| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K072163 |
03/06/2008 |
HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 |
3A HEALTH CARE S.R.L. |
MAUREEN O'CONNELL |
| K080514 |
03/26/2008 |
PECD-01 AND PECD QUICK-01 |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
| K080133 |
03/13/2008 |
MOUNTABLE ENDOSCOPIC BLADE |
A.M. SURGICAL, INC. |
VINCENT PASCALE |
| K072411 |
03/20/2008 |
AAP BONE PLATES AND SCREW IMPLANTS |
AAP IMPLANTATE AG |
MARC SEEGERS |
| K080101 |
03/25/2008 |
AAP CANNULATED SCREW AND DARCO HEADED SCREW |
AAP IMPLANTATE AG |
MARC SEEGERS |
| K071525 |
03/19/2008 |
ACTIVATED ASPARTATE AMINOTRANSFERASE |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K080264 |
03/26/2008 |
MODIFICATION TO: FOX PLUS PTA CATHETER |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
Ivalee Cohen |
| K073276 |
03/05/2008 |
IONTOPHORESIS SYSTEM |
ACCLARENT, INC. |
KERI YEN |
| K073041 |
03/11/2008 |
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER |
ACCLARENT, INC. |
KERI YEN |
| K072891 |
03/19/2008 |
SINUS SPACER |
ACCLARENT, INC. |
KERI YEN |
| K073343 |
03/13/2008 |
ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
| K080500 |
03/13/2008 |
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 |
ACUMEN MEDICAL, INC. |
KEVIN MACDONALD |
| K071120 |
03/13/2008 |
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999 |
AEMED, INC. |
RALPH JUGO |
| K072816 |
03/03/2008 |
NIOX MINO |
AEROCRINE AB |
JOEL SLOMOFF |
| K073227 |
03/20/2008 |
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300 |
AIIA COMMUNICATION INC. |
DANIEL KAMM |
| K072185 |
03/27/2008 |
AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 |
AIRISTAR TECHNOLOGIES, LLC |
DANIEL KAMM |
| K070965 |
03/05/2008 |
ALICIA MENSTRUAL CUP |
ALICIA INTERNATIONAL PTY LTD. |
TOM STONE |
| K072214 |
03/06/2008 |
PORTABLE VENTILATOR, MODEL EPV-100 |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K080318 |
03/07/2008 |
ALMA LASER NIR MODULE |
ALMA LASERS LTD. |
TATIANA EPSTEIN |
| K073553 |
03/05/2008 |
CAMLOG IMPLANT SYSTEM ABUTMENTS |
ALTATEC GMBH |
LINDA K SCHULZ |
| K071242 |
03/06/2008 |
DBEST ONE STEP OCCULT BLOOD TEST KITS |
AMERITEK USA, INC. |
K.C. YEE |
| K073526 |
03/12/2008 |
AMICAS VISION SERIES PACS, MODEL 5.5 |
AMICAS, INC. |
PATRICE NEDELEC |
| K070800 |
03/06/2008 |
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM |
ANSELL HEALTHCARE PRODUCTS LLC |
LON D MCILVAIN |
| K073265 |
03/14/2008 |
APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM |
APIERON, INC. |
RICHARD LOTTI |
| K073034 |
03/14/2008 |
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) |
APPLIED MEDICAL TECHNOLOGY, INC. |
BRIAN BAKER |
| K080482 |
03/20/2008 |
ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K080610 |
03/31/2008 |
ARTHROCARE ORTHOWAND SURGICAL DEVICE |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K073605 |
03/11/2008 |
ATRICURE COOLRAIL LINEAR PEN |
ATRICURE, INC. |
ALISON GRIMALDI |
| K072686 |
03/17/2008 |
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
Claire Dora |
| K073538 |
03/12/2008 |
DUAL CHAMBER TPN CONTAINER |
B. BRAUN MEDICAL, INC. |
TRACY MADDOCK |
| K073023 |
03/12/2008 |
STERILS SINGLE-USE I/A HANDPIECES |
BAUSCH & LOMB, INC. |
NED LUCE |
| K080494 |
03/04/2008 |
BAXANO ULTRA LOW PROFILE RONGEUR |
BAXANO, INC. |
SHARON ROCKWELL |
| K080166 |
03/19/2008 |
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 |
BECKMAN COULTER, INC. |
