FDA 510(k) Decisions During June, 2011  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K111339 06/08/2011 HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) MEDTRONIC INC. AMRA RACIC
K110508 06/03/2011 SUGLUE-10 3M ESPE AG DESI W SOEGIARTO
K100716 06/23/2011 AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 AALTO SCIENTIFIC LTD. DESSI LYAKOV
K103601 06/10/2011 AUDIT MICROCV IMMUNOASSAY LINEARITY SET AALTO SCIENTIFIC LTD. DESSI LYAKOV
K111023 06/10/2011 ABBOTT ARCHITECT LH CALIBRATORS ABBOTT LABORATORIES JOHN RIZOS
K103023 06/01/2011 UNIT, PHACOFRAGMENTATION ABBOTT MEDICAL OPTICS INC EVELYN DE LA VEGA
K110617 06/02/2011 MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER ABBOTT VASCULAR SUZANNE REDMAN
K111138 06/22/2011 THE PICC WAND (R) PEELABLE SAFETY INTRODUCER ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K110636 06/16/2011 TULA IONTOPHORESIS SYSTEM ACCLARENT, INC. GURVINDER SINGH NANDA
K110812 06/21/2011 CT-GUIDE NEEDLE GUIDANCE SYSTEM ACTIVIEWS LTD JOHN J SMITH
K102573 06/30/2011 PROVU (TM) DENTAL X-RAY SYSTEM ADVANCED IMAGE SCIENCE, INC. PAUL ROCKWELL
K103210 06/06/2011 TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS ADVANCED STERILIZATION PRODUCTS NANCY CHU
K110864 06/15/2011 BIOSPINE VBR SYSTEM AESCULAP IMPLANT SYSTEMS, LLC LISA BOYLE
K110695 06/28/2011 BIPOLAR HF DEVICE AESCULAP, INC. LISA M BOYLE
K101641 06/16/2011 AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 AG DIGITAL TECHNOLOGY CORP. JENNIFER REICH
K111638 06/24/2011 IMPAX VOLUME VIEWING AGFA HEALTHCARE N.V. KOEN COBBAERT
K102479 06/02/2011 ALARA T210 COMPUTED RADIOGRAPHY SYSTEM ALARA, INC. CHRISTOPHER MITCHELL
K102811 06/02/2011 AOS ORION IR-192 SOURCE CABLE ALPHA-OMEGA SERVICES, INC. BOB A ROBNETT
K103205 06/02/2011 BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC. OLGA LEWIS
K110936 06/10/2011 DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC. DAVID A GREER
K110859 06/23/2011 METAL OPAQUER APEX DENTAL MATERIALS, INC. CHRIS KULTON
K102274 06/15/2011 ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES CURTIS RAYMOND
K111078 06/14/2011 AEU-26L ELCTRONIC ENDODONTIC SYSTEM ASEPTICO, INC. GRANT RAMALEY
K103495 06/29/2011 ASICO SOFTIP INJECTOR SYSTEM ASICO LLC RAVI NALLAKRISHNAN
K101005 06/21/2011 ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT ASTRA TECH AB LINDA SCHULZ
K110640 06/10/2011 ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT ASTRA TECH, INC. BETSY A BROWN
K110356 06/10/2011 ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT ASTRA TECH, INC. BETSY A BROWN
K111020 06/09/2011 ATRICURE DISSECTOR ATRICURE, INC. JAMES L LUCKY
K110829 06/03/2011 ACE STAPLER AND CARTRIDGE BAROSENSE, INC SHEILA STEVENS, PHD
K111217 06/14/2011 ADDITIVE CAP BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K102614 06/03/2011 AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K103061 06/20/2011 BIOMATE STERILE ACUPUNCTURE NEEDLE BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. MICHAEL LEE
K110650 06/30/2011 ZYSTON ARC INTERBODY SPACER BIOMET SPINE (AKA EBI, LLC) MARGARET F CROWE
K111564 06/16/2011 MAXFIRE MARXMEN MENISCAL REPAIR DEVICE BIOMET SPORTS MEDICINE ELIZABETH WRAY
K102767 06/03/2011 CARDIO XP BIONET CO., LTD. MARC GOODMAN
K110900 06/24/2011 DISPOSABLE THYROID COLLAR BLOXR CORPORATION RAI CHOWDHARY
K111252 06/02/2011 ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F BOSTON SCIENTIFIC CORP. HOLLY RAMIREZ
K111498 06/30/2011 FATHOM (TM) 14 STEERABLE GUIDEWIRE BOSTON SCIENTIFIC CORP. ERIC ELLIOTT
K111485 06/30/2011 FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX BOSTON SCIENTIFIC CORPORATION ERIC ELLIOTT
K101627 06/03/2011 IPLAN BRAINLAB AG ALEXANDER SCHWIERSCH
K111488 06/30/2011 MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 BRIDGEPOINT MEDICAL JILL MUNSINGER
