| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K121075 |
07/26/2012 |
NERVEVISION SOFTWARE SYSTEMS |
3D IMAGING PARTNERS INC. |
CAROLYN PRIMUS |
| K121569 |
07/27/2012 |
MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM |
ACCEL SPINE |
DANIEL CHON |
| K121748 |
07/27/2012 |
THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
| K113162 |
07/20/2012 |
SLIDEWIRETM(TRADEMARK PENDING) |
ACME-MONACO CORP. |
BENJAMIN SWEENEY |
| K121161 |
07/13/2012 |
EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER |
ACTA MEDICAL LLC |
AARON COMPTON |
| K120903 |
07/13/2012 |
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE |
ACUMED LLC |
BRITTANY CUNNINGHAM |
| K121282 |
07/24/2012 |
MICROLUX/DL MICROLUX/BLU BIO/SCREEN |
ADDENT, INC. |
JOSHUA FRIEDMAN |
| K121253 |
07/17/2012 |
MERIDIAN CRANIAL PERFORATOR |
ADEOR MEDICAL TECHNOLOGIES GMBH |
FABIO VON ZEPPELIN |
| K121879 |
07/27/2012 |
VEGA KNEE SYSTEM |
AESCULAP IMPLANT SYSTEMS |
JULIE TOM WING |
| K121948 |
07/20/2012 |
CR 10-X DIGITIZER |
AGFA HEALTHCARE N.V. |
|
| K121871 |
07/03/2012 |
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING |
AIRSTRIP TECHNOLOGIES, LP |
ROBERT ANDREW MILLER |
| K121905 |
07/26/2012 |
ALERE PBP2A TEST |
ALERE SCARBOROUGH, INC |
Angela Drysdale |
| K113436 |
07/12/2012 |
ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT |
ALFA WASSERMANN |
HYMAN KATZ |
| K113382 |
07/19/2012 |
ACE ALT REAGENT |
ALFA WASSERMANN |
HYMAN KATZ |
| K113435 |
07/02/2012 |
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
ALFA WASSERMANN |
HYMAN KATZ |
| K113374 |
07/13/2012 |
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K113262 |
07/03/2012 |
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K121888 |
07/26/2012 |
E-CUBE 15 |
ALPINION MEDICAL SYSTEMS CO., LTD |
DONGHWAN KIM |
| K121937 |
07/26/2012 |
E-CUBE INNO |
ALPINION MEDICAL SYSTEMS CO., LTD |
DONGHWAN KIM |
| K113849 |
07/31/2012 |
HQS INTRODUCER |
ALSEAL |
JEAN-FRANCOIS DELFORGE |
| K121612 |
07/20/2012 |
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION |
AMERICAN MEDICAL SYSTEMS |
NGOC LINH PHAM LATCHMAN |
| K110898 |
07/26/2012 |
S.C.O.R.E.S. UNIT |
AMMED SURGICAL EQUIPMENT, LLC |
DAVID C FURR |
| K120836 |
07/12/2012 |
0.9% SODIUM CHLORIDE FLISH SYRINGE |
AMUSA |
KAREN THOMISON |
| K120896 |
07/26/2012 |
WI-FI BODY SCALE |
ANDON HEALTH CO., LTD |
LIU YI |
| K120827 |
07/13/2012 |
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) |
ANGIOTECH |
KIRSTEN STOWELL |
| K111260 |
07/26/2012 |
A/C ENZYMATIC VITAMIN B6 ASSAY |
ANTICANCER INC |
QINGHONG HAN |
| K120649 |
07/06/2012 |
AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM |
APEX BIO TECHNOLOGY CORP |
LISA LIU |
| K112331 |
07/05/2012 |
BIOPURE PORTABLE RO SYSTEMS |
ARION WATER, INC. |
ROBERT LIVINGSTION |
| K120969 |
07/11/2012 |
AC LENS BRANDED CONTACT LENS CASE |
ARLINGTON CONTACT LENS SERVICES,INC. |
Christian Smith |
| K121306 |
07/12/2012 |
SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE |
ARTHOCARE CORPORATION |
CHERYL FREDERICK |
| K113489 |
07/27/2012 |
ORION |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K120414 |
07/31/2012 |
OSSEOSPEED PLUS |
ASTRA TECH AB |
LINDA K SCHULZ |
| K120338 |
07/05/2012 |
ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA |
ASTRA TECH INC. |
B A BROWN |
| K120937 |
07/06/2012 |
SUNFLOWER WARNER |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
| K121788 |
07/23/2012 |
NIO 5MP |
BARCO NV |
LIEVEN DE WANDEL |
| K113073 |
