| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K132967 |
12/06/2013 |
3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP |
3B MEDICAL, INC |
ALEX LUCIO |
| K131901 |
12/23/2013 |
IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 |
3B MEDICAL, INC |
ALEX LUCIO |
| K132787 |
12/24/2013 |
LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K132511 |
12/24/2013 |
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
VRUSAHLI TEMBE |
| K132086 |
12/19/2013 |
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
QIYI XIE |
| K130284 |
12/20/2013 |
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
QIYI XIE |
| K130329 |
12/03/2013 |
SURGISEAL TOPICAL SKIN ADHESIVE |
Adhezion Biomedical, LLC |
Caridad Smith |
| K132243 |
12/20/2013 |
BARLE TISSUE ADHESIVE 2 |
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
KAY MCGRATH |
| K133081 |
12/31/2013 |
TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
KAZUNORI MIYAHARA |
| K132082 |
12/05/2013 |
AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK |
AESKU.DIAGNOSTICS |
SASCHA PFEIFFER |
| K122162 |
12/20/2013 |
AGGREGUIDE |
AGGREDYNE, INC. |
J. HARBEY KNAUSS |
| K123861 |
12/12/2013 |
AIDI DENTAL IMPLANT SYSTEM |
AIDI BIOMEDICAL LLC |
CHEN TIAN |
| K133079 |
12/17/2013 |
IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) |
ALDEN OPTICAL LABS., INC. |
KEVIN RANDALL |
| K133411 |
12/05/2013 |
ALERE BINAXNOW INFLUENZA A & B CARD |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
Angela Drysdale |
| K133637 |
12/18/2013 |
ALERE INFLUENZA A & B TEST |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
Angela Drysdale |
| K131229 |
12/05/2013 |
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS |
AMERICAN MEDICAL SYSTEMS |
TODD HILDEBRANDT |
| K133561 |
12/19/2013 |
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH |
ANGIODYNAMICS, INC. |
Lorraine M Hanley |
| K133043 |
12/06/2013 |
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
ANGIOSLIDE, LTD |
CLAY ANSELMO |
| K131766 |
12/12/2013 |
PLATINUM DRF IMAGING SYSTEM |
APELEM-DMS GROUP |
Sharyn Orton |
| K132342 |
12/20/2013 |
XVWEB |
APTERYX, INC. |
KEVIN CRUCS |
| K133342 |
12/17/2013 |
ARTHREX IBALANCE TKA SYSTEM |
ARTHREX, INC. |
MARIELA CABARCAS |
| K132896 |
12/02/2013 |
CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE |
ASIA-MED GMBH AND CO KG |
Kevin Walls |
| K121177 |
12/05/2013 |
BOND APATITE |
AUGMA BIOMATERIALS, LTD. |
KEVIN A THOMAS |
| K123474 |
12/03/2013 |
AVANT LASER |
AVANT WELLNESS SYSTEMS, LLC |
ANDY HEWITSON |
| K123248 |
12/10/2013 |
CPR RSQ ASSIST |
AVANTECH, INC. |
STEVEN B DATLOF |
| K121873 |
12/11/2013 |
AVINENT DENTAL IMPLANT SYSTEM |
AVINENT IMPLANT SYSTEM, S.L. |
ANNA CORTINA |
| K132310 |
12/23/2013 |
ASCOT |
BACKROADS CONSULTING, INC. |
KAREN E WARDEN, PHD |
| K133569 |
12/20/2013 |
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM |
BARD PERIPHERAL VASCULAR, INC. |
TIFFINI DIAGE |
| K132481 |
12/27/2013 |
EASY-LOAD LENS DELIVERY SYSTEM |
BAUSCH & LOMB |
JASON SMITH |
| K132715 |
12/20/2013 |
BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS |
BAUSCH & LOMB INCORPORATED |
JENNIFER KNICLEY |
| K132674 |
12/27/2013 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) |
Becton, Dickinson and Company |
MONICA E GIGUERE |
| K132120 |
12/12/2013 |
WTF SECURA SYRINGE AND NEEDLE |
BEIJING WANTEFU MEDICAL APPARATUS CO., LTD. |
RAYMOND SUN |
| K132688 |
12/16/2013 |
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ |
BIOCHEMICAL DIAGNOSTICS, INC. |
ALLEN PANETZ |
| K132400 |
12/19/2013 |
LP(A) CALIBRATORS, AND LP(A) CONTROLS |
BIOKIT S.A. |
JOAN GUIXER |
| K132873 |
12/11/2013 |
VANGUARD XP KNEE SYSTEM |
BIOMET, INC. |
JULIE GANTENBERG, M.S. |
| K131510 |
12/20/2013 |
POLYDIMETHYLSILOXANE IMPRESSION MATERIAL |
