| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K140219 |
04/14/2014 |
PICASSO II MIS SPINAL SYSTEM |
ACCEL SPINE |
LISA PETERSON |
| K132433 |
04/24/2014 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
JAMES PATRICK GARVEY II |
| K132549 |
04/23/2014 |
ACCUTIP COVER |
ACCUTOME, INC. |
ADAM PICKHOLTZ |
| K140517 |
04/28/2014 |
SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE |
Adhezion Biomedical, LLC |
RICHARD JONES |
| K132976 |
04/17/2014 |
ADVATX |
ADVALIGHT APS |
MAUREEN O'CONNELL |
| K132077 |
04/23/2014 |
PATIENT MONITOR |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
| K133802 |
04/17/2014 |
AIS MODULIFT VBR SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K140839 |
04/28/2014 |
CAIMAN SEAL AND CUT TECHNOLOGY |
AESCULAP, INC. |
DENISE ADAMS |
| K132933 |
04/25/2014 |
THE MOSES ELITE APPLIANCE |
ALLEN J. MOSES, DDS, LTD. |
ALLEN J MOSES, DDS |
| K140303 |
04/21/2014 |
ALAMO T |
ALLIANCE PARTNERS, LLC. |
KELLEN HILLS |
| K132021 |
04/02/2014 |
AHP 300, EMERGENCY PORTABLE VENTILATOR |
ALLIED HEALTHCARE PRODUCTS, INC. |
STEPHEN MUNDWILLER |
| K131098 |
04/09/2014 |
EMERGENCY PORTABLE VENTILATOR |
ALLIED HEALTHCARE PRODUCTS, INC. |
STEPHEN MUNDWILLER |
| K133783 |
04/16/2014 |
AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION |
AMERIWATER |
BRIAN R BOWMAN |
| K140247 |
04/25/2014 |
MTA FILLAPEX |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA |
TARA CONRAD |
| K133998 |
04/18/2014 |
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING |
ANGIOSCORE, INC. |
KIMBERLEY KLINE |
| K133606 |
04/01/2014 |
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL |
ARTHROCARE CORPORATION |
MITCHELL DHORITY |
| K140617 |
04/25/2014 |
PINIT SMALL BONE FUSION SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K133742 |
04/23/2014 |
XQ-1 INCUBATOR |
AT MEDICAL UAB |
THOMAS PEDERSEN |
| K140715 |
04/17/2014 |
ZIP MIS INTERSPINOUS FUSION SYSTEM |
AURORA SPINE, INC. |
JUSTI N EGGLETON |
| K133521 |
04/11/2014 |
AZE PHOENIX SOFTWARE |
AZE, LTD. |
KARL DIEDRICH, AZE |
| K133743 |
04/07/2014 |
BAXANO SURGICAL MIS SPINAL SYSTEM |
BAXANO SURGICAL, INC. |
KRISTEN ALLEN |
| K130531 |
04/08/2014 |
ULTRAFUSE |
BAXTER HEALTHCARE CORP. |
GRETCHEN MURRAY |
| K131189 |
04/17/2014 |
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) |
BECKMAN COULTER, INC. |
Yvette Lloyd |
| K131838 |
04/24/2014 |
DIODE LASER FOR HIAR REMOVAL |
BEIJING HONKON TECHNOLOGIES CO., LTD |
MIKE GU |
| K133915 |
04/18/2014 |
GALAXY CO2 LASER SYSTEM |
BEIJING TOPLASER TECHNOLOGY CO., LTD. |
ZHANG XIAOSONG |
| K133873 |
04/04/2014 |
TRIBALL INCENTIVE SPIROMETER |
BESMED HEALTH BUSINESS CORP. |
PAUL DRYDEN |
| K140147 |
04/22/2014 |
BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE |
BIO-MEDICAL CARBON TECHNOLOGY CO., LTD. |
DIANE SUDDUTH |
| K140764 |
04/25/2014 |
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K134013 |
04/24/2014 |
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K133844 |
04/07/2014 |
SPEED TRIAD |
BIOMEDICAL ENT., INC. |
JOE SOWARD |
| K133270 |
04/17/2014 |
SPEED ARC |
BIOMEDICAL ENTERPRISES, INC |
JOE SOWARD |
| K133939 |
04/01/2014 |
MODIFIED DISTAL RADIUS PLATING SYSTEM |
BIOMET |
SUZANA OTANO |
| K140625 |
04/18/2014 |
ORTHOSORB LS |
BIOMET, INC. |
VICTORIA SCHEITLIN |
| K140018 |
04/04/2014 |
TSP HIP FRACTURE PLATING SYSTEM |
BIOMET, INC. |
GARY BAKER |
| K132825 |
04/10/2014 |
RETROMTA-ORTHOMTA II |
BIOMTA |
Priscilla Chung |
| K133522 |
04/17/2014 |