07/27/2012 |
IO-TOME DEVICE |
BAXANO, INC. |
EDWARD J SINCLAIR |
| K121190 |
07/26/2012 |
CONTOUR NEXT BLOOD GLUCOSE METER |
BAYER HEALTHCARE LLC |
CHARLES RYAN |
| K120138 |
07/05/2012 |
BD MAX MRSA ASSAY, BD MAX INSTRUMENT |
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) |
RAYMOND J BOULE |
| K112622 |
07/19/2012 |
HANDHELD ECG MONITOR |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K121198 |
07/12/2012 |
BW685, BW685S |
BIEGLER GMBH |
PAUL DRYDEN |
| K121512 |
07/26/2012 |
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM |
BIO-LOGIC SYSTEMS CORP. |
DON WILLIAMS |
| K113610 |
07/09/2012 |
ANA-SCREEN WITH MDSS |
Bio-Rad Laboratories |
Juang Wang |
| K121794 |
07/11/2012 |
LIQUICHEK URINE CHEMISTRY CONTROL |
BIO-RAD, DIAGNOSTICS GRP. |
SUZANNE PARSONS |
| K113311 |
07/17/2012 |
TIO2MESH TM |
BIOCER ENTWICKLUNGS GMBH |
CHERYL FISHER |
| K121122 |
07/03/2012 |
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL |
BIOCHEMICAL DIAGNOSTIC, INC. |
ALLEN PANETZ |
| K121578 |
07/31/2012 |
ATOM 1 (MODEL: BRC 2200) |
BIOELECTRIC RESEARCH CORPORATION |
STEVEN KAYE |
| K121270 |
07/19/2012 |
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM |
BIOJECT MEDICAL TECHNOLOGIES INC. |
CHRISTINE BREITBACH |
| K112818 |
07/31/2012 |
VIDAS D-DIMER EXCLUSION II (DEX2) |
BIOMERIEUX, INC. |
VERONICA DAENZER |
| K121183 |
07/26/2012 |
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS |
BIOMET CORPORATION |
PATRICIA SANDBORN BERES |
| K113306 |
07/16/2012 |
CARDIO 7 |
BIONET CO., LTD. |
MARC GOODMAN |
| K121113 |
07/12/2012 |
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER |
BIOPSY SCIENCES, LLC |
SHARON ROCKWELL |
| K121441 |
07/20/2012 |
CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) |
BOVIE MEDICAL CORPORATION |
RICHARD A KOZLOFF |
| K121745 |
07/13/2012 |
MANTARAY GUIDEWIRES |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
| K120668 |
07/30/2012 |
SENTINEL |
C-RAD POSITIONING AB |
JANINA OSTLING |
| K120926 |
07/27/2012 |
ENDOBEAM HOLMIUM LASER FIBERS |
C.R. BARD, INC. |
TERRI MORRIS |
| K121856 |
07/11/2012 |
ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION |
C.R. BARD, INC. |
ERIN FOX |
| K113229 |
07/20/2012 |
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING |
C.R. BARD, INC. |
STEPHANIE BAKER |
| K121303 |
07/26/2012 |
MOBILE C-ARM |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
DIANE RUTHERFORD |
| K121897 |
07/27/2012 |
PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
| K120176 |
07/25/2012 |
SENZZZZZ AWAY |
CENTRIX, INC. |
LINDA K SCHULZ |
| K121474 |
07/16/2012 |
DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER |
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. |
CHARLES MACK |
| K121669 |
07/03/2012 |
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) |
CINCINNATI SUB-ZERO PRODUCTS, INC. |
STEVEN J BERKE |
| K121683 |
07/05/2012 |
ACCULIF TL CAGE |
COALIGN INNOVATIONS, INC. |
JUSTIN EGGLETON |
| K113498 |
07/20/2012 |
DISPOSABLE TORQUE DEVICE |
COEUR, INC. |
DEBRA F MANNING |
| K121833 |
07/16/2012 |
OSTOMY IRRIGATION SET |
COLOPLAST A/S |
TIM CRABTREE |
| K121759 |
07/24/2012 |
CONE-TROL LIQUID CHEMISTRY CONTROLS |
CONE BIOPRODUCTS |
WILL CONE |
| K120941 |
07/03/2012 |
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM |
CONSTANT CARE, LLC |
SETH A MAILHOT |
| K121275 |
07/25/2012 |
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER |
CONVATEC INC |
KATRINA FIEDLER |
| K120468 |
07/06/2012 |
NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR |
COOK INCORPORATED |
SUSANNE GALIN |
| K120834 |
07/19/2012 |
CORPATH 200 SYSTEM |
CORINDUS INC. |
MONA ADVANI |
| K120773 |
07/10/2012 |
NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM |
Covidien LLC |
CHARLIE MACK |
| K121510 |
07/25/2012 |
IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
SARAH RIZK |
| K120402 |
07/13/2012 |
CRUX VENA CAVA FILTER SYSTEM |
CRUX BIOMEDICAL |
ELISA HEBB |
| K120285 |
07/02/2012 |
K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER |
CURATIVE MEDICAL INC. |
AMY MCKINNEY |
| K121449 |
07/10/2012 |
DIRECTPATH |
CYBERNET SYSTEMS CO., LTD. |
DIANE SUDDUTH |
| K111454 |
07/05/2012 |
ILUMINAGE DIODE LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K120530 |
07/05/2012 |
DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S |
DENTIN IMPLANTS TECHNOLOGIES LTD. |
DANIELA LEVY |
| K121617 |
07/27/2012 |
SENSICARDIAC |
DIACOUSTIC MEDICAL (PTY) |
YOLANDA SMITH |
| K121053 |
07/31/2012 |
DIAZYME HOMOCYSTEINE POC TEST KIT |
DIAZYME LABORATORIES |
Abhijit Datta |
| K113562 |
07/16/2012 |
3MP COLOR LCD MONITOR, RADIFORCE RX340 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K120253 |
07/16/2012 |
ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) |
ELCAM MEDICAL A.C.A.L. |
AHARON COHEN |
| K121448 |
07/02/2012 |
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY |
ELEKTA INC. D/B/A NUCLETRON CORPORATION |
THOMAS VALENTINE |
| K122095 |
07/26/2012 |
ICP TRIAGEMANAGER |
Emergo Europe Consulting BV |
RACHIDA ZIANI |
| K121835 |
07/20/2012 |
DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE |
ENCORE MEDICAL, L.P. |
MICHAELA NORRIS |
| K121650 |
07/09/2012 |
S-SCAN |
ESAOTE, S.P.A. |
Allison Scott |
| K121600 |
07/16/2012 |
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE |
ETHICON ENDO-SURGERY, LLC |
ASIFA VONHOF |
| K121349 |
07/18/2012 |
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER |
EXTREMITY MEDICAL LLC |
JAMY GANNOE |
| K121417 |
07/18/2012 |
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM |
EXTREMITY MEDICAL LLC |
JAMY GANNOE |
| K121950 |
07/26/2012 |
MICROTARGETING XL STAR DRIVE SYSTEM |
FHC, INC. |
KERI SEITZ |
| K121125 |
07/06/2012 |
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM |
FLEXIBLE STENTING SOLUTIONS, INC. |
JOSEPH C GRIFFIN III |
| K111939 |
07/11/2012 |
M/29TM - PRESSURE INJECTABLE |
FLEXICATH LTD. |
TALI HAZAN |
| K120726 |
07/06/2012 |
FLIGHT 60 VENTILATOR |
FLIGHT MEDICAL INNOVATIONS LTD. |
CHOSHANA FRIEDMAN |
| K120413 |
07/13/2012 |
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK |
FOCUS DIAGNOSTICS, INC. |
TARA VIVIANI |
| K112193 |
07/12/2012 |
ARROW REVERSE SHOULDER SYSTEM |
FOURNITURES HOSPITALIERES INDUSTRIE |
PATRICIA DONNARD |
| K120636 |
07/05/2012 |
SYNAPSE 3D CARDIAC TOOLS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JYH-SHYAN LIN |
| K112391 |
07/26/2012 |
FUJINON COLONOSCOPES |
FUJINON, INC. |
GINA WALLJASPER |
| K120598 |
07/19/2012 |
PROCARE MONITOR B40 |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
ROBERT CASARSA |
| K120569 |
07/20/2012 |
GEMORE TENS SYSTEM |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S.P. LAI |
| K110558 |
07/12/2012 |
CS1000 LIGHT THERAPY DEVICE |
GENESIS HEALTH LIGHT CORPORATION |
PAUL ZIEMER |
| K120263 |
07/10/2012 |
VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
GENORAY CO., LTD. |
JAE KIM |
| K121922 |
07/26/2012 |
BEACON STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
