| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K130185 |
06/07/2013 |
4WEB OSTEOTOMY BONE WEDGE |
4-WEB, INC. |
RICH JANSEN, PHARM, D. |
| K130664 |
06/21/2013 |
HYRDROMAX HMEF |
A-M SYSTEMS |
PAUL DRYDEN |
| K130094 |
06/27/2013 |
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM |
ABBOTT DIABETES CARE |
DAVID G LAMBERT |
| K122449 |
06/13/2013 |
ENTERAL NUTRITION WARMER |
ACACIA, INC. |
FERGIE FERGUSON |
| K131300 |
06/07/2013 |
THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER |
ACCESS SCIENTIFIC, LLC |
ALBERT MISAJON |
| K123354 |
06/28/2013 |
REVITIVE IX |
Actegy Ltd |
JOHN J SMITH |
| K131380 |
06/10/2013 |
ACUMED TOTALW RIST FUSION PLATING SYSTEM |
ACUMED LLC |
BRITTANY CUNNINGHAM |
| K122809 |
06/17/2013 |
ADVIN MULTI-DRUG SCREEN TEST CASSETTE, DIP CARD AND CUP |
ADVIN BIOTECH |
EDWARD TUNG |
| K122791 |
06/04/2013 |
LYOPLANT ONLAY |
AESCULAP, INC. |
DENISE ADAMS |
| K112598 |
06/20/2013 |
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) |
AMERICAN SURGICAL COMPANY, LLC |
MICHAEL ALOUANE |
| K121642 |
06/06/2013 |
WIZARD 230 NASAL PILOW MASK |
APEX MEDICAL CORP. |
FRANK LIN |
| K130050 |
06/18/2013 |
TITAN REVERSE SHOULDER SYSTEM |
ASCENSION ORTHOPEDIC |
SUSAN WALTON |
| K121101 |
06/20/2013 |
SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT |
ASTORIA-PACIFIC,INC. |
CHARLES A PETERSON |
| K121343 |
06/14/2013 |
MODULAP LOOP |
ATC TECHNOLOGIES, INC. |
JOHN GILLESPIE |
| K121214 |
06/14/2013 |
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM |
BECKMAN COULTER, INC. |
KERRIE OETTER |
| K123404 |
06/27/2013 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) |
BECTON, DICKINSON & CO. |
MONICA E GIGURERE |
| K123266 |
06/26/2013 |
BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN |
Becton, Dickinson and Company |
MONICA E GIGUERE |
| K124038 |
06/21/2013 |
BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) |
BEDSIDE CLINICAL SYSTEMS INC |
DIANE SUDDUTH |
| K121284 |
06/14/2013 |
CHABNER XRT GARMENTS |
BFFL CO. INC |
EVAN P PHELPS |
| K130944 |
06/07/2013 |
ISR'OBOT MONA LISA |
BIOBOT SURGICAL PTE LTD |
JOHN BABY |
| K130914 |
06/21/2013 |
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL |
BIOFIRE DIAGNOSTICS, INC. |
BETH LINGENFELTER |
| K122979 |
06/04/2013 |
VIDAS LYME IGM |
BIOMERIEUX SA |
CATHERINE FRITSCH |
| K130310 |
06/21/2013 |
CERTAIN BELLATEK PROVISIONAL ABUTMENTS |
BIOMET 3I |
JACQUELYN A HUGHES, RAC |
| K130309 |
06/17/2013 |
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM |
BIOMET MICROFIXATION |
CHRISTINE SCIFERT |
| K130298 |
06/18/2013 |
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM |
BIOPRO, INC. |
AL LIPPINCOTT |
| K123559 |
06/28/2013 |
SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM |
Biotest Medical Corp. |
FRED LEE |
| K123653 |
06/03/2013 |
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) |
BISCO, INC. |
Michelle Schiltz-Taing |
| K130382 |
06/05/2013 |
HEARTSTRING III PROXIMAL SEAL SYSTEM |
Boston Scientific Corporation |
MARK DINGER |
| K123810 |
06/14/2013 |
PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM |
CARBOFIX ORTHOPEDICS LTD. |
