/2011 |
MULTIFIT TOTAL HIP SYSTEM |
OTIS BIOTECH CO., LTD |
SRINIVASAREDDY KROTHA |
| K100957 |
01/21/2011 |
DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION |
PACIFIC CONSOLIDATED INDUSTRIES, LLC |
GARY CLARK |
| K113209 |
11/21/2011 |
CHIBA SONO |
PAJUNK GMBH |
CHRISTIAN QUASS |
| K111840 |
11/14/2011 |
EMERGE FRACTIONAL LASER |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K102703 |
01/05/2011 |
BUILD-IT TOTAL CORE |
PENTRON CLINICAL |
Wendy Garman |
| K103305 |
01/26/2011 |
PENUMBRA EMBOLIZATION COIL SYSTEM |
PENUMBRA, INC. |
SETH A SCHULMAN |
| K113163 |
11/23/2011 |
PENUMBRA SYSTEM MAX |
PENUMBRA, INC. |
SETH SCHULMAN |
| K103415 |
01/03/2011 |
TANDA MAX |
PHAROS LIFE CORPORATION |
GORDON WEHNER |
| K103483 |
11/23/2011 |
INGENUITY TF PET/MR |
PHILIPS HEALTHCARE (CLEVELAND) |
EDUARD TOEREK |
| K102974 |
01/04/2011 |
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 |
PHILIPS MEDICAL SYSTEMS |
GARY BECKER |
| K113125 |
11/17/2011 |
INTELLIVUE MX40 PATIENT MONITOR |
PHILIPS MEDICAL SYSTEMS |
THERESA POOLE |
| K103652 |
01/13/2011 |
SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 |
PHILIPS MEDICAL SYSTESMS |
LAWRENCE MILANA |
| K103815 |
01/25/2011 |
Q-STATION |
PHILIPS ULTRASOUND, INC. |
NANCY P BURKE |
| K103646 |
01/07/2011 |
INTELLIVUE MX40 PATIENT MONITOR |
PHILLIPS MEDICAL SYSTEMS |
CLAIRE ARAKAKI |
| K112931 |
11/02/2011 |
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K111944 |
11/22/2011 |
NB3D BONE VOID FILLER |
PIONEER SURGICAL TECHNOLOGY, INC. |
FLOYD G LARSON |
| DEN090011 |
01/13/2011 |
HEM-AVERT PERIANAL STABILIZER |
PLEXUS BIOMEDICAL INC. |
DAVID BLURTON |
| K103349 |
01/07/2011 |
BACKSTOP CATHETER |
PLUROMED, INC. |
JAMES WILKIE |
| K103575 |
11/09/2011 |
SPIRO PD |
PMD HEALTHCARE |
E.J. Smith |
| K111026 |
11/16/2011 |
APOLLO |
POLLOGEN LTD |
YORAM LEVY |
| K112408 |
11/04/2011 |
POLY-CHEM 90 ISE MODULE |
POLYMEDCO, INC. |
HELEN LANDICHO |
| K102184 |
01/07/2011 |
MEDPOR CONTAIN CAN IMPLANT |
POREX SURGICAL, INC. |
STEPHANIE FULLARD |
| K111932 |
11/10/2011 |
IGLUCOSE SYSTEM |
POSITIVEID CORPORATION |
EDWARD VALDEZ |
| K112015 |
11/22/2011 |
PREMIER HB9210 HBA1C ANALYZER |
PRIMUS CORPORATION DBA TRINITY BIOTECH |
BRITT EINSPAHR |
| K101225 |
01/25/2011 |
PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 |
PROMIMIC AB |
KARIN BREDING |
| K111923 |
11/04/2011 |
SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE |
PT. INTAN HEVEA INDUSTRY |
DARWIN TANDJO |
| K111764 |
11/10/2011 |
CHARTIS CONSOLE |
PULMONX, INC. |
HANS SCHULZ |
| K110246 |
11/04/2011 |
MEDISIZE RED AND MEDISIZE BLUE |
QSERVE AMERICA, INC. |
WILLIAM GREENROSE |
| K103539 |
01/20/2011 |
QUANTA SYSTEM DUOLITE |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K101350 |
01/04/2011 |
RADSCAN EQUIPMENT SLICKER |
RADSCAN MEDICAL EQUIPMENT, INC. |
ORAN R BROWN |
| K110071 |
01/31/2011 |
COR ANALYZER |
RCADIA MEDICAL IMAGING LTD. |
DAN LAOR |
| K111773 |
11/16/2011 |
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE |
RENU MEDICAL, INC. |
L BRUCE PIERSON |
| K101750 |
01/07/2011 |
RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 |
REPROCESSING PRODUCTS CORP. |
WALLY JANSEN |
| K090145 |
01/25/2011 |
SURECALL EMG LABOR MONITOR |
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP |
