FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K090317 |
05/20/2009 |
BABI*PLUS BUBBLE PAP VALVE |
A PLUS MEDICAL |
THOMAS C LOESCHER |
K090665 |
05/22/2009 |
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
DANIELLE TAYLOR |
K091146 |
05/01/2009 |
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
ACCURAY, INC. |
ANNE SCHLAGENHAFT |
K091326 |
05/27/2009 |
ACTIVAPATCH |
ACTIVATEK INC. |
JAMAL YANAKI |
K082612 |
05/05/2009 |
GBS PNA FISH |
ADVANDX, INC. |
PAULA E BULGER |
K080868 |
05/14/2009 |
AONGEN COLLAGEN MATRIX |
AEON ASTRON EUROPE B.V. |
HORNG J LAI |
K090354 |
05/12/2009 |
LAMINOPLASTY PLATING SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
K083214 |
05/12/2009 |
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 |
AGA MEDICAL CORP. |
DIANE CARROLL |
K090672 |
05/18/2009 |
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS |
AGFA HEALTHCARE N.V. |
JEFFERY A JEDLICKA |
K082529 |
05/01/2009 |
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM |
ALATECH HEALTHCARE, LLC. |
NEIL ANDERSON |
K082858 |
05/27/2009 |
EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER |
ALCAVIS INTERNATIONAL, INC. |
GARY J MISHKIN |
K090024 |
05/04/2009 |
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM |
ALEXANDRIA RESEARCH TECHNOLOGIES, LLC |
MICHAEL RENNER |
K083628 |
05/01/2009 |
GLUCODR AUTO SYSTEM |
ALL MEDICUS CO., LTD |
MARGARET KIM |
K083507 |
05/18/2009 |
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
K090356 |
05/20/2009 |
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
K083385 |
05/14/2009 |
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
K090425 |
05/19/2009 |
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM |
ALPHATEC SPINE, INC. |
MARY STANNERS |
K083102 |
05/11/2009 |
REFINE LIFT SYSTEM |
ALURE MEDICAL INC. |
JASPER BENKE |
K090943 |
05/27/2009 |
ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 |
AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
JOHN GORMLEY |
K090432 |
05/29/2009 |
HEMORPEX SYSTEM |
ANGIOLOGICA B. M. SRL |
ROBERTO MANCO |
K083729 |
05/08/2009 |
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN |
ANIARA DIAGNOSTICA ,LLC |
OLA ANDERSON |
K090676 |
05/22/2009 |
MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES |
ANTHOGYR |
BRAYETTE SABINE |
K082436 |
05/29/2009 |
EXTT-101 |
APIMEDS, INC |
Kevin Walls |
K091133 |
05/20/2009 |
APLION TOPICAL CARE SYSTEM |
APLION MEDICAL,LLC |
CURTIS JENSEN |
K091172 |
05/05/2009 |
NIO 2MP (MDNG-2121) |
BARCO NV |
LIEVEN DE WANDEL |
K082589 |
05/22/2009 |
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 |
BAROSENSE, INC |
DANIEL J BALBIERZ |
K090413 |
05/14/2009 |
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC |
BAYER HEALTHCARE, LLC |
CATHY PETERS |
K090588 |
05/27/2009 |
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 |
BECKMAN COULTER, INC. |
MARY B TANG |
K090827 |
05/27/2009 |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
SABA MODJARRAD |
K090409 |
05/08/2009 |
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
Bio-Rad Laboratories |
DAVID V BHEND |
K090793 |
05/19/2009 |
BONGROS HA |
BIOALPHA, INC. |
HYUN-SEUNG RYU |
K090208 |
05/22/2009 |
