| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K131707 |
08/22/2013 |
3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS |
3B MEDICAL, INC |
ALEX LUCIO |
| K132365 |
08/20/2013 |
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION |
ACCEL SPINE |
AEKTA PATEL |
| K122553 |
08/05/2013 |
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM |
ACON LABORATORIES, INC. |
QIYI XIE |
| K131052 |
08/16/2013 |
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) |
ACTUATED MEDICAL, INC. |
DEBORA DEMERS, PH.D. |
| K130627 |
08/21/2013 |
SWING-OFF SCREW |
ADVANCED INTERVENTIONAL TECHNOLOGY, LLC |
EDUARDO MARCH |
| K130165 |
08/30/2013 |
PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 |
ADVANCED PLANIMETRIC SERVICES, LLC |
MARTIN WENDELKEN |
| K130887 |
08/13/2013 |
S4C NAVIGATION INSTRUMENTS |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K123882 |
08/14/2013 |
AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR |
AGELESS HEALTH INDUSTRIAL |
VICTOR WAN |
| K131408 |
08/29/2013 |
CR 12-X DIGITIZER |
AGFA HEALTHCARE N.V. |
SHAEANN CAVANAGH |
| K131313 |
08/07/2013 |
ACTIVE BREATHING COORDINATOR |
AKTINA MEDICAL CORP. |
TONY SPACCAROTELLA |
| K131515 |
08/14/2013 |
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT |
ALFA WASSERMANN |
HYMAN KATZ, PH.D. |
| K131351 |
08/15/2013 |
ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC |
HYMAN KATZ |
| K131488 |
08/19/2013 |
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT |
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC |
HYMAN KATZ |
| K123834 |
08/13/2013 |
EASYSTAND BANTAM MEDIUM |
ALTIMATE MEDICAL, INC. |
STACEY FRANK |
| K131144 |
08/15/2013 |
AMECO SHEATH INTRODUCER |
AMECO MEDICAL INDUSTRIES |
RAYMOND J KELLY |
| K123699 |
08/12/2013 |
FAHL TRACHEOSTOMY TUBES (MULTIPLE) |
ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH |
CLAUDIA WINTERSCHLADEN |
| K131049 |
08/27/2013 |
ZRP |
APEX DENTAL MATERIALS, INC. |
CHRIS KULTON |
| K132263 |
08/19/2013 |
AXERA 2 ACCESS SYSTEM |
ARSTASIS, INC. |
DEBRA COGAN |
| K132099 |
08/22/2013 |
ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND |
ARTHROCARE CORPORATION |
SHIRLEY HYINK |
| K131205 |
08/09/2013 |
ARTHROCARE HEAD AND NECK COBLATION WAND |
ARTHROCARE CORPORATION |
MITCHELL A DHORITY |
| K131360 |
08/07/2013 |
INTEGRA TITANIUM BONE WEDGE |
ASCENSION ORTHOPEDIC |
KYLA KARA |
| K130693 |
08/14/2013 |
AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM |
ASEPTICO, INC. |
CHERIE TREGONING |
| K131842 |
08/20/2013 |
STERICAN CANNULA |
B. BRAUN MEDICAL, INC. |
KIMBERLY SMITH |
| K132374 |
08/30/2013 |
BAYLIS MEDICAL RF PERFORATION PROBE V2.0 |
BAYLIS MEDICAL COMPANY INC. |
MEGHAL KHAKHAR |
| K131301 |
08/02/2013 |
BD FACS SAMPLE PREP ASSISTANT III |
BECTON DICKINSON & CO. |
KIMBERLY LIEDTKE |
| K130268 |
08/23/2013 |
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
EMILY HOWARD |
| K132259 |
08/07/2013 |
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B |
Becton, Dickinson and Company |
GREGORY P PAYNE, RAC |
| K132256 |
08/07/2013 |
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B |
Becton, Dickinson and Company |
GREGORY P PAYNE, RAC |
| K123061 |
08/13/2013 |
ACE MONOPOLAR ATTACHMENT |
BIOECONEER INC. |
MICHAEL LEE |
| K131930 |
08/05/2013 |
JBAIDS ANTHRAX DETECTION KIT |
BIOFIRE DIAGNOSTICS, INC. |
CYNTHIA PHILLIPS |
| K123947 |
08/29/2013 |
ARCHITECT IVANCOMYCIN |
BIOKIT S.A. |
GUILLEM ANGLERILL |
| DEN130013 |
08/21/2013 |
VITEK MS |
BIOMERIEUX, INC. |
Nancy Weaver |
| K130033 |
08/01/2013 |
TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO |
BIOMET MANUFACTURING CORP. |
ELIZABETH WRAY |
| K131674 |
08/08/2013 |
PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING |
BIOMET MICROFIXATION |
ELIZABETH WHEELER |
| K130126 |
08/06/2013 |
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM |
BIOMET, INC. |
TRACY B JOHNSON |
| K130610 |
08/30/2013 |
SIRIUS FEMORAL STEM |