BLACKWELL DEVICE CONSULTING |
ANGELA BLACKWELL |
| K132253 |
12/16/2013 |
REMOVABLE PATIENT LEADS ECG CABLE |
BOSTON SCIENTIFIC |
MELISSA KLAMERUS |
| K133566 |
12/20/2013 |
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS |
BOSTON SCIENTIFIC CORP. |
MAYLIN TRUESDELL |
| K130004 |
12/06/2013 |
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM |
Boston Scientific Corporation |
JANIS TARANTO |
| K132441 |
12/13/2013 |
BARD VENTRALEX HERNIA PATCH |
C.R. BARD, INC. |
MARIYA BUHARIN |
| K132134 |
12/02/2013 |
OPTIFIX ABSORBABLE FIXATION SYSTEM |
C.R. BARD, INC. |
RADHIKA PONDICHERRY |
| K133283 |
12/26/2013 |
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS |
CANDELA CORP. |
SAM WADE |
| K132708 |
12/20/2013 |
BIOMARC FIDUCIAL MARKER |
CARBON MEDICAL TECHNOLOGIES, INC. |
ANDREW J ADAMS |
| K132060 |
12/13/2013 |
DURABLUE STERILIZATION WRAP |
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
LAVENIA FORD |
| K130208 |
12/20/2013 |
BERNOULLI ENTERPRISE SOFTWARE |
CARDIOPULMONARY CORP. |
UREY KANG |
| K132867 |
12/30/2013 |
SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM |
CAYENNE MEDICAL, INC. |
SHIMA HASHEMIAN |
| K132963 |
12/16/2013 |
FUSIONSYNC, CHIMAERA FUSIONSYNC |
CHIMAERA GMBH |
MARCUS PRUEMMER |
| K130439 |
12/12/2013 |
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING |
CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD |
FIELD FU |
| K132463 |
12/03/2013 |
CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM |
CIANNA MEDICAL, INC. |
GARY MOCNIK |
| K133029 |
12/06/2013 |
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE |
COMPRESSION WORKS, LLC |
MICHAEL FORSTADT |
| K132640 |
12/05/2013 |
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA SHAH |
| K131765 |
12/20/2013 |
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM |
CONMED CORPORATION |
LISA ANDERSON |
| K130652 |
12/17/2013 |
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW HULL |
| K133634 |
12/23/2013 |
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET |
COOK, INC. |
SEAN SPENCE |
| K133627 |
12/23/2013 |
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS |
COOPERVISION, INC. |
ANNETTE NELSON |
| K132994 |
12/05/2013 |
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM |
CORELINK LLC |
J.D. WEBB |
| K131952 |
12/16/2013 |
CORIN METAFIX HIP STEM |
CORIN USA |
LUCINDA GERBER |
| K131986 |
12/16/2013 |
CORIN MINIHIP STEM |
CORIN USA |
LUCINDA GERBER |
| K132604 |
12/04/2013 |
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM |
COVIDIEN |
KELSEY LEE |
| K133338 |
12/20/2013 |
LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
DONALD HENTON |
| K132242 |
12/06/2013 |
INNO SLA SUBMERGED IMPLANT SYSTEM |
COWELLMEDI CO., LTD |
SUSAN PARK |
| K133372 |
12/06/2013 |
CROSSTREES PVA POD |
CROSSTREES MEDICAL, INC. |
JANICE HOGAN |
| K131702 |
12/06/2013 |
K SERIES CPAP SYSTEMS |
CURATIVE MEDICAL INC. |
AMY MCKINNEY |
| K132500 |
12/23/2013 |
CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED |
CURE MEDICAL LLC. |
JOHN BEASLEY |
| K133367 |
12/20/2013 |
ORTHOVIS PREOPERATIVE PLAN |
CUSTOM ORTHOPAEDIC SOLUTIONS |
JUSTIN BAKER |
| K132185 |
12/06/2013 |
FAMILY OF COOLGLIDE AESTHETIC LASERS |
CUTERA, INC. |
SANDRA HANSEN |
| K130861 |
12/09/2013 |
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) |
DAKO NORTH AMERICA, INC. |
JENNIFER M CHAMBERS |
| K132875 |
12/30/2013 |
COMPRESSYN STAPLE |
DALLEN MEDICAL, INC. |
AL MEMMOLO |
| K133074 |
12/12/2013 |
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES |
DATASCOPE CORP. |
LINDA SLUTZKY |
| K132530 |
12/20/2013 |
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) |
DATEX-OHMEDA, INC. |
JAMES P RASKOB |
| K123209 |
12/19/2013 |
SOFTVUE |
DELPHINUS MEDICAL TECHNOLOGIES, INC |