BIOPRO FEMORAL HEADS |
BIOPRO, INC. |
DAVID MRAK |
K090424 |
05/14/2009 |
DVX SPINE SYSTEM |
BK MEDITECH CO., LTD. |
ELAINE DUNCAN |
K071004 |
05/21/2009 |
OSTEOCRETE BONE VOID FILLER |
BONE SOLUTIONS, INC. |
CHRISTINE EMANUEL |
K091131 |
05/08/2009 |
PELVIC FLOOR REPAIR SYSTEM |
BOSTONSCIENTIFIC |
MICHELLE BERRY |
K082060 |
05/08/2009 |
CRANIAL IMAGE GUIDED SURGERY SYSTEM |
BRAINLAB AG |
RAINER BIRKENBACH |
K090005 |
05/19/2009 |
BRANEMARK INTEGRATION BIOHELIX IMPLANTS |
BRANEMARK INTEGRATION AB |
AGNETA SVENSSON |
K090113 |
05/14/2009 |
BREAS VIVO 40 SYSTEM |
BREAS MEDICAL AB |
BIRGITTA BOLANDER |
K081130 |
05/14/2009 |
BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER |
BRIDGEPOINT MEDICAL |
MICHAEL A DANIEL |
K091160 |
05/05/2009 |
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM |
BRONCUS TECHNOLOGIES, INC. |
MAHTAB FATEMI |
K090528 |
05/28/2009 |
DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT |
C.R. BARD, INC. |
JI HYUN KIM |
K091042 |
05/12/2009 |
CRONO S-PID 50 |
CANE S.R.L. |
CARLO MUSSO |
K091435 |
05/29/2009 |
DIGITAL RADIOGRAPHY MODEL CXDI-55G |
CANON INC. |
SHEILA DRISCOLL |
K091436 |
05/29/2009 |
DIGITAL RADIOGRAPHY, MODEL CXDI-55C |
CANON, INC. |
SHEILA DRISCOLL |
K090486 |
05/06/2009 |
ASTHMA MONITOR MODEL, AM1 |
CARDINAL HEALTH GERMANY 234 GMBH |
THOMAS GUTIERREZ |
K091250 |
05/22/2009 |
DIAGNOSTIC CATHETER SYSTEM |
CARDINAL HEALTH, INC. |
SHARON NICHOLS |
K090602 |
05/28/2009 |
CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS |
CARDIODYNAMICS INTERNATIONAL CORP. |
DON BROOKS |
K090469 |
05/22/2009 |
CARESTREAM DRYVIEW 5850 LASER IMAGER |
CARESTREAM HEALTH, INC. |
GAYLE CARROLL |
K083291 |
05/05/2009 |
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 |
CARL ZEISS MEDITEC INC |
JUDITH A BRIMACOMBE |
K082134 |
05/07/2009 |
CIRCULATOR BOOT |
CIRCULATOR BOOT CORP. |
RICHARD S DILLON |
K083499 |
05/08/2009 |
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS |
COLOPLAST A/S |
JANELL A COLLEY |
K091152 |
05/07/2009 |
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 |
COLOPLAST A/S |
ANGELA BYLAND |
K090335 |
05/06/2009 |
HD GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
LARAINE PANGELINA |
K091139 |
05/05/2009 |
CONMED AER DEFENSE SMOKE EVACUATOR |
CONMED CORPORATION |
DEMARIS VELEZ |
K090470 |
05/14/2009 |
AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES |
COVIDIEN |
JENNIFER BRENNAN |
K091050 |
05/27/2009 |
506CN PATIENT MONITOR |
CRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
K091169 |
05/13/2009 |
ELITE MPX LASER SYSTEM WITH CRYO C |
CYNOSURE, INC. |
ANTHONY BURNS |
K081286 |
05/08/2009 |
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 |
DAKO NORTH AMERICA, INC. |
KELLY MILLER |
K091068 |
05/08/2009 |
ACCUTORR V MONITOR, MODEL 0998-00-2000 |
DATASCOPE CORP., PATIENT MONITORING DIVISION |
KATHLEEN KRAMER |
K083805 |
05/22/2009 |
ANKYLOS C/X DENTAL IMPLANT SYSTEM |
DENTSPLY INTL., INC. |
HELEN LEWIS |
K081917 |
05/22/2009 |
DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
K090899 |
05/19/2009 |
DEPUY SPINE LATERAL SYSTEM |
DEPUY SPINE, INC. |
DENISE DUCHENE |
K090458 |
05/28/2009 |
DEXIS SENSOR |
DEXIS LLC |