BIOMET, INC. |
BECKY EARL |
| K131221 |
08/28/2013 |
LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 |
BIOMONDE |
ROSINA ROBINSION, RN, MED, RAC |
| K130716 |
08/28/2013 |
BIORETEC ACTIVASCREW INTERFERENCE |
BIORETEC LTD |
MARI RUOTSALAINEN |
| K130602 |
08/14/2013 |
LASSO NAV DUO LOOP CATHETER |
BIOSENSE WEBSTER, INC. |
JOHN JIMENEZ |
| K131978 |
08/23/2013 |
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K130484 |
08/09/2013 |
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER |
BOSTON SCIENTIFIC CORP. |
ANDREW NGUYEN |
| K123047 |
08/06/2013 |
BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET |
BRACCO DIAGNOSTIC, INC. |
TRACEY ALEXANDER |
| K130792 |
08/30/2013 |
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM |
C.R. BARD, INC. |
Christoph Wagner von Hoff |
| K131493 |
08/02/2013 |
SIDEKICK AND USHER SUPPORT CATHETERS |
C.R. BARD, INC. |
TIMOTHY WADE |
| K131523 |
08/22/2013 |
CRYOBALLOON FOCAL ABLATION SYSTEM |
C2 THERAPEUTICS |
PETER GARCIA-MEZA |
| K131101 |
08/26/2013 |
ITERO SOFTWARE |
CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY |
MANAS M LELE |
| K123443 |
08/13/2013 |
PRECISE SHP DIODE LASER |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K131538 |
08/08/2013 |
CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM |
CAPTIVA SPINE |
RICH JANSEN |
| K123571 |
08/01/2013 |
CARDIO VISION MICS AORTIC CLAMPS |
CARDIOMEDICAL GMBH |
ANGELIKA SCHERP |
| K132413 |
08/29/2013 |
MZ1000 |
CAREFUSION |
MICHELLE J BADAL, RAC |
| K130027 |
08/22/2013 |
DISPOSABLE NEUTRAL ELECTRODE GP202 |
CATHAY MANUFACTURING CORP. |
ZHANG HUI |
| K131325 |
08/16/2013 |
QUATTRO GL SUTURE ANCHOR |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
| K130752 |
08/15/2013 |
DYNASENSE SYSTEM |
CENTAURI MEDICAL, INC. |
LORI ADELS |
| DEN130005 |
08/08/2013 |
QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
ELIZABETH HAMELIN |
| K130461 |
08/28/2013 |
STALIF X |
CENTINEL SPINE INC. |
JUSTIN EGGLETON |
| K131305 |
08/01/2013 |
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE |
CHISON MEDICAL IMAGING CO., LTD. |
BOB LEIKER |
| K123436 |
08/26/2013 |
FIRST RESPONSE EARLY RESULT PREGNANCY TEST |
CHURCH & DWIGHT CO., INC. |
JOSEPH CICCONE |
| K131363 |
08/30/2013 |
ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM |
CILAG GMBH INTERNATIONAL |
Oyinkan Donaldson |
| K130046 |
08/06/2013 |
CLEARSPEC SINGLE USE VAGINAL SPECULUM |
CLEARSPEC LLC |
IRA DUESLER |
| K132281 |
08/30/2013 |
ReVive PV (Peripheral Vasculature) Thrombectomy Device |
Codman & Shurtleff, Inc. |
Amarilys Machado |
| K132061 |
08/02/2013 |
RESTORELLE M, RESTORELLE XL |
COLOPLAST CORP. |
TIM CRABTREE |
| K130137 |
08/23/2013 |
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER |
COLTENE/WHALEDENT |
EDWARD A KROLL |
| K131198 |
08/27/2013 |
TIPI OTC |
CONTIPI LTD. |
JONATHAN KAHAN |
| K132334 |
08/16/2013 |
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET |
COOK, INC. |
SEAN SPENCE |
| K131378 |
08/30/2013 |
SUS (STENFILCON A) CONTACT LENS |
COOPERVISION, INC. |
ANNETTE NELSON |
| K131522 |
08/09/2013 |
CORE PEDICLE SCREW SYSTEM |
CORE-NEXUS |
LISA PETERSON |
| K131532 |
08/12/2013 |
ELECTROMAGNETIC TRANSMITTING STYLET |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K123756 |
08/16/2013 |
COVAGEN |
COVALON TECHNOLOGIES LTD. |
CHRISTOPHER FREDRIC |
| K132360 |
08/27/2013 |
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER |
COVIDIEN |
ASHLEY GONCALO |
| K131614 |
08/29/2013 |
REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM |
COVIDIEN |
Daniel Campion |
| K131170 |
08/28/2013 |
SONICISION STERILIZATION TRAY |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
DAVID HORTON |
| K131079 |
08/01/2013 |
CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC |
CREGANNA MEDICAL DEVICES |
CHRISTINE NICHOLS |
| K130089 |
08/09/2013 |
CROSSTREES PVA POD |
CROSSTREES MEDICAL, INC. |
JANICE M HOGAN |
| K123830 |
08/16/2013 |
