| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K113197 |
10/31/2011 |
APC FLASH-FREE ADHESIVE |
3M UNITEK CORPORATION |
ROBERT WANG |
| K112852 |
10/18/2011 |
BABI PLUS NEONATAL RESUSCITATION BAG |
A PLUS MEDICAL |
THOMAS C LOESCHER |
| K113151 |
10/25/2011 |
IFS LASER SYSTEM |
ABBOTT MEDICAL OPTICS INC |
KESLEY E GALLAGHER |
| K112957 |
10/04/2011 |
HI-TORQUE POWERTURN |
ABBOTT VASCULAR-CARDIAC THERAPIES |
KAY SETZER |
| K113162 |
10/26/2011 |
SLIDEWIRETM(TRADEMARK PENDING) |
ACME-MONACO CORP. |
BENJAMIN SWEENEY |
| K113063 |
10/14/2011 |
CT-GUIDE NEEDLE GUIDANCE SYSTEM |
ACTIVIEWS LTD |
JOHN J SMITH |
| K112977 |
10/06/2011 |
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) |
ALCON RESEARCH, LTD. |
Catherine Goble |
| K113124 |
10/21/2011 |
ALN OPTIONAL VANA CAVA FILTER |
ALN IMPLANTS CHIRURGICAUX |
CYNTHIA COTTEREAU |
| K113046 |
10/13/2011 |
AMEDITECH IMMUTEST MILTI-DRUG SCREEN |
AMEDITECH, INC. |
Greg Cerra |
| K113011 |
10/11/2011 |
SPARTAN S3 FACET SYSTEM |
AMENDIA, INC. |
RICH JANSEN |
| K113131 |
10/24/2011 |
LIASYS 450 |
AMS |
STEFANO CORRADI |
| K113098 |
10/19/2011 |
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III |
APEX BIOTECHNOLOGY CORP. |
HSUE-MEI LEE |
| K113110 |
10/20/2011 |
AXERA ACCESS SYSTEM |
ARSTASIS, INC. |
DEBRA COGAN |
| K112990 |
10/06/2011 |
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE |
ARTHREX, INC. |
CHRISTINA FLORES |
| K112899 |
10/03/2011 |
ARTHREX BIO-SUTURE |
ARTHREX, INC. |
SALLY FOUST |
| K112979 |
10/06/2011 |
ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K113003 |
10/07/2011 |
ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... |
ASTRA TECH INC. |
BETSY A BROWN |
| K113165 |
10/26/2011 |
MINI-MEDIC |
ATHENA GTX |
SEAN MAHONEY |
| K113112 |
10/20/2011 |
CLEARWAY RX NB CATHETER |
ATRIUM MEDICAL CORP. |
MEGAN MCCAGH |
| K113059 |
10/14/2011 |
CONTIPLEX FX |
B. BRAUN MEDICAL, INC. |
LISA GIAQUINTO |
| K112909 |
10/03/2011 |
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION |
BAUSCH & LOMB, INC. |
TRICIA GARRETT |
| K113073 |
10/17/2011 |
IO-TOME DEVICE |
BAXANO, INC. |
EDWARD J SINCLAIR |
| K112893 |
10/03/2011 |
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS |
BAXTER HEALTHCARE CORPORATION |
NANETTE HEDDEN |
| K112933 |
10/03/2011 |
ACCESS THYROGLOBULIN ANITBODY |
BECKMAN COULTER, INC. |
GERALDINE L BAGLIEN |
| K112911 |
10/03/2011 |
FETAL DOPPLER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K113018 |
10/11/2011 |
APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM |
BEIJING SYNTECH LASER CO., LTD. |
Diana Hong |
| K113065 |
10/14/2011 |
RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS |
BELLA ELEVATOR, LLC |
RICK CRANE |
| K112934 |
10/03/2011 |
NEUROTECH RECOVERY |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K112987 |
10/06/2011 |
TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM |
BIOLITEC MEDICAL DEVICES, INC |
HARY HAYES |
| K113200 |
10/31/2011 |
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM |
BIOMERIEUX, INC. |
SANDRA PERREAND |
| K113069 |
