FDA 510(k) Decisions During October, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K132673 10/22/2013 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER MEDTRONIC INC. HEATHER MOROSE
K132995 10/31/2013 DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO MEDTRONIC INC. CHELSEA PIOSKE
K132236 10/16/2013 .DECIMAL PROTON APERTURE .DECIMAL, INC. KIMBERLY RUPP
K131459 10/17/2013 AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K132554 10/03/2013 AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K131625 10/03/2013 ANYSCAN-S SPECT IMAGING SYSTEM ABSOLUTE IMAGING SOLUTIONS MARK SHINA
K131981 10/09/2013 CEZANNE II INTERBODY FUSION SYSTEM ACCEL SPINE LISA PETERSON
K131636 10/10/2013 POLARUS CONNECT ACUMED LLC BRITTANY CUNNINGHAM
K130525 10/03/2013 OCCLUSION PERFUSION CATHETER ADVANCED CATHETER THERAPIES, INC. CHRIS HENZA
K132059 10/25/2013 DIAGNOSTIC ULTRASOUND SYSTEM ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K122783 10/30/2013 PLASMAFIT ACETABULAR CUP AND VITELENE INSERT AESCULAP IMPLANT SYSTEM, INC. JULIE TOM WING
K131167 10/17/2013 UNIVATION AESCULAP IMPLANT SYSTEMS, LLC JULIE T WING
K131893 10/30/2013 AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS AJW TECHNOLOGY CONSULTANTS, INC. JANET DOUGLAS
K131645 10/07/2013 INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K131975 10/02/2013 ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K132280 10/31/2013 ALTUS SPINE PEDICLE SCREW SYSTEM ALTUS PARTNERS CLAUDIA HILL
K130504 10/18/2013 ASA ORAL APPLIANCES AMERICAN SLEEP ASSOCIATION KAREN E WARDEN, PHD
K131222 10/31/2013 AMPCARE ESP THERAPY SYSTEM AMPCARE, LLC DIANE RUTHERFORD
K132461 10/16/2013 A.I.M. SUTURE ANCHOR ANCHOR INNOVATION MEDICAL, INC. HOWARD L SCHRAYER
K132905 10/04/2013 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER ARTERIOCYTE MEDICAL SYSTEMS, INC. ANN CHAREST
K130675 10/30/2013 ARTHREX UNIVERS II CA HEADS ARTHREX, INC. COURTNEY SMITH
K131709 10/04/2013 SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT ARTHROCARE CORP. ASHLEY DAWSON
K132556 10/24/2013 SHEATHLESS EAUCATH CORONARY GUIDE CATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K131947 10/18/2013 PROVOX VEGA PUNCTURE SET ATOS MEDICAL AB FERENC DAHNER
K130857 10/08/2013 PRONTOSAN WOUND GEL X B. BRAUN MEDICAL, INC. NANCY SKOCYPEC
K132183 10/03/2013 DICOM VIDEO BAR CODE COMPUTER LTD DAN LAOR
K132734 10/08/2013 NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS BAXTER HEALTHCARE CORP. GARY CHUMBIMUNE
K131546 10/09/2013 AU BICARBONATE REAGENT BECKMAN COULTER IRELAND INC DAVID G DAVIS
K130020 10/01/2013 ACCESS TOTAL BHCG (5TH IS) BECKMAN COULTER, INC. GERALDINE L BAGLIEN
K132693 10/02/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY GREGORY P PAYNE, RAC
K130947 10/03/2013 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K131047 10/16/2013 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K131859 10/18/2013 MULTIFUNCTIONAL SERIES BEIJING HONKON TECHNOLOGIES CO., LTD DIANA HONG
K132642 10/03/2013 LOCKING PLATE SYSTEM BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD. DIANA HONG
K130528 10/21/2013 BIOPLEX 2200 APLS IGM BIO-RAD LABORATORIES JUANG WANG