YAEL RUBIN |
| K130927 |
06/18/2013 |
DURABLUE STERILIZATION WRAP |
CARDINAL HEALTH 200, LLC |
LAVENIA FORD |
| K131092 |
06/24/2013 |
STEALTH 360 ORBITAL PAD SYSTEM |
CARDIO SYSTEMS, INC. |
MAUREEN MCDONNELL |
| K130567 |
06/11/2013 |
DR LONG LENGTH IMAGING SOFTWARE |
CARESTREAM HEALTH, INC. |
CAROLYN WAGNER |
| K130464 |
06/07/2013 |
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR |
CARESTREAM HEALTH,INC. |
CAROLYN WAGNER |
| K130549 |
06/26/2013 |
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR |
CARL ZEISS MEDITEC INC |
SARAH HARRINGTON |
| K130894 |
06/20/2013 |
XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE |
CEPHEID |
RAINER ZIERMANN PH.D. |
| K131303 |
06/11/2013 |
DISPOSABLE CIRCULAR STAPLER |
CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO. |
CHARLIE MACK |
| K123427 |
06/28/2013 |
NIRVANA D PERSONAL LUBRICANT (TBD) |
CHURCH & DWIGHT CO., INC. |
EMILY PEREZ |
| K131005 |
06/25/2013 |
EBA2 FEMORAL NAILING SYSTEM |
CITIEFFE S.R.L. |
CLAUDE BERTHION |
| K131528 |
06/11/2013 |
NON-PYROGENIC ULTRASOUND TRANSDUCER COVER |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
AMANDA STAHLE |
| K131443 |
06/19/2013 |
COALIGN INNOVATIONS ACCULIF XL IBF CAGE |
COALIGN INNOVATIONS, INC. |
JUSTIN EGGLETON |
| K120892 |
06/10/2013 |
DISPOSABLE 330PSI EXTENSION LINES |
COEUR, INC. |
DEBRA F MANNING |
| K123481 |
06/06/2013 |
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE |
CONVATEC INC |
KATRINA FIEDLER |
| K122917 |
06/28/2013 |
CODA BALLOON CATHETER |
COOK, INC. |
ELYSIA EASTON |
| K123394 |
06/06/2013 |
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING |
CORELEADER BIOTECH CO., LTD. |
VINCENT HUANG |
| K121436 |
06/06/2013 |
DAS MEDICAL EQUIPMENT DRAPES |
DAS MEDICAL, LLC |
ARMOND GROVES |
| K124018 |
06/14/2013 |
AMIA AUTOMATED PD SYSTEM |
DEKA RESEARCH & DEVELOPMENT CORP. |
ROGER A LEROUX |
| K131683 |
06/27/2013 |
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) |
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY |
KRISTINE CHRISTO |
| K130912 |
06/14/2013 |
OMNICUT RESECTION BLADE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
TATYANA KORSUNSKY |
| K131556 |
06/26/2013 |
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET |
DIAZYME LABORATORIES |
Abhijit Datta |
| K123785 |
06/07/2013 |
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET |
DIAZYME LABORATORIES |
Abhijit Datta |
| K130722 |
06/20/2013 |
AIRCAST VENAFLOW ELITE SYSTEM |
DJO, LLC |
LORRI TROTTER |
| K123431 |
06/17/2013 |
DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D |
DREAMCON CO., LTD |
ALBERT REGO |
| K120727 |
06/21/2013 |
MFM-CMS CENTRAL MONITORING SYSTEM |
EDAN INSTRUMENTS INC |
RANDY JIANG |
| K130099 |
06/21/2013 |
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 |
ENCORE MEDICAL, L.P. |
WILLIAM GARZON |
| K122820 |
06/18/2013 |
VIKY UP |
ENDOCONTROL |
HUGUEL CARINE |
| K122748 |
06/11/2013 |
ENGLER 25K SERIES ULTRASONIC INSERTS |
ENGLER ENGINEERING CORP. |
JOEL KATZ |
| K130503 |
06/11/2013 |
PATHASSIST LED LIGHT FIBER |
Entellus Medical, Inc. |
KAREN E PETERSON |
| K121628 |
06/25/2013 |
EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) |
EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD |
KARL M NOBERT |
| K123261 |
06/12/2013 |
EUROIMMUN ANTI-NRNP/SM ELISA (IGG) |
EUROIMMUN US |
KATHRYN KOHL |
| K131153 |
06/18/2013 |
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP |
EVENFLO FEEDING INCORPORATED |
WADE HALMA |
| K130328 |
06/05/2013 |
F&P SIMPLUS FULL FACE MASK |
FISHER & PAYKEL HEALTHCARE LIMITED |
SUE CHO |
| K130507 |
06/03/2013 |
FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER |
FOOTPRINT MEDICAL INC. |
CLYDE N BAKER |
| K130542 |
06/14/2013 |
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JYH-SHYAN LIN |
| K131267 |
06/19/2013 |
VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 |
GE HEALTHCARE |
BRYAN BEHN |
| K123144 |
06/18/2013 |
VIVO 50 |
GE HEALTHCARE, BREAS MEDICAL AB |
SHLOMI DELER |
| K130584 |
06/26/2013 |
MONITOR B40 |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
CASARSA ROBERT |
| K131395 |
06/19/2013 |
TRANSTEK BLOOD PRESSURE MONITOR |
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
LEO WANG |
| K130191 |
06/12/2013 |
MINT |
HANSBIOMED CORPORATION |
APRIL LEE |
| K130563 |
06/18/2013 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K130564 |
06/19/2013 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K122473 |
06/03/2013 |
TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 |
HILL-ROM |
ANN WATERHOUSE |
| K123627 |
06/28/2013 |
ET SMARTFIT ABUTMENT |
HIOSSEN INC. |
PATRICK LIM |
| K120945 |
06/07/2013 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
CHARLES TSOU |
| K131051 |
06/07/2013 |
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERIKA AMMIRATI |
| K131217 |
06/07/2013 |
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
CHARLES TSOU |
| K130397 |
06/20/2013 |
ARROW GPSCATH BALLOON DILATATION CATHETER |
HOTSPUR TECHNOLOGIES |
ERIC ANKERUD, JD |
| K130008 |
06/25/2013 |
DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING |
I.T.S. GMBH |
AL LIPPINCOTT |
| K123253 |
06/18/2013 |
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
| K130295 |
06/21/2013 |
LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. |
INFOPIA CO., LTD |
Priscilla Chung |
| K130598 |
06/05/2013 |
INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER |
INSPIRX, INC. |
PAUL DRYDEN |
| K130290 |
06/04/2013 |
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE |
INTEL-GE CARE INNOVATIONS LLC |
MAUREEN GLYNN |
| K130795 |
06/20/2013 |
TITAN |
INTERACOUSTICS A/S |
ERIK NIELSEN |
| K131131 |
06/21/2013 |
E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
STEVE KWON |
| K130726 |
06/07/2013 |
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK |
INTUITIVE SURGICAL, INC. |
MELISSA S GONZALEZ |
| K123158 |
06/21/2013 |
ION MAGNUM GENIUS |
ION GENIUS INC |
XANYA SOFRA-WEISS |
| K122521 |
06/11/2013 |
PREVENT SEAL |
ITENA CLINICAL |
LOUIS-PAUL MARIN |
| K122551 |
06/14/2013 |
PROVITEMP |
ITENA CLINICAL |
LOUIS-PAUL MARIN |
| K131291 |
06/14/2013 |
TORC BODY |
JOHARI DIGITAL HEALTHCARE, LTD. |
POOJA JOHARI |
| K122983 |
06/26/2013 |
KSEA BIPOLAR ELECTRODE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
