FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
DEN130010 |
07/29/2013 |
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) |
ABBOTT MOLECULAR, INC. |
NANCY W BENGTSON |
K131428 |
07/16/2013 |
RADVISION |
ACOUSTIC MEDSYSTEMS, INC. |
JENNIFER WILLIAMS |
K130986 |
07/23/2013 |
FRAG-LOC SYSTEM |
ACUMED LLC |
KARA BUDOR |
K123418 |
07/21/2013 |
GRAM-NEGATIVE QUICKFISH BC |
ADVANDX, INC. |
BENJAMIN S CRYSTAL |
K130702 |
07/23/2013 |
AIRSONETT AIR-4 |
AIRSONETT, AB |
CONSTANCE G BUNDY |
K131786 |
07/03/2013 |
AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER |
AIRSTRIP TECHNOLOGIES, LP |
ROBERT ANDREW MILLER |
K130657 |
07/15/2013 |
LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE |
ALL MEDICUS CO., LTD |
Priscilla Chung |
K131814 |
07/26/2013 |
AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER |
AMECO MEDICAL INDUSTRIES |
Ray Kelly |
K131203 |
07/19/2013 |
IHEALTH CLOUD |
ANDON HEALTH CO., LTD |
YI LIU |
K130676 |
07/08/2013 |
AMBIO REMOTE HEALTH MONITORING SYSTEM |
ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH |
KEVIN JONES |
K131182 |
07/29/2013 |
MULTIFIX S KNOTLESS FIXATION DEVICE |
ARTHOCARE CORPORATION |
MITCHELL DHORITY |
K131474 |
07/03/2013 |
ARTHREX DISTAL RADIUS PLATE SYSTEM |
ARTHREX, INC. |
COURTNEY SMITH |
K132043 |
07/31/2013 |
ARTHREX SPEEDCINCH |
ARTHREX, INC. |
LEON BROWN II, PH.D. |
K122652 |
07/02/2013 |
ARTHROCARE TURBINATOR WAND |
ARTHROCARE CORPORATION |
CHERYL FREDERICK |
K130859 |
07/25/2013 |
HAMMERTOE CORRECTION SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
K130987 |
07/17/2013 |
VALUTRODE NEUROSTIMLATION ELECTRODES |
AXELGAARD MFG. CO., LTD. |
DAN P JEFFERY |
K131040 |
07/15/2013 |
EXTAVIPRO STERICAN 30G |
B. BRAUN MELSUNGEN AG |
KARIN LUBBERS |
K121445 |
07/26/2013 |
TETRACHROME REAGENTS AND TETRACXP SYSTEM |
BECKMAN COULTER, INC. |
NANCY NADLER |
K130253 |
07/15/2013 |
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION |
BECKMAN COULTER, INC. |
NANCY NADLER |
K131358 |
07/16/2013 |
BD PEN NEEDLE |
BECTON DICKINSON & CO. |
PASQUALE AMATO |
K131331 |
07/10/2013 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
K131327 |
07/18/2013 |
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM |
BIO COMPRESSION SYSTEMS, INC. |
Maureen Garner |
K131306 |
07/22/2013 |
IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE |
BIO COMPRESSION SYSTEMS, INC. |
Maureen Garner |
K130158 |
07/25/2013 |
M-SCAN |
BIO-RESEARCH ASSOCIATES, INC. |
JOHN RADKE |
K131729 |
07/31/2013 |
JBAIDS PLAGUE DETECTION KIT |
BIOFIRE DIAGNOSTICS, INC. |
CYNTHIA PHILLIPS |
K131936 |
07/31/2013 |
JBAIDS TULAREMIA DETECTION KIT |
BIOFIRE DIAGNOSTICS, INC. |
CYNTHIA PHILIPS |
K130324 |
07/09/2013 |
STATSEAL DISC |
BIOLIFE, LLC |
CLAUDIA MASSELINK |
K130949 |
07/30/2013 |
CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS |
BIOMET 3I |
LAURA HOSHUE |
K131670 |
07/03/2013 |
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) |
BIOMET, INC. |
SUZANA OTANO |
K131475 |
07/25/2013 |
BARRICADE EMBOLIZATION COIL SYSTEM |
BLOCKADE MEDICAL |
Rebecca K Pine |
K131905 |
07/18/2013 |
SOLID GEL PAD |
BLUEMTECH |
Priscilla Chung |
K130391 |