CLAUDIA ORTIZ |
K083391 |
05/21/2009 |
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY |
DIAGNOSTIC HYBRIDS, INC. |
GAIL R GOODRUM |
K090062 |
05/18/2009 |
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM |
DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC |
Diana Hong |
K091358 |
05/28/2009 |
ECSCOPE 100 |
DYANSYS, INC. |
SRINI NAGESHWAR |
K083821 |
05/14/2009 |
VITAL SIGNS MONITOR |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
K083648 |
05/14/2009 |
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL |
EFRATGO, LTD. HI TECH BIO-SURGICAL |
GEORGE J HATTUB |
K080355 |
05/01/2009 |
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
K082834 |
05/07/2009 |
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC |
ELLMAN INT'L INC. |
RICK EPSTEIN |
K090717 |
05/08/2009 |
FLEX-TENS |
EMSI |
CHERITA JAMES |
K090979 |
05/28/2009 |
DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES |
ENCISION, INC. |
JUDITH V KING |
K083833 |
05/22/2009 |
ENABLER-P CATHETER, 1000 PART NUMBER:1160 |
ENDOCROSS, LTD. |
JOHN SMITH |
K091009 |
05/18/2009 |
MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 |
ESAOTE S.P.A. |
Allison Scott |
K083850 |
05/20/2009 |
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS |
EUROIMMUN US INC |
KATHRYN KOHL |
K090849 |
05/01/2009 |
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 |
EV3 INC. |
SARA BAKKAR |
K091194 |
05/18/2009 |
ALGISEAL PAD |
EVOLUTION MEDICAL TECHNOLOGIES LLC |
JOHN MANNING |
K090266 |
05/06/2009 |
MATCHEDFLICKER |
EYEIC CORPORATION |
MORRIS WAXLER |
K091119 |
05/15/2009 |
MODIFICATION TO THE CROSSER SYSTEM |
FLOWCARDIA, INC. |
Dustin Michaels |
K091254 |
05/29/2009 |
THE CROSSER 14 OTW CATHETER, MODEL CRU014 |
FLOWCARDIA, INC. |
Dustin Michaels |
K083838 |
05/12/2009 |
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES |
FOOK TIN TECHNOLOGIES LIMITED |
JOHN CHAI |
K090559 |
05/04/2009 |
FOOTPRINT MEDICAL SILICONE FEEDING TUBE |
FOOTPRINT MEDICAL |
CLYDE BAKER |
K082781 |
05/01/2009 |
OEC 9900 ELITE |
GE HEALTHCARE SURGERY |
MARIA C FRAME |
K091374 |
05/26/2009 |
GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
YALAN WU |
K091164 |
05/05/2009 |
GE VENUE 40, MODEL 5324338 |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
YALAN WU |
K090428 |
05/07/2009 |
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC |
Genesee BioMedical, Inc. |
JOHN WRIGHT |
K081938 |
05/01/2009 |
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 |
GENZYME DIAGNOSTICS P.E.I. INC. |
PENNY J WHITE |
K083156 |
05/08/2009 |
NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
GIGA-DRIVE SDN, BHD |
IAN NG TZE CHEU |
K081640 |
05/06/2009 |
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS |
GIMMI GMBH |
KEN BLAKE |
K082403 |
05/15/2009 |
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT |
GISH BIOMEDICAL, INC. |
HARVEY KNAUSS |
K082455 |
05/22/2009 |
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER |
GULF COAST HYPERBARICS, INC. |
JAMES W MCCARTHY |
K090365 |
05/07/2009 |
HANSEN MEDICAL ARTISAN S CONTROL CATHETER |
HANSEN MEDICAL, INC. |
KATE WHITIN |
K091107 |
05/01/2009 |
MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM |
HEMOSTATIX MEDICAL TECHNOLOGIES, LLC |
JEFF COBB |
K090957 |
05/28/2009 |
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM |
I2S MICRO IMPLANTABLE SYSTEMS, LLC |
Gary Syring |
K090234 |
05/15/2009 |
SPECTRA SYSTEM DENTAL IMPLANTS 2008 |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
K083480 |
05/05/2009 |
INCLUSIVE ZIRCONIA ABUTMENT BLANKS |
INCLUSIVE DENTAL SOLUTIONS |
KEITH D ALLRED |
K090677 |
05/07/2009 |
INNOPORT LAPAROSCOPIC ACCESS DEVICE |
INNOVIA LLC |
BRUCE WEBER |
K090421 |
05/29/2009 |
MODEL 350G GAS CONSERVER |
INSPIRED TECHNOLOGIES, INC. |
PAUL DRYDEN |
K082111 |
05/22/2009 |
STRAUMANN MEMBRAGEL |
INSTITUT STRAUMANN AG |
LISA QUAGLIA |
K090864 |
05/08/2009 |
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
INTEGRA RADIONICS, INC. |
KEVIN J O'CONNELL |
K082419 |
05/27/2009 |
REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 |
INTRA-LOCK INTERNATIONAL, INC. |
JEFFREY SAKOFF |
K082497 |
05/07/2009 |
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT |
INTUITIVE SURGICAL, INC. |
JAMES FARNWORTH |
K083751 |
05/21/2009 |
INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 |
INVACARE CORPORATION |
CARROLL MARTIN |
K083851 |
05/15/2009 |
INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 |
INVIRO MEDICAL DEVICES, INC. |
JIM BARLEY |
K090078 |
05/08/2009 |
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT |
IOP, INC. |
JASON MALECKA |
K090363 |
05/08/2009 |
ZIO PATCH, MODEL Z100 |
IRHYTHM TECHNOLOGIES, INC. |
WILLIAM H RIGHTER |
K091145 |
05/27/2009 |
FLEXIPLAN 3D AND 3D+ |
ISODOSE CONTROL B.V. |
HUB VAN DE BERGH |
K090826 |
05/11/2009 |
MONOBOND PLUS |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
K090052 |
05/29/2009 |
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C |
JOHARI DIGITAL HEALTHCARE, LTD. |
NISHA JOHARI |
K081122 |
05/26/2009 |
FUSION MEDICAL CANNULATED SCREW SYSTEM |
JOHN RICCIO |
JOHN RICCIO |
K081755 |
05/20/2009 |
FUSION MEDICAL STI |
JOHN RICCIO |
JOHN RICCIO |
K083598 |
05/29/2009 |
KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
K090489 |
05/14/2009 |
ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 |
KCI USA, INC. |
CHRISTY H OVIATT |
K091023 |
05/21/2009 |
METAMORPHOSIS |
KERR CORPORATION |
Wendy Garman |
K082824 |
05/27/2009 |
FLUID FILLED TEETHER |
KIDS II |
BILL YUNG |
K082554 |
05/01/2009 |
KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 |
KIMBERLY-CLARK CORP. |
LISA PEACOCK |
K083822 |
05/06/2009 |
LASER TOUCHONE |
LASER HEALTH TECHNOLOGIES, LLC |
Patsy Trisler |
K083253 |
05/15/2009 |
LOTUS II PULSED ER: YAG LASER SYSTEM |
LASEROPTEK CO. LTD. |
PHILLIP CHEON |
K090815 |
05/21/2009 |
PERCUTANEOUS DISCECTOMY SYSTEM |
LAURIMED LLC |
SEVRINA CIUCCI |
K090531 |
05/27/2009 |
RADCALC SOFTWARE, VERSION 6.0 |
LIFELINE SOFTWARE, INC. |
RICHARD VINCINS |
K083733 |
05/04/2009 |
LUME 2 SYSTEM, MODEL GA0005000 |
LUMENIS, LTD. |
FRANCES HARRISON |
K090092 |
05/11/2009 |
SOCKIT! AND MCMERLIN DERMAL WOUND GEL |
MCMERLIN DENTAL PRODUCTS LP |
AARON HENDERSHOTT |
K091257 |
05/08/2009 |
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM |
MEDI-GLOBE CORPORATION |
SCOTT KARLER |
K083455 |
05/18/2009 |
