| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K100235 |
05/12/2010 |
FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE |
3M COMPANY |
SCOTT ERICKSON |
| K093716 |
05/13/2010 |
BABI PLUS INFANT NASAL CANNULA SYSTEM |
A PLUS MEDICAL |
TOM LOESCHER |
| K092097 |
05/06/2010 |
A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH |
A.B. KORKOR MEDICAL, INC. |
ANDREW BLACK |
| K100750 |
05/21/2010 |
AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K092602 |
05/14/2010 |
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System |
ABBOTT DIABETES CARE INC. |
ARUL STERLIN |
| K092705 |
05/28/2010 |
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 |
ABBOTT MOLECULAR, INC. |
PAULA E MARTIN |
| K092704 |
05/28/2010 |
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 |
ABBOTT MOLECULAR, INC. |
PAULA MARTIN |
| K101011 |
05/24/2010 |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL |
ABBOTT VASCULAR INC. |
KAY SETZER |
| K093649 |
05/11/2010 |
AESCULAP STERILCONTAINER S |
AESCULAP |
KATHY RACOSKY |
| K092628 |
05/20/2010 |
ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET |
ALAN REID |
PAUL DRYDEN |
| K093710 |
05/12/2010 |
THE MOSES APPLIANCE |
ALLEN J. MOSES, DDS, LTD. |
ALLEN J MOSES |
| K100265 |
05/13/2010 |
DIAMOND ANTERIOR CERVICAL PLATE SYSTEM |
AMENDIA, INC. |
TIM LUSBY |
| K092219 |
05/12/2010 |
NAVIGATOR CLINICAL GUIDENCE SYSTEM |
APPLIED PHYSIOLOGY PTY LTD. |
ROBERT N CLARK |
| K100353 |
05/13/2010 |
SPINEWAND SURGICAL DEVICE |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K101184 |
05/18/2010 |
TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K100254 |
05/28/2010 |
REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER |
ASCENT HEALTHCARE SOLUTIONS |
AMANDA BABCOCK |
| K100537 |
05/12/2010 |
REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE |
ASCENT HEALTHCARE SOLUTIONS |
RAMONA KULIK |
| K090379 |
05/26/2010 |
AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES |
AVITA CORPORATION |
JENNIFER REICH |
| K082044 |
05/11/2010 |
ACE STAPLER, MODEL F0031 |
BAROSENSE, INC |
DANIEL J BALBIERZ |
| K100010 |
05/14/2010 |
HDL CHOLESTEROL (HDLX) ASSAY |
BECKMAN COULTER, INC. |
Yvette Lloyd |
| K100203 |
05/17/2010 |
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K092302 |
05/05/2010 |
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR |
BETTERCARE PLASTIC PRODUCTS CO., LTD. |
JIE LIU |
| K100320 |
05/05/2010 |
SLENDERTONE SYSTEM ULTRA MODEL E70/X70 |
BIO-MEDICAL RESEARCH, LTD. |
DEIRDRE BARROW |
| K100847 |
05/21/2010 |
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 |
BIOCOMPATIBLES, INC. |
WAYNE W RICHARDSON |
| K100150 |
05/25/2010 |
CERAMICS2IN1 |
BIODENTA SWISS AG |
DAVID EILER |
| K092454 |
05/21/2010 |
VITEK 2 YEAST VORICONAZOLE |
BIOMERIEUX, INC. |
Nancy Weaver |
| K093123 |
05/13/2010 |
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB |
BIOMERIX CORPORATION |
CHRISTINA L KICHULA |
| K092528 |
05/21/2010 |
BIOMET FORERUNNER LOCKING PLATE SYSTEM |
BIOMET TRAUMA (AKA EBI, LP) |
MARGARET CROWE |
| K100691 |
05/11/2010 |
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 |
BIONIX DEVELOPMENT CORP. |
JAMES HUTTNER |
| K100560 |
05/12/2010 |
EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 |
Biotest Medical Corp. |
MAGGIE CHU |
| K101078 |
05/10/2010 |
BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM |
BL HEALTHCARE, INC. |
MICHAEL MATHUR |
| K100614 |
05/04/2010 |
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES |
BLACKSTONE MEDICAL, INC. |