J. HARVEY KNAUSS |
| K102513 |
01/05/2011 |
S9 VPAP ST WITH H5I |
RESMED LTD. |
DAVID D'CRUZ |
| K112393 |
11/16/2011 |
TASMAN |
RESMED LTD. |
DAVID D'CRUZ |
| K111885 |
11/04/2011 |
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR |
RESPIRONICS INC. |
JOSEPH E OLSAVSKY |
| K101599 |
01/18/2011 |
RVT CTO DEVICE |
REVASCULAR THERAPEUTICS, INC. |
NANCY LINCE |
| K112262 |
11/02/2011 |
REFLEX BALLON GUIDE CATHETER |
REVERSE MEDICAL CORPORATION |
JEFFREY VALKO |
| K111272 |
11/29/2011 |
RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM |
RHAUSLER, INC. |
BARBARA DEBIASE |
| K102893 |
01/20/2011 |
PCP/PC STETHOSCOPE |
RNK PRODUCTS, INC. |
CHARLES R ABBRUSCATO |
| K102914 |
01/20/2011 |
TQ HBA1C GEN3 |
ROCHE |
KATHIE J GOODWIN |
| K103402 |
01/07/2011 |
ELECSYS DHEA-S CALCHECK 5 |
Roche Diagnostics |
KELLY C O'MAINE ADAMS |
| K102814 |
01/20/2011 |
ELECYSYS SHBG |
Roche Diagnostics |
KELLY FRENCH |
| K093989 |
01/25/2011 |
ORAL FLUID PHENCYCLIDINE |
Roche Diagnostics |
MICHELLE LEE NEFF |
| K112453 |
11/15/2011 |
STERISPINEPS PEDICLE SCREW |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
| K112558 |
11/10/2011 |
DIGITAL FLAT PANEL X-RAY DETECTOR |
SAMSUNG MOBILE DISPLAY CO., LTD |
DAVE KIM |
| K112751 |
11/23/2011 |
SDX-4343CS |
SAMSUNG MOBILE DISPLAY CO., LTD |
DAVE KIM |
| K111858 |
11/04/2011 |
LIFTKAR PT |
SANO TRANSPORTGERAETE GMBH |
JEANINE A CARROCCIO |
| K111342 |
11/25/2011 |
LIGHT GUIDE CABLE |
SCHOTT NORTH AMERICA |
JEFFREY ROBERTS |
| K103297 |
01/27/2011 |
REDONDO-L |
SEASPINE, INC. |
ETHEL BERNAL |
| K101863 |
11/07/2011 |
IT/IF CONTROL |
SEBIA |
KAREN ANDERSON |
| K103522 |
01/26/2011 |
SEDECAL |
SEDECAL S.A. |
DANIEL KAMM, P.E. |
| K110614 |
11/21/2011 |
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM |
SEJU ENGINEERING CO., LTD. |
EILEEN YANG |
| K103009 |
01/28/2011 |
SENTICARE PILLSTATION |
SENTICARE, INC. |
SETH A MAILHOT |
| K103376 |
11/18/2011 |
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 |
| K111557 |
11/10/2011 |
X-FORCE |
SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC |
MARK IOELE |
| K102741 |
11/08/2011 |
ENTERAL FEEDING BAG AND SETS |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
Diana Hong |
| K093627 |
01/18/2011 |
IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 |
SHANGHAI APOLO MEDICAL TECHNOLOGIES CO., LTD. |
BRANDON CHOI |
| K112002 |
11/18/2011 |
CAROTID COIL |
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
MEIJUAN CHEN |
| K103144 |
01/12/2011 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
BOB LEIKER |
| K111273 |
11/08/2011 |
FIR HEAT THERAPHY SYSYEMS |
SHENZHEN ANPAN TECHNOLOGY CO., LTD. |
WANG TAO |
| K112951 |
11/01/2011 |
BODY ANALYSIS SCALE |
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD |
CHARLIE MACK |
| K113153 |
11/28/2011 |
DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN |
| K103677 |
01/31/2011 |
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K111855 |
11/17/2011 |
HY-BOND RESIGLASS |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K102670 |
01/24/2011 |
TOTAL SHOULDER SYSTEM |
SHOULDER INNOVATIONS, LLC |
ANDREW RODENHOUSE |
| K102644 |
11/23/2011 |
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I |
SIEMENS HEALTHCARE DIAGNOSTICS |
GERARD SADRAKULA |
| K112999 |