WINKIE WONG |
| K131589 |
06/27/2013 |
KEELER SLIT LAMP H-SERIES |
KEELER LTD. |
NICKIE POWER |
| K122653 |
06/26/2013 |
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES |
KIMBERLY-CLARK CORPORATION |
DAVID LEE |
| K130599 |
06/05/2013 |
WART FREEZE |
KONINKLIJKE UTERMOHLEN NV |
KENNETH R MICHAEL |
| K131568 |
06/28/2013 |
SUDO PATH |
LD TECHNOLOGY LLC |
ALBERT MAAREK |
| K130630 |
06/13/2013 |
PLATEAU SPACER SYSTEM TITANIUM |
LIFE SPINE, INC |
RANDY LEWIS |
| K123842 |
06/24/2013 |
LAWMAX DILATOR |
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
LILY SHI |
| K131112 |
06/07/2013 |
LIMACORPORATE SMR CTA HUMERAL HEADS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K130642 |
06/12/2013 |
SMR 3-PEGS GLENOIDS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K121481 |
06/25/2013 |
INFINI RADIOFREQUENCY SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
| K123127 |
06/14/2013 |
VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 |
MAINE STANDARDS CO. |
JAMES W CHAMPLIN |
| K123288 |
06/26/2013 |
HEMOCONCENTRATOR |
MAQUET CARDIOPULMONARY AG |
INGRID RICHTER |
| K123292 |
06/11/2013 |
T3 |
MEDCOMP |
TIMOTHY HOLWICK |
| K122973 |
06/12/2013 |
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE |
MEDGYN PRODUCTS, INC. |
STEPHANIE BLAIR |
| K124046 |
06/03/2013 |
VALVED TEARAWAY INTRODUCER GENERATION II |
MEDICAL COMPONENTS INC |
TIMOTHY HOLWICK |
| K130877 |
06/20/2013 |
EXPEDIUM SPINE SYSTEM |
MEDOS INTERNATIONAL SARL |
KIRSTEN LEHMULLER |
| K131321 |
06/05/2013 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA |
LAUREN KAMER |
| K130640 |
06/04/2013 |
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
KRISTI FRISCH |
| K123423 |
06/05/2013 |
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT |
MERIDIAN BIOSCIENCE, INC. |
Michelle L Smith |
| K130566 |
06/19/2013 |
BASIXTOUCH |
MERIT MEDICAL SYSTEMS, INC. |
DAN W LINDSAY |
| K130259 |
06/07/2013 |
BEARING NSPVA EMBOLIZATION PARTICLES |
MERIT MEDICAL SYSTEMS, INC. |
LINDA VARROSO |
| K130791 |
06/07/2013 |
PRELUDE SHEATH INTRODUCER |
MERIT MEDICAL SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K123007 |
06/19/2013 |
VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM |
MICOBIOMED CO, LTD |
Priscilla Chung |
| K123016 |
06/18/2013 |
VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS |
MICOBIOMED CO, LTD |
Priscilla Chung |
| K123518 |
06/05/2013 |
ABBOTT CARBAMAZEPINE ASSAY |
Microgenics Corporation |
KAREN LEE |
| K131346 |
06/06/2013 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K130577 |
06/17/2013 |
AZUR PUSHABLE 18 & 35 SYSTEM |
MICROVENTION, INC. |
CYNTHIA VALENZUELA |
| K131115 |
06/07/2013 |
ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE |
NDS SURGICAL IMAGING |
JIM LENG |
| K130816 |
06/21/2013 |
INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) |
NEURO RESOURCE GROUP, INC. |
DAVID TURNER |
| K122503 |
06/25/2013 |
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON |
NEURO THERM, INC. |
F. DAVID ROTHKOPF |
| K130774 |
06/19/2013 |
UNIVERSAL DISTAL RADIUS SYSTEM |
NEWCLIP TECHNICS |
J.D. WEBB |