INTERMITTENT PNEUMATIC COMPRESSION DEVICE |
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. |
DORIS DONG |
| K131945 |
08/08/2013 |
GE DATEX-OHMEDA AVANCE CS2 |
DATEX-OHMEDA |
JAMES P RASKOB |
| K130244 |
08/23/2013 |
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM |
DELBIO INCORPORATION |
NICKY PAN |
| K131197 |
08/27/2013 |
EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS |
DENTAL MORELLI |
TARA CONRAD |
| K130814 |
08/01/2013 |
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K131464 |
08/13/2013 |
EXTRICARE NPWT FOOT DRESSING |
DEVON MEDICAL INC. |
RUTH WU |
| K130779 |
08/15/2013 |
LVIVO EF SYSTEM |
DIACARDIO, LTD |
George Hattub |
| K130163 |
08/16/2013 |
D-LUX |
DIADENT GROUP INTERNATIONAL |
GIL JUN, HONG |
| K131441 |
08/09/2013 |
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II |
DIASORIN, INC. |
Sandra Zimniewicz |
| K132234 |
08/28/2013 |
LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II |
DIASORIN, INC. |
JOHN ESKDALE |
| K122562 |
08/09/2013 |
E-TENG MODEL EOR 1 |
E-TENG TECHNOLOGY, INC. |
JUNNATA CHANG |
| K131818 |
08/30/2013 |
VITAL SIGNS MONITOR |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K131376 |
08/27/2013 |
SMARTCOAT 2.5% NAF VARNISH |
ELEVATE ORAL CARE |
STEVE PARDUE |
| K130301 |
08/22/2013 |
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE) |
ELIMEDICAL DEVICES (FUJIAN) INC. |
Diana Hong |
| K131949 |
08/26/2013 |
AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES |
ENCISION, INC. |
JIM LEWIS |
| K132535 |
08/23/2013 |
AUTOBAND LIGATOR |
ENDOCHOICE, INC. |
DANIEL HOEFER |
| K130793 |
08/16/2013 |
NEWA SKIN THERAPY SYSTEM |
ENDYMION MEDICAL LTD |
YORAM LEVY |
| K130900 |
08/13/2013 |
EVICEL APPLICATION DEVICE |
ETHICON INC (ON BEHALF OF OMRIX BIOPHARACEUTICALS |
SHIKHA GOLA |
| K132054 |
08/23/2013 |
GYNECARE TVT EXACT CONTINENCE SYSTEM |
ETHICON, INC. |
SUSAN LIN |
| K131616 |
08/29/2013 |
EZ3D-I, E3 |
EWOO SOFT CO., LTD |
DAVE KIM |
| K131594 |
08/29/2013 |
EZDENTI-I; E2; PRORA VIEW |
EWOO SOFT CO., LTD |
DAVE KIM |
| K131570 |
08/15/2013 |
ORTHOVISION |
EWOO SOFT CO., LTD |
DAVE KIM |
| K122337 |
08/06/2013 |
OVUSENSE |
FERTILITY FOCUS LTD |
PENNY NORTHCUTT |
| K131657 |
08/22/2013 |
FLOWER SMALL AND MEDIUM IMPLANT SET |
FLOWER ORTHOPEDICS CORPORATION |
JANICE M HOGAN |
| K131875 |
08/06/2013 |
MENICON NECT CONTACT LENS CASE |
FORESIGHT REGULATORY STRATEGIES |
Ellen M Beucler |
| K131611 |
08/29/2013 |
FRESENIUS DRY ACID DISSOLUTION UNITS |
FRESENIUS MEDICAL CARE NORTH AMERICA |
DENISE OPPERMANN |
| K123814 |
08/13/2013 |
HUMELOCK II CEMENTED SHOULDER SYSTEM |
FX SOLUTIONS |
JEAN-JACQUES MARTIN |
| K122627 |
08/22/2013 |
GIO DIGITAL PRESSURE GUAGES |
GALEMED CORP. |
TOM SHANKS |
| K131527 |
08/26/2013 |
LOGIQ S8 |
GE HEALTHCARE |
BRYAN BEHN |
| K131223 |
08/28/2013 |
CARESCAPE MONITOR B650 |
GE HEALTHCARE FINLAND OY |
JOEL KENT |
| K131414 |
08/28/2013 |
CARESCAPE MONITOR B850 |
GE HEALTHCARE FINLAND OY |
JOEL KENT |
| K131576 |
08/30/2013 |
OPTIMA CT660 |
GE MEDICAL SYSTEMS, LLC |
HELEN PENG |
| K132200 |
08/14/2013 |
PRO HMPV+ ASSAY |
GEN-PROBE PRODESSE, INC |
EMILY ZIEGLER |
| K132159 |
08/14/2013 |
PROADENO+ ASSAY |
GEN-PROBE PRODESSE, INC |
EMILY ZIEGLER |
| K132237 |
08/26/2013 |
PRODESSE PROFAST+ ASSAY |
GEN-PROBE PRODESSE, INC. |
EMILY ZIEGLER |
| K132129 |
08/09/2013 |
PRODESSE PROFLU+ ASSAY |
GEN-PROBE PRODESSE, INC. |
EMILY ZIEGLER |
| K132238 |
08/26/2013 |
PROPARAFLU+ ASSAY |
GEN-PROBE PRODESSE, INC. |
EMILY ZIEGLER |
| K130374 |
08/29/2013 |
OMNI-VUE 2 SYSTEM |
GENESIS DIGITAL IMAGING, INC. |
CARL ALLETTO |
| K130516 |
08/23/2013 |
CARDIODAY |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
BERT SCHADOW |
| K123864 |
08/12/2013 |
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM |
GIVEN IMAGING LTD. |
Tim Thomas |
| K130392 |
08/15/2013 |
KINEX BIOACTIVE |
GLOBUS MEDICAL INC. |
SARAH MARIE FITZGERALD |
| K130682 |
08/13/2013 |