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM |
BIONIME COPORATION |
Feng-Yu Lee |
| K130959 |
04/04/2014 |
AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL |
BIOPLAX LIMITED |
PAUL KETTERIDGE |
| K130065 |
04/30/2014 |
BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE |
BIOSONIC TECHNOLOGIES, LLC |
SHEPARD G BENTLEY |
| K131734 |
04/11/2014 |
ALL-BOND UNIVERSAL SC (NOT FINALIZED) |
BISCO, INC. |
Michelle Schiltz-Taing |
| K132483 |
04/02/2014 |
INNESIS PEEK CERVICAL CAGE |
BK MEDITECH CO., LTD. |
ELAINE DUNCAN |
| K133009 |
04/23/2014 |
NASAL MASK, NASAL MASK, FULL FACE MASK |
BMC MEDICAL CO., LTD |
MS. JINJING |
| K132914 |
04/03/2014 |
ACUITY PRO LEAD DELIVERY SYSTEM |
BOSTON SCIENTIFIC |
HOLLY RAMIREZ |
| K140503 |
04/15/2014 |
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER |
BOSTON SCIENTIFIC |
JEANNE O'TOOLE |
| K140745 |
04/17/2014 |
ENCORE 26 ADVANTAGE KIT |
BOSTON SCIENTIFIC CORP. |
LISA MEE |
| K140673 |
04/16/2014 |
INSERTION TOOL |
BOSTON SCIENTIFIC CORP. |
LISA MEE |
| K140495 |
04/17/2014 |
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE |
BOSTON SCIENTIFIC CORP. |
MATT BEAUCHANE |
| K140288 |
04/16/2014 |
TRUEPATH CTO DEVICE |
BOSTON SCIENTIFIC CORP. |
CAROL TIFFANY |
| K140733 |
04/28/2014 |
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER |
Boston Scientific Corporation |
MICHELLE ROEDING |
| K133933 |
04/02/2014 |
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER |
Boston Scientific Corporation |
ASHLEY SANTOS |
| K131660 |
04/17/2014 |
SMART (SMART-D, SMART-DX) |
BTS SPA |
ENRICO BISSON |
| K140501 |
04/28/2014 |
XENMATRIX SURGICAL GRAFT |
C.R. BARD |
GINA CASSIDY |
| K133470 |
04/04/2014 |
BARD RITECATH INTERMITTENT CATHETER |
C.R. BARD, INC. |
MICHELE DAVIS |
| K134010 |
04/14/2014 |
CABOCHON SYSTEM |
CABOCHON AESTHETICS, INC. |
BEN F BRIAN, PH.D. |
| K133366 |
04/08/2014 |
ORTHROS POSTERIOR STABILIZATION SYSTEM |
CAMBER SPINE |
DANIEL A PONTECORVO |
| K140831 |
04/15/2014 |
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR |
CAREFUSION |
LARRY WALKER |
| K140761 |
04/21/2014 |
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA |
CAREFUSION 2200 INC. |
JANE WEBER |
| K140271 |
04/01/2014 |
TABLET VIEWER SOFTWARE FOR IMAGE SUITE |
CARESTREAM HEALTH, INC. |
Alexandra Chamberlain |
| K133823 |
04/17/2014 |
NUFACE MINI DEVICE |
Carol Cole Company |
Rand Daoud |
| K133879 |
04/29/2014 |
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K140851 |
04/25/2014 |
INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
CDR YON YU, PHARM.D. |
| K140857 |
04/25/2014 |
INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
CDR YON YU, PHARM.D. |
| K133758 |
04/23/2014 |
CENTERVUE MACULAR INTEGRITY ASSESSMENT |
CENTERVUE SPA |
ROGER GRAY |
| K140321 |
04/17/2014 |
INITARY BETTER BLADDER-PEDIATRIC |
CIRCULATORY TECHNOLOGY, INC. |
YEHUDA TAMARI |
| K132381 |
04/04/2014 |
CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT |
CLEARMRI SOLUTIONS, INC. |
MARY ANN FERGUSON |
| K140080 |
04/24/2014 |
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB |
Codman & Shurtleff, Inc. |
HANNAH FOLEY |
| K140307 |
04/21/2014 |
ENVOY GUIDING CATHETER |
Codman & Shurtleff, Inc. |
HANNAH FOLEY |
| K133600 |
04/30/2014 |
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR |
COEUR, INC. |
DEBRA F MANNING |
| K132738 |
04/15/2014 |
COGENT MED-LIF |
COGENT SPINE LLC |
JUDE PAGANELLI |
| K133870 |
04/24/2014 |
FLUID LEVEL MONITOR |