07/10/2013 |
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT |
BOSTON SCIENTIFIC CORP. |
VICKY L HAGENS |
K130621 |
07/30/2013 |
BROADMASTER HEALTHCARE SYSTEM |
BROADMASTER BIOTECH CORPORATION |
ROGER LAI |
K131496 |
07/10/2013 |
BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) |
BSN MEDICAL, INC. |
CARROLL D HOYLE |
K131002 |
07/02/2013 |
VIDA PTV DILATATON CATHETER |
C.R. BARD, INC. |
AARON CONOVALOFF |
DEN110004 |
07/12/2013 |
CABOCHON SYSTEM |
CABOCHON AESTHETICS, INC. |
BEN BRIAN |
K131106 |
07/03/2013 |
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, |
CANON INC. |
DIANE RUTHERFORD |
K130404 |
07/05/2013 |
TIBURON SURGICAL DRAPE |
CARDINAL HEALTH 200, LLC |
LAVENIA FORD |
K131332 |
07/19/2013 |
CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER |
CARDIOSOLUTIONS INC |
MICHELE LUCE |
K131227 |
07/12/2013 |
PADSCAN HD SERIES BLADDER SCANNER |
CARENOSO TECHNOLOGY CO., LTD. |
ZHANG WENSHENG |
K130648 |
07/23/2013 |
FORUM GLAUCOMA WORKPLACE |
CARL ZEISS MEDITEC AG |
MANDY AMBRECHT |
K122458 |
07/30/2013 |
VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM |
CELLO PARTNERSHIP D/B/A VERIZON WIRELESS |
LOLITA FORBES |
DEN130032 |
07/25/2013 |
XPERT MTB/RIF ASSAY |
CEPHEID |
KERRY J FLOM |
K131511 |
07/05/2013 |
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR |
CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD |
Diana Hong |
K131159 |
07/25/2013 |
SMARTRELIEF |
CHATTEM, INC. |
ERIC JOSEPH |
K131931 |
07/26/2013 |
CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST |
CHEMTRON BIOTECH, INC. |
Jane Zhang |
K131072 |
07/09/2013 |
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC |
COLOPLAST A/S |
BRIAN SCHMIDT |
K131467 |
07/18/2013 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA SHAH |
K130360 |
07/15/2013 |
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION |
CONSTANT CARE, LLC |
SETH A MAILHOT |
K130420 |
07/12/2013 |
SOLEA |
CONVERGENT DENTAL, INC |
Carrie Hetrick |
K124030 |
07/01/2013 |
COOK HOLMIUM LASER FIBER |
COOK INCORPORATED |
CONNIE RICE |
K122091 |
07/29/2013 |
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY |
COOK, INC. |
SEAN SPENCE |
K130766 |
07/17/2013 |
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE |
COOK, INC. |
DAVID LEHR |
K131520 |
07/11/2013 |
NEXUS ANTERIOR CERVICAL PLATE SYSTEM |
CORE-NEXUS |
LISA PETERSON |
K131361 |
07/29/2013 |
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET |
COVIDIEN |
STACEY A STRAND |
K130623 |
07/26/2013 |
BARRX CHANNEL RFA ENDOSCOPIC CATHETER |
Covidien LLC |
RICHELLE HOVER |
K131705 |
07/01/2013 |
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
KATHERINE ROBERTSON |
K130906 |
07/17/2013 |
ENDOFLIP CATHETER |
CROSPON, LTD. |
PAUL DRYDEN |
K131150 |
07/30/2013 |
CURA COMPENSATOR |
CURA MEDICAL TECHNOLOGIES, LLC |
THOMAS H FARIS |
K130315 |
07/12/2013 |
IPULSE HAIR REMOVAL SYSTEM |
CYDEN LIMITED |
DAVID BRODERICK |
K130431 |
07/25/2013 |
COMPRESSYN BAND |
DALLEN MEDICAL, INC. |
AL MEMMOLO |
K130083 |
07/17/2013 |
DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE |
DEMETECH CORP. |
ANTHONY J DIMERCURIO |
K130186 |
07/15/2013 |