K132227 10/25/2013 LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY BIO-RAD LABORATORIES SUZANNE PARSONS
K130866 10/25/2013 BIOLIGHT BIODYNAM BIOLIGHT AB PAR OLAUSSON LIDO
K131640 10/16/2013 SMOOTH OR THREADED METALLIC BONE FASTENER BIOMEDICAL ENT., INC. JOE SOWARD
K132010 10/09/2013 VIDAS C DIFFICILE GDH BIOMERIEUX SA CAROLINE KOCH-MATHIAN
K131779 10/10/2013 VITEK 2 AST-ST TIGECYCLINE BIOMERIEUX, INC. NATHAN HARDESTY
K132704 10/09/2013 DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW BIOMET SUZANA OTANO
K131353 10/08/2013 COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE BIOMET MANUFACTURING CORP. PATRICIA S BERES
K130390 10/09/2013 COMPREHENSIVE CONVERTIBLE GLENOID BIOMET MANUFACTURING, INC. PATRICIA SANDBORN BERES
K132600 10/02/2013 FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING BIOMET MICROFIXATION ELIZABETH WHEELER
K131393 10/24/2013 MAK OSS FEMORAL KNEE COMPONENTS BIOMET ORTHOPEDICS CORP. GARY BAKER
K122437 10/18/2013 NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS BIOMET SPORTS MEDICINE ELIZABETH WRAY
K131867 10/29/2013 2.5MM INLINE FUSION PLATE BIOMET, INC. SUZANA OTANO
K131684 10/10/2013 BIOLOX(R) DELTA CERAMIC HEADS BIOMET, INC. BECKY EARL
K130428 10/25/2013 COVAMESH BIOMUP S.A. VALERIE CENTIS
K133003 10/24/2013 RIGHTEST CONTROL SOLUTION BIONIME CORPORATION JIGAR SHAH
K132096 10/18/2013 RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR BIOPHOR DIAGNOSTICS, INC. NATHANIEL G BUTLIN
K132510 10/24/2013 BIOPRO - INFINITY PLATE ANCHOR SYSTEM BIOPRO, INC. AL LIPPINCOTT
K132482 10/10/2013 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL REBECCA K PINE
K131058 10/25/2013 BIPOLAR FORCEPS BOSTON ENDO-SURGICAL TECHNOLOGIES, INC. JAMES ROGERS
K132947 10/18/2013 DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS BOSTON SCIENTIFIC CORP. MAUREEN SUNDEEN
K132990 10/22/2013 OCCLUSION BALLOON CATHETER BOSTON SCIENTIFIC CORP. DIANE NELSON
K131914 10/31/2013 OFFROAD RE-ENTRY CATHETER SYSTEM BOSTON SCIENTIFIC CORP. CAROL TIFFANY
K132430 10/17/2013 STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. CHRISTOPHER DACHEL
K130294 10/16/2013 BRAEMAR CARDIOKEY HOLTER RECORDER BRAEMAR MANUFACTURING LLC KENT SAYLER
K131234 10/15/2013 LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) BRONCUS MEDICAL INC MAHTAB FATEMI
K132942 10/17/2013 SITE-RITE VISION II ULTRASOUND SYSTEM C.R. BARD, INC. KERRIE HAMBLIN
K132774 10/03/2013 PICCOLO COMPOSITE NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K131824 10/03/2013 AVAFLEX VERTEBRAL BALLOON SYSTEM CAREFUSION JOY GREIDANUS
K131820 10/04/2013 AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G CAREFUSION JOY GREIDANUS
K131251 10/01/2013 TRINITY ELE CAROL COLE COMPANY RAND DAOUD
K130834 10/08/2013 R7 CEFLA S.C. CLAUDE BERTHOIN
K132675 10/03/2013 EMBOZENE MICROSPHERES CELONOVA BIOSCIENCES, INC. NICOLE BARBER
K130180 10/03/2013 CLEANSER ROOT CANAL CERKAMED WOJCIECH PAWLOWSKI KINGA WIERUCKA
K131887 10/24/2013 TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT CHURCH & DWIGHT CO., INC. EMILY PEREZ
K131178 10/10/2013 IDYS LIF CAGES CLARIANCE JANICE M HOGAN, ESQ.