ANDREA N WALLEN |
| K132308 |
12/30/2013 |
CLIQ DV-300 ASPIRATOR |
DING HWA CO., LTD. |
ROBERT O DEAN |
| K123030 |
12/19/2013 |
COMPRESSOR NEBULIZER MODEL MCN-S600XX |
DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C |
LEON LU |
| K132445 |
12/06/2013 |
PIEZON 250 |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
CYNTHIA NOLTE |
| K131379 |
12/18/2013 |
EARLYSENSE |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K131095 |
12/05/2013 |
DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS |
EL.EN. ELECTRONIC ENGINEERING SPA |
PAOLO PERUZZI |
| K132794 |
12/19/2013 |
SMARTVEST AIRWAY CLEARANCE SYSTEM |
ELECTROMED, INC. |
CHET SIEVERT |
| K133289 |
12/09/2013 |
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM |
ELLIPSE TECHNOLOGIES, INC. |
John McIntyre |
| K132776 |
12/20/2013 |
SEAL BIOPSY VALVE - REUSABLE |
ENDOCHOICE, INC. |
DANIEL HOEFER |
| K132754 |
12/12/2013 |
NEOGEN PSR SYSTEM |
ENERGIST, LTD. |
DARREN THOMAS |
| DEN130022 |
12/13/2013 |
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR |
ENEURA THERAPEUTICS |
LARRY GETLIN |
| K133425 |
12/05/2013 |
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT |
ENGINEERED MEDICAL SOLUTIONS CO. LLC. |
RYAN SAVAGE |
| K133563 |
12/20/2013 |
PATHASSIST LIGHT SEEKER |
Entellus Medical, Inc. |
GARRETT P AHLBORG |
| K132202 |
12/06/2013 |
DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET |
ENTHERMICS MEDICAL SYSTEMS, INC. |
ADAM VAN ESSEN |
| K133180 |
12/11/2013 |
ERBE ESU MODEL VIO DV WITH ACCESSORIES |
ERBE USA, INC. |
JOHN TARTAL |
| K132340 |
12/17/2013 |
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 |
ERBE USA, INC. |
JOHN TARTAL |
| K133490 |
12/30/2013 |
G-SCAN BRIO |
ESAOTE S.P.A. |
ALLISON S COTT |
| K132466 |
12/04/2013 |
MYLABSEVEN 6400, MYLABALPHA 7400 |
ESAOTE S.P.A. |
Allison Scott |
| K131996 |
12/13/2013 |
S-SCAN |
ESAOTE, S.P.A. |
ALLISON SCOTT, RAC |
| K124064 |
12/19/2013 |
YOUNG AGAIN |
ESPANSIONE MARKETING SPA |
GUIDO BONAPACE |
| K132522 |
12/16/2013 |
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE |
ETHICON ENDO-SURGERY, LLC |
DAVID LOCKE |
| K133314 |
12/03/2013 |
HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY |
ETHICON ENDO-SURGERY, LLC |
BRIAN GODWIN |
| K133356 |
12/06/2013 |
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE |
ETHICON, INC. |
ELLIOTT JANG |
| K130975 |
12/24/2013 |
SWABCAP AND SWABFLUSH |
EXCELSIOR MEDICAL CORP. |
MICHAEL HEYL |
| K130375 |
12/04/2013 |
SELF-RETAINING BICANALICULUS INTUBATON SET II |
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
BARBARA S FANT |
| K131957 |
12/04/2013 |
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT |
FISHER & PAYKEL HEALTHCARE, LTD. |
ELIZABETH GOLDSTEIN |
| K123728 |
12/11/2013 |
RETRIEVAL BAG |
FLEXBAR MACHINE CORP. |
STEPHEN T MLCOCH |
| K122932 |
12/23/2013 |
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT |
FOGLESS INTERNATIONAL AB |
JASON WALTON |
| K133454 |
12/16/2013 |
SONOSITE EDGE ULTRASOUND SYSTEM |
FUJIFILM SONOSITE,INC. |
PATRICIA LIAU |
| K130788 |
12/05/2013 |
CAPELLA |
FUTURE MOBILITY HEALTHCARE INC. |
ABDULSAMAD PANCHBHAYA |
| K133431 |
12/24/2013 |
VENUE 50 |
GE HEALTHCARE |
BRYAN BEHN |
| K132533 |
12/04/2013 |
CARESCAPE MONITOR B450 |
GE HEALTHCARE FINLAND OY |
JOEL KENT |
| K132437 |
12/04/2013 |
MARS HOLTER ANALYSIS WORKSTATION |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
KRISTIN PABST |
| K133605 |
12/20/2013 |
BD MAX MRSA XT, BD MAX INSTRUMENT |
GENEOHM SCIENCES CANADA, INC. |
PATRICIA DIONNE |
| K130317 |
12/11/2013 |
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM |
GENESYS SPINE |
WILLIAM W SOWERS |
| K130913 |
12/13/2013 |
GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM |
GENESYS SPINE |
WILLIAM W SOWERS |
| K130082 |
12/20/2013 |