DENTEK EASY BRUSH WITH FLUORIDE |
DENTEK ORAL CARE, INC. |
LINDA GILES |
K130680 |
07/26/2013 |
ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS |
DENTSOLL, INC. |
DAVID C FURR |
K122424 |
07/05/2013 |
ISUS IMPLANT SUPRASTRUCTURES |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
K130862 |
07/23/2013 |
CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM |
DENTSPLY INTL., INC. |
HELEN LEWIS |
K131191 |
07/22/2013 |
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
SUSAN KAGAN |
K131974 |
07/25/2013 |
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
K131743 |
07/01/2013 |
CIRONA DVT FOOT GARMENT |
DEVON MEDICAL INC. |
RUTH WU |
K123364 |
07/15/2013 |
25OH VITAMIN D TOTAL ELISA TEST |
DIASOURCE IMMUNOASSAYS, S.A. |
NAPOLEON MONCE |
K131572 |
07/22/2013 |
MICRO AMBULATORY ECG RECORDER |
DIMETEK DIGITAL MEDICAL TECHNOLOGIES LTD |
JIMMY GUAN |
K131248 |
07/11/2013 |
ETCH GEL |
DMG AMERICA, LLC |
PAMELA PAPINEUA, RAC |
K131498 |
07/25/2013 |
IQQA-LIVER MULTIMODALITY SOFTWARE |
EDDA TECHNOLOGY, INC. |
DANIEL KAMM, P.E. |
K123714 |
07/24/2013 |
EDWARDS EMBOL-X INTRODUCER SHEATH |
EDWARDS LIFESCIENCES, LLC. |
LUKE MEIDELL |
K131090 |
07/03/2013 |
2MP COLOR LCD MONITOR, RADIFORCE MX215 |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
K122202 |
07/01/2013 |
ELLEX 2RT |
Ellex Medical Pty. Ltd. |
KEVIN HOWARD |
K123366 |
07/12/2013 |
SURGITRON 4.0 DUAL RF S5-IEC |
ELLMAN INTERNATIONAL, INC. |
Alison Sathe |
K131480 |
07/03/2013 |
EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM |
EMERGE MEDICAL |
VICTORIA TRAFKA |
K124055 |
07/19/2013 |
T1040 AKA AURAWAVE |
ENDURANCE THERAPEUTICS |
BRAD BREZDEN |
K123234 |
07/05/2013 |
ERMIS STERILIZATION CONTAINER SYSTEM |
ERMIS MEDIZINTECHNIK |
ANDRE WEINGERL |
K130068 |
07/19/2013 |
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) |
ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M |
KEN SEISE |
K123660 |
07/17/2013 |
25-OH VITAMIN D ELISA |
EUROIMMUN US |
KATHRYN KOHL |
K131185 |
07/15/2013 |
ANA SCREEN ELISA (IGG) |
EUROIMMUN US |
MICHAEL LOCKE |
K131595 |
07/26/2013 |
EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM |
EUROTROL B.V. |
PAUL KOOIJMANS |
K131130 |
07/19/2013 |
NAVIGATION PIN |
EVERGREEN ORTHOPEDIC RESEARCH LAB |
JEFF STEPHANIAN |
K131575 |
07/03/2013 |
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT |
EXACTECH, INC. |
PATRICK HUGHES |
K130339 |
07/11/2013 |
CLINICAL ALERT NOTIFICATION |
EXTENSION , INC |
TIM GEE |
K130001 |
07/25/2013 |
CARE SU01A SUCTION ASPIRATOR |
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. |
GANG WU |
K123831 |
07/29/2013 |
OPHTACATH KIT |
FRANCE CHIRURGAE INSTRUMENTATION |
BARBARA S FANT |
K124035 |
07/03/2013 |
2008K@HOME HEMODIALYSIS MACHINE |
FRESENIUS MEDICAL CARE NORTH AMERICA |
DENISE OPPERMANN |
K123631 |
07/23/2013 |
MFP-051 |
GC AMERICA, INC. |
MARK HEISS |
K131514 |
07/12/2013 |
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
GE VINGMED ULTRASOUND AS |
BRYAN BEHN |
K131264 |
07/26/2013 |
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS |
GEBR. BRASSELER GMBH & CO. KG |
ERELA DANA |
K130088 |
07/18/2013 |
PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM |
GENORAY CO., LTD. |
JAE KIM |
K113126 |
07/17/2013 |
ACRYLIC HERBST APPLIANCE |
GERGENS ORTHODONTIC LAB |
KAREN E WARDEN, PHD |
K130785 |
07/26/2013 |
SEER 1000 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
BERT SCHADOW |
K131338 |
07/10/2013 |
DERMA HOOD |
GLOBALMEDIA GROUP, LLC |
NICHOLAS CAMPBELL |
K131449 |
07/30/2013 |
COALITION SPACER |
GLOBUS MEDICAL, INC. |
CHRISTINA KICHULA |
K130478 |
07/26/2013 |
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS |
GLOBUS MEDICAL, INC. |
SARAH MARIE FITZGERALD |
K131763 |
07/15/2013 |
TRUSCOPE SERIES PATIENT MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Diana Hong |
K131754 |
07/31/2013 |
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K130473 |
07/05/2013 |
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) |
HARTALEGA SDN BHD |
NURUL AISYAH KONG BT ABDULLAH |
K123881 |
07/11/2013 |
HEARTSINE SAMARITAN PAD 350P |
HEARTSINE TECHNOLOGIES, INC. |
JAMES MCGUINNESS |
K131233 |
07/16/2013 |
HERMES MEDICAL IMAGING SUITE V5.3 |
HERMES MEDICAL SOLUTIONS, AB |
JOAKIM ARWIDSON |
K123641 |
07/03/2013 |
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH |
HERTART |
HENRIK DORGE |
K131424 |
07/12/2013 |
MIPLATFORM MEDICAL IMAGING SUITE |
HINACOM SOFTWARE AND TECHNOLOGY, LTD. |
YI ISABELLE SUN |
K123471 |
07/05/2013 |
ETII SA FIXTURE SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
K131463 |
07/08/2013 |
WRIST AUTOMATIC BLOOD PRESSURE MONITOR |
HONSUN (NANTONG) CO., LTD |
SELINA QIAN |
K123171 |
07/03/2013 |
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT |
HORIBA ABX S.A.S. |
CAROLINE FERRER |
K130059 |
07/29/2013 |
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP |
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD. |
ELISSA BURG |
K131549 |
07/26/2013 |
CHEMOLOCK, CHEMOLOCK PORT |
ICU MEDICAL INC |
KATHERINE KENNER |
K130224 |
07/18/2013 |
ICT |
IMRIS, INC. |
Daniel Biank |
K131805 |
07/18/2013 |
INPULSE LASER |
INCISIVE INC. |
KATHY MAYNOR |
K130181 |
07/31/2013 |
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
K131620 |
07/25/2013 |
JONES-FX FRACTURE SYSTEM |
INSTRATEK, INC. |
Jeff Seavey |
K123753 |
07/17/2013 |
IMDX VANR FOR ABBOTT M2000 |
INTELLIGENT MEDICAL DEVICES, INC |
FRAN WHITE |
K120977 |
07/03/2013 |
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC |
INTERNATIONAL TECHNIDYNE CORP. |
LAWRENCE PICCIANO |
K122532 |
07/30/2013 |
DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES |
INTUITIVE SURGICAL, INC. |
MELISSA S GONZALEZ |
K131382 |
07/15/2013 |
EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL |
INVIVO CORPORATION |
RUSTY KELLY |
K131282 |
07/11/2013 |
NEXUS HEMORRHOID LIGATOR |
INX MEDICAL |
PAUL DRYDEN |
K123787 |
07/17/2013 |
GREENCROSS SURGICAL MASK |
JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,L |
XIANGYANG SONG |
K131137 |
07/18/2013 |
21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) |
JVC KENWOOD CORPORATION |
TSUKASA TASHIRO |
K121310 |
07/11/2013 |
MESOTHELIUM DENTAL MEMBRANE |
KENSEY NASH CORPORATION |
LORI BURNS, MS, RAC |
K131448 |
07/26/2013 |
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION |
KOELIS |
LAETITIA GERVAIS |
K131117 |
07/26/2013 |
ZIRMON SERIES |
KUWOTECH CO., LTD |
Priscilla Chung |
K131547 |
07/12/2013 |
LANX FUSION SYSTEM |
LANX, INC. |
Alan Burkholder |
K123177 |
07/03/2013 |
STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM |
LASERSTIM, INC. |
DAVID C FURR |
DEN110019 |
07/15/2013 |
NEBA SYSTEM |
LEXICOR MEDICAL TECHNOLOGY, LLC |
E. HOWARD MERRY |
K131077 |
07/17/2013 |
LIFE SPINE PLATEAU SPACER SYSTEM |
LIFE SPINE |
RANDY LEWIS |
K130305 |
07/24/2013 |
LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE |
LINA MEDICAL APS |
RICHARD GILLIS |
K131035 |
07/02/2013 |
Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM |
LINVATEC CORPORATION D/B/A CONMED LINVATEC |
JOY LOVETT |
K123332 |
07/18/2013 |
NAOMI-CT |
LK CONSULTING GROUP |
Priscilla Chung |
K131666 |
07/05/2013 |
ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING |
MAQUET CARDIOPULMONARY AG |
SARAH BETZ |
K130300 |
07/01/2013 |
HEATER-COOLER UNIT HCU 40 |
MAQUET CARDIOPULMONARY AG |
HELDER A SOUSA |
K130855 |
07/29/2013 |
PTFE SUPER SHEATH INTRODUCER |
MARTECH MEDICAL PRODUCTS |
ALEXIS ERAZO |
K123908 |
07/31/2013 |
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES |
MATRIX SURGICAL USA |
JULIE STEPHENS |
K123721 |
07/26/2013 |
GMK REVISION EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
K131671 |
07/05/2013 |
MECTALIF |
MEDACTA INTERNATIONAL |
ADAM GROSS |
K124000 |
07/30/2013 |
MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM |
MEDAPPS INC., DBA ALERE CONNECT |
KENT DICKS |
K130923 |
07/31/2013 |
5F DIGNITY CT TITANIUM PORT |
MEDICAL COMPONENTS INC |
SARAH SHAFFER |
K123807 |
07/23/2013 |
SHARPSCAN |
MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC. |
TIM CORESSEL |
K132040 |
07/31/2013 |
VIAL CONNECTOR 13MM CLOSED COLLAR |
MEDIMOP MEDICAL PROJECTS, LTD. |
ILANIT GOLDGRABER |
K130381 |
07/29/2013 |
ANGIOJET ULTRA POWER PULSE KIT |
MEDRAD, INC. |
AMRA RACIC |
K132008 |
07/30/2013 |
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP |
MEDTRONIC INC. |
MICHELE MACHACEK |
K131964 |
07/24/2013 |
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE |
MEDTRONIC INC. |
LISA STONE |
K130536 |
07/16/2013 |
EXPORT ADVANCE ASPIRATION CATHETER |
MEDTRONIC INC. |
COLLEEN MULLINS |
K123027 |
07/25/2013 |
CAPSTONE(R) SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
LEE GRANT |
K131269 |
07/10/2013 |
DLP CORONARY OSTIAL PERFUSION CANNULAE |
MEDTRONIC, INC. |
KEVIN T LAM |
K130805 |
07/03/2013 |
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION |
MENICON CO. LTD. |
Ellen M Beucler |
K131853 |
07/17/2013 |
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER |
MENTOR WORLDWIDE LLC |
MANCHI CHEUNG |
K131401 |
07/02/2013 |
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER |
MERCATOR MEDSYSTEMS, INC. |
PLAMENA ENTCHEVA-DIMITROV, PHD |
K131710 |
07/29/2013 |
MERIT HYDROPHILIC GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
MARTHA FOLAN |
K132041 |
07/31/2013 |
REXTAR X |
META BIOMED, INC. |
BLIX WINSTON |
K123343 |
07/11/2013 |
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS |
MICROGENICS CORP. |
KAREN LEE |
K131278 |