| K130416 |
06/12/2013 |
NEXUS TKO-6P LUER ACTIVATED DEVICE |
NEXUS MEDICAL, LLC |
HEATHER TURNER |
| K120954 |
06/05/2013 |
NOBELPROCERA PEEK ABUTMENTS |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K131509 |
06/28/2013 |
ZOE FLUID STATUS MONITOR |
NONINVASIVE MEDICAL TECHNOLOGIES, INC. |
MARC O'GRIOFA |
| K130995 |
06/14/2013 |
NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY |
NUANCE MEDICAL, LLC |
MARC S LIEBERMAN |
| K130281 |
06/21/2013 |
OAK RIDGE PRODUCTS SHARP CONTAINER |
OAK RIDGE PRODUCTS, LLC |
TIBOR B KOVARI |
| K130819 |
06/19/2013 |
CLL- V1 LIGHT SOURCE |
OLYMPUS WINTER & IBE GMBH |
SHERI L MUSGNUNG |
| K131181 |
06/25/2013 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE |
OMEGA LABORATORIES, INC. |
ROBERT J BARD, JD, RAC, CQE |
| K121902 |
06/06/2013 |
NATRATONE |
ORELLE CORPORATION LTD |
PATRICIA COOMBES |
| K120931 |
06/06/2013 |
CRITICAL CARE VENTILATOR |
ORICARE, INC. |
DAVID JAMISON |
| K122588 |
06/12/2013 |
VUSION CS PLUS |
ORTHO DEVELOPMENT CORP. |
TOM HAUETER |
| K130446 |
06/07/2013 |
FASTBRACES CERAMIC BRACKETS |
ORTHODONTIC DESIGN AND PRODUCTION, INC. |
RICHARD MERRELL |
| K124023 |
06/10/2013 |
STARBAND |
ORTHOMERICA PRODUCTS, INC. |
DAVID L HOOPER |
| K130217 |
06/20/2013 |
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM |
ORTHOPEDIATRICS, CORP. |
MARK FOX |
| K130380 |
06/13/2013 |
ORTHOSENSOR KNEE BALANCER |
ORTHOSENSOR, INC. |
KIMBERLEE WASHBURN |
| K130104 |
06/13/2013 |
GUIDEWIRE, PURSUER SERIES |
Oscor Inc. |
MILA DOSKOCIL |
| K131445 |
06/18/2013 |
OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM |
OSTEOMED LP |
BLESSON ABRAHAM |
| K123885 |
06/03/2013 |
OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR |
OSTEOMED LP |
PIEDAD PENA |
| K130443 |
06/14/2013 |
I-MAX TOUCH 3D |
OWANDY |
Claude Berthoin |
| K131141 |
06/27/2013 |
EARPROBE |
PATH MEDICAL GMBH |
JOHANN OSWALD |
| K122997 |
06/26/2013 |
23GA CURVED ILLUMINATING LASER PROBE |
PEREGRINE SURGICAL LTD. |
RYAN O'LEARY |
| K123275 |
06/28/2013 |
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM |
PHADIA AB |
MARTIN MANN |
| K123576 |
06/07/2013 |
IMR SOFTWARE APPLICATION |
PHILIPS HEALTHCARE (CLEVELAND) |
CHRISTINE ANDERSON |
| K130638 |
06/28/2013 |
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
KLIEN VAN DAM |
| K130992 |
06/14/2013 |
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DIANE SUDDUTH |
| K130849 |
06/14/2013 |
INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
| K130499 |
06/18/2013 |
IU22 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
JESSICA STENBERG |
| K130790 |
06/27/2013 |
LYRIC2 |
PHONAK LLC |
JOHN J SMITH |
| K124012 |
06/04/2013 |
INFILL OBLIQUE TLIF DEVICE |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
| K131100 |
06/27/2013 |
STREAMLINE TL SPINAL SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCINTYRE |
| K130427 |
06/05/2013 |
PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC. |
SARAH MCINTYRE |
| K131237 |
06/13/2013 |
PIPELINE TOTAL HIP SYSTEM |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
| K131543 |
06/20/2013 |
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED |
PROCTER & GAMBLE CO. |
KATHLEEN BLIESZNER |
| K131524 |
06/23/2013 |
PROTEUS PATCH INCLUDING INGESTIBLE SENSOR |
PROTEUS DIGITAL HEALTH, INC. |
ZAHEDEH HATAMKHANY |
| K130487 |
06/25/2013 |
FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE |
PYNG MEDICAL CORP. |
Michele Tyler |
| K130787 |
06/13/2013 |
QUANTUM DENTAL IMPLANT SYSTEM |
QUANTUM BIOENGINEERING, LTD. |
LINDA SCHULZ |
| K131619 |
06/28/2013 |
QUICKVUE INFLUENZA A+B |
QUIDEL CORP. |
JOHN D TAMERIUS |
| K123793 |
06/17/2013 |
SOFIA STREP A FIA |
QUIDEL CORPORATION |
JOHN D TAMERIUS, PH.D. |
| K131329 |
06/06/2013 |
VECTOR PTA BALLOON DILATATION CATHETER |
R4 VASCULAR, INC. |
LAURIE LEWANDOWSKI |
| K130337 |
06/19/2013 |
RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| K130773 |
06/05/2013 |
TEMPUS PRO PATIENT MONITOR |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
| K130002 |
06/28/2013 |
SURECALL LABOR MONITOR |
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP |
J. HARVEY KNAUSS |
| K122715 |
06/17/2013 |
STELLAR 150 |
RESMED GERMANY INC. |
JIM CASSI |
| K131287 |
06/24/2013 |
CARDIOSLEEVE |
RIJUVEN CORP |
E.J. Smith |
| K123106 |
06/20/2013 |
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A |
SAMSUNG ELECTRONICS CO., LTD. |
CHARLIE MACK |
| K123105 |
06/07/2013 |
XGEO GU60 |
SAMSUNG ELECTRONICS CO., LTD. |
CHARLIE MACK |
| K122567 |
06/19/2013 |
JOULE 810/940/980 MULTI-PLATFORM SYSTEM |
SCITON, INC. |
JAY M PATEL |
| K131654 |
06/27/2013 |
STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER |
SENORX, INC. |
SARAH MCCARTNEY |
| K130015 |
06/13/2013 |
SHASER V-MINI HAIR REMOVAL SYSTEM |
SHASER, INC. |
SARAH HACKETT |
| K130833 |
06/21/2013 |
DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN |
| K130695 |
06/19/2013 |
Z5 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
WU ZICUI |
| K131569 |
06/14/2013 |
PG-800A SERIES |
SHENZHEN PANGO ELECTRONIC CO., LTD |
Diana Hong |
| K130739 |
06/06/2013 |
ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K123520 |
06/11/2013 |
MAMMOMAT INSPIRATION PRIME |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K123598 |
06/28/2013 |
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION |
SMITH & NEPHEW, INC. |
Bradley Heil |
| K130193 |
06/14/2013 |
FRAXEL DUAL 1550/1927 LASER SYSTEM |
SOLTA MEDICAL, INC. |
Raymond Lee |
| K130025 |
06/11/2013 |
SONENDO ENDOTHERAPY SYSTEM |
SONENDO, INC. |
DAN W MILLER |
| K131213 |
06/21/2013 |
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
| K130801 |
06/14/2013 |
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
| K131103 |
06/06/2013 |
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR |
SORIN GROUP ITALIA S.R.L. |
SCOTT LIGHT |
| K130279 |
06/20/2013 |
REFORM PEDICLE SCREW SYSTEM |
SPINAL USA |
MEREDITH MAY |
| K130545 |
06/18/2013 |
MULTI LEAD TRIAL CABLE |
ST. JUDE MEDICAL |
Lakshmi Padmanabhan |
| K122365 |
06/04/2013 |
ULTRACHECK CURVE BLOOD PRESSURE CUFFS |
STATCORP MEDICAL |
WAYNE EMMERT |
| K130724 |
06/28/2013 |
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE |
STRAUMANN USA |
ELAINE ALAN |
| K130808 |
06/28/2013 |