JEFFREY L KOLL |
| K073589 |
03/05/2008 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS |
BECTON, DICKINSON & CO. |
Monica Giguere |
| K073262 |
03/26/2008 |
BELLA |
BEEKLEY CORP. |
MARTINE M BOUTTE |
| K073299 |
03/05/2008 |
BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE |
BETELCARE SDN BHD |
KENG BENG SIAH |
| K071666 |
03/12/2008 |
SLENDERTONE ENERVIVE, MODEL 561 |
BIO-MEDICAL RESEARCH CORP. |
ANNE-MARIE KEENAN |
| K080471 |
03/05/2008 |
RADIO BIOAQUACARE |
BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC |
JONATHAN KAHAN |
| K072036 |
03/19/2008 |
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 |
BIOKIT S.A. |
JOAN GUIXER |
| K073345 |
03/07/2008 |
CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT |
BIOMET 3I, INC. |
PRISCILLA CARO |
| K073637 |
03/20/2008 |
PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS |
BIOMET MANUFACTURING CORP. |
ELIZABETH WRAY |
| K080204 |
03/20/2008 |
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS |
BIOMET, INC. |
GARY BAKER |
| K072321 |
03/25/2008 |
BIOFLEX |
BIOSPINE CO., LTD. |
JUSTIN EGGLETON |
| K072329 |
03/25/2008 |
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K080394 |
03/13/2008 |
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K080407 |
03/13/2008 |
BLACKSTONE SFS PARALLEL ROD CONNECTORS |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K073713 |
03/28/2008 |
BLUE SKY BIO DENTAL IMPLANT SYSTEM |
BLUE SKY BIO, LLC |
MICHELE VOVOLKA |
| K073623 |
03/13/2008 |
ATLANTIS 018 PERIPHERAL IMAGING CATHETER |
BOSTON SCIENTIFIC CORP. |
EMILLY TOJIMA |
| K080272 |
03/11/2008 |
ATLANTIS PVIMAGING CATHETER, MODEL H749364560 |
BOSTON SCIENTIFIC CORP. |
JANICE BROWN |
| K072719 |
03/07/2008 |
CONVOY ADVANCED DELIVERY SHEATH |
BOSTON SCIENTIFIC CORP. |
CINDY MORROW |
| K070310 |
03/31/2008 |
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM |
BRAHMS AKTIENGESELLSCHAFT |
JONAS LEICHTNER |
| K080170 |
03/25/2008 |
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) |
C.R. BARD, INC. |
SKIP RIMER |
| K080154 |
03/20/2008 |
ACUITY UNIVERSAL CUTTER |
CARDIAC PACEMAKERS, INC. |
KATHLEEN VITTUM |
| K080076 |
03/14/2008 |
RX DC X-RAY UNIT |
CEFLA S.C.R.L. |
CLAUDE BERTOIN |
| K073475 |
03/10/2008 |
SYSTEM PLUS |
CONTINENTAL DENTAL LABORATORY |
KAREEN CHAMBERLAIN |
| K071763 |
03/07/2008 |
AMADEUS ADAPTIVE COMPRESSION THERAPY |
CONVATEC |
MARILYN KONICKY |
| K073391 |
03/21/2008 |
SURGISIS BIODESIGN TISSUE GRAFT |
COOK BIOTECH, INC. |
MARY A FADERAN |
| K073627 |
03/04/2008 |
FLEXOR EVAC ASPIRATION CATHETER |
COOK, INC. |
KAREN BRADBURN |
| K073164 |
03/05/2008 |
IVS TUNNELLER DEVICES |
COVIDIEN UK MANUFACTURING LTD |
SHARON ALEXANDER |
| K080406 |
03/10/2008 |
IPULSE, MODEL I400 |
CYDEN LIMITED |
MICHEAL KIERNAN |
| K073604 |
03/13/2008 |
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD |
DADE BEHRING, INC. |
YUK-TING LEWIS |
| K071694 |
03/20/2008 |
COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX |
DAIKEN MEDICAL CO, LTD. |
FUMIAK KANAI |
| K080207 |
03/12/2008 |
DANYANG HUAYI K2 AND K7 WHEELCHAIRS |
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
NORMAN F ESTRIN |
| K073075 |
03/31/2008 |
FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K080203 |
03/26/2008 |
MTA ROOT CANAL SEALER |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K072730 |
03/27/2008 |
FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS |
DENTSPLY INTL. |
