FDA 510(k) Decisions During February, 2011  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K103386 02/11/2011 MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS MEDTRONIC INC. ANU GAUR
K113235 12/02/2011 PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS MEDTRONIC INC. AMRA RACIC
K103310 02/09/2011 CRYONIZE TM 3JT ENTERPRISES LLC ANTHONY GOLDBOSS
K110457 12/07/2011 3M TEGADERM MATRIX DRESSING 3M COMPANY MARIA RUIZ
K102803 02/17/2011 CLARITY ADVANCED CERAMIC BRACKETS 3M UNITEK CORPORATION MARLYN L SCHEFF
K112316 12/14/2011 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) 4-WEB, INC. RICH JANSEN, PHARM. D.
K103491 02/14/2011 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM A JOHNSON & JOHNSON COMPANY FRANK S JURCZAK
K110381 12/22/2011 CELL-DYN EMERALD 22 SYSTEM ABBOTT LABORATORIES MICHELLE B ROEDING
K103403 02/04/2011 MULTICONSTITUENT CALIBRATOR ABBOTT LABORATORIES LINDA MORRIS
K111446 12/21/2011 SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM ABBOTT MEDICAL OPTICS INC ROSANNE M YETEMIAN
K103195 02/08/2011 I-STAT 1 WIRELESS ANALYZER ABBOTT POINT OF CARE INC. LARRY W KRASLEY
K112430 12/20/2011 I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE ABBOTT PONT OF CARE INC YUKO HARTLEY
K103101 02/10/2011 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE ABBOTT VASCULAR-CARDIAC THERAPIES KAY SETZER
K110134 02/11/2011 NC TREK RX CORONARY DILATATION CATHETER ABBOTT VASCULAR-CARDIAC THERAPIES SUZANNE REDMAN
K111617 12/22/2011 PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 ACARE TECHNOLOGY CO., LTD. DIANA HONG
K103387 02/02/2011 MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL ACON LABORATORIES, INC. RICHARD LENART
K112317 12/21/2011 FM-9000 PLUS FETAL AND MATERNAL MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K103772 02/25/2011 VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE) ADVANCED MEDICAL DEVICES FACTORY XINGYUAN WANG
K103573 12/28/2011 ARTS2 SPINAL FIXATION SYSTEM ADVANCED MEDICAL TECHNOLOGIES J. D WEBB
K100945 02/09/2011 FUSE PLIF CAFE ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K092755 02/25/2011 STERRAAD 100NX EXPRESS CYCLE TEST PACK ADVANCED STERILIZATION PRODUCTS NANCY CHU
K103222 02/25/2011 STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS YOGI SHAH
K103544 12/07/2011 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D AGAMATRIX INC WILLIAM H MCGRAIL
K111324 12/22/2011 CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER AGFA HEALTHCARE N.V. PHIL CUSCUNA
K103445 02/22/2011 ALACER SURGICAL SCAFFOLD ALACER BIOMEDICAL INC CONNIE GARRISON
K111313 12/14/2011 EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE ALCAVIS HDC LLC GARY J MISHKIN
K110207 02/17/2011 ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD CEHOVSKY
K111680 12/23/2011 DR. GREENSBURG'S HYBRID ALWAYS MORE MARKETING INC JONATHAN GREENBURG
K110794 12/21/2011 "AMECATH CVC" AND "AMECATH PRESSURE CVC" SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS AMECO MEDICAL INDUSTRIES RAY KELLY
K110793 12/16/2011 "AMECATH" AND "AMECATH UNIQATH SOFT" SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS AMECO MEDICAL INDUSTRIES RAY KELLY
K113501 12/05/2011 AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) AMEDITECH, INC. BRETT CASEY
K113011 12/06/2011 SPARTAN S3 FACET SYSTEM AMENDIA, INC. RICH JANSEN
K111830 12/09/2011 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO ANDON HEALTH CO., LTD LIU YI
K110330 02/18/2011 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD LIU YI
K111826 12/09/2011 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD LIU YI
K102939 02/23/2011 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 ANDON HEALTH CO.,LTD LIU YI
K103158 02/07/2011 STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER ANGSTROM MFG., INC. CHRIS CARRON
K112752 12/16/2011 TINNITUS THERAPY SYSTEM ANM T30 CR ANM ADAPTIVE NEUROMODULATION GMBH INGRID ROHM
K113400 12/16/2011 FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K100954 02/25/2011 ADAPT, MODEL AX-03SN APELIOTUS VISION SCIENCE, INC JOHN G EDWARDS
K103535 02/24/2011 VACPLUS SUCTION UNIT APEX MEDICAL CORP.