COLEMAN LABORATORIES |
LE-JUN YIN |
| K131541 |
04/03/2014 |
FLEXIBLE COOAGEN NERVE CUFF |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K133597 |
04/18/2014 |
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY |
COOK, INC. |
SEAN SPENCE |
| K132993 |
04/24/2014 |
COUNTER OTC TENS DEVICE |
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD. |
GUENTER GINSBERG |
| K123555 |
04/09/2014 |
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY |
COVIDIEN |
JIM WELSH |
| K140609 |
04/09/2014 |
RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS |
COVIDIEN |
CLARE SANTULLI |
| K140339 |
04/10/2014 |
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM |
COVIDIEN |
BRIANNA REYNOLDS |
| K133821 |
04/28/2014 |
EMPRINT ABLATION SYSTEM |
Covidien LLC |
HEATHER V NIGRO |
| K132105 |
04/03/2014 |
PERCLOT TOPICAL |
CRYOLIFE, INC. |
KIMBERLY DICONO |
| K140092 |
04/16/2014 |
CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) |
CURRIE MEDICAL SPECIALTIES, INC. |
OWEN J BRY |
| K132596 |
04/11/2014 |
PROPOSED OPTIMUS |
CUSTOM SPINE, INC. |
HANAA SHAHIN |
| K131525 |
04/24/2014 |
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES |
DEFIBTECH, LLC |
Ed Horton |
| K133834 |
04/03/2014 |
DEPUY GLOBAL UNITE SHOULDER SYSTEM |
DEPUY (IRELAND) |
KELLIE MYERS |
| K133007 |
04/24/2014 |
DX3000-L |
DEXCOWIN CO., LTD |
Claude Berthoin |
| K131202 |
04/03/2014 |
MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X |
DIALYSIS MEDICAL SOLUTIONS, LLC |
COURTNEY J MILLER |
| K140031 |
04/28/2014 |
SUCTION PUMP |
DING HWA CO., LTD |
ROBERT O DEAN |
| K132284 |
04/10/2014 |
VECTRA NEO CLINICAL THERAPY SYSTEM |
DJO, LLC |
MARIA PRONINA |
| K140461 |
04/03/2014 |
MACH LED 2MC |
DR. MACH GMBH & CO. KG |
GUDRUN BUSCH, PH.D. |
| K140460 |
04/03/2014 |
MACH LED 2SC |
DR. MACH GMBH & CO. KG |
GUDRUN BUSCH, PH.D. |
| K132478 |
04/11/2014 |
AIR-FLOW HANDY 3.0 |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
CYNTHIA J NOLTE |
| K140123 |
04/24/2014 |
POLARIS SPINAL SYSTEM -TRANSLATION SCREW |
EBI, LLC |
MIKE MEDINA |
| K140702 |
04/04/2014 |
8MP COLOR LCD MONITOR, RADIFORCE RX850 |
EIZO CORPORATION |
HIROAKI HASHIMOTO |
| K140131 |
04/03/2014 |
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET |
EMED TECHNOLOGIES CORPORATION |
PETER KOLLINGS |
| K132930 |
04/14/2014 |
MYHEALTHPOINT TELEHEALTH MANAGER |
ENTRA HEALTH SYSTEMS |
RICHARD STROBRIDGE |
| K133537 |
04/28/2014 |
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Cynthia Hung |
| K133389 |
04/15/2014 |
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Cynthia Hung |
| K132940 |
04/14/2014 |
ERCHONIA ALLAY |
ERCHONIA MEDICAL, INC. |
Kevin Walls |
| K132315 |
04/18/2014 |
ERGONOMIC PRODUCTS WORKSTATION |
ERGONOMIC PRODUCTS, INC. |
RENEE GOULD |
| K133905 |
04/15/2014 |
6200 / 6250 ULTRASOUND SYSTEM |
ESAOTE S.P.A. |
Allison Scott |
| K140677 |
04/25/2014 |
MYLABSSOGNO |
ESAOTE S.P.A. |
Allison Scott |
| K140560 |
04/22/2014 |
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING |
ETHICON ENDO-SURGERY, LLC |
ASIFA VONHOF |
| K140645 |
04/11/2014 |
GIBRALT ROD-TO-ROD CROSS CONNECTORS |
EXACTECH SARASOTA |
PATRICK HUGHES |
| K123607 |
04/25/2014 |
OCTANE ELEVATE SPINAL IMPLANT SYSTEM |
EXACTECH, INC. |
PATRICK HUGHES |
| K133573 |
04/30/2014 |
FIAGON NAVIGATION SYSTEM |
FIAGON GMBH |
DIRK MUCHA |
| K133516 |
04/30/2014 |
CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER |
FLEXICARE |
CHRISTOPHER WATKINS |
| K140473 |
04/10/2014 |