HELEN LEWIS |
| K080352 |
03/12/2008 |
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K073260 |
03/13/2008 |
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 |
DEVICE PARTNERS INTERNATIONAL |
MONICA E DOUGHERTY |
| K073118 |
03/05/2008 |
PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM |
DIAGNOSTIC DEVICES INC. |
ERICA LI |
| K073488 |
03/07/2008 |
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX |
DIAZYME LABORATORIES |
CHARLES YU |
| K063443 |
03/11/2008 |
DRAEGER ALCOTEST 6510 |
DRAGER SAFETY |
EVE DAMIANO |
| K070855 |
03/20/2008 |
SLEEP QUALITY |
DYNADX CORPORATION |
EJ Smith |
| K080087 |
03/11/2008 |
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K080422 |
03/10/2008 |
5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K080457 |
03/20/2008 |
COLOR LCD MONITOR, MODEL RADIFORCE RX211 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K080423 |
03/11/2008 |
INTEGRE, MODEL LP581 |
Ellex Medical Pty. Ltd. |
KEVIN HOWARD |
| K080717 |
03/27/2008 |
HABIB HEXABLATE 10 |
EMCISION, LTD. |
NAGY HABIB |
| K071869 |
03/07/2008 |
TENS/IF 14 |
EMSI |
CHERITA JAMES |
| K080402 |
03/28/2008 |
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K080258 |
03/10/2008 |
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
ENDIUS, INC. |
REGINA WAGNER |
| K073709 |
03/11/2008 |
MODIFICATION TO VIEWMATE SYSTEM |
EP MEDSYSTEMS |
LARRY PICCIANO |
| K073507 |
03/05/2008 |
ANCHORAGE ACCESS KIT |
EPITEK, INC. |
WERNER HAMPL |
| K073484 |
03/10/2008 |
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 |
ETHICON ENDO-SURGERY, INC. |
RENEE L ROWE |
| K072301 |
03/18/2008 |
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 |
EV3 INC. |
David Worrell |
| K073339 |
03/03/2008 |
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR |
FENWAL, INC. |
TAMMY DAVIS |
| K073706 |
03/31/2008 |
RESPIRATORY HUMIDIFIER, MODEL MR850 |
FISHER & PAYKEL HEALTHCARE, LTD. |
ADELE BINDON |
| K070355 |
03/04/2008 |
FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY |
FOTONA D.D. |
STOJAN TROST |
| K072425 |
03/10/2008 |
JNE IMPLANT SYSTEM |
GC AMERICA, INC. |
CARL JENKINS |
| K061907 |
03/27/2008 |
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES |
GE HEALTHCARE |
JOEL C KENT |
| K080157 |
03/24/2008 |
DASH 2500 PATIENT MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
SHARON UNTZ |
| K073062 |
03/10/2008 |
OMNI-VUE SYSTEM |
GENESIS DIGITAL IMAGING, INC. |
CARL ALLETTO |
| K073636 |
03/13/2008 |
TINNITUS SOUND GENERATOR MODULE |
GN RESOUND A/S |
LARS HAGANDER |
| K073064 |
03/11/2008 |
GRAFTYS BCP |
GRAFTYS |
ANTHONY LE NAOUR |
| K080025 |
03/19/2008 |
LED.L, LED.M, LED.G, LED.B |
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
CHARLIE MACK |
| K080066 |
03/05/2008 |
VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) |
GX CORPORATION SDN BHD |
FOO KHON PU |
| K080560 |
03/18/2008 |
HENKE SASS WOLF OF AMERICA ARTHROSCOPE |
HENKE SASS WOLF OF AMERICA, INC. |
LYNETTE HOWARD |
| K072256 |
03/12/2008 |
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL |
HILL LABORATORIES CO. |
BRADY ALLER |
| K072369 |
03/21/2008 |
EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM |
HMD BIOMEDICAL LLC |
MERRELL SHYE |
| K072847 |
03/28/2008 |
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS |
HOLOGIC, INC. |
BRYAN COWELL |
| K071779 |
03/05/2008 |
ABX PENTRA URINE CAL |
HORIBA ABX |
OLIVIER DUCAMP |
| K080667 |
03/19/2008 |