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT |
HAGER & MEISINGER GMBH |
WIEBKE STOLTEN |
| K123076 |
08/09/2013 |
PROFTHAND MECHANICAL WHEELCHAIR |
HARMONY HILL INTERNATIONAL |
TINA LAI |
| K130685 |
08/09/2013 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERIKA AMMIRATI |
| K131581 |
08/22/2013 |
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) |
HOLOGIC, INC. |
SARAH FAIRFIELD |
| K131736 |
08/22/2013 |
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK) |
HOLOGIC, INC. |
SARAH FAIRFIELD |
| K131870 |
08/14/2013 |
GLIDE DEVICE |
HOME SKINOVATIONS LTD. |
AHAVA STEIN |
| K123604 |
08/16/2013 |
ABG III MONOLITHIC HIP STEM |
HOWMEDICA OSTEONICS CORP |
COLLEEN BURDEL |
| K131419 |
08/09/2013 |
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM |
i-SENS, Inc. |
CHAE YUN LIM |
| K130696 |
08/21/2013 |
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM |
i-SENS, Inc. |
CHAE YUN LIM |
| K131722 |
08/07/2013 |
I.T.S. EXTREMITY FIXATION SYSTEMS |
I.T.S. GMBH |
AL LIPPINCOTT |
| K131279 |
08/09/2013 |
ICONACY I-HIP SYSTEM |
ICONACY ORTHOPEDIC IMPLANTS, LLC |
MARC E RUHLING |
| K123724 |
08/28/2013 |
DERMISEB CREAM |
IGI LABORATORIES, INC. |
FREDERICK WEISS |
| K131097 |
08/22/2013 |
LEGACY3 6MM LENGTH IMPLANTS |
IMPLANT DIRECT SYBRON MANUFACTURING LLC |
INES ARAVENA |
| K130846 |
08/08/2013 |
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN |
INDUSTRIAL CLOTHINGS, LTD. |
S.N. HARI |
| K131277 |
08/28/2013 |
SEVIIN FRACTURE SHOULDER |
INGEN ORTHOPEDICS LLC |
PERRY A GEREMAKIS |
| K130635 |
08/26/2013 |
SEVIIN SURFACE REPLACEMENT SHOULDER |
INGEN ORTHOPEDICS LLC |
PERRY A GEREMAKIS |
| K123987 |
08/27/2013 |
IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET |
INNOVATIVE MEDICAL TECHNOLOGIES, INC. |
BRAD BROWN |
| K131294 |
08/29/2013 |
OMNIPOD INSULIN MANAGEMENT SYSTEM |
INSULET CORPORATION |
TARA N TURNEY |
| K131184 |
08/30/2013 |
INTEGRA LICOX PTO2 MONITOR |
INTEGRA LIFESCIENCES CORP. |
ELIZABETH MCMENIMAN |
| K130821 |
08/09/2013 |
INTEL-GE CARE INNOVATIONS CONNECT RCM |
INTEL-GE CARE INNOVATIONS LLC |
MAUREEN GLYNN |
| K131584 |
08/21/2013 |
IMDX FLU A/B AND RSV FOR ABBOTT M2000 |
INTELLIGENT MEDICAL DEVICES, INC |
FRAN WHITE |
| K130140 |
08/01/2013 |
INTRA-LOCK OP DENTAL IMPLANT |
INTRA-LOCK INTERNATIONAL |
DIANA TAYLOR |
| K130266 |
08/29/2013 |
ENDOWRIST ONE VESSEL SEALER |
INTUITIVE SURGICAL, INC. |
CRYSTAL ONG |
| K132359 |
08/30/2013 |
MRI PATIENT MONITORING SYSTEM |
INVIVO CORPORATION |
RUSTY KELLY |
| K130436 |
08/20/2013 |
MULTILINK HYBRID ABUTMENT CEMENT |
IVOCLAR VIVADENT AG |
DONNA MARIE HARTNETT |
| K124014 |
08/09/2013 |
SUREFIX INTERSPINOUS FUSION SYSTEM |
JG SPINE, LLC |
JOHN KAPITAN |
| K130931 |
08/30/2013 |
EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS |
JIANGSU HORIEN CONTACT LENS CO., LTD. |
JENNIFER REICH |
| K131124 |
08/28/2013 |
COLIGN |
JILIN CORONADO MEDICAL LTD. |
ERIC CHIEN |
| K131784 |
08/30/2013 |
RANGE SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K131254 |
08/20/2013 |
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE |
KIMBERLY-CLARK CORP. |
MARCIA JOHNSON |
| K113806 |
08/20/2013 |
KIMGUARD ONE STEP STERILIZATION WRAP |
KIMBERLY-CLARK HEALTH CARE |
CHRISTOPHER B SWANSON |
| K130936 |
08/22/2013 |
AERODR SYSTEM WITH P-31 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSEL MUNVES |
| K131430 |
08/30/2013 |
CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
| K131432 |
08/22/2013 |
CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
| K131068 |
08/27/2013 |
TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
| K123999 |
08/28/2013 |
ILLUMASK ACNE LIGHT THERAPY MASK |
LA LUMIERE, LLC |
ROBERT SEIPLE, RAC |
| K130798 |
08/23/2013 |
PRE-FORMED GUIDEWIRES |
LAKE REGION MEDICAL, INC. |
MATHEW PEXA |
| K132190 |
08/05/2013 |
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME |
LEMAITRE VASCULAR, INC. |
Anna Kasseris |
| K123473 |
08/13/2013 |