10/17/2011 |
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
| K113121 |
10/21/2011 |
COMPREHENSIVE REVERSE SHOULDER |
BIOMET MANUFACTURING, INC. |
PATRICIA S BERES |
| K112905 |
10/03/2011 |
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM |
BIOMET ORTHOPEDICS LLC. |
GARY BAKER |
| K113007 |
10/07/2011 |
BIONIME DIABETES MANAGEMENT SYSTEM VI.0 |
BIONIME CORPORATION |
Feng-Yu Lee |
| K112994 |
10/07/2011 |
CRE DITATATION BALLON |
Boston Scientific Corporation |
JANIS TARANTO |
| K113101 |
10/19/2011 |
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL |
Boston Scientific Corporation |
SUSAN EICHLER-HUSTON |
| K113090 |
10/19/2011 |
LEVEEN SUPERSLIM NEEDLE ELECTRODE |
Boston Scientific Corporation |
ASHLEY PYLE |
| K113119 |
10/21/2011 |
ENDOGATOR ADVANTAGE IRRIGATION PUMP |
BYRNE MEDICAL, INC. |
Brent Geiger |
| DEN110004 |
10/31/2011 |
CABOCHON SYSTEM |
CABOCHON AESTHETICS, INC. |
BEN BRIAN |
| K112975 |
10/05/2011 |
CARBONAID C02 DIFFUSER |
CARDIA INNOVATION AB |
JEFFREY R SHIDEMAN |
| K113176 |
10/28/2011 |
MYSENSE HEART |
CARDIAC SCIENCE CORPORATION |
NEIL SHELLER |
| K112918 |
10/03/2011 |
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP |
CARDINAL HEALTH 200, LLC |
LAVENIA FORD |
| K113096 |
10/19/2011 |
MICRO I |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
| K112904 |
10/04/2011 |
STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS |
CASE MEDICAL, INC. |
TANIA LUPU |
| K112985 |
10/06/2011 |
CATHETER CONNECTIONS' DUALCAP DUO |
CATHETER CONNECTIONS, INC. |
DONALD D SOLOMON |
| K112960 |
10/05/2011 |
LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
| K113168 |
10/27/2011 |
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI |
| K113132 |
10/24/2011 |
DISPOSABLE HEMOSTATIC Y-CONNECTORS |
COEUR, INC. |
DEBRA F MANNING |
| K113058 |
10/14/2011 |
TIGER SPINE SYSTEM |
CORELINK LLC |
JUSTIN EGGLETON |
| K113060 |
10/14/2011 |
UNITY TOATAL KNEE SYSTEM |
CORIN U.S.A. |
LUCINDA GERBER |
| K113187 |
10/31/2011 |
AVIVO MOBILE PATIENT MANAGEMENT |
CORVENTIS, INC. |
KATHLEEN LUNDBERG |
| K113021 |
10/11/2011 |
TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT |
CSA MEDICAL, INC. |
COLLEEN KISTLER |
| K112974 |
10/05/2011 |
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
CURVE DENTAL, INC. |
GEORGE STANTCHEV |
| K113106 |
10/20/2011 |
DNE EXTERNAL FIXATION SYSTEM |
D.N.E., LLC |
J.D. WEBB |
| K113152 |
10/25/2011 |
ULTRASONIC SURGERY MACHINE |
DMETEC CO., LTD. |
DANIEL NAM |
| K113040 |
10/12/2011 |
CERAMIR CROWN & BRIDGE |
DOXA DENTAL AB |
MARGARETH JORVID |
| K113095 |
10/19/2011 |
E-CARE INFRARED EAR THERMOMETER |
E-CARE TECHNOLOGY CORPORATION |
KIN-YUAN KO |
| K112992 |
10/06/2011 |
EARLOGIC OAE TESTER |
EARLOGIC CORPORATION |
SHIN KUK YOO |
| K113050 |
10/13/2011 |
CLEARPATH LOWER GI |
EASYGLIDE LTD. |
PAUL DRYDEN |
| K113166 |
10/27/2011 |
CLEARPATH UPPER GI |
EASYGLIDE LTD. |
PAUL DRYDEN |
| K113182 |
10/28/2011 |
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER |
EDWARDS LIFESCIENCES, LLC. |
SPENCER WALKER |
| K113170 |
10/27/2011 |