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 |
MEDI-KHAN USA, INC |
JULIE SANTIAGO |
K090037 |
05/22/2009 |
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG |
MEDICALGORITHMICS SP Z.O.O. |
MARTIN JASINSKI |
K090834 |
05/15/2009 |
EPICARDIA 5000 |
MEDICOMP, INC. |
SUSAN D GOLDSTEIN-FALK |
K090390 |
05/15/2009 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MELISA LANSKY |
K090833 |
05/12/2009 |
SEGMENT |
MEDVISO |
EINAR HEIBERG |
K090700 |
05/28/2009 |
IMMUNOCARD STAT CAMPY, MODEL 751530 |
MERIDIAN BIOSCIENCE, INC. |
Michelle L Smith |
K090870 |
05/01/2009 |
ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY |
MICRO THERAPEUTICS, INC. |
TOM DAUGHTERS |
K091040 |
05/13/2009 |
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN GOLDSTEIN-FALK |
K083922 |
05/06/2009 |
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
K072288 |
05/06/2009 |
PATHFAST D-DIMER |
MITSUBISHI KAGAKU IATRON |
HELEN LANDICHO |
K081509 |
05/01/2009 |
MONTERIS MEDICAL AUTOLITT LASER PROBE |
MONTERIS MEDICAL |
CRAIG COOMBS |
K083441 |
05/22/2009 |
FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION |
MOTION MEDICAL PRODUCTS LLC |
GARY BUSSETT |
K083088 |
05/01/2009 |
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST |
NANOSPHERE, INC |
GREGORY W SHIPP |
K091261 |
05/12/2009 |
NMI PICC |
NAVILYST MEDICAL, INC. |
NICHOLAS CONDAKES |
K090452 |
05/22/2009 |
NEOSS IMPLANT SYSTEM 03.25 |
NEOSS LTD |
CHERITA JAMES |
K083322 |
05/27/2009 |
NEUROMETRIX BIOAMPLIFIER |
NEUROMETRIX, INC. |
RAINER MAAS |
K090042 |
05/06/2009 |
PAINMASTER MCT PATCH |
NEWMARK, INC. |
DEBORAH LIVORNESE |
K090069 |
05/07/2009 |
PROCERA IMPLANT BRIDGE OVERDENTURE |
NOBEL BIOCARE AB |
HERBERT CRANE |
K090182 |
05/04/2009 |
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) |
NUCLEMED S.A. |
RAYMOND KELLY |
K091154 |
05/18/2009 |
UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, |
NUCLETRON CORPORATION |
ELAINA COLBY |
K091071 |
05/08/2009 |
NUVASIVE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
HAN FAN |
K090725 |
05/20/2009 |
OCULUS MICROCYN WOUND GEL |
OCULUS INNOVATIVE SCIENCES, INC. |
ANTIOINETTE DOUGLAS |
K083184 |
05/14/2009 |
TEARLAB OSMOLARITY SYSTEM |
OCUSENSE, INC. |
JANICE M HOGAN |
K083633 |
05/01/2009 |
HS II SHORT FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
K090440 |
05/20/2009 |
HINGE PEDIATRIC PLATING SYSTEM |
PEGA MEDICAL INC. |
ARIEL DUJOVNE |
K090288 |
05/05/2009 |
ORTHADAPT PR |
PEGASUS BIOLOGICS, INC. |
AMY BOUCLY |
K090196 |
05/19/2009 |
EG-3670URK |
PENTAX MEDICAL COMPANY |
PAUL SILVA |
K090197 |
05/19/2009 |
EG-3870UTK |
PENTAX MEDICAL COMPANY |
PAUL SILVA |
K090262 |
05/28/2009 |
PERCUCATH URINARY CATHETER |
PERCUVISION LLC |
ERROL SINGH |
K083117 |
05/28/2009 |
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 |
PHADIA US INC. |
MARTIN ROBERT MANN |
K091195 |
05/27/2009 |
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MICHAEL CHILBERT |
K090360 |
05/04/2009 |
PHILIPS M3001A MULTI MEASUREMENT SERVER |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
JENS-PETER SEHER |
K091269 |
05/08/2009 |
NEUROPET |
PHOTODETECTION SYSTEMS, INC. |
STEWART TUTTLE |
K091099 |
05/22/2009 |