MERIAM YOUSSEF |
| K121107 |
07/03/2012 |
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) |
GLOBUS MEDICAL, INC. |
SARAH M FITZGERALD |
| K121908 |
07/25/2012 |
SAFETY INFUSION SET |
GREINER BIO-ONE NORTH AMERICA, INC. |
JUDITH SMITH |
| K121557 |
07/25/2012 |
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K120474 |
07/10/2012 |
GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY |
GYRUS ACMI, INC. |
GRAHAM BAILLE |
| K111401 |
07/19/2012 |
BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE |
HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
ALLYSON ZHOU |
| K111406 |
07/19/2012 |
BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL) |
HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
ALLYSON ZHOU |
| K120958 |
07/25/2012 |
POSISEP AND POSISEP X HEMOSTAT DRESSINGS |
HEMOSTASIS, LLC |
BERNARD HORWATH |
| K120914 |
07/25/2012 |
FLEXITIME FAST & SCAN LIGHT FLOW |
HERAEUS KULZER, LLC |
JAMIE MEARNA |
| K113574 |
07/13/2012 |
FLEXITIME MONOPHASE PRO SCAN |
HERAEUS KULZER, LLC |
CHRIS HOLDEN |
| K113307 |
07/27/2012 |
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM |
HMD BIOMEDICAL, INC. |
JESSICA TUNG |
| K120564 |
07/16/2012 |
CALYPSO SYSTEM |
HOGAN LOVELLS US LLP |
JANICE M HOGAN |
| K121868 |
07/19/2012 |
MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) |
HOLOGIC, INC. |
SARAH FAIRFIELD |
| K120582 |
07/06/2012 |
HEATLUX |
HOME SKINOVATIONS LTD. |
AMIR WALDMAN, PH.D |
| K121308 |
07/30/2012 |
HIP SYSTEMS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K120920 |
07/16/2012 |
HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA |
HSINER COMPANY |
TOM SHANKS |
| K110425 |
07/27/2012 |
HC-BIOS DENTAL IMPLANT |
HUNG CHUN BIO-S CO., LTD. |
MICHAEL LEE |
| K121133 |
07/10/2012 |
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM |
i-SENS, Inc. |
HYUN JOON OH |
| K121517 |
07/20/2012 |
VERSAVUE ENTERPRISE SUITE |
ICAD, INC. |
MICHAEL A PATZ |
| K120753 |
07/26/2012 |
CLARISCT |
ICRCO INC. |
GREG WACHTLER |
| K121231 |
07/30/2012 |
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST |
IND NDIAGNOSTIC INC. |
KAI LOU |
| K113192 |
07/13/2012 |
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K120374 |
07/09/2012 |
SEVIIN REVERSE SHOULDER |
INGEN ORTHOPEDICS LLC |
PERRY GEREMAKIS |
| K112634 |
07/03/2012 |
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP |
INOTEC AMD LTD. |
Diane Horwitz |
| K112545 |
07/31/2012 |
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM |
INOVA DIAGNOSTICS, INC. |
MICHAEL MAHLER |
| K121159 |
07/20/2012 |
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER |
INTEGRA LIFESCIENCE CORPORTATION |
STEVEN PELTIER |
| K113620 |
07/12/2012 |
MYRIAN 1.11 |
INTRASENSE |
FREDERIC BANEGAS |
| K121319 |
07/18/2012 |
ZIO PATCH |
IRHYTHM TECHNOLOGIES, INC. |
MICHAEL RIGHTER |
| K121572 |
07/19/2012 |
CONTINUOUS SINGLE CULTURE COMPLETE |
IRVINE SCIENTIFIC SALES CO., INC. |
JAYME YAMAGUCHI-OWENS |
| K121338 |
07/27/2012 |
ZEOBI |
IVIVI HEALTH SCIENCE, LLC |
KATHRYN CLUBB |
| K121359 |
07/27/2012 |
IPS 99 ONE AND IPS 99 CERAM |
IVOCLAR VIVADENT AG |
DONNA MARIE HARTNETT |
| K120377 |
07/25/2012 |
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K121808 |
07/20/2012 |
CASIAN, 3.5/4.5 CONNECTORS |
K2M, INC. |
NANCY GIEZEN |
| K121301 |
07/30/2012 |
XPRESSWAY RX CATHETER (6F LD-VERISON) |
KANEKA PHARMA AMERICA LLC |
JOSEPH DEPAOLO |
| K113056 |
07/03/2012 |
ORANGE COLORED CONDOMS ORANGE SCENT |
KAREX INDUSTRIES SDN BHD |