CERVICAL PLATE |
EISERTECH, LLC |
LUKAS EISERMANN |
| K112937 |
10/03/2011 |
MRSA/SA ELITE MGB |
ELITECH |
DEBRA K HUTSON |
| K113062 |
10/14/2011 |
ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES |
ENDOSERVICE OPTICAL INSTRUMENTS GMBH |
ANDREA PECSI |
| K112901 |
10/03/2011 |
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Cynthia Hung |
| K113205 |
10/31/2011 |
ARTISYN Y-SHAPED MESH |
ETHICON, INC. |
SARAH MCMANUS |
| K113004 |
10/07/2011 |
PDS(TM) BARBED SUTURES |
ETHICON, INC. |
PETER CECCHINI |
| K112996 |
10/07/2011 |
EUROIMMUN ANTI-ENA POOL ELISA (IGG) |
EUROIMMUN US |
KATHRYN KOHL |
| K113010 |
10/11/2011 |
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR |
FAMIDOC TECHNOLOGY CO., LTD |
CAO LIANG |
| K113202 |
10/31/2011 |
TISSUE MARKER |
FOCAL THERAPEUTICS |
GEORGE HERMANN |
| K112944 |
10/04/2011 |
FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES |
FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD. |
RAM KAMATH |
| K113034 |
10/11/2011 |
GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM |
GE HEALTHCARE |
CAROL ALLOIAN |
| K113126 |
10/24/2011 |
ACRYLIC HERBST APPLIANCE |
GERGENS ORTHODONTIC LAB |
KAREN E WARDEN, PHD |
| K113107 |
10/20/2011 |
MSA HIP SYSTEM |
GLOBAL MANUFACTURING TECHNOLOGY |
HOLLACE S RHODES |
| K112976 |
10/06/2011 |
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM |
HARTALEGA SND. BHD. |
NURUL A KONG |
| K113129 |
10/24/2011 |
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) |
HEIDELBERG ENGINEERING GMBH |
GERHARD ZINSER |
| K113054 |
10/13/2011 |
EQUIVITAL |
HIDALGO LIMITED |
EKTA SOOD |
| K112910 |
10/03/2011 |
AP 72OS SEMI-AUTOMATED INSTRUMENT |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
DONALD POSTEL |
| K113145 |
10/25/2011 |
ECHELON OVAL MRI SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K113020 |
10/11/2011 |
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS |
IMMCO DIAGNOSTICS, INC. |
KEVIN J LAWSON |
| K113143 |
10/25/2011 |
IMMULISA SCI-70 ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN J LAWSON |
| K113192 |
10/31/2011 |
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K113088 |
10/19/2011 |
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) |
INNERSPACE, INC |
DON BOBO |
| K113111 |
10/20/2011 |
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION |
INOVO, INC. |
MICHAEL T DILDINE |
| K112945 |
10/04/2011 |
ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM |
INRAD INC. |
RYAN GOOSEN |
| K112995 |
10/07/2011 |
GEM PREMIER 4000 |
INSTRUMENTATION LABORATORY CO. |
CARL MARBLE |
| K113211 |
10/31/2011 |
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL |
INSTRUMENTATION LABORATORY CO. |
Jacqueline Emery |
| K113104 |
10/20/2011 |
INTEGRA WOUND MATRIX (THIN) |
INTEGRA LIFESCIENCES CORPORATION |
STEPHEN H BEIER |
| K112986 |
10/06/2011 |
LATERAL FUSION DEVICE |
INTEGRA SPINE (INTEGRA LIFESCIENCES) |
DALE DAVISON |
| K112950 |
10/04/2011 |
JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR |
JIANGSU HEALTHY MEDICAL EQUIPMENT CO;LTD |
JEN KE-MIN |