DARLA CHEW |
| K092467 |
05/06/2010 |
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED |
BRAINLAB AG |
ALEXANDER DRUSE |
| K100913 |
05/26/2010 |
IQVITALS AND IQVITALS SYSTEM |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
GREG HOLLAND |
| K093909 |
05/06/2010 |
BUSSE SURGICAL DRAPES IV |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K093747 |
05/07/2010 |
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS |
C.R. BARD, INC. |
JOHN KNORPP |
| K101169 |
05/20/2010 |
DESARA MESH MODEL: CAL-DS01 |
CALDERA MEDICAL, INC. |
VICKI GAIL |
| K093094 |
05/11/2010 |
VELA VENTILATOR |
CARDINAL HEALTH 207, INC. |
FAROKH ETEMADIEH |
| K100008 |
05/18/2010 |
CARDO MEDICAL CERAMIC HIP SYSTEM |
CARDO MEDICAL, INC |
DAVE LAMB |
| K100508 |
05/05/2010 |
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B |
CAREMATIX INC. |
SUKHWANT KHANUJA |
| K092187 |
05/27/2010 |
MAIA, MODEL 1 |
CENTERVUE SPA |
GIULIANO BARBARO |
| K100553 |
05/25/2010 |
BLOOD PRESSURE METER MODEL CH-101 |
CITIZEN SYSTEMS JAPAN CO., LTD. |
NATHAN A BEAVER |
| K093973 |
05/26/2010 |
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM |
Codman & Shurtleff, Inc. |
Amarilys Machado |
| K092608 |
05/28/2010 |
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K100878 |
05/26/2010 |
SELF CATH CATHETER |
COLOPLAST MANUFACTURING US, LLC |
BRIAN SCHMIDT |
| K100686 |
05/21/2010 |
CONMED MACROLYTE DISPERSIVE ELECTRODE |
CONMED CORPORATION |
SHAWN RIEDEL |
| K100047 |
05/14/2010 |
SUREFIT DUAL DISPERSIVE ELECTRODE |
CONMED CORPORATION |
SHAWN RIEDEL |
| K093895 |
05/20/2010 |
ALLY PLATFORM SYSTEM |
CONTINUITY HEALTH SOLUTIONS |
BRIAN POTEET |
| K100974 |
05/06/2010 |
SPECTRUM TURBO-JECT PICC SET |
COOK INCORPORATED |
SUSANNE GALIN |
| K100365 |
05/20/2010 |
FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K100306 |
05/04/2010 |
KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES |
COVIDIEN |
MIA PROLI |
| K092021 |
05/25/2010 |
CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) |
CRYOLIFE, INC. |
JOHN D FERROS |
| K101151 |
05/19/2010 |
REGENT ANTERIOR CERVICAL PLATE |
CUSTOM SPINE |
SAAD ATTIYAH |
| K093886 |
05/03/2010 |
ENGSTROM CARESTATION, ENGSTROM PRO |
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
JIM RASKOB |
| K100238 |
05/11/2010 |
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K093390 |
05/25/2010 |
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
| K093168 |
05/21/2010 |
MEDIFLASH AND ESTEFLASH |
DERMEO |
E.J. Smith |
| K092229 |
05/18/2010 |
THYRETAIN TM TSI REPORTER BIOASSAY |
DIAGNOSTIC HYBRIDS, INC. |
Ronald H Lollar |
| K101215 |
05/12/2010 |
NUANCE |
DISCUS DENTAL, LLC |
WINKIE WONG |
| K100704 |
05/14/2010 |
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE |
DISETRONIC MEDICAL SYSTEMS AG |
Scott Thiel |
| K092062 |
05/24/2010 |
EVERON 1.0 |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K101094 |
05/17/2010 |
CLEARJET |
EASYGLIDE LTD. |
PAUL DRYDEN |
| K100220 |
05/17/2010 |
POLARIS SPINAL SYSTEM |
EBI, L.P. |
SHIKHA GOLA |
| K091336 |
05/07/2010 |
IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V |
ENTHERMICS MEDICAL SYSTEMS, INC. |
EMALEE G MURPHY |
| K100336 |
05/12/2010 |
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 |
ERAGEN BIOSCIENCES |
RANDAL VADER |
| K100423 |
05/04/2010 |
DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 |
ETHICON, INC. |
NEELU MEDHEKAR |
| K100435 |
05/28/2010 |
AMEDA PLATINUM BREAST PUMP |
EVENFLO COMPANY, INC. |
STEVE NOWAK |
| K093978 |
05/11/2010 |