K110205 02/09/2011 AAIO-7, AAIO WIRLESS APPASAMY ASSOCIATES K RENGASAMY
K102892 02/03/2011 ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS AQUA SCIENCES, INC. MICHAEL J TODD
K112675 12/12/2011 ARROW-LOK DIGITAL SYSTEM ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC THOMAS J TWARDZIK
K103143 02/02/2011 ARSTASIS ONE LATCHWIRE ACCESS SYSTEM ARSTASIS, INC. DEBRA COGAN
K112990 12/19/2011 ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE ARTHREX, INC. CHRISTINA FLORES
K112040 12/15/2011 ARTHREX BIOCOMPOSITE TRANSFIX ARTHREX, INC. SALLY FOUST
K112437 12/21/2011 ARTHREX FRACTURE SYSTEM ARTHREX, INC. COURTNEY SMITH
K110164 02/07/2011 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL ARTHROCARE CORP. VALERIE DEFIESTA-NG
K110183 02/16/2011 ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE ARTHROCARE CORP. VALERIE DEFIESTA-NG
K112979 12/01/2011 ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K110700 12/06/2011 ASCENSION ATLAS HUMERAL PLATING SYSTEM ASCENSION ORTHOPEDICS, INC. SUSAN WALTON
K103634 02/23/2011 ASCOM CLINICALCONNEX CARDIOMAX ASCOM (US), INC. THOMAS KROENKE
K103399 02/28/2011 GENERAL DENISTRY MOTOR ASEPTICO, INC. CHERIE TREGONING
K101392 02/04/2011 NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D ASTORIA-PACIFIC,INC. JASON C REYNOLDS
K101732 02/23/2011 ASTRA TECH IMPLANT SYSTEM ASTRA TECH AB LINDA K SCHULZ
K112138 12/01/2011 ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT ASTRA TECH, INC. BETSY A BROWN
K103020 02/03/2011 ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT ATLANTIS COMPONENTS, INC. BETSY BROWN
K110110 02/15/2011 ATRIUM CENTRILFX MESH ATRIUM MEDICAL CORPORATION RAYMOND J KELLY
K112443 12/19/2011 ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE I DORA
K110056 02/15/2011 AFINION ANALYZER AXIS-SHIELD POC AS KARI SKINNEMOEN
K100919 12/16/2011 PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 B-K MEDICAL APS RANDI HAUERBERG
K112515 12/22/2011 PENCAN SPINAL NEEDLE B. BRAUN MEDICAL, INC. LISA GIAQUINTO
K093835 02/04/2011 BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN BAM CORP., LTD. MARY MEJAES
K113227 12/08/2011 NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K102192 02/23/2011 INDISCAL DIGITAL MANOMETER BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K110192 02/08/2011 DEFIBRILLATOR ANALYZER - DA-2006P BC GROUP INTERNATIONAL, INC JACK SLOVICK
K110615 12/02/2011 WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE BEBE TOYS MANUFACTORY LTD. PAUL A WARE
K112933 12/27/2011 ACCESS THYROGLOBULIN ANITBODY BECKMAN COULTER, INC. GERALDINE L BAGLIEN
K112412 12/23/2011 AU5800(R) CHEMISTRY ANALYZER BECKMAN COULTER, INC. DAVID G DAVIS
K103373 02/07/2011 SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 BECKMAN COULTER, INC. YVETTE LLOYD
K102921 12/20/2011 ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES BEMA-GMBH & CO. KG ANGELIKA SCHERP
K112799 12/23/2011 MED-RX EXTENSION SET WITH T-CONNECTOR BENLAN INC CHERYL BROWN
K112623 12/16/2011 AIRLIGHT DENTAL HANDPIECE BEYES DENTAL CANADA INC ANTHONY HOPKINS
K112869 12/16/2011 EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 BEYES DENTAL CANADA INC ANTHONY HOPKINS
K103280 02/24/2011 BHDENTAL IMPLANT SYSTEM BHDENTAL LTD EILAT EZRA
K111831 12/19/2011 MX-7000 MICROXEL BIO-MED U.S.A., INC. YOUNG CHI
K112987 12/16/2011 TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC HARY HAYES