| K112948 |
10/04/2011 |
JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR |
JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO;LTD |
JEN KE-MIN |
| K113091 |
10/19/2011 |
SYRINGES AND NEEDLES |
JIANGYIN CAINA TECHNOLOGY CO., LTD |
Diana Hong |
| K112913 |
10/03/2011 |
SPOTLIGHT ACCESS SYSTEM |
JOHNSON & JOHNSON |
LAURA BLEYENDAAL |
| K113138 |
10/25/2011 |
ALEUTIAN SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K112920 |
10/03/2011 |
RANGE SPINAL SYSTEM (MESA AND DENALI) |
K2M, INC. |
NANCY GIEZEN |
| K113056 |
10/14/2011 |
ORANGE COLORED CONDOMS ORANGE SCENT |
KAREX INDUSTRIES SDN BHD |
LAI PENG LIM |
| K113061 |
10/14/2011 |
LARGE/EXTRA LAGRE CONDOM |
KAREX INDUSTRIES SDN BHD. |
LAI PENG |
| K113199 |
10/31/2011 |
KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT |
KEVO MEDICAL SUPPLIES |
E.J. Smith |
| K113036 |
10/12/2011 |
U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS |
KIMBERLY-CLARK CORPORATION |
LORI BARR |
| K113157 |
10/26/2011 |
AILERON INTERSPINOUS FIXATION SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K113115 |
10/21/2011 |
EPICARE YAG |
LIGHT AGE, INC. |
ELIZABETH REDDINGTON |
| K112898 |
10/03/2011 |
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K112900 |
10/03/2011 |
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K113139 |
10/24/2011 |
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K112965 |
10/05/2011 |
NANO SUTURE ANCHOR |
LINVATEC CORPORATION D/B/A CONMED LINVATEC |
ASHLEA RICCI |
| K113100 |
10/19/2011 |
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
MAXTER GLOVE MANUFACTURING SDN BHD |
YAP P GEEH |
| K113080 |
10/18/2011 |
TUBALGATOR |
MECTRA LABS, INC. |
CHARLES E ALLGOOD |
| K113074 |
10/17/2011 |
CMAP PRO |
MEDICAL TECHNOLOGIES, INC. |
ANGELA MORRIS |
| K112921 |
10/03/2011 |
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM |
MEDICAL.GORITHMICS S.A. |
MARTIN JASINSKI |
| K113028 |
10/11/2011 |
MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS |
MEDISISS |
JOYCE ELKINS |
| K112907 |
10/03/2011 |
CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G |
MEDOS INTERNATIONAL SARL |
ROBIN DINARDO |
| K113133 |
10/24/2011 |
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE |
MEDRAD, INC. |
MIKE BURNSIDE |
| K113174 |
10/27/2011 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRIS MCKEE |
| K112917 |
10/03/2011 |
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID |
MEDTRONIC, INC. |
DEBORAH KIDDER |
| K113190 |
10/31/2011 |
TRU LEGIONELLA |
MERIDIAN BIOSCIENCE, INC. |
SUSAN BOGAR |
| K113017 |
10/11/2011 |
SYS*STIM 240 |
METTLER ELECTRONICS CORP. |
CHRISTINA CAYUELA |
| K113128 |
10/24/2011 |
MICROAIRE SURGICAL INSTRUMENTS LLC |
MICROAIRE SURGICAL INSTRUMENTS, LLC |
DARREN REEVES |
| K113015 |
10/11/2011 |
ALDAHOL V HIGH LEVEL DISINFECTANT |
MICROCHEM LABORATORIES, INC. |
NORMAN MINER |
| K113141 |
10/24/2011 |
MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K112930 |
10/03/2011 |
MOBILE MIM |
MIM SOFTWARE INC. |
LYNN HANIGAN |
| K113167 |
10/27/2011 |