DUALGUARD |
FLEXICARE MEDICAL LTD. |
CHRISTOPHER WATKINS |
| K130171 |
04/08/2014 |
FLIGHT 60 VENTILATOR |
FLIGHT MEDICAL INNOVATIONS LTD. |
SHOSHANA FRIEDMAN |
| K133588 |
04/25/2014 |
FORA CARE BLOOD PRESSURE MONITORING SYSTEM |
FORA CARE INC. |
Sharon Peng |
| K133006 |
04/17/2014 |
NEOV DIODE LASER FAMILY |
G.N.S NEOLASER LTD. |
GIL SHAPIRA |
| K132679 |
04/18/2014 |
AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER |
GALEMED CORP. |
TOM SHANKS |
| K133957 |
04/14/2014 |
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE |
GALEMED CORP. |
PAUL DRYDEN |
| K133182 |
04/09/2014 |
HTFX-222 |
GC AMERICA, INC. |
MARK HEISS |
| K133922 |
04/18/2014 |
GENTLECARE AR APPLICATOR |
GC MEDTECH, LLC |
GREGORY MATHISON |
| K133882 |
04/30/2014 |
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
ROBERT CASARSA |
| K133278 |
04/24/2014 |
DISCOVERY IGS 740 |
GE MEDICAL SYSTEMS SCS |
MICHEL GENUER |
| K133649 |
04/22/2014 |
HEPATIC VCAR |
GE MEDICAL SYSTEMS SCS |
HUY DOAN |
| K133705 |
04/11/2014 |
REVOLUTION CT |
GE MEDICAL SYSTEMS, LLC |
HELEN PENG |
| K131612 |
04/18/2014 |
ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES |
GS MEDICAL CO., LTD. |
DONALD W GUTHNER |
| K140089 |
04/08/2014 |
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K132423 |
04/08/2014 |
THE GYNOCULAR |
GYNIUS AB |
MATTHEW VOLSKY |
| K132184 |
04/28/2014 |
ACESSA GUIDANCE HANDPIECE |
HALT MEDICAL INC |
CLARISA TATE |
| K131956 |
04/24/2014 |
QUICK RELAX PRO |
HEALTHCARE INNOVATIONS, LLC |
SHEPARD G BENTLEY, RAC |
| K140639 |
04/16/2014 |
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM |
HITACHI ALOKA MEDICAL, LTD. |
ANGELA VANARSDALE |
| K131917 |
04/29/2014 |
NEURODYN COMPACT, NEURODYN II |
IBRAMED EQUIPAMENTOS MEDICOS |
TARA CONRAD |
| K132724 |
04/17/2014 |
ICONN ANSWER SUTURE ANCHOR |
ICONN ORTHOPEDICS, LLC |
WHITT ISRAEL |
| K140445 |
04/23/2014 |
DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC |
IMAGING SCIENCES INTERNATIONAL, LLC |
SANJAY AHUJA |
| K133669 |
04/04/2014 |
MEDINAUT KYPHOPLASTY SYSTEM |
IMEDICOM |
Priscilla Chung |
| K132911 |
04/04/2014 |
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW |
IN2BONES SAS |
ERIC FOURCAULT |
| K133045 |
04/10/2014 |
ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
SeonMi Shin |
| K132406 |
04/18/2014 |
ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K133897 |
04/23/2014 |
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER |
Infraredx, Inc. |
STEVEN J CHARTIER |
| K133932 |
04/11/2014 |
INION FREEDOMPIN |
INION OY |
KATI MARTTINEN |
| K133542 |
04/28/2014 |
PURACYN PLUS SKIN AND WOUND |
INNOVACYN, INC. |
FRED L MA |
| K131883 |
04/11/2014 |
AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) |
INOVISE MEDICAL, INC. |
EARL ANDERSON |
| K134047 |
04/11/2014 |
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS |
INTEGRA LIFESCIENCES CORPORATION |
RUTHANNE VENDY |
| K130557 |
04/24/2014 |
NEURAGEN 3D |
INTEGRA LIFESCIENCES CORPORATION |
STEPHEN H BEIER |
| K131962 |
04/17/2014 |
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES |
INTUITIVE SURGICAL, INC. |
MIKE YRAMATEGUI |
| K132179 |
04/28/2014 |
ARASYS |
ION GENIUS INC |
XANYA SOFRA-WEISS, PH.D |
| K130456 |
04/08/2014 |
WUNDER PREGNANCY TEST |
JAMES NGUYEN |
JAMES NGUYEN, M.D. |
| K131944 |
04/10/2014 |
IEEG |
JORDAN NEUROSCIENCE, INC. |
ANNE PERRY |
| K133614 |
04/03/2014 |
ALEUTIAN IBF SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K140420 |
04/01/2014 |