HOPER PTCA BALLOON CATHETER |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
ARTHUR GODDARD |
| K132204 |
08/22/2013 |
INSUFLOW SYNERGY XL PORT |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K131048 |
08/28/2013 |
LIDCO CNAP MODULE |
LIDCO LTD. |
GREGORY SPELLER |
| K123563 |
08/20/2013 |
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM |
MAGELLAN DIAGNOSTICS |
STUART NAYLOR |
| K131158 |
08/21/2013 |
CORVIEW |
MARREK, INC |
JEREMY M FOTHERINGHAM |
| K130345 |
08/01/2013 |
AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING |
MAYER LABORATORIES, INC. |
DAVID P MAYER |
| K131310 |
08/22/2013 |
GMK FULL PE TIBIAL COMPONENTS |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K130299 |
08/15/2013 |
GMK HINGE |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K130687 |
08/15/2013 |
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER |
MEDICAL COMPONENTS INC |
JESSICA LEO |
| K131687 |
08/16/2013 |
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET |
MEDICAL COMPONENTS INC |
JESSICA LEO |
| K130179 |
08/08/2013 |
MP VIAL ADAPTER 13MM |
MEDIMOP MEDICAL PROJECTS, LTD. |
ILANIT GOLDGRABER |
| K131155 |
08/28/2013 |
UGFT3; FHT7 |
MEDISIM LTD. |
MOSHE YARDEN |
| K122885 |
08/29/2013 |
MEDISIZE GOLD HEATER AND BOOSTER T-PIECE |
MEDISIZE BV |
IFFAT NOOR |
| K132332 |
08/22/2013 |
MOUNTAINEER OCT SPINAL SYSTEM |
MEDOS INTERNATIONAL SARL |
KIRSTEN LEHMULLER |
| K131517 |
08/02/2013 |
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING |
MEDRAD, INC. / BAYER MEDICAL CARE, INC. |
LISA A EWING |
| K131425 |
08/14/2013 |
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER |
MEDTRONIC NAVIGATION, INC. |
REGINA HOLMES |
| K130608 |
08/07/2013 |
QUADCUT |
MEDTRONIC NAVIGATION, INC. |
SHARON MCDERMOTT |
| K132111 |
08/06/2013 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA |
LAUREN KAMER |
| K131878 |
08/23/2013 |
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM |
MEDYSSEY USA, INC. |
RICH JANSEN |
| K123988 |
08/15/2013 |
ANYONETM INTERNAL IMPLANT SYSTEM |
MEGAGEN IMPLANT CO., LTD |
APRIL LEE |
| K123792 |
08/30/2013 |
HORIZON XVU (FFR) |
MENNEN MEDICAL LTD. |
IFAT SHWARTS |
| K132226 |
08/09/2013 |
METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K132409 |
08/29/2013 |
CONCIERGE GUIDING CATHETER |
MERIT MEDICAL SYSTEMS, INC. |
VICKI GODWIN |
| K130076 |
08/22/2013 |
PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS |
MERZ DENTAL GMBH |
|
| K131085 |
08/22/2013 |
CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 |
MESPERE LIFESCIENCES INC. |
HELEN TAN |
| K124010 |
08/23/2013 |
ACCUSONIC ADVANTAGE |
METRON MEDICAL AUSTRALIA PTY LTD |
DAVID MITCHELL |
| K131247 |
08/14/2013 |
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM |
MFS - MEDICAL FLOW SYSTEMS LTD |
OFER SHAY |
| K122766 |
08/20/2013 |
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY |
MICROGENICS CORP. |
KAREN LEE |
| K123605 |
08/16/2013 |
SMARTFLOW CATHETER |
MRI INTERVENTIONS, INC. |
EDWARD F WADDELL |
| K123904 |
08/07/2013 |
PROTHELIAL |
MUELLER MEDICAL INTERNATIONAL LLC |
RICKY W MCCULLOUGH MD |
| K131391 |
08/21/2013 |
JUSHA-M32 MEDICAL DISPLAY |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
MIKE GU |
| K131345 |
08/07/2013 |
TIARRAY DENTAL IMPLANT SYSTEM |
NASSEO, INC. |
Allison C Komiyama |
| K131694 |
08/08/2013 |
NMI PORT II CATHETER |
NAVILYST MEDICAL, INC. |
BRANDON M BRACKETT |
| K132587 |
08/29/2013 |
MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR |
NED DISPLAY SOLUTIONS LTD. |
TONY HSU |
| K131471 |
08/28/2013 |
SELF-COMPRESSIVE SCREW |
NEOSTEO |
JD WEBB |
| K131374 |
08/23/2013 |
TEMPUS(TM) CERVICAL PLATE SYSTEM |
NEUROSTRUCTURES, LLC |
MEREDITH MAY |
| K131415 |
08/09/2013 |
LIVE VIEW PANEL (LVP) |
NEUROTRONICS, INC. |
DAVID PEZET |
| K123797 |
08/27/2013 |
NT1D VITAL SIGNS MONITOR |
NEW TECH, INC. |
Diana Hong |
| K131082 |
08/26/2013 |
INTERFORM INTERBODY CAGE SYSTEM |
NEXT ORTHOSURGICAL |
J.D. WEBB |