MTF NEW BONE VOILD FILLER |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY JOY |
| K113173 |
10/27/2011 |
NANOVIS SPINAL SYSTEM |
NANOVIS, LLC |
KAREN E WARDEN PHD. |
| K113198 |
10/31/2011 |
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML |
NAVILYST MEDICAL, INC. |
MARION W GORDON |
| K113033 |
10/12/2011 |
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML |
NEPHRON PHARMACEUTICALS CORP. |
MARCUS JULIANO |
| K113117 |
10/21/2011 |
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX |
NIHON KOHDEN AMERICA, INC. |
STEVE GEERDES |
| K112969 |
10/05/2011 |
AIR-BAG SYSTEM |
NIIGATA MECHATRONICS CO., LTD. |
TOSHIYA NIMONJI |
| K112988 |
10/06/2011 |
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 |
| K112955 |
10/04/2011 |
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM |
NOVA BIOMEDICAL CORPORATION |
PAUL W MACDONALD |
| K113102 |
10/19/2011 |
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING |
NUCLETRON |
MICHEAL PAUL |
| K113023 |
10/11/2011 |
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
| K113066 |
10/17/2011 |
CORVIS ST |
OCULUS OPTIKGERATE GMBH |
ECKHARD LOH |
| K113120 |
10/21/2011 |
CHF-Y0005 |
OLYMPUS MEDICAL SYSTEMS CORP. |
SHERI MUSGNUNG |
| K113185 |
10/28/2011 |
MODEL HBP-1300 |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K113048 |
10/12/2011 |
MAXLOCK EXTREME SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K113006 |
10/07/2011 |
I-FUSE HAMMER TOE SYSTEMS |
ORTHOPRO LLC |
J D WEBB |
| K112952 |
10/05/2011 |
ILWAIT TIMER OCULOPRESSOR |
ORYX MEDICAL PTY LTD |
ANNE F JONES |
| K113113 |
10/20/2011 |
ENDOSSEOUS DENTAL IMPLANT |
OT MEDICAL GMBH |
SABINE SCHMAHL |
| K113164 |
10/26/2011 |
DISCOVERY TMAX MANUAL WHEELCHAIR |
OTTO BOCK HEALTHCARE, LP |
WILLIAM KABITZ |
| K113209 |
10/31/2011 |
CHIBA SONO |
PAJUNK GMBH |
CHRISTIAN QUASS |
| K113207 |
10/31/2011 |
SONO TAP, TUOHY SONO |
PAJUNK GMBH |
CHRISTIAN QUASS |
| K113188 |
10/31/2011 |
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN G QUASS |
| K113196 |
10/31/2011 |
VASCULAR SONO |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN G QUASS |
| K113037 |
10/12/2011 |
PAIN-AID |
PDI WORKS, LLC. |
THU-HA DUNCAN |
| K113163 |
10/26/2011 |
PENUMBRA SYSTEM MAX |
PENUMBRA, INC. |
SETH SCHULMAN |
| K113082 |
10/18/2011 |
SONOVISION |
PERIDOT TECHNOLOGIES NY INC |
OMAR BARLAS |
| K112959 |
10/04/2011 |
CALG-STR EXERCISE ECG ANALYSIS ALGORITHM |
PHILIPS HEALTHCARE |
GRETEL LUMLEY |
| K113125 |
10/24/2011 |
INTELLIVUE MX40 PATIENT MONITOR |
PHILIPS MEDICAL SYSTEMS |
THERESA POOLE |
| K113144 |
10/25/2011 |
PAGEWRITER TC 20, 30, 50, 70 |
PHILIPS MEDICAL SYSTEMS |
PAUL SCHRADER |
| K112931 |
10/03/2011 |
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K113076 |
10/17/2011 |
CAAS A-VALVE |
PIE MEDICAL IMAGING B.V. |
Florie Daniels |
| K113122 |
10/21/2011 |
PIPELINE CR PRIMARY KNEE SYSTEM |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
| K112967 |
10/05/2011 |
PMMA CAD/CAM DISC |
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY |
JANJA LIPUSCEK |
| K113070 |
10/17/2011 |
