FDA 510(k) Decisions During January, 2011  

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
K102333 11/21/2011 APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE APTUS ENDOSYSTEMS, INC. BURT GOODSON
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
K110013 01/14/2011 WRIST FULLY AUTOMATIC BLOOD PRESSURE METER FUDAKANG INDUSTRIES CO., LTD STEPHEN LING
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
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K112484 11/22/2011 ZAVATION SPINAL SYSTEM ZAVATION LLC JOHN WALKER
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