| K131061 |
08/28/2013 |
RESTORE BUNION CORRECTION SYSTEM |
NEXTREMITY SOLUTIONS |
JANET WEBB |
| K132072 |
08/15/2013 |
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM |
NIPRO DIAGNOSTICS, INC. |
BETH FOSTER |
| K131641 |
08/28/2013 |
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD-MCLEOD |
| K123347 |
08/02/2013 |
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 |
NORMED MEDIZIN-TECHNIK GMBH |
DAVID C FURR |
| K123766 |
08/15/2013 |
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN |
NOVO NORDISK INC. |
LOIS KOTKOSKIE, PH. D |
| K130242 |
08/29/2013 |
MAVEN PRO |
NSEQUENCE |
RHONDA ALEXANDER, MS, MPA |
| K131014 |
08/12/2013 |
PANA SPRAY PLUS |
NSK AMERICA CORP. |
DIANE RUTHERFORD |
| K131869 |
08/08/2013 |
PTS-X SIZING BALLOON CATHETER |
NUMED, INC. |
NICHELLE LAFLESH |
| K130868 |
08/29/2013 |
NUVASIVE DECADE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
Cynthia Adams |
| K130820 |
08/08/2013 |
EXPANDABLE LUMBAR INTERBODY SYSTEM |
NUVASIVE, INCORPORATED |
JEREMY MARKOVICH |
| K131780 |
08/29/2013 |
EVIS EXERA III VIDEO SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORP. |
DAPHNEY GERMAIN-KOLAWOLE |
| K131126 |
08/22/2013 |
OPTI CCA-TS2 |
OPTI MEDICAL SYSTEMS INC. |
LEN OWENS |
| K131785 |
08/20/2013 |
PAGODA PEDICLE SCREW SYSTEM |
ORTHO DEVELOPMENT CORP. |
TOM HAUETER |
| K130743 |
08/06/2013 |
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL |
ORTHO KINEMATICS, INC. |
JOHN J SMITH |
| K130932 |
08/07/2013 |
FIREBIRD SPINAL FIXATION SYSTEM |
ORTHOFIX, INC. |
JACKI GEREN |
| K130832 |
08/15/2013 |
ORTHOHELIX STAPLE SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
BRIAN HOCKETT |
| K131478 |
08/15/2013 |
CONTRAST CONSERVATION SYSTEM |
OSPREY MEDICAL, INC. |
JILL MUNSINGER |
| K131810 |
08/08/2013 |
OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM |
OSSEUS FUSION SYSTEMS, LLC |
J.D. WEBB |
| K131450 |
08/06/2013 |
FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 |
OSTIAL CORPORATION |
JAKE WOLENBERG |
| K130672 |
08/13/2013 |
OPTIFLOW II FLOWABLE COMPOSITE, LC |
PAC-DENT INTERNATIONAL, INC. |
WENYING ZHU |
| K131451 |
08/22/2013 |
PALTOP DENTAL IMPLANT - STERILE ACCESSORIES |
PALTOP ADVANCED DENTAL SOLUTIONS LTD |
TAL HAMMER-TOPAZ |
| K130462 |
08/27/2013 |
PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT |
PALTOP ADVANCED DENTAL SOLUTIONS LTD |
TAL HAMMER-TOPAZ |
| K130273 |
08/08/2013 |
PANPAC VAGINAL DILATORS |
Panpac Medical Corporation |
Yen-Ming Pan |
| K132197 |
08/12/2013 |
CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER |
PENDRACARE INTERNATIONAL, B.V. |
TOM NOLAN |
| K122197 |
08/28/2013 |
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES |
PHADIA US INC. |
MARTIN MANN |
| K122063 |
08/02/2013 |
INTELLISAVE AX700 ANESTHESIA SYSTEM |
PHILIPS ANESTHESIA CARE |
NEIL BATTISTE |
| K131032 |
08/12/2013 |
PHILIPS SURESIGNS CENTRAL |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
| K131241 |
08/30/2013 |
SWIP |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
SUSAN QUICK |
| K131829 |
08/16/2013 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HERBERT VAN DYK |
| K132304 |
08/21/2013 |
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
JESSICA STENBERG |
| K132165 |
08/09/2013 |
QLAB QUANTIFICATION SOFTWARE |
PHILIPS ULTRASOUND, INC. |
PENNY GRECO |
| K130454 |
08/21/2013 |
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K123399 |
08/01/2013 |
MYOVISION 3.0 WIREFREE SYSTEM |
PRECISION BIOMETRICS, INC. |
ERIC CHEN |
| K131212 |
08/26/2013 |
PREMIER CERAMIC PRIMER |
PREMIER DENTAL PRODUCTS CO. |
VINCENT D'ALESSANDRO |
| K130933 |
08/02/2013 |
SOLUTIS |
QUANTEL MEDICAL |
MAUREEN O'CONNELL |
| K131728 |
08/29/2013 |
QUIDEL MOLECULAR INFLUENZA A + B ASSAY |
QUIDEL CORP. |
Ronald H Lollar |
| K131166 |
08/02/2013 |
SOFIA(R) HCG FIA |
QUIDEL CORP. |
JOHN D TAMERIUS |
| K130398 |
08/13/2013 |
SOFIA(R) RSV FIA |
QUIDEL CORP. |
JOHN D TAMERIUS, PH.D. |
