FDA 510(k) Decisions During May, 2010  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K101139 05/21/2010 PROSTIVA RF THERAPY MODEL 8929 HAND PIECE MEDTRONIC INC. THOMAS REICHEL
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 TEST STRIPS, MODELS 100 COUNT: 70827-22, 70827-23, 50 COUNT, 70819-20, 70822-22 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
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
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