LAI PENG LIM |
| K111465 |
07/25/2012 |
COMPOTHIXO |
KERRHAWE SA |
Wendy Garman |
| K113199 |
07/30/2012 |
KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT |
KEVO MEDICAL SUPPLIES |
E.J. Smith |
| K120650 |
07/11/2012 |
POISE PERSONAL LUBRICANT |
KIMBERLY-CLARK CORPORATION |
Swarna Mukund |
| K121583 |
07/25/2012 |
CLEARFIL MAJESTY FLOW |
KURARAY NORITAKE DENTAL INC. |
KIYOYUKI ARIKAWA |
| K121096 |
07/06/2012 |
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM |
L & K BIOMED CO., LTD |
KI HYANG KIM |
| K113285 |
07/26/2012 |
LDR SPINE USA AVENUE L INTERBODY FUSION |
LDR SPINE USA INC. |
MARITZA ELIAS |
| K120511 |
07/30/2012 |
AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM |
LETO ENTERPRISE LTD. |
SABRINA WEI |
| K120640 |
07/18/2012 |
INSUFLOW SYNERGY PORT |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K121838 |
07/11/2012 |
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM |
LIEBEL-FLARSHEIM |
CRAIG BUEHLER |
| K121471 |
07/10/2012 |
LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS |
LIGHTSCALPEL LLC |
GERALD S PALECKI |
| K111014 |
07/13/2012 |
LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES |
LSI SOLUTIONS, INC. |
JUDE S SAUER, M.D. |
| K120514 |
07/05/2012 |
CARDIOPACS |
LUMEDX |
CHRIS PEARCE |
| K121912 |
07/24/2012 |
E1 EAR SENSORS |
MASIMO CORPORATION |
DAVID COLLETTE |
| K120733 |
07/05/2012 |
SIMPLANT GO |
MATERIALISE DENTAL NV |
GEERT APPELTANS |
| K112389 |
07/20/2012 |
SURGICASE CONNECT, SURGICASE GUIDE |
MATERIALISE N.V. |
Alexandra Razzhivina |
| K113621 |
07/06/2012 |
SMARTDRIVE WHEELCHAIR POWER-ASSIST |
MAX MOBILITY, LLC |
WILLIAM M RICHTER |
| K120812 |
07/12/2012 |
RENAISSANCE |
MAZOR ROBOTICS LTD |
AHAVA STEIN |
| K121416 |
07/20/2012 |
GMK SPHERE |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K121115 |
07/18/2012 |
M.U.S.T PEDICLE SCREW SYSTEM |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K121376 |
07/24/2012 |
COMPRESSION CARE FLIGHT |
MEDICAL MINDS LLC |
DAVID PLATT |
| K121323 |
07/18/2012 |
MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE |
MEDICREA INTERNATIONAL |
LAURE AVIRON-VIOLET |
| K120849 |
07/20/2012 |
HYBRID ARCTICGEL PAD |
MEDIVANCE, INC. |
LYNNE ARONSON |
| K120966 |
07/03/2012 |
DEPUY PULSE LUMBAR CAGE SYSTEM |
MEDOS INTERNATIONAL SARL |
ROBIN DINARDO |
| K120424 |
07/11/2012 |
MEDSOURCE IV ADMINSTRATION SET |
MEDSOURCE INTERNATIONAL, LLC. |
JENNIFER NESS |
| K121767 |
07/13/2012 |
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE |
MEDTRONIC INC. |
MARY E DONLIN |
| K120988 |
07/25/2012 |
DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT |
MEDTRONIC INC. |
JACQUELINE HAUGE |
| K121982 |
07/26/2012 |
SOVEREIGN SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LAUREN KAMER |
| K121680 |
07/05/2012 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRIS MCKEE |
| K121832 |
07/17/2012 |
RESOLVE BILIARY LOCKING DRAINAGE CATHETER |
MERIT MEDICAL SYSTEMS, INC. |
CASEY HUGHES |
| K113513 |
07/13/2012 |
PLANCET |
MICROPOINT TECHNOLOGIES PTE LTD |
CHEE Y LIM |
| K112390 |
07/13/2012 |
MONICA AN24 |
MONICA HEALTHCARE LTD. |
IAN HOW |
| K120865 |
07/19/2012 |
RSCRIBE ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC |
CHARLES MORREALE |
| K120195 |
07/06/2012 |
SAFETY SUBCUTANEOUS TISSUE INFUSION SET |
MULTI MED |
TANYA O'BRIEN |
| K121954 |
07/17/2012 |
NMI MICROCATHETER |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
| K112674 |
07/06/2012 |
NAVIS TORQUER |