PROTEUS INGESTION CONFINMATION SYSTEMS |
PROTEUS BIOMEDICAL, INC. |
JAFAR SHENASA |
| K112946 |
10/04/2011 |
ACTIV VARNISH |
PULPDENT CORPORATION |
KENNETH J BERK |
| K113177 |
10/28/2011 |
COMPLETE D 25-OH VITAMIN D CONTROL |
QUANTIMETRIX CORP. |
KALYNA SNYLYK |
| K113118 |
10/21/2011 |
STENTUBE LACRIMAL INTUBATION SET |
QUEST MEDICAL, INC. |
AMY CLENDENING-WHEELER |
| K113105 |
10/20/2011 |
TEMPUSIC PATIENT MONITOR |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
| K113084 |
10/18/2011 |
RENOVIS CANNULATED SCREW SYSTEM |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
DAVID F ROTHKOPF |
| K112897 |
10/03/2011 |
RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
DAVID A TEICHER |
| K113127 |
10/24/2011 |
MIRAGE QUATTRO |
RESMED LTD. |
DAVID D'CRUZ |
| K112914 |
10/03/2011 |
VPAP TX |
RESMED LTD. |
DAVID D'CRUZ |
| K113201 |
10/31/2011 |
NARVAL CC |
RESMED SAS |
DAVID D'CRUZ |
| K113053 |
10/13/2011 |
BIPAP A 30 VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
ELAINE LARKIN |
| K113068 |
10/17/2011 |
REMSTAR AUTO A-FLEX HT |
RESPIRONICS, INC. |
FRANK KADI |
| K113103 |
10/19/2011 |
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K112936 |
10/03/2011 |
SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM |
REXAM CONSUMMER PLASTICS INC.D/B/A REXAM PHARMA |
SANDRA ANDERSON |
| K113042 |
10/12/2011 |
REVOIS IMPLANT SYSTEM |
RIEMSER ARZNEIMITTEL AG |
James M Clinton |
| K112924 |
10/03/2011 |
RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME |
RIVERSTONE RESOURCES SDN. BHD. |
CHONG CHU MEE |
| K112928 |
10/03/2011 |
RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME |
RIVERSTONE RESOURCES SDN. BHD. |
CHONG CHU MEE |
| K113137 |
10/24/2011 |
GLUCOSE TEST SYSTEM |
Roche Diagnostics |
KHONESAVANH SAYSANA |
| K113072 |
10/17/2011 |
TINA-QUANT ALBUMIN GEN.2 |
ROCHE DIAGNOSTICS OPERATIONS |
PATRICK STIMART |
| K112991 |
10/06/2011 |
MODIFIED ROG SUTURE ANCHOR |
ROG SPORTS MEDICINE, INC. |
CURTIS RAYMOND |
| K113146 |
10/24/2011 |
PCXX VARNISH |
ROSS HEALTHCARE INC. |
MARC N ROSS |
| K112961 |
10/04/2011 |
CLO-SURPLUS P.A.D. |
SCION CARDIO-VASCULAR, INC. |
CRAIG PAGAN |
| K113183 |
10/28/2011 |
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 |
SHANGHAI 3F ELECTRONICS CO LTD |
CHARILIE MACK |
| K112951 |
10/04/2011 |
BODY ANALYSIS SCALE |
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD |
CHARLIE MACK |
| K113153 |
10/25/2011 |
DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN |
| K113186 |
10/28/2011 |
STERILE INSULIN PEN NEEDLE |
SHINA CORP. |
JISEOP JEONG |
| K112999 |
10/07/2011 |
DIMENSION CLINICAL CHEMISTRY SYSTEM |
SIEMENS HEALTHCARE DIAGNOSTICS |
LORRAINE H PIESTRAK |
| K113027 |
10/11/2011 |
SYNGO AORTIC VALVEGUIDE SOFTWARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K113029 |
10/11/2011 |
SYNGO VIA MI WORKFLOWS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K113179 |
10/28/2011 |
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
ROBERT F LAWRENCE |
| K112997 |
10/07/2011 |
HD-IVUS ULTRASOUND IMAGING SYSTEM |
