FDA 510(k) Decisions During November, 2011  

FDA 510(k) Number Decision Date Device Name Applicant Contact
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
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
K110765 11/04/2011 FXA (TM) ACES GMBH FRANK T TRAUTWEIN
K111930 11/08/2011 ACKERMANN EUROPCLIP ACKERMANN INSTRUMENTE GMBH KAREN E WARDEN, PHD
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
K112551 11/21/2011 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K103058 11/10/2011 MULTIFUNCTION KEITO AGUIFLAI IBERICA S.L. XAVIER CASALS
K112425 11/21/2011 INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE ALCON MANUFACTURING, LTD. MARTIN A KAUFMAN
K112361 11/30/2011 ALAMO C ALLIANCE PARTNERS, LLC JENNIFER PALINCHIK
K110170 11/28/2011 RAPTOR FACET FIXATION SYSTEM ALPHATEC SPINE, INC. OLGA LEWIS
K110962 11/18/2011 AMBU ASCOPE 2 AMBU A/S SANJAY PARIKH
K113046 11/10/2011 AMEDITECH IMMUTEST MILTI-DRUG SCREEN AMEDITECH, INC. Greg Cerra
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
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
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
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
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
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
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
K111908 11/29/2011 BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM BIOMET MICROFIXATION, INC. KIM REED
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
K111648 11/03/2011 BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR BRACCO DIAGNOSTIC, INC. TRACEY ALEXANDER
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
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
K111690 11/22/2011 DEVINE SPINAL SYSTEM CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. Diana Hong
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
K112168 11/21/2011 COMPONEER COLTENE/WHALEDENT AG MARK VAN METER
K112838 11/10/2011 VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS COMPRESSION THERAPY CONCEPTS, INC. LEONARD NASS
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
K111901 11/09/2011 ASA 'MPHI FAMILY DIODE LASER CYNOSURE, INC. ANTHONY BURNS
K112152 11/09/2011 CERCON HT DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K112220 11/22/2011 DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL DEVILBISS HEALTHCARE LLC JAMES P FROEHLICH
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
K112354 11/30/2011 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K111960 11/18/2011 ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS ELITECHGROUP DEBRA K HUTSON
K112069 11/15/2011 RSP GLENOID BASEPLATE POROUS COATED ENCORE MEDICAL, L.P. WILLIAM GARZON
K112033 11/08/2011 ENSEAL G2 TISSUS SEALERS ETHICON ENDO-SUGERY, LLC DONOVAN MAY
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
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
K111097 11/09/2011 HUMELOCK CEMENTED SHOULDER PROSTHESIS FX SOLUTIONS CHERYL HASTINGS
K112570 11/30/2011 CENTRICITY CARDIO IMAGING GE HEALTHCARE INTEGRATED IT SOLUTIONS JOHN MANARIK
K111290 11/18/2011 PIEZO BONE SURGERY GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD CHARLIE MACK
K103803 11/23/2011 HAMILTON-G5 HAMILTON MEDICAL AG FREDERIKE BRUEHSCHWEIN
K110276 11/09/2011 POWERPRESS UNIT HANURI DISTRIBUTION, INC JUNG HYUN MOON
K113129 11/08/2011 SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) HEIDELBERG ENGINEERING GMBH GERHARD ZINSER
K103788 11/08/2011 PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT HORIBA ABX SAS CAROLINE FERRER
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
K112601 11/09/2011 INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER INTRICON DATRIX CORPORATION TANYA O'BRIEN
K111748 11/23/2011 RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A JOY LONG JOY LONG
K113279 11/14/2011 IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT KETTENBACH GMBH & CO KG SIMONE MATUSCHKA
K113036 11/02/2011 U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS KIMBERLY-CLARK CORPORATION LORI BARR
K111982 11/17/2011 CLEARFIL DC CORE PLUS KURARAY AMERICA, INC. KIYOYUKI ARIKAWA
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
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
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
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
K110612 11/08/2011 FM20 MEDIANA CO., LTD. AMY KIM
K112190 11/09/2011 PATIENT MONITOR MEDIANA CO., LTD. CHARLIE MACK
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
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
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
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
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
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
K113234 11/17/2011 MOBCARDIO SYSTEM MOBHEALTH INCORPORATION PATRICIA LIN
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
K110442 11/09/2011 NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM NANOVIS, LLC KEVIN A THOMAS, PHD
K113198 11/28/2011 NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML NAVILYST MEDICAL, INC. MARION W GORDON
K110989 11/03/2011 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
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
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
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
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
K111087 11/29/2011 FOUNDATION OLYMPUS TERUMO BIOMATERIALS CORPORATION PATSY J TRISLER
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
K112640 11/16/2011 HYPERELASTIC WIRE ORMCO CORP. Wendy Garman
K110661 11/17/2011 ACCELEDENT ORTHOACCEL TECHNOLOGIES, INC MICHAEL E KAUFMAN
K112053 11/18/2011 OBC BONE ANCHORED HEARING SYSTEM OTICON MEDICAL AB KAROLIN ISBERG JERNBY
K113209 11/21/2011 CHIBA SONO PAJUNK GMBH CHRISTIAN QUASS
K111840 11/14/2011 EMERGE FRACTIONAL LASER PALOMAR MEDICAL PRODUCTS, INC. Sharon Timberlake
K113163 11/23/2011 PENUMBRA SYSTEM MAX PENUMBRA, INC. SETH SCHULMAN
K103483 11/23/2011 INGENUITY TF PET/MR PHILIPS HEALTHCARE (CLEVELAND) EDUARD TOEREK
K113125 11/17/2011 INTELLIVUE MX40 PATIENT MONITOR PHILIPS MEDICAL SYSTEMS THERESA POOLE
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
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
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
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
K111773 11/16/2011 RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE RENU MEDICAL, INC. L BRUCE PIERSON
K112393 11/16/2011 TASMAN RESMED LTD. DAVID D'CRUZ
K111885 11/04/2011 SIMPLYGO PORTABLE OXYGEN CONCENTRATOR RESPIRONICS INC. JOSEPH E OLSAVSKY
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
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
K101863 11/07/2011 IT/IF CONTROL SEBIA KAREN ANDERSON
K110614 11/21/2011 PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM SEJU ENGINEERING CO., LTD. EILEEN YANG
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
K112002 11/18/2011 CAROTID COIL SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD MEIJUAN CHEN
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
K111855 11/17/2011 HY-BOND RESIGLASS SHOFU DENTAL CORP. DAVID P MORAIS
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
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
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
K112406 11/14/2011 PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES SMITH & NEPHEW, INC. DAVID HENLY
K112784 11/22/2011 RENASYS AB ABOMINAL DRESSING KIT SMITH & NEPHEW, INC. LAURA D REYNOLDS
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
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
K112962 11/02/2011 SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) SPACELABS MEDICAL INC. DAVVID J GERAGHTY
K112688 11/09/2011 ENSITE VELOCITY SYSTEM V.3.0 ST. JUDE MEDICAL DONNA R LUNAK
K112214 11/17/2011 OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS ST. JUDE MEDICAL NEUROMODULATION PENNY HOUSTON
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
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
K111509 11/09/2011 SWEETSPOT DIABETES DATA MANAGEMENT SERVICE SWEETSPOT DIABETES CARE, INC. CHRIS LOGAN
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
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
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