NAVIS MEDICAL,INC |
MATTHEW J HUDDLESTON |
| K120244 |
07/05/2012 |
SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR |
NEXERA MEDICAL INC |
PAUL SALLARULO |
| K121195 |
07/25/2012 |
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER |
NINEPOINT MEDICAL, INC |
CINDY DOMECUS |
| K121529 |
07/12/2012 |
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES |
NORTHSTAR HEALTHCARE HOLDINGS |
WESLEY TOAVS |
| K121464 |
07/05/2012 |
BLUE POWER FREE NITRILE EXAMINATION GLOVE |
NORTHSTAR HEALTHCARE HOLDINGS |
MICHAEL RIORDAN |
| K121506 |
07/03/2012 |
UTB BLUE POWDER FREE NITRILE |
NORTHSTAR HEALTHCARE HOLDINGS |
WESLEY TOAVS |
| K120302 |
07/06/2012 |
MECHANICAL WHEELCHAIR |
NOVAF ANDALUCIA 2007, SL |
FERNANDO SAENZ DE SANTAMARIA |
| K120283 |
07/31/2012 |
DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT |
NOVOCOL, INC. |
CORA BRACHO-TROSONIS |
| K121837 |
07/16/2012 |
NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM |
NUVASIVE, INC. |
Cynthia Adams |
| K121407 |
07/09/2012 |
OXYBAND WOUND DRESSING |
O2S, LLC |
DAVID E PETKO, P.E. |
| K121604 |
07/27/2012 |
ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT |
OBP CORPORATION |
JASON SWIFT |
| K121293 |
07/26/2012 |
CS-SERIES-FP WITH 3030+OPTION |
OMEGA MEDICAL IMAGING, LLC |
BRIAN J FLEMING |
| K112368 |
07/19/2012 |
CAPNOSTREAM20P WITH AI/ODI |
ORIDION MEDICAL 1987 LTD. |
RACHEL WEISSBROD |
| K113869 |
07/26/2012 |
ORIGEN REINFORCED DUAL LUMEN CATHETER |
Origen Biomedical, Inc. |
RICHARD MARTIN |
| K121658 |
07/20/2012 |
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) |
ORTHOFIX INC. |
ALLY BADUEL |
| K120566 |
07/24/2012 |
O2PAK OXYGEN GENERATOR |
PACIFIC PRECISION PRODUCTS |
GERALD WHITE |
| K113819 |
07/11/2012 |
MONGOOSE ANGIOGRAPHIC CATHETER |
PEDIACATH INC. |
CAROLINE TONTINI |
| K120884 |
07/03/2012 |
PERICAM PSI |
PERIMED AB |
MARIA LILJEVRET |
| K121638 |
07/18/2012 |
ST80I STRESS TEST SYSTEM |
PHILIPS HEALTHCARE |
GRETAL LUMLEY |
| K120366 |
07/18/2012 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
| K121733 |
07/13/2012 |
INFILL INTERVERTEBRAL BODY FUSION DEVICE |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
| K120016 |
07/26/2012 |
PIONEER STERNAL ASSIST IMPLANT SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCINTYRE |
| K112101 |
07/17/2012 |
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS |
POLYMED THERAPEUTICS, INC |
TERRI WALLACE |
| K113544 |
07/27/2012 |
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER |
PROSPERA CORPORATION |
Kevin Walls |
| DEN120011 |
07/10/2012 |
PROTEUS INGESTION CONFINMATION SYSTEMS |
PROTEUS BIOMEDICAL, INC. |
JAFAR SHENASA |
| K113118 |
07/31/2012 |
STENTUBE LACRIMAL INTUBATION SET |
QUEST MEDICAL, INC. |
AMY CLENDENING-WHEELER |
| K121428 |
07/17/2012 |
NON-CONTACT CLINICAL THERMOMETER |
RADIANT INNOVATION INC. |
JAMES HUANG |
| K121746 |
07/11/2012 |
RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K121609 |
07/02/2012 |
ASTHMAPOLIS SYSTEM |
RECIPROCAL LABS CORPORATION |
INGER L COUTURE |
| K113656 |
07/26/2012 |
CAREGUIDE OXIMETER |
REFLECTANCE MEDICAL INC |
Nandini Murthy |
| K112413 |
07/13/2012 |
RI MSC (MIGRATION SEDIMENTATION CHAMBER) |
RESEARCH INSTRUMENTS LTD. |
DAVID LANSDOWNE |
| K121170 |
07/13/2012 |
RESIN 11 |
RESPINNOVATION SAS |
PAUL DRYDEN |
| K120562 |
07/17/2012 |
PERFORMAX PEDIATRIC EE TOTAL FACE MASK |
RESPIRONICS, INC. |
MICHELLE BRINKER |
| K120639 |
07/10/2012 |
PERFORMAX PEDIATRIC SE TOTAL FACE MASK |
RESPIRONICS, INC. |