K130644 10/16/2013 PEDIATRIC FOLDING WHEELCHAIR COLUMBIA MEDICAL MFG, LLC GARY WERSCHMIDT
K131437 10/11/2013 MODIFIED CONCENTRIC MICROCATHETER CONCENTRIC MEDICAL, INC. CHRISTINA ROWE
K131492 10/03/2013 MODIFIED FLOWGATE BALLOON GUIDE CATHETER CONCENTRIC MEDICAL, INC. RHODA SANTOS
K131015 10/08/2013 BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT COOK BIOTECH, INC. MARY A FADERAN
K132885 10/11/2013 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET COOK INCORPORATED SEAN SPENCE
K132020 10/25/2013 ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER COOK, INC. STEVEN LAWRIE
K131201 10/07/2013 ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET COOK, INC. ERUM B NASIR
K122295 10/24/2013 CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS CORE 3D PROTECH, S.L. ANNA CORTINA
K130904 10/25/2013 TRELLIS-8 PERIPHERAL INFUSION SYSTEM COVIDIEN JENNIFER SULLIVAN
K132493 10/23/2013 ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN LLC KATHERINE KASSIM
K132337 10/07/2013 ESOFLIP BALLOON DILATION CATHETER CROSPON, LTD. PAUL DRYDEN
K132338 10/24/2013 DA01 BLOOD GLUCOSE MONITORING SYSTEM DELBIO INCORPORATION ERICA LI
K132139 10/10/2013 DELTEX MEDICAL CARDIOQ-EDM+ DELTEX MEDICAL LIMITED RONALD S WARREN
K131042 10/03/2013 LEDEX DENTMATE TECHNOLOGY CO., LTD. CHENG-FENG CHOU
K130999 10/25/2013 OSSEOSPEED PROFILE EV DENTSPLY IMPLANTS MANUFACTURING GMBH LINDA K SCHULZ
K132145 10/11/2013 MTM(R) CLEAR ALIGNER DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K132199 10/03/2013 DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST DEROYAL INDUSTRIES, INC. COURTNEY RINEHART
K130534 10/30/2013 DIPLOMAT DIPLOMAT DENTAL S.R.O. STUART R GOLDMAN
K131190 10/29/2013 MYPATCH DMS-SERVICE LLC LYNDA S COLE
K130274 10/29/2013 BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM ELITE SURGICAL SUPPLIES (PTY) LTD. JOHN O'TOOLE
K132468 10/17/2013 MRSA/SA ELITE MGB, ELITE MGB SOFTWARE ELITECHGROUP EPOCH BIOSCIENCES DEBRA K HUTSON
K131677 10/11/2013 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES INC. JOHN MCINTYRE
K130110 10/08/2013 MEDDUSA BIPOLAR SYSTEM ELLIQUENCE LLC OSCAR R PAREDES
K130048 10/29/2013 REVERSE SHOULDER PROSTHESIS MONOBLOCK ENCORE MEDICAL, L.P. TEFFANY HUTTO
K131991 10/15/2013 ENDOCHOICE HOT BIOPSY FORCEPS ENDOCHOICE, INC. DANIEL HOEFER
K131422 10/10/2013 PEERSCOPE SYSTEM ENDOCHOICE, INC. TAMAR FUERST
K123696 10/25/2013 MEDUSA VASCULAR PLUG ENDOSHAPE, INC. MICHAEL PARMENTER
K132440 10/04/2013 XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC. KAREN E PETERSON
K133017 10/07/2013 ESTECH COBRA(R) GENESIS BIPOLAR CLAMP ESTECH, INC. TAMER IBRAHIM
K131663 10/18/2013 ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK ETHICON ENDO-SURGERY, LLC CHRISTINA CANTER
K131435 10/03/2013 ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, ETHICON ENDO-SURGERY, LLC MARICA ARENTZ
K132512 10/24/2013 HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE ETHICON ENDO-SURGERY, LLC DAVID LOCKE