GENPRIME DRUGS OF ABUSE READER SYSTEM |
GENPRIME, INC |
Maureen Garner |
| K132559 |
12/30/2013 |
MONUMENT SPACERS |
GLOBUS MEDICAL INC. |
CHRISTINA KICHULA |
| K130977 |
12/24/2013 |
SIGNIFY BIOACTIVE |
GLOBUS MEDICAL INC. |
SARAH MARIE FITZGERALD |
| K132240 |
12/16/2013 |
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K130691 |
12/20/2013 |
ELECTROTHERAPY DEVICE (COMBO UNIT) |
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD |
FIELD FU |
| K131933 |
12/20/2013 |
ELECTRONIC PULSE MASSAGER |
GURIN PRODUCTS, LLC |
SANJAY GUPTA |
| K133213 |
12/05/2013 |
STARCERAM |
H.C. STARCK CERAMICS GMBH |
MAUREEN O'CONNELL |
| K131550 |
12/06/2013 |
HEART SYNC |
HEART SYNC INC. |
DANIEL KAMM |
| K131961 |
12/04/2013 |
HEINE BETA 200(R) OPHTHALMOSCOPE |
HEINE OPTOTECHNIK GMBH & CO. KG. |
MANFRED BARTSCH-TITTMANN |
| K130512 |
12/02/2013 |
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS |
HEINZ KURZ GMBH MEDIZINTECHNIK |
KRISTINA BITZER |
| K130736 |
12/17/2013 |
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS |
HELIX MEDICAL, LLC |
THOMAS M VASSALLO |
| K132520 |
12/31/2013 |
NASAL EASE ALLERGY BLOCKER |
HI-TECH PHARMACAL, INC. |
GARY APRIL |
| K132067 |
12/20/2013 |
MULTI ANGLED ABUTMENT SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K130895 |
12/27/2013 |
REUNION RSA SHOULDER SYSTEM |
HOWMEDICA OSTEONICS CORP |
ESTELA CELI |
| K133346 |
12/19/2013 |
SMARTLOG DIABETES MANAGEMENT SOFTWARE |
i-SENS, Inc. |
HYE YOUNG KANG |
| K123678 |
12/16/2013 |
HYALMIX CREAM |
IGI LABORATORIES, INC. |
FREDERICK WEISS |
| K123763 |
12/24/2013 |
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
| K130572 |
12/24/2013 |
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM |
IMPLANT DIRECT SYBRON MANUFACTURING LLC |
INES ARAVENA |
| K132966 |
12/05/2013 |
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K132862 |
12/12/2013 |
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K132996 |
12/17/2013 |
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS |
ISORAY, INC |
FREDRIC SWINDLER |
| K132876 |
12/18/2013 |
ARIX HAND LOCKING SYSTEM |
JEIL MEDICAL CORPORATION |
HYEROUNG LEE |
| K132428 |
12/20/2013 |
IDEAL |
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT |
GONG BO |
| K133181 |
12/03/2013 |
21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258) |
JVC KENWOOD CORPORATION |
TSUKASA TASHIRO |
| K133185 |
12/03/2013 |
21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358) |
JVC KENWOOD CORPORATION |
TSUKASA TASHIRO |
| K133511 |
12/19/2013 |
21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) |
JVC KENWOOD CORPORATION |
TSUKASA TASHIRO |
| K133126 |
12/09/2013 |
K7 LUMBAR SPACERS |
K7 LLC |
KAREN E WARDEN, PHD |
| K131953 |
12/20/2013 |
IMAGE1 SPIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
WINKIE WONG |
| K131787 |
12/23/2013 |
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES |
KEELER LTD. |
EUGENE R VANARSDALE |
| K133169 |
12/20/2013 |
MESO TENDON MATRIX |
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL |
BRIANNA JORDAN |
| K131879 |
12/20/2013 |
KC 300 SURGICAL MASK |
KIMBERLY-CLARK CORP. |
MONICA KING |
| K133111 |
12/26/2013 |
KINGTECH DIGITAL THERMOMETER |
KINGTECH ENTERPRISE, LTD. |
Ke-Min Jen |
| K133113 |
12/26/2013 |
KINGTECH FOREHEAD THERMOMETER |
KINGTECH ENTERPRISE, LTD. |
KE MIN JEN |
| K132514 |
12/02/2013 |
KINSA SMART THERMOMETER |
KINSA, INC. |
LAEL J PICKETT |
| K130758 |
12/11/2013 |
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER |
KRONNER PROTOTYPES, INC. |
RICHARD F KRONNER, M.D. |
| K133078 |
12/20/2013 |
K-ETCHANT SYRINGE; NEEDLE TIP (E) |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
| K133133 |
12/23/2013 |
LAURIMED POLYPVAC MICRODEBRIDER |
LAURIMED LLC |
NANCY LINCE, RAC |
| K131006 |