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS |
STRAUMANN USA |
ELAINE ALAN |
| K123843 |
06/05/2013 |
NEUROEPG SYSTEM |
STROHL MEDICAL TECHNOLOGIES |
JIM GRECO |
| K130907 |
06/10/2013 |
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
| K121920 |
06/27/2013 |
LASERBRUSH |
SUNETICS INTERNATIONAL MARKETING GROUP, LLC |
JOHN CARULLO |
| K131314 |
06/25/2013 |
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) |
SWISSRAY MEDICAL AG |
TODD SHOPP |
| K130902 |
06/14/2013 |
EMORY CARDIAC TOOLBOX 3.2 |
SYNTERMED, INC. |
KENNETH VAN TRAIN |
| K131193 |
06/18/2013 |
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM |
TACTILE SYSTEMS TECHNOLOGY INC |
DAVE HALVERSON |
| K121045 |
06/19/2013 |
HUMAN ALBUMIN CSF KIT |
THE BINDING SITE GROUP, LTD. |
JILL CONSTANTINE |
| K122965 |
06/03/2013 |
HUMAN CAERULOPLASMIN KIT |
THE BINDING SITE GROUP, LTD. |
JILL CONSTANTINE |
| K122950 |
06/14/2013 |
LASER HELMET |
THERADOME INC. |
LARRY PETERSEN |
| K130850 |
06/25/2013 |
PRIMI AND SECONDI SUPPORT CATHETERS |
THERMOPEUTIX INC. |
JASON FORD |
| K123101 |
06/05/2013 |
TRC-50DX RETINAL CAMERA |
TOPCON MEDICAL SYSTEMS, INC. |
MAUREEN O'CONNELL |
| K130645 |
06/06/2013 |
AQUILION PRIME, V5.00 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K131489 |
06/25/2013 |
TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION |
TRACTUS CORPORATION |
MARK JOB |
| K130414 |
06/15/2013 |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 |
TRIREME MEDICAL, INC. |
SHIVA ARDAKANI |
| K123087 |
06/18/2013 |
TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K122957 |
06/21/2013 |
TEZO TITANIUM CAGE FAMILY |
ULRICH GMBH & CO. KG |
HANS STOVER |
| K130149 |
06/06/2013 |
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K130794 |
06/20/2013 |
CELLTRACKS ANALYZER II SYSTEM |
VERIDEX, LLC |
KIMBERLY PRESCOTT |
| K130636 |
06/07/2013 |
TELERADPRO EDGE; TELERADPRO EDGE HD-CCD |
VIDAR SYSTEMS CORP. |
CARRIE L BRANCART |
| K130867 |
06/14/2013 |
ENFLOW IV FLUID WARMER INSULATED STRAP |
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY |
STACIE GEFFNER-ATIYA |
| K130486 |
06/20/2013 |
FUTURABOND UNIVERSAL |
VOCO GMBH |
T. GERKENSMEIER |
| K131288 |
06/21/2013 |
VERRATA PRESSURE GUIDE WIRE |
VOLCANO CORPORATION |
JWALA JAWHARKAR |
| K130753 |
06/13/2013 |
STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE |
WATCHDOG GROUP, LC |
JOHN O'HARA |
| K121618 |
06/14/2013 |
BEL-GEN COLD STORAGE SOLUTION |
WATERS MEDICAL SYSTEMS, LLC |
ROBERT WARREN |
| K123590 |
06/17/2013 |
VINYL EXAMINATION POWDER FREE GLOVES, CLEAR |
WEILIN PLASTIC AND RUBBER PRODUCTS CO., LTD. |
LING ZHU |
| K131373 |
06/25/2013 |
SHANGRING |
WUHU SNNDA MEDICAL TREATMENT APPLIANCE TECHNOLOGY |
BO GONG |
| K130438 |
06/27/2013 |
AXLE INTERSPINOUS FUSION SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN, M.D. |
| K122763 |
06/20/2013 |
PHYSIOLOGICAL DATA PROCESSOR |
ZEPHYR TECHNOLOGY CORPORATION |
RICHARD KEEN |
| K122020 |
06/05/2013 |
PHOTON PHOTON PLUS |
ZOLAR TECHNOLOGY & MFG. CO. INC. |
SUSAN D GOLDSTEIN-FALK |
| K130690 |
06/12/2013 |
Z-800 INFUSION SYSTEM |
ZYNO MEDICAL LLC |
MEI ZHANG PHD |