11/22/2011 |
DIMENSION CLINICAL CHEMISTRY SYSTEM |
SIEMENS HEALTHCARE DIAGNOSTICS |
LORRAINE H PIESTRAK |
| K112142 |
11/04/2011 |
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE T MARINELLI |
| K103612 |
01/25/2011 |
DIMENSION VISA ENZ 2 CAL |
SIEMENS HEALTHCARE DIAGNOSTICS INC |
ANNA MARIE K ENNIS |
| K111242 |
11/23/2011 |
MAGNETOM AERA AND MAGNETOM SKYRA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MICHELLE L BYRNE |
| K103424 |
11/22/2011 |
SAFIRE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALICIA BUSTOS-JUERGENSEN |
| K103275 |
01/11/2011 |
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALICIA BUSTOS-JUERGENSEN |
| K113027 |
11/22/2011 |
SYNGO AORTIC VALVEGUIDE SOFTWARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K113029 |
11/18/2011 |
SYNGO VIA MI WORKFLOWS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K111843 |
11/14/2011 |
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
JANICE HASELTON |
| K102544 |
01/05/2011 |
SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
KATHLEEN SOLOMON |
| K102982 |
01/05/2011 |
ENDOBUTTON DIRECT |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
DEANA BOUSHELL |
| K101459 |
01/27/2011 |
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 |
SMITH & NEPHEW, INC. |
JULIE ACKER |
| K112406 |
11/14/2011 |
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES |
SMITH & NEPHEW, INC. |
DAVID HENLY |
| K102370 |
01/19/2011 |
R3 XLPE ANTEVERTED LINERS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K112784 |
11/22/2011 |
RENASYS AB ABOMINAL DRESSING KIT |
SMITH & NEPHEW, INC. |
LAURA D REYNOLDS |
| K103256 |
01/31/2011 |
SMITH & NEPHEW SMF HIP STEM |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
| K112134 |
11/22/2011 |
TRUCLEAR OPERATIVE HYSTEROSCOPE |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K111692 |
11/08/2011 |
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC |
SOMATEX MEDICAL TECHNOLOGIES GMBH |
HARALD JUNG |
| K100649 |
01/14/2011 |
SOUNDBITE HEARING SYSTEM BY SONITUS |
SONITUS MEDICAL INC |
ROBERT J CHIN |
| K112602 |
11/07/2011 |
S6 DIAGNOSTIC ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
Diana Hong |
| K113156 |
11/15/2011 |
SONOSITE EDGE ULTRASOUND SYSTEM |
SONOSITE,INC. |
SCOTT PAULSON |
| K103168 |
01/06/2011 |
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K103762 |
01/20/2011 |
SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON, RN, MED, RAC |
| K103469 |
01/18/2011 |
STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K103468 |
01/20/2011 |
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K101953 |
01/07/2011 |
SMDIA-1000 |
SOUTHMEDIC, INC. |
PAUL DRYDEN |
| K112962 |
11/02/2011 |
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) |
SPACELABS MEDICAL INC. |
DAVVID J GERAGHTY |
| K110048 |
01/26/2011 |
CERSR ELECTROMYOGRAPHY SYSTEM |
SPINEMATRIX, INC. |
JANICE M HOGAN |
| K102363 |
01/27/2011 |
SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004 |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K112688 |
11/09/2011 |
ENSITE VELOCITY SYSTEM V.3.0 |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K110085 |
01/26/2011 |
VANTAGE VIEW SYSTEM |
ST. JUDE MEDICAL |
KRIS MILLER |
| K112214 |
11/17/2011 |
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS |
ST. JUDE MEDICAL NEUROMODULATION |
PENNY HOUSTON |
| K103250 |
01/19/2011 |
CPS DIRECT SL II SLITTABLE OUTER CATHETER |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
COLLEEN CANAN |
| K101807 |
01/26/2011 |
STAYHEALTHY BODY COMPOSITION MONITOR-BCM |
STAYHEALTHY, INC. |
JESUS FARINAS |
| K112760 |
11/22/2011 |
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K102752 |
11/09/2011 |
STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS |
STINGRAY SURGICAL PRODUCTS, INC |
MARK MCBRINN |
| K112280 |
11/16/2011 |
STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM |
STRAUMANN USA |
ELAINE ALAN |
| K102885 |
01/14/2011 |
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX |
STRYKER CORP. |
ZAMIR BAR-DAVID |
| K102460 |
01/13/2011 |
AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH |
SUMMIT MEDICAL PRODUCTS, INC |
MARKO VAN AMEN |
| K113195 |
11/16/2011 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD |
CHU XIAOAN |
| K113191 |
11/17/2011 |
POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD |
CHU XIAOAN |
| K102101 |
01/26/2011 |
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA |
SURGIVISION, INC. |
EDWARD WADDELL |
| K101024 |
01/06/2011 |
KENZ CARDY302 MAX |
SUZUKEN CO., LTD. |
LINDA MORGAN |
| K111509 |
11/09/2011 |
SWEETSPOT DIABETES DATA MANAGEMENT SERVICE |
SWEETSPOT DIABETES CARE, INC. |
CHRIS LOGAN |
| K103243 |
01/21/2011 |
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM |
SYNTHES (USA) |
CHRISTOPHER HACK |
| K111891 |
11/28/2011 |
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS |
SYNTHES (USA) PRODUCTS LLC |
CHRISTOPHER HACK |
| K112085 |
11/17/2011 |
SYNTHES LCP PEDIATRIC PLATE SYSTEMS |
SYNTHES (USA) PRODUCTS LLC |
ANGELA F LASSANDRO |
| K111323 |
11/16/2011 |
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS |
SYNTHES INC |
ALAN T HALEY |
| K103287 |
01/05/2011 |
SYNTHES 6.0 COCR AND CPT TI-3 RODS |
SYNTHES SPINE |
ELIZABETH KIERZEK |
| K111358 |
11/18/2011 |
SYNTHES USS |
SYNTHES SPINE |
HEATHER GUERIN |
| K112068 |
11/07/2011 |
SYNTHES ZERO-P VARIABLE ANGLE (VA) |
SYNTHES SPINE CO.LP |
STACEY BONNELL |
| K102722 |
01/27/2011 |
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY |
SYNTHES USA PRODUCTS LLC |
JEFFREY L DOW, JD |
| K101616 |
01/06/2011 |
THE GRAPPLR AND GRAPPLR EXTENDER |
TAG MEDICAL CORP. |
GEORGE J HATTUB |
| K112963 |
11/22/2011 |
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS |
TaiDoc Technology Corporation |
TELING HSU |
| K110893 |
11/22/2011 |
VTRUST FINGER TYPE PULSE OXIMETER |
TaiDoc Technology Corporation |
TELING HSU |
| K111210 |
11/09/2011 |
T:SLIM (TM) INSULIN DELIVERY SYSTEM |
TANDEM DIABETES CARE, INC. |
DON CANAL |
| K110427 |
11/22/2011 |
FEMTEC LASER SYSTEM FOR CAPSULOTOMY |
TECHNOLAS PERFECT VISION GMBH |
BETTY M JOHNSON |
| K103433 |
01/03/2011 |
F20 |
TEKNIMED SA |
J.D. WEBB |
| K112554 |
11/18/2011 |
TRANSRADIAL ARTERY ACCESS DEVICES |
Teleflex Medical, Inc. |
CHRISTINE FORD |
| K110020 |
01/20/2011 |
TERASON T3200 ULTRASOUND SYSTEM |
TERATECH CORP. |
CHARLES F HOTTINGER |
| K112285 |
11/04/2011 |
MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE... |
TGM MEDICAL, INC. |
DENNIS H CRANE |
| K102154 |
01/21/2011 |
TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS |
THE LAGADO CORP. |
JOHN M SZABOCISK |
| K111345 |
11/02/2011 |
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS |
THE SEE CLEAR COMPANY, INC |
KEVIN RANDALL |
| K103228 |
01/05/2011 |
PARAMOUNT R IBF DEVICE |
THEKEN SPINE LLC |
DALE DAVISON |
| K103319 |
01/03/2011 |
I-SEED |
THERAGENICS CORP. |
BESTY CORTELLONI |
| K112219 |
11/18/2011 |
TAPAS CATHETER |
THERMOPEUTIX INC. |
THOMAS SCHROEDER |
| K111984 |
11/10/2011 |
SPI VARIO ANGLED ABUTMENT |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| K102713 |
01/25/2011 |
TIGER FLAT SURGICAL MASK |
TIGER MEDICAL PRODUCTS LTD |
MAGGIE ZHONG |
| K103782 |
01/27/2011 |
4D MV-ASSESSMENT 2.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
| K111902 |
11/03/2011 |
AEQUALIS SHOULDER SYSTEM |
TORNIER |
SEVERINE BONNETON |
| K102924 |
01/31/2011 |
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K113052 |
11/22/2011 |
INFINIX-CCI |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K103645 |
01/12/2011 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
PAUL BIGGINS |
| K112145 |
11/07/2011 |
MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2 |
TOTOKU ELECTRIC CO., LTD |
TSUKASA TASHIRO |
| K111642 |
11/18/2011 |
ONCO TRAC MODEL 1, 2, 4 |
TRANSLATIONAL SCIENCES CORPORATION |
ALLEN GREEN, MD, PHD, JD |
| K111615 |
11/08/2011 |
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS |
CYNTHIA C KNAPP |
| K112276 |
11/16/2011 |
VIZION |
TREK DIAGNOSTIC SYSTEMS |
CYNTHIA C KNAPP |
| K110762 |
11/18/2011 |
AVO BARRIER TOPICAL EMULSION |
TRIGEN LABORATORIES, INC. |
GEORGE MCCAULEY |
| K112509 |
11/04/2011 |
TRIMED CLAVICLE FIXATION SYSTEM |
TRIMED, INC. |
DOUG STEINBERGER |
| K103534 |
01/05/2011 |
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE |
TRIREME MEDICAL, INC. |
SHIVA ARDAKANI |
| K113280 |
11/23/2011 |
CAROTID COIL GE 1.5T |
TURSIOP TECHNOLOGIES LLC |
RAJU VISWANTHAN |
| K100784 |
11/01/2011 |
UC-CARE NAVIGO SYTEM |
UC-CARE LTD. |
JOHN KAHAN |
| K102853 |
01/25/2011 |
FLAMENCO SPINAL FIXATION SYSTEM |
ULRICH GMBH & CO. KG |
HANS STOVER |
| K103710 |
01/19/2011 |
WBR XPRESS PET |
ULTRASPECT LTD. |
DAN LAOR |
| K112544 |
11/22/2011 |
UNIMED BLOOD PRESSURE CUFF |
UNIMED MEDICAL SUPPLIES INC. |
XINMEI TAN |
| K092183 |
01/11/2011 |
EMBRYOSCOPE AND EMBRYOSLIDE |
UNISENSE FERTILITECH A/S |
METTE MUNCH |
| K111771 |
11/30/2011 |
NON-CONTACT TEAR FILM THERMOGRAGH |
UNITED INTEGRATED SERVICES CO., LTD. |
JEN KE-MIN |
| K111028 |
11/01/2011 |
EUS BALLOON |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K111709 |
11/18/2011 |
FOUNDATION DENTAL RESIN |
UNIX-JAPAN CO., LTD. |
TOSHIKO BOYD |
| K103688 |
01/14/2011 |
G-PROX EZ ENDOSCOPIC GRASPER |
USGI MEDICAL |
Mary Lou Mooney |
| K101535 |
01/11/2011 |
BT-CATH |
UTAH MEDICAL PRODUCTS, INC. |
KEVIN CORNWELL |
| K112839 |
11/14/2011 |
VARIAN HIGH ENERGY LINEAR ACCELERATOR |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K103394 |
01/12/2011 |
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
VY TRAN |
| K101604 |
01/24/2011 |
VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V |
VASCULAR SOLUTIONS, INC. |
JENNIFER RUETHER |
| K102378 |
11/02/2011 |
VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI |
VECTRACOR, INC |
BRAD S SCHRECK |
| K102934 |
01/14/2011 |