12/06/2013 |
ANESTHESIA CONDUCTION NEEDLES |
LCCS PRODUCTS LIMITED |
MIKE GU |
| K133026 |
12/31/2013 |
UNBALLOON NON-OCCLUSION MODELING CATHETER |
LEMAITRE VASCULAR, INC. |
ANDREW HODGKINSON |
| K132618 |
12/16/2013 |
ONETOUCH REVEAL |
LIFESCAN, INC. |
GABRIELLE LOGAN |
| K132837 |
12/19/2013 |
LINA POWERBLADE PLUS |
LINA MEDICAL APS |
CHRISTINE E NICHOLS |
| K130797 |
12/18/2013 |
LUCO HYBRID OSA APPLIANCE |
LUCO HYBRID OSA APPLIANCE INC. |
KEN LUCO |
| K133039 |
12/10/2013 |
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM |
MAKO SURGICAL CORPORATION |
JONATHAN REEVES |
| K132743 |
12/03/2013 |
HARVESTING CANNULA |
MAQUET CARDIOVASCULAR, LLC |
MARK DINGER |
| DEN110009 |
12/18/2013 |
RESTLESS LEG DEVICE |
MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEEPER'S |
MARY M SORG |
| K131497 |
12/05/2013 |
MCKESSON CARDIOLOGY HEMO |
MCKESSON ISRAEL LTD. |
PAUL SUMNER |
| K133630 |
12/20/2013 |
GMK SHORT STEM |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K132878 |
12/18/2013 |
M.U.S.T. EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K132803 |
12/12/2013 |
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK |
MEDAPPS INC., DBA ALERE CONNECT |
KENT DICKS |
| K133460 |
12/18/2013 |
APTUS CANNULATED COMPRESSION SCREWS |
MEDARTIS AG |
ALLISON KOMIYAMA |
| K132177 |
12/12/2013 |
MEDCOMP GEN III POWER INJECTABLE PORT |
MEDCOMP (MEDICAL COMPONENTS) |
SARAH SHAFFER |
| K132395 |
12/06/2013 |
LIGAPASS |
MEDICREA INTERNATIONAL |
AUDREY VION |
| K131682 |
12/05/2013 |
UD IMPLANT SYSTEM |
MEDIMECCA CO., LTD. |
Priscilla Chung |
| K132783 |
12/09/2013 |
EXOSHAPE DUO SOFT TISSUE FASTENER |
MEDSHAPE, INC |
STEPHEN LAFFOON |
| K130467 |
12/05/2013 |
POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE |
MEDSHAPE, INC |
KENNETH M DUPONT, PH.D. |
| K132623 |
12/19/2013 |
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE |
Medtronic |
MONICA HERNANDEZ-SOTO |
| K132974 |
12/03/2013 |
AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR |
MEDTRONIC ADVANCED ENERGY, LLC |
GABRIELA ANCHONDO |
| K133650 |
12/20/2013 |
CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
GREGORY MASCHEK |
| K132328 |
12/06/2013 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
BECKY RONNER |
| K132584 |
12/04/2013 |
PERIMETER C SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MICHAEL SCOTT |
| K132897 |
12/11/2013 |
CLYDESDALE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
BRAD SHEALS |
| K131789 |
12/27/2013 |
CEREBRALOGIK- AEEG |
MENNEN MEDICAL LTD. |
IFAT SHWARTS |
| K131169 |
12/24/2013 |
MOZEC - RX PTCA BALLOON DILATATION CATHETER |
MERIL LIFE SCIENCES PRIVATE LIMITED |
H. Semih Oktay |
| K133230 |
12/12/2013 |
INQWIRE DIAGNOSTIC GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
SIOBHAN KING |
| K133626 |
12/20/2013 |
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K132952 |
12/19/2013 |
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K122393 |
12/10/2013 |
TG-BODY MI&BODY S-TRAINER |
MIGA MEDICAL CO., LTD. |
YANG HO DONG |
| K130073 |
12/16/2013 |
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS |
MIKRON MAKINA SANAYI VE TICARET LTD STI |
OMAR DIKER |
| K132026 |
12/20/2013 |
V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 |
MINDRAY DS USA, INC. |
RUSSELL OLSEN |
| K132232 |
12/04/2013 |
MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM |
MINILAP TECHNOLOGIES |
ALLAN ALWARD |
| K121248 |
12/13/2013 |
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC |
MOLLER MEDICAL GMBH |
GRANT GECKELER |
| K133806 |
12/31/2013 |
M1 CAPNOGRAPHY MASK |
MONITOR MASK, INC. |
STUART R GOLDMAN |
| K131929 |
12/03/2013 |
SURVEYOR CENTRAL STATION |
MORTARA INSTRUMENT, INC. |
AMY YANG |
| K132264 |
12/17/2013 |
PRIMADO2 TOTAL SURGICAL SYSTEM |
NAKANISHI, INC. |