07/11/2013 |
MONTERIS MEDICAL NEUROBLATE SYSTEM |
MONTERIS MEDICAL, INC. |
CRAIG COOMBS |
K131955 |
07/30/2013 |
NEUROBLATE(TM) SYSTEM |
MONTERIS MEDICAL, INC. |
CRAIG COOMBS |
K130706 |
07/25/2013 |
DUOFLEX COIL SUITE (1.5T) |
MR INSTRUMENTS, INC. |
ROBERT BECK |
K131942 |
07/31/2013 |
NMI PICC III CATHETER, NMI HPICC III CATHETER |
NAVILYST MEDICAL, INC. |
Lorraine M Hanley |
K131688 |
07/18/2013 |
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL |
NEOSURGICAL LTD |
ORLA BRENNAN |
K130919 |
07/02/2013 |
SENSUS |
NEUROMETRIX, INC. |
RAINER MAAS |
K130806 |
07/12/2013 |
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
K130399 |
07/18/2013 |
CERTUS 140 CERTUSURGGT SURGICAL TOOL |
NEUWAVE MEDICAL, INC. |
DAN KOSEDNAR |
K130879 |
07/09/2013 |
NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS |
NEXUS MEDICAL, LLC |
HEATHER TURNER |
K131417 |
07/12/2013 |
FACET FIXX |
NEXXT SPINE LLC |
KAREN E WARDEN PHD |
K131542 |
07/24/2013 |
NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC |
Novabay Pharmaceuticals, Inc |
PATSY J TRISLER |
K124062 |
07/10/2013 |
QDC-PRO, AND NOX-RIP |
NOX MEDICAL |
KOLBRUN E OTTOSDOTTIR |
K131238 |
07/02/2013 |
AFFIX SPINOUS PROCESS PLATE SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
K130460 |
07/11/2013 |
NXSTAGE DOSING CALCULATOR |
NXSTAGE MEDICAL, INC. |
NNAMDI NWACHUKWU |
K131742 |
07/24/2013 |
HEM-6131 |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
K130656 |
07/03/2013 |
IFUSION |
OPTOVUE, INC. |
WILLIAM "BILL" JACKSON |
K130920 |
07/02/2013 |
CORRECT PLUS 1 |
PENTRON CLINICAL |
Wendy Garman |
K122402 |
07/16/2013 |
LPP (LOW PROFILE PORT) |
PFM MEDICAL, INC |
Salvadore Palomares, RAC |
K131738 |
07/10/2013 |
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H |
PHADIA AB |
CARINA MAGNUSSON |
K130553 |
07/03/2013 |
ABSOCLEAR |
PHARMAPLAST S.A.E. |
CYNTHIA PRITCHARD |
K132087 |
07/24/2013 |
PERCUNAV SYSTEM |
PHILIPS HEALTHCARE |
DAVE SZCZUPAKOWSKI |
K123599 |
07/12/2013 |
INGENUITY DIGITAL PET/CT |
PHILIPS HEALTHCARE (CLEVELAND) |
MICHAEL S PRETO |
K131263 |
07/24/2013 |
XPERGUIDE |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
JOS V VROONHOVEN |
K130353 |
07/01/2013 |
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
K130667 |
07/24/2013 |
POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL |
PREVENTIVE CARE, INC. |
ANIL SEGAT |
K130442 |
07/03/2013 |
NEWTOM VGI AND NEWTOM 5G |
QR S.R.L. |
BERTHOIN CLAUDE |
K123983 |
07/03/2013 |
FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS |
Qualigen, Inc. |
MICHAEL S POIRIER |
K131081 |
07/03/2013 |
CYBER TM FAMILY |
Quanta System SpA |
Maurizio Bianchi |
K130256 |
07/02/2013 |
MDK MULTI-APPLICATIONS PLATFORM |
Quanta System SpA |
Maurizio Bianchi |
K131606 |
07/05/2013 |
SOFIA INFLUENZA A+B FIA |
QUIDEL CORP. |
JOHN D TAMERIUS, PH.D. |
K131599 |
07/05/2013 |
QUICK VUE INFLUENZA |
QUIDEL CORPORATION |
JOHN D TAMERIUS, PH.D. |
K130962 |
07/24/2013 |
R&D 5D RETIC HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
AMBREEN ATHAR |
K130144 |
07/31/2013 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
Martin Gabler |
K131776 |
07/18/2013 |