INFRARED EAR THERMOMETER, MODEL IR-04MT |
VEGA TECHNOLOGIES, INC. |
JOSEPH LU |
| K103818 |
11/16/2011 |
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY |
VENTANA MEDICAL SYTEMS, INC |
GEORGE DE LA ROSA |
| K093617 |
01/27/2011 |
VENTLAB 6000 SERIES HUMIDIFIER |
VENTLAB CORP. |
JAMES A COCHIE |
| K102915 |
01/12/2011 |
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM |
VIEWRAY INCORPORATED |
JANICE BROWNLEE |
| K102413 |
11/14/2011 |
FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL |
VILEX, INC. |
ABE LAVI |
| K112416 |
11/09/2011 |
CPK REAGENT |
VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD |
MELITA LAMBIRIS |
| K112531 |
11/18/2011 |
VITREA CT MYOCARDIAL ANALYSIS |
VITAL IMAGES, INC. |
Daniel Biank |
| K110525 |
11/23/2011 |
VITALOGRAPH MODEL 7100 - VITALOJAK |
VITALOGRAPH(IRELAND) LTD. |
TOM J HEALY |
| K102123 |
01/24/2011 |
VIZION DR |
VIZTEK, INC. |
DANIEL KAMM, P.E. |
| K112447 |
11/08/2011 |
GRANDIO CORE DUAL CURE |
VOCO GMBH |
T. GERKENSMEIER |
| K103580 |
01/21/2011 |
GRANDIO SO FLOW |
VOCO GMBH |
MANFRED THOMAS PLAUMANN |
| K112167 |
11/16/2011 |
SOYALA SILKGEL FULL FACE MASK |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
RALF EGENOLF |
| K112687 |
11/22/2011 |
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K103212 |
01/03/2011 |
ROUGHRIDER |
WHIRLWIND WHEELCHAIR INTERNATIONAL |
MARC KRIZACK |
| K110596 |
11/18/2011 |
MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM |
WIDE CORPORATION |
CARL ALLETTO |
| K103187 |
01/26/2011 |
TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM |
WILDCAT MEDICAL INC |
JOE ADKINS |
| K112647 |
11/22/2011 |
BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM |
WISTRON CORPORATION |
TELING HSU |
| K110770 |
11/16/2011 |
HEALTHTRACKER |
WISTRON CORPORATION |
TELING HSU |
| K102319 |
01/28/2011 |
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008 |
WON INDUSTRIAL CO. |
BRANDON CHOI |
| K111392 |
11/04/2011 |
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) |
WOOJEON COMPANY |
PETER CHUNG |
| K102380 |
01/07/2011 |
EVOLUTION MP TOTAL KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN ROSS |
| K112150 |
11/23/2011 |
PROFEMUR GLADIATOR HA HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K113019 |
11/10/2011 |
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K102823 |
01/07/2011 |
DISPOSABLE BLOOD PRESSURE CUFF |
WUXI MEDICAL INSTRUMENT FACTORY |
Diana Hong |
| K112036 |
11/08/2011 |
CALIX PC SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
| K112475 |
11/10/2011 |
XTRACT SYRINGE KEY SYSTEM |
XTRACT SOLUTIONS |
KEITH LOWREY |
| K102508 |
01/10/2011 |
YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 |
YU LONG SHENG TECHNOLOGY CO., LTD |
TONY C CHANG |
| K112484 |
11/22/2011 |
ZAVATION SPINAL SYSTEM |
ZAVATION LLC |
JOHN WALKER |
| K112932 |
11/01/2011 |
TRANSTEK |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
| K111119 |
11/23/2011 |
TRABECULAR METAL (TM) FUSION DEVICE |
ZIMMER SPINE, INC |
JENNIFER TRIBBETT |
| K103033 |
01/10/2011 |
TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX |
ZIMMER TRABECULAR METAL TECHNOLOGY |
KATHLEEN M RUTHERFORD |
| K111983 |
11/18/2011 |
VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX |
ZIMMER TRABECULAR METAL TECHNOLOGY |
KATHLEEN RUTHERFORD |