| K130714 |
08/22/2013 |
PROGIGY SUPPORT CATHETER |
RADIUS MEDICAL, LLC |
RICHARD DEMELLO |
| K132090 |
08/08/2013 |
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K131455 |
08/30/2013 |
RESTORE MODULAR STERILIZATION TRAY SYSTEM |
RESTORE MEDICAL SOLUTIONS, INC. |
PATSY J TRISLER |
| K122355 |
08/23/2013 |
VANISHPOINT BLOOD COLLECTION SET |
RETRACTABLE TECHNOLOGIES, INC. |
RHONDA WELLS |
| K121610 |
08/08/2013 |
COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY |
ROCHE DIAGNOSTICS OPERATIONS |
Susan Hollandbeck |
| K131029 |
08/09/2013 |
ACCU-CHEK AVIVA PLUS TEST STRIP |
ROCHE DIAGNOSTICS OPERATIONS INC |
KHONE SAYSANA |
| K131635 |
08/29/2013 |
ROTATION MEDICAL BONE STAPLE (RMB STAPLE) |
ROTATION MEDICAL, INC. |
GAIL SCHROEDER |
| K131642 |
08/07/2013 |
RSH BILIARY STONE REMOVAL DEVICE |
RSH LLC |
AMY SPRINGS |
| K132352 |
08/22/2013 |
SAS FLUALERT A & B, SAS INFLUENZA A TEST |
SA SCIENTIFIC LTD. |
Nelson Torres |
| K123582 |
08/16/2013 |
ENDO A CLASS |
SAEYANG MICROTECH CO., LTD |
JIGAR SHAH |
| K123608 |
08/16/2013 |
ENDO E CLASS |
SAEYANG MICROTECH CO., LTD |
JIGAR SHAH |
| K132228 |
08/20/2013 |
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
KYEONG-MI PARK |
| K130342 |
08/05/2013 |
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER |
SAUFLON PHARMACEUTICALS, LTD. |
CHRISTOPHER SMEJKAL |
| K130130 |
08/26/2013 |
ATG/SM-OSA APPLIANCES |
SELANE PRODUCTS, INC. |
CAROLYN PRIMUS |
| K122610 |
08/05/2013 |
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES |
SEN MU TECHNOLOGY CO., LTD. |
MING-YIE JN, PH.D. |
| K131582 |
08/28/2013 |
SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM |
SENSUS HEALTHCARE |
KAL FISHMAN |
| K124044 |
08/30/2013 |
ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS |
SEVEN OAKS RANCH, INC. |
Calley Herzog |
| K131512 |
08/07/2013 |
KATIA SYSTEM |
SHANGHAI SANYOU MEDICAL CO, LTD |
KIMBERLY STROHKIRCH |
| K132341 |
08/15/2013 |
DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K131558 |
08/30/2013 |
PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 |
SHENZHEN PANGO ELECTRONIC CO., LTD |
XIAOYUN YANG |
| K131536 |
08/12/2013 |
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL |
Siemens Healthcare Diagnostics Inc. |
Garo Mimaryan |
| K131634 |
08/16/2013 |
SYMBIA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELAINE CHANG |
| K130749 |
08/20/2013 |
SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K123540 |
08/29/2013 |
SYNGO CT PULMO 3D |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUM |
| K130951 |
08/22/2013 |
SIM |
SIMAVITA PTY LIMITED |
JOHN J SMITH, MD,JD |
| K130748 |
08/04/2013 |
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 |
SMITH & NEPHEW, INC. |
Bradley Heil |
| K131969 |
08/22/2013 |
SYMBOTEX(TM) COMPOSITE MESH |
SOFRADIM PRODUCTION |
CLARE SANTULLI |
| K131803 |
08/20/2013 |
GUARDIAN URETHRAL SHEATH |
SOLACE THERAPEUTICS |
WILLIAM GRUBER |
| K130948 |
08/14/2013 |
C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM |
SOUTHERN SPINE, LLC |
JULIE STEPHENS |
| K123891 |
08/12/2013 |
SPARTAN RX CYP2C19 TEST SYSTEM |
SPARTAN BIOSCIENCE INC |
LORRY HUFFMAN |
| K130863 |
08/09/2013 |
FACET SCREW SYSTEM |
SPINAL USA |
JANICE M HOGAN |
| K132154 |
08/09/2013 |
CAPSURE PS SYSTEM |
SPINE WAVE, INC. |
JOSEPH MERCADO |
| K131071 |
08/20/2013 |
STAXX IBL SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K123390 |
08/08/2013 |
PEDIGUARD NERVE DETECTOR SYSTEM |
SPINEGUARD, S.A. |
JOHN J SMITH, M.D. J.D. |
| K131063 |
08/15/2013 |
AMPLATZER TORQ VUE LP DELIVERY SYSTEM |
ST. JUDE MEDICAL |
HEATHER TAYLOR |
| K130727 |
08/29/2013 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K132146 |
08/30/2013 |
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A) |
ST. SHINE OPTICAL CO., LTD. |
ELLA LEE |
| K122883 |
08/05/2013 |
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM |
STELKAST COMPANY |
DAVID STUMPO |
| K130160 |
08/16/2013 |