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM |
EXACTECH, INC. |
SHING JEN TAI |
| K093275 |
05/27/2010 |
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER |
EXACTECH, INC. |
LINDY KNISELY |
| K100269 |
05/27/2010 |
NOVATION CROWN CUP GXL LINERS |
EXACTECH, INC. |
GRAHAM L CUTHBERT |
| K093863 |
05/10/2010 |
EPIDRUM |
EXMOOR PLASTICS LTD. |
MARGARET BLACKMORE |
| K093218 |
05/18/2010 |
FEMEYE TWO |
FEMSUITE, LLC |
PAVAN SETHI |
| K094039 |
05/07/2010 |
HYALO GYN |
FIDIA FARMACEUTICI SPA |
GIUSI LOCASTRO |
| K100554 |
05/28/2010 |
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441 |
FISHER & PAYKEL HEALTHCARE, LTD. |
IVY CHENG |
| K100148 |
05/24/2010 |
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 |
FOCUS DIAGNOSTICS, INC. |
TARA VIVIANI |
| K093902 |
05/27/2010 |
MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
RANDOLPH QUINN |
| K091812 |
05/07/2010 |
FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS |
FRONTIER DEVICES, INC. |
DON PETERSEN |
| K091615 |
05/06/2010 |
MED CONTOUR |
GENERAL PROJECT S.R.L. |
MAUREEN O'CONNELL |
| K093161 |
05/10/2010 |
ACTIPROTECT UF N95 RESPIRATOR |
GLAXOSMITHKLINE CONSUMER HEALTHCARE |
ZINATARA A MANJI |
| K100788 |
05/14/2010 |
COCR RODS |
GLOBUS MEDICAL INC. |
KELLY BAKER |
| K100839 |
05/11/2010 |
BARIREP |
GORBEC PHARMACEUTICAL SERVICES, INC. |
MATTHEW POPP |
| K090191 |
05/27/2010 |
HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB |
HANDYLAB, INC |
MARTHA J RUMFORD |
| K101142 |
05/26/2010 |
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
| K101143 |
05/26/2010 |
HEARTWAY POWER MOBILITY SCOOTER, S11 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
| K100369 |
05/20/2010 |
POWDER-FREE NITRILE GLOVES, BLACK |
HL RUBBER INDUSTRIES SDN BHD |
LAU SIONG HUT |
| K100271 |
05/14/2010 |
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES |
HOWMEDICA OSTEONICS CORP. |
MELISSA MATARESE |
| K101056 |
05/13/2010 |
VARIAX ELBOW SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MELISSA MATARESE |
| K100734 |
05/18/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
HUANFU PLASTIC PRODUCTS LIMITED |
CHU XIAOAN |
| K100523 |
05/04/2010 |
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA |
HYGIA HEALTH SERVICES, INC. |
LAKE TRECHSEL |
| K093813 |
05/10/2010 |
OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE |
IMBIOTECHNOLOGIES |
ROSINA ROBINSON |
| K091168 |
05/27/2010 |
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 |
INFOPIA CO., LTD |
MARIA F GRIFFIN |
| K092586 |
05/12/2010 |
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU |
INNOLATEX (THAILAND) LIMITED |
GOH SAING |
| K091556 |
05/21/2010 |
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K093737 |
05/04/2010 |
HEMOSIL F11 & FV DNA CONTROL |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K092129 |
05/18/2010 |
INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 |
INTERSURGICAL, INC. |
MICHAEL ZALEWSKI |
| K092349 |
05/10/2010 |
CLEARVIEW EXACT II INFLUENZA A & B TEST |
INVERNESS MEDICAL, INC. |
Anne Jepson |
| K100857 |
05/27/2010 |
FUSION MEDICAL RING LOCK SYSTEM |
JOHN J RICCIO |
JOHN RICCIO |
| K100349 |
05/21/2010 |
VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER |
JOHNSON & JOHNSON VISION CARE, INC. |
CATHERINE DILLON |
| K094061 |
05/18/2010 |
KENSEY NASH ECM SURGICAL PATCH |
KENSEY NASH CORPORATION |
LORI A BURNS, MS, RAC |
| K101175 |
05/20/2010 |
KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER |
KFX MEDICAL |
GAYLE HIROTA |
| K090633 |
05/13/2010 |