DIANE RUTHERFORD |
| K130738 |
12/13/2013 |
ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS |
NANJING MAIDIXIN MEDICAL DEVICE CO., LTD. |
Diana Hong |
| K133422 |
12/26/2013 |
1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE |
NEOCOIL, LLC |
KATIE GONZALEZ |
| K133281 |
12/20/2013 |
NEOTRACT UROLIFT SYSTEM |
NEOTRACT, INC. |
Nancy E Isaac |
| K130570 |
12/26/2013 |
NEUROVISION MEDICAL MOTION SENSOR |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
| K133475 |
12/19/2013 |
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS |
NEXXT SPINE LLC |
ERIC LINTULA |
| K123006 |
12/20/2013 |
AIR BARRIER SYSTEM (ABS) |
NIMBIC SYSTEMS, INC |
HARVEY KNAUSS |
| K131381 |
12/19/2013 |
ELISIO-H HEMODIALYZER |
NIPRO MEDICAL CORPORATION |
CAROLYN GEORGE |
| K131935 |
12/20/2013 |
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER |
NIPRO MEDICAL CORPORATION |
CAROLYN GEORGE |
| K122952 |
12/04/2013 |
NIPRO PUREFLUX-L HEMODIALYZER |
NIPRO MEDICAL CORPORATION |
CAROLYN GEAORGE |
| K132153 |
12/05/2013 |
SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD-MCLEOD |
| K132329 |
12/20/2013 |
NIVATOPIC PLUS |
NIVAGEN PHARMACEUTICALS INC. |
LARA NOAH |
| K132033 |
12/04/2013 |
BM3/BM3 PLUS |
NOBLITT & RUELAND |
MARC GOODMAN |
| K133035 |
12/13/2013 |
NORMED PELLEGRIN CALCANEUS STOP SCREW |
NORMED MEDIZIN-TECHNIK GMBH |
DALENE BINKLEY |
| K133052 |
12/20/2013 |
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM |
NUVASIVE, INC. |
OLGA LEWIS |
| K132601 |
12/24/2013 |
COROENT STERILE IMPLANTS SYSTEM |
NUVASIVE, INCORPORATED |
OLGA LEWIS |
| K131050 |
12/27/2013 |
NXSTAGE 1.6M2 DIALYZER |
NXSTAGE MEDICAL, INC. |
NNAMDI NWACHUKWU |
| K132917 |
12/20/2013 |
OCULAR FORCE GAUGE |
OCULAR THERAPEUTIX, INC. |
Eric Ankerud |
| K132095 |
12/26/2013 |
OLEA SPHERE |
OLEA MEDICAL |
CAROLINE LENE |
| K130669 |
12/06/2013 |
SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS |
OLSEN MEDICAL |
DALENE BINKLEY |
| K132186 |
12/18/2013 |
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 |
OPTOMED OY |
JYRI LESKELA, QUALITY MANAGER |
| K132368 |
12/19/2013 |
VAPOR CERAMIC BRACKET |
ORTHODONTIC DESIGN AND PRODUCTION, INC. |
RICHARD MERRELL |
| K133437 |
12/02/2013 |
1ST MTP PLATE |
OSTEOMED |
BLESSON ABRAHAM |
| K131851 |
12/06/2013 |
OSTEOMED NEURO RONGEUR |
OSTEOMED |
PIEDAD PENA, M.S. |
| K132775 |
12/09/2013 |
PONTO PLUS AND PONTO PLUS POWER |
OTICON MEDICAL AB |
SATU HJARTSTAM |
| K131586 |
12/10/2013 |
CANCARY BREATHING SYSTEM |
PALO ALTO HEALTH SCIENCES, INC. |
LORI ADELS, PHD |
| K122834 |
12/11/2013 |
POLYSITE IMPLANTABLE INFUSION PORTS |
Perouse Medical |
Isabelle Jeanty |
| K131821 |
12/23/2013 |
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY |
PHADIA US INC. |
MARTIN R MANN |
| K130704 |
12/13/2013 |
MICRODOSE SI |
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB |
GUSTAV LINS |
| K130519 |
12/24/2013 |
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS |
PHILIPS LIGHTING COMPANY |
JAMES R CYRE |
| K132147 |
12/16/2013 |
2D PERFUSION |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LISELOTTE KORNMANN |
| K130579 |
12/19/2013 |
PHYSOFT AMS |
PHYSICIANS SOFTWARE SYSTEMS, LLC |
LEWIS A MITCHELL |
| K131724 |
12/24/2013 |
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE |
PIONEER SURGICAL TECHNOLOGY, INC |
EMILY M DOWNS |
| K131758 |
12/18/2013 |
SURGEN U |
POLLOGEN LTD |
JONATHAN S KAHAN |
| K133474 |
12/10/2013 |
BIOSIGN FLU A + B, STATUS FLU A & B |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K131060 |
12/16/2013 |
CLEARGUARD HD END CAP |
PURSUIT VASCULAR, INC |
LAURIE E LYNCH, PH.D. |
| K133503 |
12/20/2013 |
AMPLIVUE GBS ASSAY |
QUIDEL CORPORATION |
Ronald H Lollar |
| K133423 |
12/20/2013 |
REST ASSURED EXTRA COMFORT NITE PROTECTOR |