K132612 10/17/2013 HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE ETHICON ENDO-SURGERY, LLC BRIAN GODWIN
K130178 10/29/2013 INSPIRATION VENTILATOR SYSTEM 5I/7I EVENT MEDICAL LTD RICK WATERS
K132161 10/11/2013 OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS EXACTECH, INC. PATRICK HUGHES
K131530 10/23/2013 DYNAMESH -CICAT FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL NEIL R ARMSTRONG
K131895 10/24/2013 AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER FISHER & PAYKEL HEALTHCARE, LTD. BRETT WHISTON
K132619 10/11/2013 CLASSIC INTERMITTENT CATHETER FLEXICARE MEDICAL LTD. CHRISTOPHER WATKINS
K132248 10/30/2013 FLOWER BONE SCREW SET FLOWER ORTHOPEDICS CORPORATION JANICE M HOGAN
K131908 10/11/2013 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC DENISE OPPERMANN
K132188 10/25/2013 MAMMOGRAPHY VIEWER SMV658 FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K132272 10/17/2013 GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION GLOOKO, INC. SHILPA MYDUR
K130908 10/03/2013 DISPOSABLE SILICONE FOLEY CATHETER GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD DIANA HONG
K131774 10/09/2013 HAMILTON-G5 HAMILTON MEDICAL AG RALPH AGUILA
K131479 10/07/2013 V8 SP NORMAL CONTROL, ABNORMAL CONTROL HELENA LABORATORIES JUSTIN PADIA
K132462 10/28/2013 S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA AMMIRATI
K132251 10/17/2013 APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) HOLOGIC / GEN-PROBE INCORPORATED
K132316 10/30/2013 MULTIVIEW HOLOGIC, INC. EILEEN M BOYLE
K132627 10/23/2013 AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HONSUN (NANTONG) CO., LTD. SELINA QIAN
K132796 10/30/2013 SUNTOUCH EYE SPEAR HUIZHOU FORYOU MEDICAL DEVICES CO, LTD DIANA HONG
K123713 10/25/2013 IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K132303 10/10/2013 IMPLANET SPINE SYSTEM IMPLANET S.A. JANICE M HOGAN
K130719 10/17/2013 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER INFRAREDX, INC. STEVE CHARTIER
K131362 10/08/2013 INMODE WMBODY DEVICE INMODE MD LTD. AHAVA STEIN
K130958 10/17/2013 TRUE SPINAL FIXATION SYSTEM INNOVATIVE SURGICAL DESIGNS ED MORRIS
K132651 10/28/2013 ITCLAMP 50 INNOVATIVE TRAUMA CARE INC RICHARD WAITE
K130660 10/11/2013 AUDICOR CPAM WITH SDB (SINGLE SENSOR) INOVISE MEDICAL, INC. EARL ANDERSON
K131446 10/28/2013 INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES INTEGRA LIFESCIENCES CORPORATION STEPHANIE N SHEESLEY
K131585 10/08/2013 INTEL-GE CARE INNOVATIONS QUIETCARE INTEL-GE CARE INNOVATIONS LLC MAUREEN GLYNN
K132900 10/25/2013 MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM INTELLIGENT IMPLANT SYSTEMS, LLC MICHAEL NUTT
K132235 10/11/2013 IMDX C.DIFFICILE FOR ABBOTT M2000 INTELLIGENT MEDICAL DEVICES, INC. FRAN WHITE
K122040 10/31/2013 INVOTEC LARYNGEAL ELECTRODE INVOTEC INTERNATIONAL, INC. JEFFREY L AULL