LENSAR LASER SYSTEM |
LENSAR, INC. |
SHIRLEY MCGARVEY |
| K100616 |
05/20/2010 |
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 |
LIFE TECHNOLOGIES CORPORATION |
KELLI TANZELLA |
| K093087 |
05/12/2010 |
BWF-5 MEDICAL LASER SERIES |
LITECURE, LLC |
LIANG LU |
| K092689 |
05/20/2010 |
MANUKAPLI WOUND DRESSING |
MANUKA MEDICAL LIMITED |
James Smith |
| K094046 |
05/14/2010 |
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K100617 |
05/28/2010 |
MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K100056 |
05/07/2010 |
MEDCOM RT-VIEWER SYSTEM |
MEDCOM GMBH |
STEFAN WALTER |
| K092116 |
05/12/2010 |
EASYCELL CELL LOCATOR |
MEDICA CORP. |
FRAN WHITE |
| K100187 |
05/05/2010 |
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT |
MEDICA CORP. |
Photios Makris |
| K083798 |
05/19/2010 |
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF |
MEDICREA TECHNOLOGIES |
DONALD GUTHNER |
| K090386 |
05/28/2010 |
NON-INVASIVE INFRARED (NIR) |
MEDISIM LTD. |
YEVGENIA LIBSTER |
| K093738 |
05/14/2010 |
MRI PATIENT POSITIONING DEVICES |
MEDTEC, INC. |
JAMES LEONG |
| K100274 |
05/10/2010 |
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L |
MEDTRONIC INC. |
CARALEE WALTON |
| K101139 |
05/21/2010 |
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE |
MEDTRONIC INC. |
THOMAS REICHEL |
| K100521 |
05/14/2010 |
COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS |
MEGO AFEK AC LTD |
AVAHA STEIN |
| K100677 |
05/20/2010 |
LYMPHA PRESS 201MAX, MODEL 201MAX |
MEGO AFEK AC LTD |
AHAVA STEIN |
| K093820 |
05/19/2010 |
SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
| K093766 |
05/07/2010 |
VITALOGIK 6000/6500 |
MENNEN MEDICAL LTD. |
IFAT OREN SHWARTS |
| K093114 |
05/12/2010 |
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY |
MICROGENICS CORP. |
HEWUAN TAKKELE |
| K100953 |
05/17/2010 |
MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K101275 |
05/28/2010 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K091255 |
05/12/2010 |
MINXRAY, MODEL: BPD60 |
MINXRAY, INC. |
DANIEL KAMM |
| K093479 |
05/19/2010 |
DISPOSABLE SUCTION AND IRRIGATION SYSTEM |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
EUGENE YEUNG |
| K091734 |
05/21/2010 |
SONIC SHOT GX |
NEMOTO KYORINDO CO., LTD. |
MASAHIRO SAKAKIBARA |
| K093739 |
05/07/2010 |
BLOOD PRESSURE MONITOR/ MODELS |
NINGBO DIAIER ELECTRONIC CO., LTD. |
LAO XIKUN |
| K094054 |
05/14/2010 |
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE |
NUVASIVE, INC. |
Sheila Bruschi |
| K093862 |
05/06/2010 |
CAREVENT HANDHELD CPAP SYSTEM |
O-TWO MEDICAL TECHNOLOGIES, INC. |
David Zhang |
| K100151 |
05/28/2010 |
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) |
OMNLIFE SCIENCE |
Robert Zoletti |
| K100194 |
05/20/2010 |
OPTICAL INTEGRITY LASERGUARD FIBERS |
OPTICAL INTEGRITY, INC. |
RONALD E BOWMAN |
| K100019 |
05/04/2010 |
PASCAL STREAMLINE PHOTOCOAGULATOR |
OPTIMEDICA CORPORATION |
DARLENE CROCKETT-BILLING |
| K094012 |
05/12/2010 |
CAPNOSTREAM20 WITH MICROMEDICO2 MODULE |
ORIDION CAPNOGRAPHY, INC. |
RACHEL WEISSBROD |
| K100240 |
05/17/2010 |
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K092560 |
05/06/2010 |
PARI SINUS |
PARI RESPIRATORY EQUIPMENT, INC. |
MICHAEL JUDGE |
| K100462 |
05/19/2010 |
JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIT BAIRD |
| K100769 |
05/21/2010 |
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 |
PENUMBRA, INC. |
MICHAELA MAHL |
| K101067 |
05/07/2010 |
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068 |