C-PORT - HP POWER INJECTABLE PORT |
PHS MEDICAL GMBH |
DONALD F HULTS |
K090155 |
05/22/2009 |
CAAS MR FLOW 1.0 |
PIE MEDICAL IMAGING B.V. |
SASKIA LLOYD |
K090270 |
05/15/2009 |
BACKSTOP CATHETER, MODEL 60-0000-3100 |
PLUROMED, INC. |
JAMES WILKIE |
K082474 |
05/08/2009 |
PMT SUBDURAL CORTICAL ELECTRODES |
PMT CORP. |
ERIC CAILLE |
K090160 |
05/20/2009 |
SUPRATHEL WOUND AND BURN DRESSING |
POLYMEDICS INNOVATIONS GMBH |
KENNETH K KLEINHENZ |
K091215 |
05/18/2009 |
INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
K091113 |
05/11/2009 |
MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS SCHAPPERT |
K082817 |
05/21/2009 |
PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M |
PRIMUS STERILIZER COMPANY, LLC. |
LYLE LOHRMEYER |
K090079 |
05/01/2009 |
VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 |
PROGENY, INC. |
ALAN KREMA |
K091097 |
05/27/2009 |
PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 |
PROMEDICAL PRODUCTS CO., LTD. |
DAVID POWER |
K090340 |
05/22/2009 |
FREEHAND |
PROSURGICS LIMITED |
GEROGE MYERS |
K083502 |
05/05/2009 |
PANTHER REALART, MODEL 4.7 |
PROWESS, INC. |
RACHEL SCARANO |
K090457 |
05/21/2009 |
ORALUBE |
PULPDENT CORPORATION |
KENNETH J BERK |
K090391 |
05/11/2009 |
PULPDENT MICRO-HYBRID COMPOSITE |
PULPDENT CORPORATION |
KENNETH J BERK |
K091114 |
05/01/2009 |
TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL |
QUALITY ELECTRODYNAMICS |
CHRISTIE ZYDYK |
K091175 |
05/08/2009 |
GRIND NO MORE VERSION 2 AND 3 |
RANIR LLC |
JONATHAN S KAHAN |
K090338 |
05/08/2009 |
ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE |
REPROCESSING PRODUCTS CORP. |
WALLY JANSEN |
K090490 |
05/06/2009 |
MIRAGE ECHO |
RESMED CORP. |
DAVID D'CRUZ |
K090243 |
05/08/2009 |
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
K091271 |
05/29/2009 |
RESPIRONICS PERFORMAX TOTAL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ANDREW P ZELTWANGER |
K091112 |
05/15/2009 |
RESPIRONICS SLEEPEASY CPAP SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
K090321 |
05/27/2009 |
RIC CONFORMAL SOURCE, MODEL 100 |
RI CONSULTANTS, LLC |
THOMAS GOLEMBESKI |
K081138 |
05/07/2009 |
SAFEFLO VENA CAVA FILTER |
RMT MEDICAL TECHNILOGIES INC. |
JANICE M HOGAN |
K090311 |
05/05/2009 |
ELECSYS RUBELLA IGG CALCHECK |
Roche Diagnostics |
KELLY FRENCH |
K090530 |
05/20/2009 |
SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01 |
ROSS CREEK MEDICAL INC. |
MICHAEL KOLBER |
K090071 |
05/28/2009 |
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
K090601 |
05/11/2009 |
FSC 2 |
SCHOELLY IMAGING, INC. |
F. DAVID ROTHKOPF |
K090800 |
05/18/2009 |
VS-100 ILLUMINATION AND IMAGING SYSTEM |
SCHOELLY IMAGING, INC. |
KEN SPECTOR |
K090265 |
05/15/2009 |
BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V |
SCICAN LTD. |
BRENDA MURPHY |
K090994 |
05/06/2009 |
LIGAFIX INTERFACE SCREW |
SCIENCE FOR BIOMATERIALS |
DENIS CLEMENT |
K090385 |
05/06/2009 |
LARIAT II SUTURE DELIVERY DEVICE |
SENTREHEART INC. |
LINDA GUTHRIE |
K090520 |
05/18/2009 |
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE) |
SHANDONG HUAYUE GLOVE CO., LTD. |
JINYOU LIN |
K090513 |
05/08/2009 |
VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED) |