VARIAX DISTAL RADIUS TORX SCREWS |
HOWMEDICA OSTEONICS CORP. |
DANIELLE HILLMAN |
| K080322 |
03/05/2008 |
HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 |
HYCOR BIOMEDICAL, INC. |
P. NARAYAN NAYAK |
| K080184 |
03/26/2008 |
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINOCOTT |
| K073161 |
03/07/2008 |
REPLUS DENTAL IMPLANTS (HA) |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K072944 |
03/05/2008 |
QUANTA LITE CCP3.1 IGG/IGA ELISA |
INOVA DIAGNOSTICS, INC. |
RUFUS BURLINGAME |
| K080280 |
03/14/2008 |
SUB-TALAR LOK, MODEL 7-11 MM |
INSTRATEK, INC. |
Jeff Seavey |
| K080291 |
03/19/2008 |
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER |
INTUITIVE SURGICAL, INC. |
KAREN UYESUGI |
| K080155 |
03/06/2008 |
MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K073485 |
03/03/2008 |
VISTAKON (NARAFILCON) A SOFT CONTACT LENS |
JOHNSON & JOHNSON VISION CARE, INC. |
ROSALIND B WILLIAMS |
| K080302 |
03/24/2008 |
CAYMAN BUTTRESS PLATE SYSTEM |
K2M, INC. |
RICHARD WOODS |
| K073519 |
03/28/2008 |
QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 |
KENSEY NASH CORP. |
CINDY VARUGHESE |
| K073008 |
03/11/2008 |
KFH ENERGY, MODEL: E1 |
KINGFISHER HEALTHCARE NV |
NEIL R ARMSTRONG |
| K080661 |
03/24/2008 |
MODELS TENS 7000, EMS 7500 AND TWIN STIM |
KOALATY PRODUCTS, INC. |
JAY MANSOUR |
| K080010 |
03/14/2008 |
NOCC HYDROPHILIC WOUND DRESSING |
KYTOGENICS, INC |
MARINA ZAZANIS |
| K073552 |
03/05/2008 |
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY |
LABORIE MEDICAL TECHNOLOGIES, CORP |
BARBARA MORNET |
| K080508 |
03/21/2008 |
MANDREL GUIDEWIRES OR M-WIRE |
LAKE REGION MEDICAL |
KAREN MORTENSEN |
| K073274 |
03/17/2008 |
SPINAL SPHERE SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K073506 |
03/07/2008 |
LUMINEX LX 100/200 INSTRUMENT |
LUMINEX CORP. |
NANCY KRUNIC |
| K072421 |
03/06/2008 |
K-Y BRAND YOURS+MINE |
MCNEIL-PPC, INC. |
NADER FOTOUHI |
| K080391 |
03/18/2008 |
DRIVE SOLSTICE OXYGEN CONCENTRATOR |
MEDICAL DEPOT |
ARTHUR WARD |
| K073476 |
03/07/2008 |
COMPACT AUTO-SAFETY INJECTOR (CASI) |
MEDICAL HOUSE (ASI) LIMITED |
ROSE Y GUANG |
| K063175 |
03/14/2008 |
IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) |
MEDICAL TECHNOLOGY SYSTEMS, INC. |
ELLIS K NAM |
| K073156 |
03/04/2008 |
QPLAQUE MR |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
| K073718 |
03/19/2008 |
MEDLINE GASTROSTOMY TUBE |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K071244 |
03/05/2008 |
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K073324 |
03/13/2008 |
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R |
MEDTRONIC INC. |
BECKY HANNACK |
| K073255 |
03/24/2008 |
XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
DAVID GUZEK |
| K063157 |
03/10/2008 |
MERRIES K-PHATE BONE GRAFT SUBSTITUTE |
MERRIES INTERNATIONAL INC. |
SOPHIA LEE |
| K072197 |
03/12/2008 |
POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR |
METACURE SURGICAL GLOVES SDN BHD |
AZMAN ISMAIL |
| K073401 |
03/14/2008 |
EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 |
MICROMEDICS, INC. |
TOM LOPAC |
| K080393 |
03/13/2008 |
MODIFICATION TO REBOUND HRD |
MINNESOTA MEDICAL DEVELOPMENT, INC. |
JULIE BULVER |
| K072793 |
03/04/2008 |
LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 |
MOELLER MEDICAL GMBH & CO. KG |
BILL KELLEY |
| K073176 |
03/19/2008 |
KANTERON DICOM STATION (KDS), MODEL 3.0 |
MONICA VEYTIA |
MONICA VEYTIA |
| K080035 |