PHILIPS MEDICAL SYSTEMS |
PENG CUI |
| K093268 |
05/11/2010 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K093590 |
05/12/2010 |
PLANMECA PROMAX 3D MAX |
PLANMECA OY |
LARS MORING |
| K100524 |
05/24/2010 |
POLYTEL(R) APT MODEL: PWA-08-01 |
POLYMAP WIRELESS, LLC |
PIERRE LANDAU |
| K100341 |
05/04/2010 |
SPERMCHECK FERTILITY |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K100503 |
05/12/2010 |
PULPDENT COPAL VARNISH WITH FLUORIDE |
PULPDENT CORPORATION |
KENNETH J BERK |
| K093264 |
05/28/2010 |
VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED |
QINGDAO LANG HUI IMPORT & EXPORT CO., LTD |
MARSHAL MA |
| K100735 |
05/18/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
RAYU PLASTIC PRODUCTS LIMITED |
CHU XIAOAN |
| K100606 |
05/28/2010 |
VATEA ENDONTIC IRRIGATION SYSTEM |
REDENT NOVA LTD |
JONATHAN S KAHAN |
| K092955 |
05/10/2010 |
REDSENSE-HOME USE |
REDSENSE MEDICAL AB |
CONSTANCE G BUNDY |
| K101264 |
05/11/2010 |
TEMPUS IC PROFESSIONAL PATIENT MONITOR |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
| K093905 |
05/12/2010 |
TRILOGY 202 VENTILATOR |
RESPIRONICS, INC. |
JOSEPH OLSAVSKY |
| K092117 |
05/28/2010 |
SCENAR, MODEL 10 |
RITM OKB ZAO |
LARISA SHPUNGINA |
| K100006 |
05/10/2010 |
HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED |
RIVERPOINT MEDICAL |
DOUG ROWLEY |
| K100139 |
05/04/2010 |
SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 |
SAFELIFE CORP. |
ALBERT REGO |
| K100182 |
05/10/2010 |
SALVIN DENTAL SPECIALTIES FIXATION SCREW |
SALVIN DENTAL SPECIALTIES, INC. |
ROBERT SALVIN |
| K093794 |
05/14/2010 |
SMART-READ EZTEST-STEAM SCBI AND TEST PACK |
SGM BIOTECH, INC. |
JOHN R GILLIS, PH.D. |
| K093327 |
05/10/2010 |
INTCO TAB ELECTRODE |
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. |
CHRIS HEALY |
| K100211 |
05/11/2010 |
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA |
SHEN WEI (USA), INC. |
BELLE CHOU |
| K100626 |
05/21/2010 |
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 |
SHENZHEN BIOCARE ELECTRONICS CO., LTD |
Diana Hong |
| K092164 |
05/13/2010 |
TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA |
SHENZHEN DELICATE ELECTRONICS CO., LTD. |
WILLIAM STERN |
| K100830 |
05/05/2010 |
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K100699 |
05/20/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG STAR PLASTIC CO., LTD |
CHU XIAOAN |
| K100697 |
05/13/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD |
CHU XIAOAN |
| K092617 |
05/20/2010 |
ROYAL GUARD |
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. |
KOK-KEE HON |
| K100637 |
05/26/2010 |
SYNGO.CT CORONARY ANALYSIS |
SIEMENS AG, MEDICAL SOLUTIONS |
RALF HOFMANN |
| K093939 |
05/19/2010 |
ADVIA CHEMISTRY SALICYLATE REAGENT |
SIEMENS HEALTHCARE DIAGNOSTICS |
KIRA GORDON |
| K100289 |
05/10/2010 |
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 |
SIEMENS HEALTHCARE DIAGNOSTICS |
Sandra D White |
| K100778 |
05/05/2010 |
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE T MARINELLI |
| K100433 |
05/13/2010 |
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROBERT C EUSEBIO |
| K100619 |
05/07/2010 |
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 |
SIEMENS MEDICAL SOLUTIONS USA INC. |
ELAINE CHANG |
| K100160 |
05/11/2010 |
ZZOMA POSITIONAL SLEEPER MODEL 001 |
SLEEP SPECIALISTS, LLC |
HOWARD MANN |
| K100412 |
05/05/2010 |
BIOLOX DELTA CERAMIC FEMORAL HEADS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K100897 |
05/13/2010 |