K110080 02/24/2011 RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM BIOLITEC, INC. NANCY FOLEY
K110926 12/08/2011 BONE PLATE; BONE SCREW BIOMATERIALS KOREA INC. KEVIN WALLS
K112567 12/23/2011 BIOMERIX ASSURE BIOMERIX CORPORATION CHRISTINA L KICHULA
K112499 12/23/2011 BIOMERIX COMPOSITE SURGICAL MESH BIOMERIX CORPORATION CHRISTINA L KICHULA
K110362 02/28/2011 VANGUARD ASYMMETRICAL PATELLAR COMPONENT BIOMET MANUFACTURING CORP. TAMARA WEST
K113121 12/16/2011 COMPREHENSIVE REVERSE SHOULDER BIOMET MANUFACTURING, INC. PATRICIA S BERES
K103393 02/02/2011 POLARIS SPINAL SYSTEM BIOMET SPINE VIVIAN KELLY
K103145 02/09/2011 HAMMERLOC TM TIBIAL FIXATION DEVICE BIOMET SPORTS MEDICINE ROBERT FRIDDLE
K111746 12/15/2011 COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) BIOMET, INC. PATRICIA SANDBORN BERES
K102125 02/23/2011 PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS BIOMET, INC. GARY BAKER, MS, RAC
K112352 12/23/2011 GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT BIONOSTICS, INC. RANDY BYRD
K103553 02/10/2011 LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION BIONOSTICS, INC. RANDY BYRD
K113213 12/05/2011 LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 BIOSENSE WEBSTER, INC. JOHN JIMENEZ
K101398 02/04/2011 STEREOS WORKSTATION BIOSPACE MED JOHN J SMITH
K112857 12/13/2011 INTERFACE BONE VOID FILLER BIOSTRUCTURES, LLC KEVIN A THOMAS
K113493 12/21/2011 TCX-I REMOTE CARE MANAGEMENT SYSTEM BL HEALTHCARE, INC. MICHEAL MATHUR
K110010 02/09/2011 NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM BLACKROCK MICROSYSTEMS, INC JERRY ALPERIN
K110198 12/22/2011 BLUE SKY BIO TCP BLUE SKY BIO, LLC MICHELE VOVOLKA
K082254 02/07/2011 MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT BODYSTAT LTD. I. J. MEEUWSEN
K082255 02/07/2011 QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT BODYSTAT LTD. I J. MEEUWSEN
K102714 02/11/2011 COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL BOSTON SCIENTIFIC CORP. DEBBIE MCINTIRE
K103355 02/16/2011 GDC 360 DETEACHABLE COIL BOSTON SCIENTIFIC CORP. RHODA M SANTOS
K112543 12/29/2011 WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM BOSTON SCIENTIFIC CORPORATION THOMAS HIRTE
K103345 02/11/2011 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) BREATHE TECHNOLOGIES, INC. JOSEPH CIPILLONE
K102449 02/11/2011 BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM BRIGHT SPINE, INC ROBERT SIMONSON
K103128 02/23/2011 CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, CADWELL LAB, INC. CHRIS L BOLKAN
K102499 12/20/2011 DUOFERTILITY CAMBRIDGE TEMPERATURE CONCEPTS LTD. SCOTT R MACKIE
K113176 12/21/2011 MYSENSE HEART CARDIAC SCIENCE CORPORATION NEIL SHELLER
K111159 12/22/2011 HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME CARDIO COMM SOLUTIONS, INC. JONATHAN WARD
K101873 02/10/2011 MASTERSCREEN IOS CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K103056 02/01/2011 VISULAS TRION LASER SYSTEM WITH THE VITE OPTION CARL ZEISS MEDITEC AG JUDITH A BRIMACOMBE
K102742 02/02/2011 NASAL CEASE CATALINA, INC. RICHARD J FREER
K112876 12/15/2011 CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K110104 02/04/2011 BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM CINCINNATI SUB-ZERO PRODUCTS, INC. STEVEN J BERKE