RANIR LLC |
PAULA BOJSEN |
| K131979 |
12/13/2013 |
PROVANT THERAPY SYSTEM |
REGENESIS BIOMEDICAL, INC. |
RICHARD ISENBERG |
| K132887 |
12/20/2013 |
AIRFIT N10 |
RESMED LTD. |
JIM CASSI |
| K122035 |
12/13/2013 |
HEPAFAT SCAN |
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD |
GREG HOLLAND |
| K133243 |
12/17/2013 |
OPTION ELITE VENA CAVA FILTER SYSTEM |
REX MEDICAL LP |
SUSAN D GOLDSTEIN-FALK |
| K132418 |
12/18/2013 |
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 |
Roche Diagnostics |
KHOA TRAN |
| K132828 |
12/04/2013 |
ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 |
Roche Diagnostics |
KELLI TURNER |
| K132270 |
12/02/2013 |
COBAS CT/NG V2.0 TEST |
ROCHE MOLECULAR SYSTEMS, INC. |
WILK VON GUSTEDT |
| K132148 |
12/04/2013 |
S HEALTH |
SAMSUNG ELECTRONICS CO., LTD. |
Priscilla Chung |
| K133505 |
12/27/2013 |
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
PARK KYEONG-MI |
| DEN110011 |
12/18/2013 |
SYMPHONY DEVICE |
SENSORY MEDICAL, INC |
FRED BURBANK |
| K132652 |
12/20/2013 |
VIA MICROCATHETER, VIA PLUS MICROCATHETER |
SEQUENT MEDICAL, INC |
MELANIE PARRAVI |
| K131259 |
12/27/2013 |
LASER-STIM |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
JIANGPING KANG |
| K130325 |
12/24/2013 |
ARM AUTOMATIC BLOOD PRESSURE MONITOR |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
IVY CHEN |
| K132748 |
12/04/2013 |
BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K132532 |
12/09/2013 |
SYNGO.PLAZA VB10A |
SIEMENS AG HEALTHCARE |
VIKTORIA BENZ |
| K131164 |
12/24/2013 |
ACUSON |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K133435 |
12/12/2013 |
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K133016 |
12/09/2013 |
VENT-OS SINUS DILATION SYSTEM |
SINUSYS CORPORATION |
MICHAELE A DANIEL |
| K132773 |
12/11/2013 |
SIDEXIS 4 |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K130708 |
12/11/2013 |
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS |
SMITH & NEPHEW, INC. |
Bradley Heil |
| K132079 |
12/05/2013 |
TFCC FAST-FIX KIT |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K132015 |
12/13/2013 |
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS |
SMITH & NEPHEW, INC. |
Bradley Heil |
| K130394 |
12/09/2013 |
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 |
SMITHS MEDICAL ASD, INC. |
PAULA CORDERO |
| K132594 |
12/13/2013 |
CROSSCHECK PLATING SYSTEM |
SOLANA SURGICAL, LLC |
JOE CLIFT |
| K133586 |
12/18/2013 |
VISI MOBILE MONITIORING SYSTEM |
SOTERA WIRELESS, INC |
EBEN GORDON |
| K133207 |
12/06/2013 |
STAXX(R) SYSTEM |
SPINE WAVE, INC. |
JOSEPH MERCADO |
| K131521 |
12/24/2013 |
VELOX ANTERIOR CERVICAL PLATE SYSTEM |
SPINECRAFT LLC |
AMI AKALLAL-ASAAD |
| K133587 |
12/20/2013 |
PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 |
ST. JUDE MEDICAL SYSTEMS AB |
ERDULFO DE PERALTA |
| K132007 |
12/27/2013 |
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU |
STERICYCLE, INC. |
LORI ADELS |
| K132519 |
12/06/2013 |
STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT |
Stryker |
ROB YAMASHITA |
| K132747 |
12/30/2013 |
VISUM BLADE LED SURGICAL LIGHTING SYSTEM |
STRYKER COMMUNICATIONS |
TREY THORSEN |
| K132671 |
12/20/2013 |
STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM |
STRYKER CORPORATION |
MICHELLE JUMP |
| K132785 |
12/16/2013 |
STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY |
Stryker Endoscopy |
LIFEI LIU |
| K133188 |
12/17/2013 |
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL |
STRYKER SPINE |
SORAYA KING |
| K132629 |
12/31/2013 |
REPROCESSED DILATING TIP TROCARS |
STRYKER SUSTAINABILITY SOLUTIONS |
AMANDA BABCOCK |
| K133440 |
12/18/2013 |
AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION |
Stryker Trauma AG |
Elijah Wreh |
| K132646 |
12/20/2013 |