VADO STEERABLE SHEATH |
KALILA MEDICAL, INC. |
CARRIE NEUBERGER |
| K133815 |
04/16/2014 |
INTESS CERVICAL CAGE SYSTEM |
KALITEC DIRECT, LLC |
J.D. WEBB |
| K140072 |
04/03/2014 |
CRYOTOP(R) SC |
KITAZATO BIOPHARMA CO., LTD. |
RICHARD VINCINS |
| K133716 |
04/09/2014 |
TRC-PASTE |
KM CORPORATION |
Priscilla Chung |
| K133155 |
04/07/2014 |
HYDROPHILIC COATED GUIDEWIRE |
LAKE REGION MEDICAL |
TRACY MEYER |
| K140482 |
04/08/2014 |
MANDREL GUIDEWIRE |
LAKE REGION MEDICAL |
MATHEW PEXA |
| K140042 |
04/10/2014 |
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME |
LEMAITRE VASCULAR, INC. |
BRYAN COWELL |
| K130878 |
04/04/2014 |
CLOUDEKG |
MAKROMED, INC. |
BARRY V ASHAR |
| K133149 |
04/30/2014 |
BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM |
MAR COR PURIFICATION, INC. |
KINNARI SHAH |
| K140257 |
04/02/2014 |
SIGNATURE PLANNER, SIGNATURE GUIDES |
MATERIALISE N.V. |
OLIVER CLEMENS |
| K132290 |
04/10/2014 |
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES |
MATERIALISE N.V. |
OLIVER CLEMENS |
| K133534 |
04/18/2014 |
MCKESSON CARDIOLOGY ECG MOBILE |
MCKESSON ISRAEL LTD. |
PAUL SUMNER |
| K133914 |
04/03/2014 |
VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE |
MEDCOM GMBH |
LUCA SALVATORE |
| K130889 |
04/28/2014 |
SPLIT CATH RG |
MEDCOMP |
TIMOTHY HOLWICK |
| K133941 |
04/18/2014 |
MITEK ARTHROSCOPES |
MEDOS INTERNATIONAL SARL |
SUSAN KAGAN |
| K140402 |
04/03/2014 |
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET |
MEDSOURCE INTERNATIONAL, LLC. |
JENNIFER NESS |
| K140442 |
04/22/2014 |
MEDSOURCE SELECTABLE IV SET |
MEDSOURCE INTERNATIONAL, LLC. |
JENNIFER NESS |
| K133903 |
04/10/2014 |
BIO-PROBE TRANSDUCER (ADULT) |
MEDTRONIC INC. |
RAHUL SHAH |
| K133653 |
04/28/2014 |
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
JULIE BASSETT |
| K140375 |
04/18/2014 |
MASTERGRAFT PUTTY, MASTERGRAFT STRIP |
MEDTRONIC SOFAMOR DANEK USA, INC. |
KELLY ANGLIN |
| K132617 |
04/30/2014 |
MEDTRONIC INPUT PS INTRODUCER |
MEDTRONIC, INC. |
NISARG SHAH |
| K140069 |
04/07/2014 |
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K140475 |
04/16/2014 |
ROTATING ADAPTERS |
MERIT MEDICAL SYSTEMS, INC. |
CORY MARSH |
| K134015 |
04/11/2014 |
M-PM-DISC |
MERZ DENTAL GMBH |
RICHARD G HUNTER |
| K134008 |
04/09/2014 |
MD-FLEX HEAVY BODY |
META BIOMED, INC. |
BLIX WINSTON |
| K140043 |
04/03/2014 |
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD |
MICROPORT ORTHOPEDICS INC. |
MAX MORTENSEN |
| K133554 |
04/08/2014 |
SURGICAL LIGHT HANDLE COVER |
MICROTEK MEDICAL, INC. AN ECOLAB COMPANY |
ANDY ROLLER |
| K132075 |
04/18/2014 |
PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) |
MINDRAY NORTH AMERICA |
RUSSELL OLSEN |
| K133624 |
04/18/2014 |
COMPASS CT, COMPASS CT PORT |
MIRADOR BIOMEDICAL |
JUSTIN HULVERSHORN |
| K130852 |
04/14/2014 |
AVANCE« FOAM ABDOMINAL DRESSING KIT |
MOLNLYCKE HEALTHCARE |
ANGELA L BUNN |
| K132547 |
04/17/2014 |
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS) |
MONARCH MEDICAL TECHNOLOGIES |
ANN A GRAHAM |
| K132178 |
04/30/2014 |
MOSTDI DENTAL IMPLANT SYSTEM |
MOSTDI INNOVATIONS SDN BHD |
SUSAN PARK |
| K133235 |
04/07/2014 |
THREADED PEEK K-WIRE |
MTP SOLUTIONS LLC |
ROBERT HOY |
| K140194 |
04/14/2014 |
NAMIC RCS SYRINGE |
NAVILYST MEDICAL, INC. |
BRANDON M BRACKETT |
| K140125 |
04/29/2014 |
NEW STETIC DENTAL AMALGAM ALLOY |
NEW STETIC |
JOHN O'BRIEN |
| K133951 |
04/25/2014 |
SMARTTOUCH |
NEXUS6, LTD. |
GARTH SUTHERLAND |