SHANDONG HUAYUE GLOVE CO., LTD. |
JINYOU LIN |
K090691 |
05/07/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHIJIAZHUANG BENESTAR PLASTIC CO., LTD |
CHU XIAOAN |
K082957 |
05/29/2009 |
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
K083844 |
05/08/2009 |
ADVIA CENTAUR TSH3-ULTRA METHOD |
SIEMENS HEALTHCARE DIAGNOSTICS |
Ernest Joseph |
K090257 |
05/26/2009 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
K081769 |
05/28/2009 |
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 |
SIEMENS HEALTHCARE DIAGNOSTICS |
RADAMES RIESGO |
K090330 |
05/22/2009 |
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 |
Siemens Healthcare Diagnostics Inc. |
ROSE T MARINELLI |
K090683 |
05/08/2009 |
SYNGO RT THERAPIST CONNECT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
K091373 |
05/20/2009 |
SYNGO TRUED |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMES E KUHN JR |
K091286 |
05/15/2009 |
SYNGO US WORKPLACE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
K083327 |
05/18/2009 |
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GUNHILD PAULSEN |
K091070 |
05/19/2009 |
MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM |
SIERRA SCIENTIFIC INSTRUMENTS, INC. |
REIC S FINKELMAN |
K090505 |
05/07/2009 |
SPEQ ULTRASOUND SYSTEM |
SIGNOSTICS PTY LTD |
CHARLES F HOTTINGER |
K090420 |
05/27/2009 |
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0 |
SMITH & NEPHEW, INC. |
SUSAN BELL |
K090261 |
05/01/2009 |
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G |
SMITHS MEDICAL ASD, INC. |
CINDY ENGELHARDT |
K083557 |
05/01/2009 |
BCI WW1030 PULSE OXIMETER |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
K090858 |
05/06/2009 |
PARIETEX MONOFILAMENT POLYESTER MESH |
SOFRADIM PRODUCTION |
ANGELA BUNN |
K090127 |
05/01/2009 |
METATARSAL DECOMPRESSION IMPLANT, MODEL 100 |
SOLANA SURGICAL LLC |
BRUCE LAWRENCE |
K090684 |
05/01/2009 |
AVANTE LEUCITE BLOCKS |
SOMERSET DENTAL PRODUCTS, INC. |
CINDY SALTER |
K090913 |
05/04/2009 |
CROSS-PILOT TURBO ELITE SUPPORT CATHETER |
SPECTRANETICS CORP. |
BRANDON HANSEN |
K090033 |
05/06/2009 |
MODIFICATION TO: PSS SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
K083118 |
05/27/2009 |
SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE |
SPINAL USA |
JEFFREY JOHNSON |
K090383 |
05/29/2009 |
SRI LEVEL II SURGICAL GOWN |
SRI SURGICAL |
NISSA MULNICK |
K083328 |
05/22/2009 |
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 |
ST. JUDE MEDICAL |
KAREN MCKELVEY |
K081803 |
05/13/2009 |
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM |
ST. JUDE MEDICAL |
ANDREA HUDACK |
K090567 |
05/27/2009 |
ORTHODONTIC CERAMIC BRACKET |
STAR DENTECH KOREA., CORP |
BRANDON CHOI |
K090371 |
05/01/2009 |
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM |
STERIS Corporation |
JOHN ROBERT SCOVILLE, JR. |
K090308 |
05/01/2009 |
RESTEP DVY SYSTEM, MODEL RSP-101 |
STORTFORD MEDICAL LLC |
CHRIS DAUGHTERY |
K091016 |
05/04/2009 |
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE |
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN |
TIM M LOHNES |
K090966 |
05/15/2009 |
AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) |