MICHELLE BRINKER |
| K121347 |
07/12/2012 |
PRESSON ELECTRODE |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES MEWBORNE |
| K111353 |
07/17/2012 |
ACCU-CHECK COMBO SYSTEM |
Roche Diagnostics |
Scott Thiel |
| K120625 |
07/25/2012 |
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV |
Roche Diagnostics |
K. Colleen Adams |
| K113546 |
07/24/2012 |
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 |
Roche Diagnostics |
Michael Leuther |
| K121030 |
07/06/2012 |
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE |
SACKS HOLDINGS, INC. |
DEVIN CHODOROW |
| K121299 |
07/30/2012 |
STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
| K121162 |
07/18/2012 |
POLARIS Q-SWITCH RUBY SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
| K112872 |
07/10/2012 |
STATIM 2000 G4 CASSETTE |
SCICAN LTD. |
TERESA BOYCE |
| K121734 |
07/30/2012 |
PLATO MICROCATH 27 MICROCATHETER |
SCIENTIA VASCULAR , LLC |
SHARON ROCKWELL |
| K112840 |
07/13/2012 |
CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR |
SEEBREATH AB |
ANETTE SJOGREN |
| K121355 |
07/18/2012 |
WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
REN YUNHUA |
| K120797 |
07/27/2012 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHANDONG SHOUGUANG KINGLIYUAN MEDICAL APPARATUS & |
KEVIN XU |
| K120230 |
07/27/2012 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE |
SHANDONG TAIXIANG MEDICAL PRODUCTS CO., LTD. |
RAY ZHOU |
| K122010 |
07/20/2012 |
Z6 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANG ZHAOHUI |
| K121907 |
07/23/2012 |
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE T MARINELLI |
| K121160 |
07/16/2012 |
MAGNETOM SPECTRA |
SIEMENS MEDICAL SOLUTIONS USA INC. |
NADIA SOOKDEO |
| K121292 |
07/30/2012 |
DYNAPBV BODY SOFTWARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K121807 |
07/10/2012 |
V5MS TRANSDUCER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K120463 |
07/27/2012 |
MOJO, VERASEAL |
SLEEPNET CORPORATION |
PAUL DRYDEN |
| K120211 |
07/19/2012 |
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING |
SMITH & NEPHEW, INC. |
JOHN CONNOR |
| K121909 |
07/26/2012 |
INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR |
SORIN GROUP ITALIA S.R.L. |
SCOTT LIGHT |
| K121229 |
07/23/2012 |
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K121017 |
07/13/2012 |
CAPNOGRAPHY PAD (92516) |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
| K120177 |
07/03/2012 |
SPINAL ELEMENTS CERCLAGE SYSTEM |
SPINAL ELEMENTS, INC. |
BENJAMIN A KIMBALL |
| K120467 |
07/30/2012 |
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
BENJAMIN A KIMBALL |
| K112748 |
07/11/2012 |
SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM |
SPINAL USA LLC |
FRANKIE CUMMINS |
| K121060 |
07/03/2012 |
SPINE FRONTIER INDUS ACP SYSTEM |
SPINEFRONTIER, INC. |
FREDY H VARELA |
| K120509 |
07/26/2012 |
STRYKER ALL SUTURE ANCHORS |
Stryker |
KELLY KUCHARCZYK |
| K120824 |
07/18/2012 |
3.9MM REELX STT SUTURE ANCHOR SYSTEM |
STRYKER CORP. |
KELLY KUCHARCZYK |
| K121252 |
07/25/2012 |
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM |
STRYKER CORP. |
ESTELA CELI |
| K121336 |
07/03/2012 |
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 |
SURGIQUEST, INC. |
DANIEL DONOVAN |
| K121426 |
07/10/2012 |
AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS |
SYNERGETICS, INC |
GARY OLIVEROS |
| K120838 |
07/31/2012 |
SYNTHES MATRIX SYSTEM |
SYNTHES SPINE |
HEATHER GUERIN |
| K121852 |
07/25/2012 |