03/03/2008 |
LED CURING LIGHT |
MONITEX INDUSTRIAL CO., LTD. |
SHU-LUNG WANG |
| K073647 |
03/03/2008 |
MINITAPE EXTRA URETHRAL SLING |
MPATHY MEDICAL DEVICES, LTD. |
LOUIS J MAZZARESE |
| K073699 |
03/26/2008 |
MCT-DIABETES |
MYCARE TEAM, INC. |
DIANE MANDELL HORWITZ |
| K073652 |
03/20/2008 |
ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE |
NAKAMURA MAGNIFIER CO., LTD. |
CHARLIE ITO |
| K073671 |
03/26/2008 |
PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE |
NDO SURGICAL, INC. |
JOHN J VOZELLA |
| K072116 |
03/20/2008 |
SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM |
NEUROSPINE INNOVATIONS AND SOLUTIONS |
RICHARD JANSEN |
| K080540 |
03/13/2008 |
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
| K073455 |
03/25/2008 |
E-VAC |
NEW LEAF MEDICAL, INC. |
RICHARD T NOCK |
| K073550 |
03/28/2008 |
PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K080228 |
03/27/2008 |
ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH |
NOVAMIN TECHNOLOGY, INC. |
ROBERT G ROTHFRITZ |
| K080340 |
03/05/2008 |
COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG |
NOVARTIS NUTRITION CORP. |
THOMAS A DOLD |
| K073278 |
03/28/2008 |
SPINOUS PROCESS PLATE SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K073293 |
03/19/2008 |
DURETTE IMPLANT |
OCULO PLASTIK, INC. |
JEAN-FRANCOIS DURETTE |
| K072957 |
03/18/2008 |
EVIS EXERA II 180 SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K071254 |
03/25/2008 |
SMALL INTESTINAL VIDEOSCOPE SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K073714 |
03/19/2008 |
TRAUMACAD VERSION 2.0 |
ORTHOCRAT, LTD. |
GEORGE J HATTUB |
| K073624 |
03/20/2008 |
MODULAR FOOT SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K070184 |
03/24/2008 |
DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT |
OSPOL AB |
LENNART CARLSSON |
| K073247 |
03/07/2008 |
US/SS/GS SYSTEM |
OSSTEM IMPLANT CO LTD |
MINJOO KIM |
| K080387 |
03/07/2008 |
HU II / HS II FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MIN JOO KIM |
| K073405 |
03/03/2008 |
PLEXUR M |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K073363 |
03/20/2008 |
THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 |
PALADIN BIOMEDICAL CORPORATION |
ROBERT BICKFORD |
| K073583 |
03/26/2008 |
MODIFICATION TO PALOMAR LUX1540 HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K080098 |
03/10/2008 |
MRJ EXTENDED |
PARAMED SRL |
MICHAEL A DOUGLAS |
| K073698 |
03/19/2008 |
SECURE |
PARKELL, INC. |
DANIEL R SCHECHTER |
| K072481 |
03/07/2008 |
JET PORT PLUS HP CATHETER SYSTEM |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K080461 |
03/13/2008 |
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 |
PHILIPS MEDICAL SYSTEMS |
ZETY BILLARD |
| K080495 |
03/24/2008 |
SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
| K080120 |
03/10/2008 |
HFO SHOULDER COIL |
PHILIPS MEDICAL SYSTEMS MR FINLAND |
CATHERINE CONNELL |
| K080548 |
03/27/2008 |
HD7 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILLIPS MEDICAL SYSTEMS |
NANCY BURKE |
| K073659 |
03/05/2008 |
XTRAC ULTRA 2, MODEL AL10000 |
PHOTO MEDEX, INC. |
JEFF LEVATTER |
| K072459 |
03/03/2008 |
OMNILUX NEW-U |
PHOTO THERAPEUTICS, INC. |
SUE DARCY |
| K080504 |
03/20/2008 |
PIONEER LOWTOP SPINAL ROD SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K080518 |
03/20/2008 |
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K073638 |
03/20/2008 |
SWIFT LT |
RESMED LTD. |