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K131999 |
07/26/2013 |
HBA1C CONTROL, LEVEL 1 AND LEVEL 2 |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
K130935 |
07/02/2013 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA |
RAYENCE CO., LTD |
DAVE KIM |
K130079 |
07/19/2013 |
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER |
REFLECTANCE MEDICAL INC |
Nandini Murthy |
K131087 |
07/12/2013 |
SHARPSTANK REUSABLE SHARPS CONTAINER |
REHRIG PACIFIC COMPANY |
DAVID OLMSTEAD |
K131804 |
07/12/2013 |
REMEL XPECT FLU A&B |
REMEL, INC. |
CINDY KNAPP |
K123803 |
07/02/2013 |
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM |
REVERSE MEDICAL CORPORATION |
JEFFREY VALKO |
K130750 |
07/22/2013 |
RHYTHMIA MAPPING SYSTEM |
RHYTHMIA MEDICAL, INC |
LEON AMARIGLIO |
K130220 |
07/22/2013 |
MR CONDITIONAL PRESSON ELECTRODE |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES M MEWBORNE |
K131544 |
07/17/2013 |
COBAS C BILIRUBIN TOTAL GEN.3 |
Roche Diagnostics |
LISA K KLINEDINST |
K131637 |
07/12/2013 |
ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) |
ROTATION MEDICAL, INC. |
GAIL SCHROEDER |
K130125 |
07/24/2013 |
MTA CEMENTS |
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN |
CHRISTIAN BOETTCHER |
K131561 |
07/24/2013 |
SAM JUNCTIONAL TOURNIQUET |
SAM MEDICAL PRODUCTS |
JACK N MCCUTCHEON |
K130331 |
07/26/2013 |
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER |
SAUFLON PHARMACEUTICALS, LTD. |
CHRISTOPHER SMEJKAL |
K130953 |
07/15/2013 |
NEOTIS; NEOTIS 50 |
SBM SCIENCES FOR BIO MATERIALS |
DENIS CLEMENT |
K130500 |
07/26/2013 |
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT |
SEBIA |
KAREN ANDERSON |
K123074 |
07/03/2013 |
IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
K131690 |
07/24/2013 |
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANG ZHAOHUI |
K131504 |
07/16/2013 |
UNIVERSAL OPAQUE |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
K132062 |
07/23/2013 |
ESIE APPS SUITE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICK J LYNCH |
K131812 |
07/25/2013 |
SENSIS, SENSIS LITE |
SIEMENS MEDICAL SOLUTIONS, INC. |
PATRICIA D JONES |
K131372 |
07/02/2013 |
MOBIS II |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN |
K130225 |
07/11/2013 |
QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE |
SILVERBAY LLC, D/B/A QUASAR BIO-TECH |
ROBERT WAGNER |
K122988 |
07/19/2013 |
KLOCKNER DENTAL IMPLANT ABUTMENTS |
SOADCO, S.L. |
MARIA MITJANETA |
K124045 |
07/10/2013 |
FUSEFORCE IMPLANT SYSTEM |
SOLANA SURGICAL, LLC |
JOE CLIFT |
K131816 |
07/23/2013 |
SORIN CONNECT DATA MANAGEMENT SYSTEM |
SORIN GROUP DEUTSCHLAND GMBH |
RENATE GOEBERT |
K130207 |
07/23/2013 |
SPACELABS HEALTHCARE CARDIOEXPRESS |
SPACELABS HEALTHCARE LTD. |
THOMAS KROENKE |
K131343 |
07/24/2013 |
REFORM PEDICLE SCREW SYSTEM |
SPINAL USA |
MEREDITH MAY |
K130302 |
07/30/2013 |
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT |
SPINEVISION, S.A. |
HELENE PLAS |
K130211 |
07/05/2013 |
AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS |
SPS MEDICAL SUPPLY CORP. |
MICHAEL G NOLAN |
K130731 |
07/19/2013 |
STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW |
STABILIZ ORTHOPAEDICS, LLC |
DOUGLAS L CERYNIK, MD |
K122659 |
07/26/2013 |
VDRIVE W/V-SONO |
STEREOTAXIS, INC. |
HORWITZ |
K131120 |
07/16/2013 |
AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM |
STERIS Corporation |
BILL BRODBECK |
K123768 |
07/26/2013 |
RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM |
STERIS Corporation |
MARCIA L BENEDICT |
K131078 |
07/05/2013 |
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM |
STERIS Corporation |
MARCIA L BENEDICT |
DEN110006 |
07/12/2013 |
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR |
STERIS Corporation |
ROBERT SULLIVAN |
K130408 |
07/01/2013 |
ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT |
STERNGOLD DENTAL LLC |
MARIA RAO |
K130183 |
07/07/2013 |
SFI BAR ABUTMENTS |
STERNGOLD DENTAL LLC |
MARIA RAO |
K130424 |
07/11/2013 |
STIMEL-03 |
STIMEL LTD |
RAYMOND J KELLY IV |
K120510 |
07/19/2013 |
TRANSCEND |
SYNERON MEDICAL LTD. |
SAM WADE |
K130136 |
07/19/2013 |
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, |
TECHNOMED EUROPE |
PIERRE VREULS |
K123256 |
07/03/2013 |
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS |
THE BINDING SITE GROUP, LTD. |
JILL CONSTANTINE |
K131179 |
07/18/2013 |
CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR |
THORATEC CORP |
YVERRE BOBAY |
K130051 |
07/15/2013 |
611 ANKLE FUSION NAIL |
Tornier SAS |
DAMIEN GUILLAUD |
K131822 |
07/23/2013 |
ULTRAEXTEND USWS-900A V2.1 AND V3.1 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
|
K121178 |
07/05/2013 |
TRANSCORP ACIF SYSTEM |
TRANSCORP, INC. |
ANDREW RODENHOUSE |
K131007 |
07/10/2013 |
AIGIS RX N MEDIUM; AIGIS RX N LARGE |
TYRX ,INC |
SUSAN OLINGER |
K131811 |
07/19/2013 |
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
K130585 |
07/15/2013 |
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
K131046 |
07/18/2013 |
VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF) |
VENOUS HEALTH SYSTEMS, INC. |
RICH LAGUNA |
K131434 |
07/16/2013 |
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
K130350 |
07/02/2013 |
PROCELLERA |
VOMARIS INNOVATIONS INC. |
Mary Maijer |
K131573 |
07/03/2013 |
CP150 ELECTROCARDIOGRAPH |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
K123075 |
07/11/2013 |
BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E |
WELL-LIFE HEALTHCARE LIMITED |
CHIN-CHIH HSIEH |
K130376 |
07/03/2013 |
DYNASTY ACETABULAR SYSTEM WITH CERAMIC |
WRIGHT MEDICAL TECHNOLOGY, INC. |
DEAN NACHTRAB |
K131283 |
07/05/2013 |
PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Danielle Mueller |
K130658 |
07/19/2013 |
ELIXBO PM545 |
XBO MEDICAL SYSTEMS CO., LTD |
JINHONG GUO |
K130410 |
07/26/2013 |
DENTAL UNIT WITH CHAIR |
XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO. |
Diana Hong |
K131036 |
07/12/2013 |
YAMAHACHI DENTURE BASE RESINS |
YAMAHACHI DENTAL MANUFACTURING CO. |
Claude Berthoin |
K131123 |
07/05/2013 |
CLICKFINE AUTOPROTECT PEN NEEDLE |
YPSOMED AG |
BENJAMIN REINMANN |
K131125 |
07/05/2013 |
CLICKFINE PEN NEEDLE |
YPSOMED AG |
BENJAMIN REINMANN |
K130740 |
07/23/2013 |
NIGHTINGALE MONITORING SYSTEM |
ZOE MEDICAL, INC. |
JAMES CHICKERING |