| K140191 |
04/14/2014 |
ELISIO-H HEMODIALYZER |
NIPRO MEDICAL CORPORATION |
CAROLYN GEORGE |
| K133377 |
04/04/2014 |
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE |
NOBEL BIOCARE AB |
PHUONG NGUYEN |
| K133910 |
04/04/2014 |
NORDICBRAINEX |
NORDICNEUROLAB |
CHANDANA GURUNG BHANDARI |
| K140003 |
04/03/2014 |
COROENT SMALL INTERBODY SYSTEM |
NUVASIVE, INC. |
Cynthia Adams |
| K131140 |
04/01/2014 |
OMNYX IDP FOR HER2 MANUAL APPLICATION |
OMNYX, LLC |
GAIL E RADCLIFFE |
| K132208 |
04/10/2014 |
ONTEX AND OTHERS PROPRIETARY NAMES |
ONTEX BVBA |
RACHEL PAUL |
| K132595 |
04/23/2014 |
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS |
ONTEX BVBA |
RACHEL PAUL |
| K134039 |
04/11/2014 |
DAYTONA ICG (P200TICG) |
OPTOS PLC |
RANDY PREBULA |
| K131563 |
04/09/2014 |
SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM |
OPUS KSD, INC. |
ROSINA ROBINSON, RN, MED, RAC |
| K133387 |
04/29/2014 |
ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED |
ORIGIO A/S |
TOVE KJAER |
| K133707 |
04/16/2014 |
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS |
ORIGIO A/S |
TOVE KJAER |
| K132999 |
04/14/2014 |
CERVICAL STAND ALONE SYSTEM |
ORTHOFIX INC. |
NATALIA VOLOSEN |
| K140414 |
04/01/2014 |
IMBIBE NEEDLE |
ORTHOVITA, INC. |
John Urtz |
| K140406 |
04/17/2014 |
DESTINO TWIST, STEERABLE GUIDING SHEATH |
Oscor Inc. |
TINA STRICKLAND |
| K132401 |
04/09/2014 |
MEGA ISQ |
OSSTELL AB |
CHERITA JAMES |
| K133271 |
04/28/2014 |
OPTEO, VIDEOGRAPH HD |
OWANDY |
Claude Berthoin |
| K133397 |
04/18/2014 |
P-POD |
P-POD |
LINDA BRADDON |
| K132620 |
04/16/2014 |
INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL |
PAN MEDICAL LTD |
JENNIE BUDDING |
| K140397 |
04/17/2014 |
PARALOCK PLATING SYSTEM / TUFFNEK SCREW |
PARAGON 28 |
KAREN E WARDEN |
| K131946 |
04/25/2014 |
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS |
PENTAX MEDICAL COMPANY |
KRISHNA GOVINDARAJAN |
| K131028 |
04/10/2014 |
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) |
PENTAX MEDICAL COMPANY |
KRISHNA GOVINDARAJAN |
| K131855 |
04/09/2014 |
PENTAX VIDEO COLONOSCOPES (EC FAMILY) |
PENTAX MEDICAL COMPANY |
KRISHNA GOVINDARAJAN |
| K131902 |
04/10/2014 |
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) |
PENTAX MEDICAL COMPANY |
KRISHNA GOVINDARAJAN |
| K140771 |
04/25/2014 |
PHILIPS ELEVA WORKSPOT |
PHILIPS MEDICAL SYSTEMS DMC GMBH |
GEROLD SCHWARZ |
| K140808 |
04/17/2014 |
Q-STATION |
PHILIPS ULTRASOUND, INC. |
PENNY GRECO |
| K132563 |
04/24/2014 |
PINOOK STIMULATOR |
PINOOK USA |
TEJAS SHAH |
| K140696 |
04/10/2014 |
STREAMLINE TL SPINAL FIXATION SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCINTYRE |
| K133524 |
04/16/2014 |
PVMED DDR 2430T |
PORTAVISION MEDICAL LLC |
TERRY ANCAR |
| K140179 |
04/25/2014 |
EASY GO VAC |
PRECISION MEDICAL, INC. |
JAMES PARKER |
| K133857 |
04/28/2014 |
BRELLA-SPEC(TM) VAGINAL SPECULUM |
PROA MEDICAL, INC. |
VICTORIA NADERSHAHI |
| K132390 |
04/22/2014 |
INSTINCT; PLAIN, DOTTED, ULTRA THIN |
PROFILATEX, S.A. DE C.V. |
JUAN ERNESTO DE LA PUENTE |
| K131889 |
04/23/2014 |
EUM 100PRO |
PROMEDIC, INC. |
PAUL DRYDEN |
| K133936 |
04/04/2014 |
ARTUS C. DIFFICILE QS-RGQ MDX KIT |
QIAGEN, GMBH |
Kimberly Mapp |
| DEN140005 |
04/16/2014 |
LYRA DIRECT STREP ASSAY |
QUIDEL CORPORATION |
Ronald H Lollar |
| K140646 |
04/11/2014 |
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G |
RAYENCE CO., LTD |
DAVE KIM |
| K133923 |
04/11/2014 |