VERIFY PROCESS INDICATOR FOR RELIANCE EPS |
STERIS Corporation |
MARCIA L BENEDICT |
| K130826 |
08/01/2013 |
PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER |
Stryker Endoscopy |
REBECCA GOLDBERG |
| K131862 |
08/21/2013 |
3DVH |
SUN NUCLEAR CORPORATION |
JEFF KAPATOES |
| K131704 |
08/05/2013 |
EPIDOSE |
SUN NUCLEAR CORPORATION |
JEFF KAPATOES |
| K131466 |
08/20/2013 |
MAPCHECK2, ARCCHECK |
SUN NUCLEAR CORPORATION |
JEFF KAPATOES |
| K123975 |
08/16/2013 |
QUICKIE & ZIPPIE SERIES |
SUNRISE MEDICAL |
LAURIE ROBERTS |
| K132268 |
08/23/2013 |
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
SURGICAL SPECIALTIES CORPORATION DBA ANGIOTECH |
KIRSTEN STOWELL |
| K132169 |
08/22/2013 |
SURGIQUEST AIRSEAL IFS |
SURGIQUEST, INC. |
DANIEL DONOVAN |
| K131012 |
08/23/2013 |
SUTTER BIPOLAR FORCEPS - SUPERGLISS |
SUTTER MEDIZINTECHNIK GMBH |
SABINE KLUGBAUER |
| K121925 |
08/28/2013 |
POWDERED LATEX SURGEON'S GLOVE |
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. |
ZHU YINGQIU |
| K130541 |
08/05/2013 |
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS |
SYMMETRY SURGICAL |
DALENE BINKLEY |
| K131286 |
08/05/2013 |
PRIMATRIX DERMAL REPAIR SCAFFOLD |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K131744 |
08/08/2013 |
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE |
TERUMO BCT, INC.. |
TINA O'BRIEN |
| K130403 |
08/23/2013 |
MAGSTIM DOUBLE 70-2 COIL |
THE MAGSTIM COMPANY LTD. |
J. P OUELLETTE |
| K131759 |
08/08/2013 |
METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM |
TIANJIN WALKMAN BIOMATERIAL CO., LTD. |
Diana Hong |
| K123633 |
08/16/2013 |
TRS CRANIAL BONE VOID FILLER(TRS C-BVF) |
TISSUE REGENERATION SYSTEMS, INC. |
JIM FITZSIMMONS |
| K130960 |
08/20/2013 |
SURESUBTRACTION ORTHO |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K131507 |
08/28/2013 |
XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
CHARLEMAGNE CHUA |
| K130012 |
08/22/2013 |
WET PLATINUM PERSONAL LUBRICANT |
TRIGG LABORATORIES, INC. |
ERNIE JOHNSON |
| K131200 |
08/29/2013 |
ASPIRON ACP SYSTEM |
U & I CORPORATION |
GYEONG-JE KWON |
| K132207 |
08/30/2013 |
UTF STEM-REDUCED, ADDITIONAL SIZES |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K130148 |
08/07/2013 |
FOREIGN BODY HOOD |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL MARTIN |
| K121370 |
08/02/2013 |
VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE |
VECTEC |
Diane Horwitz |
| K130109 |
08/01/2013 |
ENDOGRAPH DC |
VILLA SISTEMI MEDICALI S.P.A. |
PAOLO CASAGRANDE SANTIN |
| K122181 |
08/15/2013 |
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM |
VISGENEER, INC. |
JACK YANG |
| K131133 |
08/12/2013 |
VIVORTE BVF LITE |
VIVORTE, INC |
STEPHEN J PEOPLES |
| K130421 |
08/14/2013 |
MERON APPLICATION CAPSULES |
VOCO GMBH |
T. GERKENSMEIER |
| K122100 |
08/22/2013 |
POWDERED VINYL EXAMINATION GLOVES |
WANG TONG XINGHUA CO., LTD |
GUO YANG |
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PERF-GEN PULSATILE PERFUSION SOLUTION |
WATERS MEDICAL SYSTEMS, LLC |
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GYMFORM ABS-A-ROUND |
WELL BRAIN INTERNATIONAL, LTD. |
VICTOR K WAI |
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JIAJIAN CMN STIMULATOR |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
DORIS DONG |
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IRIX-C CERVICAL INTEGRATED FUSION SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
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CAS PSI SHOULDER |
ZIMMER CAS |
JASON HECKAMAN |
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AVENIR CEMENTED HIP STEM |
ZIMMER GMBH |
KAREN O'LEARY |
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ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM |
ZIMMER INC. |
ALLISON SCOTT, RAC |
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TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM |
ZIMMER SPINE, INC. |
JONATHAN GILBERT |