SYNTHES ZERO-P VARIABLE ANGLE (VA) |
SYNTHES SPINE CO.LP |
MONIKA MCDOLE-RUSSELL |
| K121601 |
07/06/2012 |
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE |
SYNTHES USA |
ANGELA F LASSANDRO |
| K120807 |
07/06/2012 |
SYNTHES MULTILOC HUMERAL NAILING SYSTEM |
SYNTHES USA PRODUCTS LLC |
REBECCA BLANK |
| K120634 |
07/03/2012 |
U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
PINJUNG CHEN |
| K120839 |
07/20/2012 |
NOVACATH SECURE IV CATHETER SYSTEM-18G |
TANGENT MEDICAL TECHNOLOGIES, INC. |
KAY FULLER |
| K120970 |
07/19/2012 |
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE) |
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD |
CHU XIAOAN |
| K120426 |
07/31/2012 |
VICTUS LASER PLATFORM |
TECHNOLAS PERFECT VISION GMBH |
KEN NEHMER |
| K113335 |
07/16/2012 |
HEARTRAIL III GUIDING CATHETER |
TERUMO Corporation |
MARK UNTERREINER |
| K113349 |
07/11/2012 |
HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO |
THE BINDING SITE GROUP LTD |
MARIANNE SENDER |
| K120305 |
07/09/2012 |
THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV |
THINKING SYSTEMS CORP. |
JB WANG |
| K120739 |
07/05/2012 |
AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K120262 |
07/25/2012 |
HLS UNI EVOLUTION & U-KNEETEC |
TORNIER, INC. |
STEPHANIE BERNARD |
| K120481 |
07/13/2012 |
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR, |
TOSAMA D.O.O. |
MARJETKA KRALJ KUNCIC |
| K121553 |
07/26/2012 |
AQUILION RXL |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K121134 |
07/25/2012 |
TL TRISEB CREAM |
TRIGEN LABORATORIES, INC. |
MELISSA GOODHEAD |
| K103577 |
07/03/2012 |
TRINON Q & Q3 IMPLANT SYSTEM |
TRINON TITANIUM GMBH |
MARKUS DENK |
| K112010 |
07/11/2012 |
AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) |
TRUDELL MEDICAL INTL. |
DARRYL FISCHER |
| K121777 |
07/18/2012 |
U2 ACETABULAR CUP, PLASMA SPRAY |
UNITED ORTHOPEDIC CORP. |
FANG-YUAN HO |
| K113754 |
07/19/2012 |
CFR QUANT |
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON |
K. LANCE GOULD |
| K120993 |
07/26/2012 |
GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K103555 |
07/27/2012 |
MULTIPLATE 5.0 AGGREGOMETER |
VERUM DIAGNOSTICA GMBH |
MAXIMILIAN ZUCKER |
| K113446 |
07/16/2012 |
VIGNET TELEHEALTH MANAGER |
VIGNET INC. |
CARLOS GONZALEZ |
| K120202 |
07/27/2012 |
EON CHOLESTEROL REAGENT |
VITAL DIAGNOSTICS PTY. LTD |
MELITA LAMBIRIS |
| K120325 |
07/18/2012 |
CONNECTED CARE MOBILE APPLICATION |
WATERMARK MEDICAL |
MICHAEL J LEIGH |
| K120584 |
07/10/2012 |
POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES |
WEALTH ON (JIANGSU) CO., LTD |
CHARLES SHEN |
| K121013 |
07/26/2012 |
CONNEX VITAL SIGNS MONITOR 6000 SERIES |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K111781 |
07/11/2012 |
GYMFORM DUAL FLEX BELT MODEL WB-162 |
WELL BRAIN INTERNATIONAL, LTD. |
VICTOR K WAI |
| K121629 |
07/03/2012 |
COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR |
WILLIAM COOK EUROPE APS |
Jennifer Brown |
| K121544 |
07/30/2012 |
DYNASTY BIOFOAM SHELL |
WRIGHT MEDICAL TECHNOLOGY, INC. |
YUAN LI |
| K113421 |
07/11/2012 |
MINICAT |
XORAN TECHNOLOGIES, INC. |
MARTHA RUMFORD |
| K113397 |
07/26/2012 |
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K121531 |
07/17/2012 |
A&J 5L POCA SERIES OXYGEN CONCENTRATOR |
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. |
JUNHONG AN |
| K121671 |
07/18/2012 |
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM |
ZIMMER SPINE, INC. |
DAVID PADGETT |