K121447 10/04/2013 ISCHEMA VIEW RAPID ISCHEMA VIEW, INC. MARC GOODMAN
K132209 10/31/2013 IPS E.MAX CAD ABUTMENT SOLUTIONS IVOCLAR VIVADENT AG DONNA HARTNETT
K131336 10/28/2013 TX WHEELCHAIR CHASSIS JCM SEATING SOLUTIONS LTD STUART R GOLDMAN
K130231 10/15/2013 NON-CONTACT INFRARED THERMOMETER JINXINBAO ELECTRONIC CO.,LTD HELEN NAN
K132361 10/03/2013 EVEREST SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K122800 10/04/2013 INNER PEACE KAMABRY, INC., DBA INNER PEACE FOR WOMEN YOLANDA SMITH
K132025 10/30/2013 MESO BILAYER SURGICAL MESH KENSEY NASH CORPORATION DBA DSM BIOMEDICAL SUSAN PILEGGI
K132343 10/23/2013 MARIGEN WOUND DRESSING KERECIS LIMITED GUDMUNDUR F SIGURJONSSON
K131534 10/11/2013 KATANA ZIRCONIA KURARAY NORITAKE DENTAL INC. IVAN WASSERMAN
K130940 10/07/2013 KYMCO EQ20C SCOOTER KWANG YANG MOTOR CO., LTD. JUNNATA CHANG
K130686 10/16/2013 NASAL COMFORT FREEDOM LAKEVIEW SLEEP CENTER ANDY BLACK
K130942 10/17/2013 LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF LEGACY MEDICAL, INC. DEB ROBERTSON
K122848 10/18/2013 LENSTEC LC INJECTION SYSTEM LENSTEC, INC. JIMMY CHACKO
K132589 10/08/2013 ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) LIFE SPINE, INC RANDY LEWIS
K132760 10/03/2013 NAUTILUS SPINAL SYSTEM LIFE SPINE, INC RANDY LEWIS
K132866 10/28/2013 NAUTILUS SPINAL SYSTEM LIFE SPINE, INC RANDY LEWIS
K122536 10/03/2013 AMCAD-UT DETECTION MODEL 2.0 LIN & ASSOCIATES, LLC. CHIU S LIN
K131797 10/10/2013 3B LASER NEEDLE LIVETEC GMBH KEVIN WALLS
K130213 10/18/2013 QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE LUMIQUICK DIAGNOSTICS, INC. FENG-YU LEE
K132829 10/08/2013 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS MAQUET CARDIOPULMONARY AG WHITNEY TORNING
K132166 10/30/2013 VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT MAQUET CARDIOPULMONARY AG INGRID RICHTER
K131458 10/01/2013 MPACT DM LINER CONVERTER MEDACTA INTERNATIONAL ADAM GROSS
K130897 10/22/2013 MEDCOMP VASCU-PICC WITH VALVE MEDCOMP (MEDICAL COMPONENTS) JESSICA LEO
K130123 10/11/2013 BASIC AND DOMINANT FLEX SUCTION PUMPS MEDELA AG ADRIENNE LENZ
K131719 10/30/2013 OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS MEDICAL DEVICES (PVT) LTD. TAUSEEF AJMAL
K131023 10/11/2013 THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN MEDICAL PRODUCTS, LLC DAVID MCGILL
K132575 10/03/2013 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL AUDREY VION
K122949 10/16/2013 MEDLINE SUCTION COAGULATOR MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K132471 10/08/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. SOWMYA SHETTY
K131673 10/03/2013 MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT MEDTRONIC SOFAMOR DANEK USA, INC. KELLY ANGLIN
K132972 10/28/2013 AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE MEDTRONIC, INC. JULIA A NELSON
K132924 10/31/2013 MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) MEDTRONIC, INC. ERIC KALMES