LEGION POROUS + HA TIBIAL BASEPLATES |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K100325 |
05/04/2010 |
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES |
SMITH & NEPHEW, INC. |
LAURA MEDLIN |
| K101197 |
05/05/2010 |
PARIE TENE PROGRIP MESH |
SOFRADIM PRODUCTION |
SHARON ALEXANDER |
| K100193 |
05/18/2010 |
OTOMAG BONE CONDUCTION HEARING SYSTEM |
SOPHONO, INC |
Mary Armstrong |
| K094002 |
05/07/2010 |
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM |
SPARTEK MEDICAL, INC. |
HENRY KLYCE |
| K092476 |
05/07/2010 |
SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M |
SPORT-ELEC |
KIMBERLY ROSS |
| K100852 |
05/06/2010 |
STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 |
STRYKER COMMUNICATIONS |
ALMA RELJA |
| K100257 |
05/10/2010 |
VLOC9ABSORBABLE WOUND CLOSURE DEVICE |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
JENNIFER BRENNAN |
| K100180 |
05/05/2010 |
SURGIQUEST ANCHORPORT SIL KIT |
SURGIQUEST, INC. |
KOUROSH AZARBARZIN |
| K100824 |
05/25/2010 |
MECHANICAL WHEELCHAIR, MODEL DS 202-S |
SUZHOU KD MEDICAL |
JACOB CHANG |
| K100856 |
05/19/2010 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K100849 |
05/21/2010 |
SYNC-RX SYSTEM, MODEL AS00010 |
SYNC-RX LTD |
A ANSELMO |
| K092812 |
05/11/2010 |
SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K092190 |
05/11/2010 |
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS |
SYNTHES (USA) |
JILL R YELTON |
| K100089 |
05/13/2010 |
SYNTHES T-PAL SPACER |
SYNTHES SPINE |
HEATHER GUERIN |
| K094005 |
05/05/2010 |
FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
NICKY PAN |
| K100427 |
05/28/2010 |
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY |
TaiDoc Technology Corporation |
TELING HSU |
| K100406 |
05/11/2010 |
FORA V20 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
NICKY PAN |
| K100942 |
05/26/2010 |
U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118 |
TaiDoc Technology Corporation |
NICKY PAN |
| K100232 |
05/21/2010 |
LUMINESSE ZR BLANKS |
TALLADIUM, INC. |
EDWARD HARMS |
| K092789 |
05/12/2010 |
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
CHRISTINA THOMAS |
| K093992 |
05/19/2010 |
TERUMO LAUER LOCK ADAPTER |
Terumo Cardiovascular Systems Corporation |
EILEEN DORSEY |
| K100142 |
05/06/2010 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
TORNIER |
SEVERIEN BONNETON |
| K092695 |
05/21/2010 |
TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM |
TRANSCORP, INC. |
ANDREW RODENHOUSE |
| K101062 |
05/12/2010 |
GLIDER PTA BALLOON CATHETER |
TRIREME MEDICAL INC |
SHIVA ARDAKANI |
| K090861 |
05/21/2010 |
MAMBO, MODEL CS 18XX-XX |
ULRICH GMBH & CO. KG |
MERLE SYMES |
| K100363 |
05/21/2010 |
ULTRA DCI MODEL 5000 |
ULTRASOUND MEDICAL DEVICES, INC. |
PAUL KORTESOJA |
| K100095 |
05/10/2010 |
CENTRAL VISION ANALYZER MODEL 1000 |
VIMETRICS,LLC. |
STEPHEN H H SINCLAIR,MD |
| K100656 |
05/26/2010 |
COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) |
WONJIN MULSAN CO., LTD. |
BRANDON CHOI |
| K093405 |
05/25/2010 |
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K100154 |
05/21/2010 |
FIXCET SPINAL FACET SCREW SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K101113 |
05/21/2010 |
GUARDIAN II NC HEMOSTASIS VALVE |
ZERUSA LIMITED |
LIAM MULLOY |
| K100486 |
05/05/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD |
FRANK LIU |
| K100294 |
05/14/2010 |
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO YINGHAO MEDICAL PRODUCTS CO., LTD |
FRANK LIU |
| K092507 |
05/11/2010 |
ZIT-Z |
ZITERION |
STEFFEN KAHDEMANN |