SILICON VALLY MEDICAL INSTRUMENTS, INC. |
RICHARD E ANDERSON |
| K113008 |
10/07/2011 |
KODAMA INTRAVASCULAR ULRASOUND CATHETER |
SILICON VALLY MEDICAL INSTRUMENTS, INC. |
RICHARD E ANDERSON |
| K113022 |
10/11/2011 |
PURESLEEP |
SLEEP SCIENCE PARTNERS, INC. |
HEATHER FLICK |
| K112982 |
10/06/2011 |
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) |
SMALL BONE INNOVATIONS INC. |
JOHN MINIER |
| K112941 |
10/04/2011 |
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K113012 |
10/11/2011 |
PROMOS MODULAR SHOULDER SYSTEM |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K113038 |
10/12/2011 |
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K113039 |
10/12/2011 |
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS |
SMITH & NEPHEW, INC. |
NATALIE P WILLIAMS |
| K113156 |
10/26/2011 |
SONOSITE EDGE ULTRASOUND SYSTEM |
SONOSITE,INC. |
SCOTT PAULSON |
| K113203 |
10/31/2011 |
SONY LMD-2451MT LCD MONITOR |
SONY ELECTRONICS, INC. |
CYNTHIA SINCLAIR |
| K113051 |
10/13/2011 |
SPACELABS ARKON ANESTHESIA WORKSTATION |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
| K112962 |
10/05/2011 |
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) |
SPACELABS MEDICAL INC. |
DAVVID J GERAGHTY |
| K113030 |
10/12/2011 |
SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
BRYAN BECKER |
| K113032 |
10/12/2011 |
SNAP WOUND CARE SYSTEM |
SPIRACUR, INC. |
SARAH CANIO |
| K112915 |
10/03/2011 |
SPIRTIUS CUFF INFLATION SYRINGE |
SPIRITUS TECHNOLOGIES LLC |
BRANDON W CLOSE |
| K113049 |
10/13/2011 |
SOCKET GRAFT |
STEINER LABORATORIES |
GREGORY G STEINER |
| K113109 |
10/20/2011 |
STRYKER RESORBABLE FIXATION SYSTEM |
Stryker |
Manish Patel |
| K112926 |
10/03/2011 |
AXSOS LOCKING PLATE SYSTEM |
STRYKER CORP. |
KELLY KUCHARCZYK |
| K113154 |
10/26/2011 |
IVAS BALLOON CATHETER |
STRYKER CORPORATION |
MEGHAN ARREAZA |
| K113043 |
10/13/2011 |
DIRECT ANTIBIOTIC INFUSION KIT |
SUMMIT MEDICAL PRODUCTS, INC |
MARKO V AMEN |
| K112981 |
10/06/2011 |
SUN 125C IONIZATION CHAMBER |
SUN NUCLEAR CORP. |
NOEL DOWNEY |
| K113193 |
10/31/2011 |
PATIENT EXAMINATION GLOVE |
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD |
CHU XIAOAN |
| K113194 |
10/31/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR |
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD |
CHU XIAOAN |
| K113195 |
10/31/2011 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD |
CHU XIAOAN |
| K113191 |
10/31/2011 |
POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD |
CHU XIAOAN |
| K112923 |
10/03/2011 |
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM |
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
CURTIS RAYMOND |
| K113148 |
10/24/2011 |
E-PASS |
SYNEXMED(SHENZHEN)COMPANY LIMITED |
TONY ZHANG |
| K113071 |
10/17/2011 |
SYNTHECEL DURA REPLACEMENT DEVICES |
SYNTHES |
ANDREA M TASKER |
| K113079 |
10/17/2011 |
SYNTHES HEMOSTATIC BONE PUTTY |
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION |
JEFFREY L DOW |
| K113044 |
10/12/2011 |
SYNTHES MIRS |
SYNTHES SPINE |
HEATHER GUERIN |
| K113149 |
10/24/2011 |