DAVID D'CRUZ |
| K072723 |
03/20/2008 |
RESPIRONICS GOLOX |
RESPIRONICS, INC. |
ZITA A YURKO |
| K073111 |
03/27/2008 |
PORTRAIT PSR, MODEL 745915 |
RHYTEC INCORPORATED |
Robert Zoletti |
| K073544 |
03/05/2008 |
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES |
RJ MEDICAL, INC. |
JIM INNES |
| K063684 |
03/21/2008 |
COBAS LITHIUM |
ROCHE DIAGNOSTICS CORP. |
THERESA AMBROSE BUSH |
| K080183 |
03/25/2008 |
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 |
ROCHE DIAGNOSTICS CORP. |
DIMITRIS DEMIRTZOGLOU |
| K073277 |
03/06/2008 |
ROCHE-CREACTIVE PROTEIN (LATEX) |
ROCHE DIAGNOSTICS CORP. |
KERWIN L KAUFMAN |
| K073342 |
03/26/2008 |
SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW |
SALVIN DENTAL SPECIALTIES, INC. |
ROBERT SALVIN |
| K080171 |
03/06/2008 |
SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 |
SANARUS MEDICAL, INC. |
LISA HENRY |
| K080698 |
03/31/2008 |
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP |
SENORX, INC. |
EBEN GORDON |
| K072406 |
03/21/2008 |
NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) |
SGMP CO., LTD. |
JANNA P TUCKER |
| K072400 |
03/27/2008 |
NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES |
SGMP CO., LTD. |
JANNA P TUCKER |
| K072403 |
03/27/2008 |
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS) |
SGMP CO., LTD. |
JANNA P TUCKER |
| K073705 |
03/24/2008 |
MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE |
SHANDONG QIAOPAI GROUP CO., LTD |
MARK JOB |
| K072739 |
03/21/2008 |
JIERUI SYRINGES AND NEEDLES |
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
Diana Hong |
| K080640 |
03/21/2008 |
M5 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K073674 |
03/24/2008 |
BONE FIXATION WIRE (KIRSCHNER WIRE) |
SIGNAL MEDICAL CORP. |
LOUIS A SERAFIN |
| K080349 |
03/10/2008 |
KIMBA MINI |
SIGNUS MEDIZINTECHNIK GMBH |
ALAN ALEXANDER |
| K073635 |
03/19/2008 |
SBI SR MTP TOE IMPLANT |
SMALL BONE INNOVATIONS INC. |
JEFFREY ZIGLER |
| K072212 |
03/07/2008 |
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K073509 |
03/04/2008 |
TWINFIX PK FP SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
DEANA BOUSHELL |
| K072144 |
03/07/2008 |
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR |
SMITHS MEDICAL MD, INC. |
PHIL NEURURER |
| K073287 |
03/13/2008 |
PREVADH MESH |
SOFRADIM PRODUCTION |
SHARON ALEXANDER |
| K073095 |
03/19/2008 |
TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 |
SOMATEX MEDICAL TECHNOLOGIES GMBH |
SUSANNE RAAB |
| K073240 |
03/20/2008 |
PSS SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
| K063385 |
03/10/2008 |
DUREX PLAY MASSAGE GEL LUBRICANT |
SSL AMERICAS, INC. |
CHRIS ROBINSON |
| K072864 |
03/13/2008 |
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
COLLEEN CANAN |
| K073586 |
03/13/2008 |
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM |
STAAR SURGICAL CO. |
DIANA SMITH |
| K073591 |
03/13/2008 |
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM |
STAAR SURGICAL CO. |
DIANA SMITH |
| K073361 |
03/18/2008 |
MUSCLE PAIN DEVICE (MPD) |
STEVENS PROOF OF CONCEPT, INC. |
JECKIN D SHAH |
| K080286 |
03/07/2008 |
CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS |
STRAUMANN USA |
ELAINE ALAN |
| K080758 |
03/27/2008 |
AVS PL PEEK SPACERS, MODELS 48351 AND 48353 |
STRYKER CORP. |
VIKKI M O'CONNOR |
| K072702 |
03/19/2008 |
STRYKER ANTIMIC CATHETER |
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