K112743 12/16/2011 SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL CLEAN MEDICAL MANFACTURING CO;LTD AARON RICHARD
K113465 12/12/2011 ACCULIF TL CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K112095 12/01/2011 ACCULIF TL-PEEK IBF CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K102961 02/18/2011 HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM CODMAN & SHURTLEFF, INC. JOCELYN RAPOSO
K101439 02/07/2011 CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P CODONICS, INC. GARY W ENOS
K093610 02/17/2011 MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K112780 12/15/2011 CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K103665 02/16/2011 CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O CONMED CORPORATION SHAWN RIEDEL
K100799 02/25/2011 FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 CONTRACT MEDICAL INTL. GMBH JAN KLOBOUCNIK
K110163 02/25/2011 APPROACH PRO ST WIRE GUIDE COOK INCORPORATED AARON SANTNER
K113300 12/09/2011 ATB ADVANCE PTA DILATATION CATHETER COOK, INC. ELYSIA POOR
K110009 02/02/2011 ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE COOK, INC. KAREN BRADBURN
K112302 12/21/2011 PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES COOPER VISION, INC. LISA HAHN
K113245 12/02/2011 AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL COOPERVISION, INC. GWEN SHARP
K113267 12/02/2011 BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC COOPERVISION, INC. GWEN SHARP
K103120 02/28/2011 CORIN BIOLOX DELTA FEMORAL HEADS CORIN USA LUCINDA GERBER
K103253 02/24/2011 SILS PORT COVIDEN (FORMERLY REGISTERED AS US SURGICAL, A DIV TIM M LOHNES
K102470 02/07/2011 LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER COVIDIEN, FORMERLY VALLEYLAB, DAVID M HORTON
K101797 02/24/2011 SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO DAVID M HORTON
K113468 12/20/2011 ELM PTA BALLON DILATATION CATHETER CREAGH MEDICAL LTD MAUREEN O'CONNELL
K111452 12/09/2011 PRESAGE ST2 ASSAY CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG JAMES SNIDER
K113543 12/16/2011 ONDEMAND3D CYBERMED, INC. YONG KI IM
K102494 12/09/2011 THE BUZZ FACIAL TONING SYSTEM DAKA INTERNATIONAL LTD. BOB WAGNER
K103321 02/16/2011 DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES DANA PRODUCTS, INC. HARRY BALA
K102753 02/04/2011 TURBO TEMP 3 DANVILLE MATERIALS, INC. LINDSAY TILTON
K112722 12/16/2011 GE DATEX-OHMEDA AVANCE DATEX-OHMEDA, INC. JIM RASKOB
K102776 02/18/2011 EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM DELTAMED GMBH EMANUEL MESARIC
K110079 02/10/2011 SPPHINE PLUS STM 3W DIODE LASER DEN-MAT HOLDINGS, LLC ALAN B METTHEWS
K111310 12/08/2011 BRUX MOUTHGUARDS DENTAL ARTE, INC. CAROLYN PRIMUS
K103244 02/14/2011 QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION DENTSPLY INTL., INC. HELEN LEWIS
K113534 12/20/2011 HEALIX KNOTLESS ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K112218 12/15/2011 ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K103001 02/17/2011 ROCKWOOD CLAVICLE PINS DEPUY ORTHOPAEDICS, INC. SUZANNA OTANO
K101793 02/22/2011 MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC. RONALD S WARREN
K110701 12/02/2011 ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 DNA GENOTEK INC CHANTAL HEMENS-DAVIS
K110881 12/16/2011 ULTRASONIC SURGICAL UNIT DONG IL TECHNOLOGY LTD. PETER CHUNG