SUNETICS CLINICAL BIO-STIMULATION LASER |
SUNETICS INTERNATIONAL MARKETING GROUP, LLC |
JOHN CARULLO |
| K131649 |
12/11/2013 |
ME |
SYNERON BEAUTY LTD. |
JANICE M HOGAN |
| K131792 |
12/16/2013 |
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY |
SYNTHES INC |
HEATHER GUERIN |
| K132910 |
12/16/2013 |
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM |
SYNTHES USA PRODUCTS, LLC |
EUGENE BANG |
| K132992 |
12/18/2013 |
TI STAR IMPLANT SYSTEM |
T-PLUS IMPLANT TECH. CO., LTD. |
DANA CHENG |
| K133127 |
12/23/2013 |
LIPIFLOW THERMAL PULSATION SYSTEM |
TEARSCIENCE, INC. |
CHRISTY STEVENS, OD, MPH |
| K133202 |
12/03/2013 |
HEM-O-LOK LIGATING CLIP |
TELEFLEX MEDICAL |
ASHLEA RICCI |
| K131447 |
12/24/2013 |
INTUITION - TDA, TVA, PARAMETRIC MAPPING |
TERARECON, INC. |
EMILLY T NURTHEN |
| K132429 |
12/06/2013 |
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET |
TERUMO BCT, INC.. |
TINA O'BRIEN |
| K133687 |
12/11/2013 |
THD N-ANO ANOSCOPE |
THD SPA |
GUIDO BONAPACE |
| K131053 |
12/31/2013 |
ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM |
THE ANSPACH EFFORT, INC. |
ANNETTE M HILLRING |
| K132555 |
12/20/2013 |
HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT |
THE BINDING SITE |
Paul Kenny |
| K130052 |
12/20/2013 |
TONE-A-MATIC |
TONE-A-MATIC INTERNATIONAL, INC. |
ANNIA KORDIUK |
| K133305 |
12/16/2013 |
RHYTHM VIEW WORKSTATION |
TOPERA, INC. |
DENNIS POZZO |
| K133376 |
12/05/2013 |
AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT |
TORNIER, INC. |
JANELL A COLLEY |
| K132285 |
12/05/2013 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
TORNIER, SAS |
MAGALIE HENNEQUIN |
| K132523 |
12/12/2013 |
MYOPERFUSION |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K132218 |
12/17/2013 |
PERFIX ILIAC SCREW SYSTEM |
U & I CORPORATION |
YOUNG-GEUN KIM |
| K132028 |
12/11/2013 |
ULTHERA SYSTEM |
ULTHERA, INC. |
SUZON LOMMEL |
| K121812 |
12/02/2013 |
SONIXGPS |
UltraSonix Medical Corporation |
RAYMOND KELLY |
| K133513 |
12/20/2013 |
MULTI-STAGE SNARE |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL MARTIN |
| K133641 |
12/20/2013 |
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE |
VOLCANO CORPORATION |
MARCUS GARCIA |
| K132558 |
12/12/2013 |
SYNC-RX SYSTEM |
VOLCANO CORPORATION |
ELAINE ALAN |
| K132742 |
12/03/2013 |
M-VU BREAST DENSITY |
VUCOMP, INC. |
RICHARD MORRONEY |
| K132998 |
12/20/2013 |
WANDY SELF-ADHESIVE ELECTRODES |
WANDY RUBBER INDUSTRIAL CO., LTD |
JACK YI |
| K131664 |
12/18/2013 |
COPRA TEMP PMMA-DISK |
WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG |
JOHN WATERS |
| K131596 |
12/11/2013 |
WOUND MEASURING & MONITORING DEVICE |
WOUNDVISION, LLC |
GRETCHEN MILLER BOWKER |
| K132484 |
12/13/2013 |
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K133094 |
12/11/2013 |
CERTEX OCT SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN, M.D. |
| K130611 |
12/19/2013 |
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE |
XERIDIEM MEDICAL DEVICES |
MICHELLE LOTT |
| DEN130007 |
12/18/2013 |
AXIOS STENT AND DELIVERY SYSTEM |
XLUMENA, INC |
JANE BEGGS |
| K132854 |
12/23/2013 |
EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
YUNG SHENG OPTICAL CO., LTD. |
WEN-HAN CHEN |
| K132904 |
12/05/2013 |
ZIEHM VISION RFD |
ZIEHM IMAGING GMBH |
RICHARD L WESTRICH |
| K132790 |
12/20/2013 |
INFIX ANTERIOR LUMBAR SYSTEM |
ZIMMER SPINE, INC |
DONNA SEMLAK |
| K133291 |
12/17/2013 |
ST360 DEGREES SPINAL FIXATION SYSTEM |
ZIMMER SPINE, INC |
MICHELLE LENZ |
| K132386 |
12/23/2013 |
TOTALSHIELD SURGICAL HELMET SYSTEM |
ZIMMER, INC. |
ALLISON SCOTT, RAC |
| K133246 |
12/17/2013 |
ZIMMER DISTAL RADIUS PLATING SYSTEM |
ZIMMER, INC. |
ROMIL SHETH |
| K131919 |
12/17/2013 |
ZOLL EPCR IOS |
ZOLL MEDICAL CORPORATION |
SHANNON DUHAMEL |