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET |
REFLECTANCE MEDICAL INC |
Nandini Murthy |
| K140742 |
04/25/2014 |
RELIANCE ANTERIOR CERVICAL PLATE |
Reliance Medical Systems, LLC |
Bret M Berry |
| K132755 |
04/29/2014 |
NEUROMATE FRAMELESS GEN II |
RENISHAW MAYFIELD SARL |
STEPHANE VINOT |
| K132312 |
04/11/2014 |
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
Sharyn Orton, Ph.D. |
| K133345 |
04/11/2014 |
REVEEL ENDOSCOPIC RETRACTOR |
RETRACTION LIMITED |
STUART MORAN |
| DEN130016 |
04/03/2014 |
XSTAT |
REVMEDX, INC. |
JOHN J SMITH |
| K132138 |
04/11/2014 |
RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES M MEWBORNE |
| K133862 |
04/29/2014 |
ACCU-CHEK AVIVA PLUS SYSTEM |
ROCHE DIAGNOSTICS CORPORATION |
KHONE SAYSANA |
| K130778 |
04/14/2014 |
DISCOSCOPES, CERVICAL ENDOSCOPES |
RZ MEDIZINTECHNIK GMBH |
ANDRE WEINGREL |
| K130014 |
04/04/2014 |
A1C GEAR SYSTEM |
Sakae Corporation |
ERICA B AMMIRATI |
| K131906 |
04/11/2014 |
SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE |
SATELEC-ACTEON GROUP |
RICK ROSATI |
| K132009 |
04/09/2014 |
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM |
SCHOELLY FIBEROPTIC, GMBH |
PAMELA PAPINEAU, RAC |
| K140368 |
04/29/2014 |
FAMILY OF DISPOSABLE LENSES |
SENSOR MEDICAL TECHNOLOGY, LLC |
MAUREEN O'CONNELL |
| K132882 |
04/24/2014 |
ELECTRIC BREAST PUMP |
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD |
MIKE GU |
| K122377 |
04/11/2014 |
POWDER FREE VINYL EXAMINATION GLOVES |
SHU TONG XINGHUA CO., LTD. |
SU SONG SHI |
| K122176 |
04/11/2014 |
POWDERED VINYL EXAMINATION GLOVES |
SHU TONG XINGHUA CO., LTD. |
SU SONG SHI |
| K140541 |
04/01/2014 |
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C |
Siemens Healthcare Diagnostics Inc. |
Garo Mimaryan |
| K140959 |
04/30/2014 |
ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNN |
| K133580 |
04/28/2014 |
ARTIS ONE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K133589 |
04/17/2014 |
SOMATOM FORCE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K133590 |
04/30/2014 |
SOMATOM PERSPECTIVE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K132902 |
04/07/2014 |
SYNGO DUAL ENERGY SOFTWARE PACKAGE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K132934 |
04/10/2014 |
MULTIX SELECT DR |
SIEMENS MEDICAL SOLUTIONS, INC. |
PATRICIA D JONES |
| K140372 |
04/07/2014 |
FRAGMENT PLATE SYSTEM |
SKELETAL DYNAMICS, LLC |
ANA M ESCAGEDO |
| K140199 |
04/01/2014 |
VUPAD |
SONOMED, INC. |
CHARLES C O'NEAL |
| K140047 |
04/09/2014 |
LEXICONTURE MECHANICAL DILATOR SHEATH SET |
SPECTRANETICS CORP. |
PHAROAH GARMA |
| K130757 |
04/03/2014 |
KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET |
SPENCER FILLMORE |
CHRISTINA BERNSTEIN |
| K140007 |
04/07/2014 |
ABACUS TM SPACER SYSTEM |
SPINE WAVE, INC. |
JOSEPH MERCADO |
| K140474 |
04/18/2014 |
JULIET OL |
SPINEART |
FRANK PENNESI |
| K140010 |
04/23/2014 |
FORTRESS PEDICLE SCREW SYSTEM |
SPINEOLOGY, INC. |
Karen Roche |
| K133340 |
04/11/2014 |
SPINEWORKS ANTERIOR LUMBAR DEVICE |
SPINEWORKS, LLC |
ROBERT POGGIE, PHD |
| K133791 |
04/16/2014 |
ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] |
STERNGOLD DENTAL LLC |
MARIA RAO |
| K133421 |
04/17/2014 |
STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW |
STRAUMANN USA, LLC |
CHARLOTTE RINGLEB |
| K133285 |
04/09/2014 |
STRYKER TEMPORARY CONDYLAR PROSTHESIS |
Stryker |
JAMSHED BADARPURA |
| K133578 |
04/10/2014 |
REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER |
STRYKER SUSTAINABILITY SOLUTIONS |
JILL CLARK |
| K140376 |
04/03/2014 |
VARIAX 2 SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
| K140769 |
04/17/2014 |
VARIAX 2 SYSTEM |
Stryker Trauma AG |
ELIJAH N WREH |
| K140259 |
04/01/2014 |
VARIAX CLAVICLE HOOK PLATE |
Stryker Trauma AG |
ELIJAH N WREH |
| K133781 |
04/11/2014 |
DECLIPSESPECT LAPAROSCOPY |
SURGICEYE GMBH |
MORITZ HOYER |
| K133238 |
04/10/2014 |
CONTOUR I V3.1 SYSTEM |
SYNERON MEDICAL LTD |
JANICE M HOGAN |
| K140834 |
04/25/2014 |
TERASON USMART3400 ULTRASOUND SYSTEM |
TERATECH CORP. |
BEN CHIAMPA |
| K140396 |
04/16/2014 |
FREELITE HUMAN LAMBDA FREE KIT |
THE BINDING SITE GROUP, LTD. |
DOUG KURTH |
| K140664 |
04/16/2014 |
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS |
THE BINDING SITE GROUP, LTD. |
JON LAUDER |
| K140229 |
04/29/2014 |
GENERAL SPINAL SYSTEM |
TIANJIN WALKMAN BIOMATERIAL CO., LTD. |
Diana Hong |
| K133949 |
04/08/2014 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
TOP CALIBRE SDN BHD |
ROSNITA MAODIN |
| K133777 |
04/04/2014 |
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR |
TORNIER, INC. |
Mireille Lemery |
| K133761 |
04/22/2014 |
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
CHARLEMAGNE CHUA |
| K140648 |
04/10/2014 |
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET |
Tosoh BioScience, Inc. |
ROBERT L WICK |
| K131852 |
04/17/2014 |
HC-1 AND HC-1 CLASSIC |
TRANSCENDENCIAS COMERCIALES SL TRANSCOM |
RAMON ECHEVARRIA |
| K132570 |
04/29/2014 |
ELECTRIC HANDPIECE SYSTEM |
TTBIO CORP. |
SHU-CHING LEE |
| K134023 |
04/25/2014 |
2300 SERIES MGO PORTABLE OXYGEN |
ULTRA ELECTRONICS LIMITED PRECISION AIR & LAND SY |
ANDY CHILTON |
| K140763 |
04/24/2014 |
MONOFILAMENT POLYPECTOMY SNARE |
UNITED STATES ENDOSCOPY |
SAGAR D PIMPALWAR |
| K140315 |
04/04/2014 |
US ENDOSCOPY DISTAL ATTACHMENT CAP |
UNITED STATES ENDOSCOPY GROUP, INC. |
SAGAR D PIMPALWAR |
| K133572 |
04/04/2014 |
ARIA RADIATION THERAPY MANAGEMENT |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K132789 |
04/17/2014 |
FLIP INTRODUCER ACCESS KIT |
VASCULAR SOLUTIONS, INC. |
ELLIE GILLESPIE |
| K133237 |
04/25/2014 |
GEL-BEAD EMBOLIZATION SPHERES |
VASCULAR SOLUTIONS, INC. |
ELLIE GILLESPIE |
| K133837 |
04/09/2014 |
VIORA V-TOTAL |
VIORA LTD. |
YORAM LEVY |
| K132447 |
04/03/2014 |
VITALCONNECT PLATFORM BY VITAL CONNECT INC. |
Vital Connect, Inc |
SAM MOSTAFAVI |
| K133829 |
04/22/2014 |
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF |
VIVONIC GMBH |
ANDREAS HESSBERGER |
| K133139 |
04/03/2014 |
VIZION ULTRA |
VIZTEK LLC |
DANIEL KAMM, P.E. |
| K133652 |
04/28/2014 |
GSP NEONATAL TOTAL GALACTOSE KIT |
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. |
JEANETTE SCHIER-PUGSLEY |
| K140146 |
04/29/2014 |
COMFORTSOFT SOFT DENTURE LINER SYSTEM |
WHIP MIX CORP. |
JOHN WATERS |
| K140749 |
04/25/2014 |
INFINITY TOTAL ANKLE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE REDDEN |
| K132042 |
04/28/2014 |
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND |
X6D, LTD. |
KAREL VAN GORP |
| K140561 |
04/23/2014 |
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) |
XLUMENA, INC. |
JANE BEGGS |
| K133212 |
04/09/2014 |
ZELTIQ COOLSCULPTING SYSTEM |
ZELTIQ AESTHETICS, INC. |
SHRUTI JAYAKUMAR |
| K134045 |
04/25/2014 |
ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM |
ZIMMER DENTAL INC. |
JULIE LAMOTHE |
| K132488 |
04/03/2014 |
ZOLL CODE WRITER |
ZOLL MEDICAL CORPORATION |
SHANNON DUHAMEL |