JULIE PRYOR |
| K073470 |
03/06/2008 |
AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX |
STRYKER SPINE |
SIMONA VOIC |
| K080271 |
03/31/2008 |
INREACH SYSTEM |
SUPERDIMENSION, LTD. |
JONATHAN KOVACH |
| K080680 |
03/21/2008 |
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE |
SURGICAL SPECIALTIES CORP. |
TRUDY D ESTRIDGE |
| K073450 |
03/17/2008 |
SUTTER ELECTROSURGICAL CABLES |
SUTTER MEDIZINTECHNIK GMBH |
THOMAS A BOONE |
| K080193 |
03/05/2008 |
SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR |
Synergeyes, Inc. |
RICHARD E LIPPMAN |
| K072307 |
03/14/2008 |
QUANTITATIVE NEUROQ 3.0 |
SYNTERMED, INC. |
KENNETH TRAIN |
| K080109 |
03/20/2008 |
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM |
SYNTHES (USA) |
JILL R SHERMAN |
| K073119 |
03/03/2008 |
CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
ERICA LI |
| K073185 |
03/06/2008 |
APX21 |
TECHDENT TECHNOLOGIES, LTD. |
BENNY ARAZY |
| K073474 |
03/05/2008 |
CAPIOX CIRCUIT CONNECTORS |
TERUMO CORP. |
GARRY COURTNEY |
| K080415 |
03/07/2008 |
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K080563 |
03/20/2008 |
RUNTHROUGH NS EXTENSION WIRE |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K063787 |
03/13/2008 |
INPLEX CF MOLECULAR TEST |
THIRD WAVE TECHNOLOGIES, INC. |
ANDREW A LUKOWIAK |
| K071489 |
03/28/2008 |
HOMECHECK MULTIPLE DRUG CUP TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
ARMANDO A TORRESCANO |
| K080211 |
03/14/2008 |
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K073515 |
03/11/2008 |
TRANS1 FACET SCREW |
TRANS1 INCORPORATED |
WILLIAM JACKSON |
| K073653 |
03/20/2008 |
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K073558 |
03/13/2008 |
SENSITITRE 18-24 SUSCEPTIBILITY PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K072441 |
03/25/2008 |
EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K071468 |
03/20/2008 |
CLARIVEIN CATHETER |
VASCULAR INSIGHTS LLC |
JOHN P MARANO |
| K080104 |
03/26/2008 |
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 |
VASCULAR SOLUTIONS, INC. |
JAMES CHAPMAN |
| K073028 |
03/07/2008 |
VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30 |
VENOWAVE, INC. |
JOHN SARINGER |
| K063813 |
03/26/2008 |
VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA |
VENTLAB CORP. |
JAMES A COCHIE |
| K073502 |
03/24/2008 |
VERTEBRON VBR SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K080051 |
03/21/2008 |
VIRTUAL PORTS ENDOCLEAR SYSTEM |
VIRTUAL PORTS LTD |
YORAM LEVY |
| K073279 |
03/05/2008 |
VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
| K073673 |
03/28/2008 |
SOYALA FULL FACE MASK GEL VENTED |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
RALF EGENOLF |
| K073374 |
03/07/2008 |
COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET |
WILLIAM COOK EUROPE APS |
MOLLY BUSENBARK |
| K080130 |
03/14/2008 |
OCCLUFAST CAD |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K073346 |
03/21/2008 |
ZIEHM VISION 2 |
ZIEHM IMAGING, INC. |
RICHARD WESTRICH |
| K073567 |
03/13/2008 |
BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES |
ZIMMER GMBH |
PATRICIA JENKS |
| K071723 |
03/07/2008 |
ZIMMER POROLOCK MIS STEM |
ZIMMER GMBH |
DALENE T BINKLEY |
| K073286 |
03/07/2008 |
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM |
ZIMMER, INC. |
BRANDON HIPSHER |
| K072527 |
03/19/2008 |
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 |
ZOLL CIRCULATION |
MARK PERKINS |