SVRC INDUSTRIES, INC. |
DEAN EMERSON |
K083921 |
05/20/2009 |
SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS |
Synergeyes, Inc. |
RICHARD E LIPPMAN |
K090549 |
05/21/2009 |
SYNTHES SYNAPSE TRANSCONNECTOR |
SYNTHES SPINE |
STACEY BONNELL |
K090187 |
05/12/2009 |
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 |
TaiDoc Technology Corporation |
Yuhua Chen |
K090831 |
05/29/2009 |
TANTHERA-T35 |
TANTHERA, INC. |
NATHAN A BEAVER, ESQ |
K091417 |
05/22/2009 |
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A |
TERUMO CORP. |
MARK UNTERREINER |
K090973 |
05/01/2009 |
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) |
TERUMO CORP. |
LYNNE WITKOWSKI |
K083514 |
05/22/2009 |
TERUMO SYRINGE WITH/WITHOUT NEEDLE |
TERUMO EUROPE N.V. |
M.J. AERTS |
K091329 |
05/29/2009 |
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
K083289 |
05/06/2009 |
HUMAN BETA-2 MICROGLOBULIN KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K090282 |
05/29/2009 |
QMS LIDOCAINE |
THERMO FISHER SCIENTIFIC INC. |
JACK ROGERS |
K090856 |
05/27/2009 |
JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) |
THYSSENKRUPP CETECO SRL |
FEDELE FABRIZIO |
K090461 |
05/22/2009 |
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
K091295 |
05/15/2009 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K091043 |
05/11/2009 |
POWER DRIVE CHAIR, MODEL: TMM6 |
TRANSMOTION MEDICAL INC. |
EDWARD A KROLL |
K091206 |
05/18/2009 |
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL |
TRANSOMA MEDICAL |
LISA STONE |
K091073 |
05/14/2009 |
WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS |
ULTRASPECT LTD. |
DAN LAOR |
K082686 |
05/11/2009 |
MULTI-CHANNEL LASER THERAPY SYSTEM |
UNITED INTEGRATED SERVICES CO., LTD. |
DAVID O CHANG |
K081147 |
05/29/2009 |
ISOFLOW INFUSION CATHETER |
VASCULAR DESIGNS INC. |
GRACE HOLLAND |
K083920 |
05/01/2009 |
FLOWPICC CATHETER |
VASONOVA INC. |
KIM TOMPKINS |
K091267 |
05/06/2009 |
VONFLEX PUTTY |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
K081591 |
05/15/2009 |
NEUCODIA |
VERISCI CORPORATION |
GEORGE HU |
K081823 |
05/18/2009 |
MASTERSCREEN PAED - BABY BODY |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
K090749 |
05/18/2009 |
ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 |
VILLA SISTEMI MEDICALI S.P.A. |
PAOLO C SANTIN |
K090157 |
05/04/2009 |
ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5. |
WCM WASTE & COMPLIANCE MANAGEMENT, INC. |
SARA BETH WATSON |
K090066 |
05/15/2009 |
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE |
WEAR SAFE (MALAYSIA) SDN. BHD. |
S.H. TAM |
K090692 |
05/08/2009 |
ORTHOLOC 2.0/2.4 PLATE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
FRED W BOWMAN |
K091212 |
05/27/2009 |
WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H |
WU'S TECH CO., LTD. |
JEN KE-MIN |
K090880 |
05/27/2009 |
XYLOS POROUS SURGICAL MESH |
XYLOS CORPORATION |
JOYCE ELKINS |
K090094 |
05/20/2009 |
ZELTIQ SYSTEM |
ZELTIQ AESTHETICS |
DONALD V JOHNSON |
K083545 |
05/15/2009 |
ZIEHM VISION RFD |
ZIEHM IMAGING, INC. |
RICHARD WESTRICH |
K090736 |
05/20/2009 |
POWER INFUSER, MODEL M100B-3A |
ZOLL MEDICAL CORPORATION |
EILEEN M BOYLE |