K132645 10/04/2013 THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES MEDTRONIC, INC. CHELSEA PIOSKE
K132083 10/28/2013 AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 MICRO VENTION, INC. LARAINE PANGELINA
K131948 10/04/2013 MICROPLEX COIL SYSTEM (MCS) MICROVENTION, INC. LARAINE PANGELINA
K130784 10/30/2013 SPIROTEL MIR MEDICAL INTL. RESEARCH SRL GERDA VAN HOUTS
K131162 10/25/2013 MIRADRY SYSTEM MIRAMAR LABS, INC. KATHY O'SHAUGHNESSY
K130628 10/04/2013 PATHFAST CK-MB-II CALIBRATORS MITSUBISHI CHEMICAL MEDIENCE CORPORATION JUDI SMITH
K132110 10/03/2013 NATUS WARMETTE BLANKET AND DUAL CABINETS NATUS NICOLET IRELAND LTD MICHAEL GALVIN
K123910 10/29/2013 WOUNDWASH SALINE SPRAY NEILMED PHARMACEUTICALS, INC. KETAN MEHTA
K130198 10/21/2013 NEO DENTA ZIRCONIA NEO GROUP LIMITED MIKE ADAMS
K130117 10/29/2013 NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS NETWORK MEDICAL PRODUCTS, LTD. ALISON MARCH
K132412 10/10/2013 INERTIA MIS PEDICLE SCREW SYSTEM NEXXT SPINE LLC JUSTIN EGGLETON
K131894 10/31/2013 NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT NIDEK CO., LTD. YONEJI MIZUNO
K130254 10/16/2013 PROW FUSION NLT SPINE LTD JONATHAN KAHAN
K131013 10/17/2013 FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD, PHD
K130601 10/17/2013 BIOROOT RCS NOVOCOL, INC. CORA BRACHO-TROCONIS
K132014 10/31/2013 GSB GLOBAL SPINAL BALANCE SYSTEM NUVASIVE, INC. OLGA LEWIS
K131739 10/10/2013 NXSTAGE CONNECTED HEALTH SYSTEM NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K132181 10/21/2013 GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER OLYMPUS SURGICAL TECHNOLOGIES AMERICA NEIL KELLY
K131472 10/08/2013 APEX KNEE MODULAR TIBIA SYSTEM OMNI LIFE SCIENCE, INC. BRANDON MOLINA
K131749 10/07/2013 HEM-6221 OMRON HEALTHCARE, INC. PAUL DRYDEN
K130971 10/23/2013 OPTUM TELEHEALTH APPLICATION OPTUMHEALTH CARE SOLUTIONS, INC. ROSHANA AHMED, MA, RAC
K124041 10/17/2013 NBM-200MP ORSENSE LTD MARK A HELLER
K131337 10/11/2013 BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA ORTHO DEVELOPMENT CORP. TOM HAUETER
K131022 10/16/2013 OVATION 10/12 HIP STEM ORTHO DEVELOPMENT CORP. TOM HAUETER
K131748 10/31/2013 OSSEOFUSE DENTAL IMPLANT SYSTEM OSSEOFUSE, INC. APRIL LEE
K132586 10/31/2013 PAXERAPACS PAXERAMED CARL ALLETTO
K131617 10/03/2013 COLONGLIDE(R) LUBRICANT PEDIATRIC PHARMACEUTICALS, INC. ROBERT M HARRIS
K131253 10/22/2013 PERIFLUX SYSTEM 6000 PERIMED AB MARIA LILJEVRET
K131590 10/23/2013 INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE PHILIPS MEDICAL SYSTEMS CHRISTINE TREFETHEN
K130684 10/18/2013 PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR PHILIPS MEDICAL SYSTEMS NANCY BURKE
K131483 10/07/2013 PHILIPS PIXIUM 4343RC PHILIPS MEDICAL SYSTEMS DMC GMBH JENNIFER CARTLEDGE
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K130379 10/09/2013 ROLLINS 7 OXYGEN MASK ROLLINS MEDICAL SOLUTIONS, INC. E. J SMITH
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