SYNTHES USS CONNECTORS |
SYNTHES SPINE |
HEATHER GUERIN |
| K113077 |
10/17/2011 |
BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
LINDA KO |
| K112963 |
10/05/2011 |
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS |
TaiDoc Technology Corporation |
TELING HSU |
| K113159 |
10/26/2011 |
U-RIGHT TD-1240 THERMOMETER |
TaiDoc Technology Corporation |
LINDA KO |
| K112983 |
10/06/2011 |
SPACER-S |
TECRES SPA |
CHRISTINE BRAUER |
| K112958 |
10/05/2011 |
HUMID-VENT HEPA |
TELEFLEX MEDICAL |
LIZ PAUL |
| K113184 |
10/28/2011 |
LOGICSCAN 64 LOGICSCAN 128 |
TELEMED |
YURY SOKOLOV |
| K112953 |
10/04/2011 |
TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS |
TERATECH CORP. |
|
| K113214 |
10/31/2011 |
TLINK DATA MANAGEMENT SYSTEM (DMS) |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
REBECCA ANDERSEN |
| K113086 |
10/18/2011 |
ACQA |
TEXAS MEDICAL IMAGING CONSULTANTS |
TINSU PAN |
| K113123 |
10/21/2011 |
OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM |
THE ORTHOPAEDIC IMPLANT COMPANY |
Kevin Walls |
| K113097 |
10/19/2011 |
LASER HELMET |
THERADOME INC. |
LARRY PETERSEN |
| K112989 |
10/06/2011 |
AQUILION CXL |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K113052 |
10/13/2011 |
INFINIX-CCI |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K113093 |
10/19/2011 |
VANTAGE TITAN 3T |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K112906 |
10/03/2011 |
KLASSIC KNEE SYSTEM |
TOTAL JOINT ORTHOPEDICS, INC. |
HEATHER LAKE |
| K113136 |
10/24/2011 |
21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256) |
TOTOKU ELECTRIC CO., LTD |
TSUKASA TASHIRO |
| K113083 |
10/18/2011 |
TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR |
TRULY INSTRUMENT CO., LTD. |
MAX WONG |
| K113085 |
10/18/2011 |
TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR |
TRULY INSTRUMENT CO., LTD. |
MAX WONG |
| K112916 |
10/03/2011 |
TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K113075 |
10/17/2011 |
EMBRYO VIEWER SOFTWARE |
UNISENSE FERTILITECH A/S |
METTE MUNCH |
| K113135 |
10/24/2011 |
UNISTRIP 1 |
UNISTRIP TECHNOLOGIES, LLC |
E.J. Smith |
| K113140 |
10/25/2011 |
VARI-LASE WIREFIBER LASER FIBER |
VASCULAR SOLUTIONS, INC. |
JENIFER RUETHER |
| K113181 |
10/28/2011 |
CELLTRACKS ANALYER II |
VERIDEX, LLC |
PATRICIA HOJNOSKI |
| K112929 |
10/03/2011 |
THERMOFLASH(TM) INFRARED THERMOMETER |
VISIOMED GROUP SA |
ERIC SEBBAN |
| K112902 |
10/04/2011 |
ENFLOW IV FLUID WARMER |
VITAL SIGNS, INC. |
STACIE GEFFNER-ATIYA |
| K113014 |
10/11/2011 |
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PEGGY S RIVERS |
| K113019 |
10/11/2011 |
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K113045 |
10/13/2011 |
BIOHARNESS |
ZEPHYR TECHNOLOGY CORPORATION |
RICHARD KEEN |
| K112932 |
10/03/2011 |
TRANSTEK |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
| K113092 |
10/19/2011 |
ZIMMER CONTOUR PROVISIONAL COPING |
ZIMMER DENTAL INC. |
JEREMY MARKOVICH |
| K112998 |
10/07/2011 |
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 |
ZOLL CIRCULATION |
SAM NANAVATI |