K110364 12/07/2011 DORNIER MEDILAS D LITEBEAM+ 1470 DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K113040 12/28/2011 CERAMIR CROWN & BRIDGE DOXA DENTAL AB MARGARETH JORVID
K102968 02/18/2011 INFINITY CNAP SMARTPOD DRAEGER MEDICAL SYSTEMS, INC. JOYCE KILROY
K103076 02/23/2011 DYNAFLEX DYNAFLEX STUART R GOLDMAN
K102637 02/16/2011 DYNAREX ULTRASOUND GEL DYNAREX CORPORATION DANIEL CONSAGA
K110103 02/11/2011 EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER EDWARDS LIFESCIENCES LLC SPENCER WALKER
K113182 12/07/2011 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER EDWARDS LIFESCIENCES, LLC. SPENCER WALKER
K110167 02/18/2011 PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) EDWARDS LIFESCIENCES, LLC. MARGUERITE THOMLINSON
K113226 12/17/2011 8MP COLOR LCD MONITOR,RADIFORCE RX840 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K112485 12/06/2011 H-WAVE ELECTRONIC WAVEFORM LAB, INC. RYAN P HEANEY
K112613 12/16/2011 INTEGRITY(TM) ELEKTA LIMITED ANDREW HEDGES
K113269 12/29/2011 ELITTECH CLINICAL SYSTEMS ALP IFCC SL ELITECHGROUP DEBRA K HUTSON
K101510 02/17/2011 FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR ENDYMED MEDICAL LTD YORAM LEVY
K102366 02/15/2011 FINESS ENDOSCOPE ENTELLUS MEDICAL, INC. KAREN E PETERSON
K103213 02/02/2011 FINESS ENDOSCOPE STERILIZATION TRAY ENTELLUS MEDICAL, INC. KAREN E PETERSON
K112506 12/21/2011 XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC. KAREN E PETERSON
K102270 02/22/2011 ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN ENVITEC-WISMAR GMBH STEPHEN GORSKI
K103554 12/20/2011 METRON-CP/MD EPONATECH LLC K. BRIAN MATLOCK
K112901 12/23/2011 EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. CYNTHIA HUNG
K110238 02/17/2011 G-SCAN ESAOTE S.P.A. ALLISON SCOTT
K092202 02/10/2011 ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT ESWALLOW USA DANIEL KAMM
K112056 12/19/2011 ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ETHICON ENDO-SURGERY, LLC ASIFA VONHOF
K110049 02/10/2011 REUSABLE LINEAR STAPLER HANDLE ETHICON ENDO-SURGERY, LLC DENNIS HAHN
K113004 12/20/2011 PDS(TM) BARBED SUTURES ETHICON, INC. PETER CECCHINI
K111751 12/02/2011 VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS ETHICON, INC. BRIAN A KANERVIKO
K112733 12/16/2011 ER35 ERO-SCAN PRO HEARING TEST SYSTEM ETYMOTIC RESEARCH, INC. JACK KENT
K102109 02/15/2011 ADVANCED MEMBRANE GAS EXCHANGE ("AMG"), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 EUROSETS S.R.L. MARIO GENMARI
K113309 12/08/2011 EXACTECH EQUINOXE CAGE GLENOIDS EXACTECH, INC. PATRICK HUGHES
K101270 02/10/2011 SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 EXCELSIOR MEDICAL CORP. NANCY RUTH
K113564 12/15/2011 EXSALT T7 WOUND DRESSING EXCITON TECHNOLOGIES INC. MELANIE USSYK
K101969 02/04/2011 MH1 MICROHOLTER RECORDER EXELYS LLC NEAL KOLBER
K112832 12/05/2011 EYE CARE CURE CONTACT LENS CASE EYE CARE AND CURE LINDY V DALEN
K103840 02/28/2011 CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE FLEXBAR MACHINE CORP. STEPHEN T MLCOCH
K112522 12/30/2011 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. JOSEPH C GRIFFIN III
K113591 12/22/2011 COLS PEEK FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K070049 02/03/2011 FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR FRESENIUS MEDICAL CARE NORTH AMERICA JANET C KAY
K113427 12/21/2011 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
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