K110883 06/08/2011 J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA BUSSE HOSPITAL DISPOSABLES MUHAMAD ANSARI
K110088 06/10/2011 DEFENDO Y-OPSY IRRIGATOR BYRNE MEDICAL INCORPORATED JOHN WILLIS
K111100 06/16/2011 ENCOR ENSPIRE BREAST BIOPSY SYSTEM C.R. BARD, INC. JUSTIN LOVELACE
K102496 06/09/2011 POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS CARDIAC SCIENCE CORPORATION KATHLEEN ROBERTS
K110272 06/08/2011 STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG CARDINAL HEALTH, INC. TATYANA BOGDAN
K111131 06/17/2011 TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES CAREFUSION 209, INC. GLEN HERMANSON
K103562 06/23/2011 CENTURION PRESSURE INJECTABLE EXTENSION SET CENTURION MEDICAL PRODUCTS CORPORATION MATTHEW K PRICE
K111233 06/24/2011 SUPRIS RETROPUBIC SLING SYSTEM COLOPLAST A/S TIM CRABTREE
K110297 06/15/2011 POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES COMFORT RUBBER GLOVES INDUSTRIES SDN BHD TAN KENG BENG
K110730 06/24/2011 MONACO RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K110950 06/27/2011 CONSENSUS KNEE SYSTEM CONSENSUS ORTHOPEDICS, INC. MATTHEW M HULL
K101692 06/28/2011 PATIENT MONITOR CONTEC MEDICAL SYSTEM CO., LTD. DIANA HONG
K110402 06/20/2011 BIODESIGN NIPPLE RECONSTRUCTION CYLINDER COOK BIOTECH, INC. PERRY W GUINN
K111244 06/14/2011 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) COOK, INC. MIRONDA CARPENTER
K110099 06/29/2011 PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT COOPERVISION, INC. SARAH HARRINGTON
K102942 06/22/2011 CORELEADER ALGIPLASTER MODEL AP 050501 CORELEADER BIOTECH CO., LTD. IAN LI
K111046 06/29/2011 CORIN MINIHIP FEMORAL STEM CORIN USA LUCINDA GERBER
K111442 06/03/2011 V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H ROBERT ZOTT
K110133 06/10/2011 EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER CREGANNA-TACTX MEDICAL DENNIS WONG
K102954 06/22/2011 CUTERA QSWITCH LASER SYSTEM CUTERA, INC. CONNIE HOY
K110753 06/06/2011 MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K111444 06/22/2011 UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K110704 06/24/2011 SENSI DIACOUSTIC MEDICAL DEVICES (PTY) LTD. E.J. SMITH
K102566 06/03/2011 OWL CANNULAE DIROS TECHNOLOGY, INC. GEORGE DARMOS
K103736 06/10/2011 DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE DMC MEDICAL LTD. TRACY BEST
K110759 06/10/2011 TEMPOCEM DMG USA, INC. PAMELA PAPINEAU
K103086 06/07/2011 DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC DYNAREX CORPORATION DANIEL CONSAGA
K110728 06/08/2011 IMESH TACKER EASYLAP LTD. PAUL DRYDEN
K110597 06/14/2011 EV1000 CLINICAL PLATFORM EDWARDS LIFESCIENCES MARGUERITE THOMLINSON
K103520 06/24/2011 CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING EDWARDS LIFESCIENCES, LLC. DARYL RICHARDSON
K110223 06/29/2011 WAVEGUARD (TM) EEG CAP EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH DANIEL KAMM
K103724 06/08/2011 10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030) EIZO GMBH GUENTER M VOLZ
K111016 06/09/2011 SAFEPORT MANIFOLD (TM) (OR STOPCOCK) ELCAM MEDICAL A.C.A.L. NATASHA EVRONYAN
K103738 06/01/2011 H-WAVE ELECTRONIC WAVEFORM LABORATORY, INC. RYAN P HEANEY
K110830 06/21/2011 ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH ELITECHGROUP DEBRA K HUTSON
K110739 06/14/2011 ENTELLUS MEDICAL SINUS GUIDEWIRE ENTELLUS MEDICAL, INC. KAREN E PETERSON
K110158 06/07/2011 ILLUMINATING SINUS SEEKER ENTELLUS MEDICAL, INC. KAREN E PETERSON
K102345 06/21/2011 EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 EPS BIO TECHNOLOGY CORP. Y.C. LEI
K103637 06/08/2011 ERKA. PERFECT-ANEROID ERKA KALLMEYER MEDIZINTECHNIK GMBH JAN WEISS
K110688 06/02/2011 MYLABGOLD ESAOTE ALLISON SCOTT
K101990 06/13/2011 ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11 ETHICON ENDO-SUGERY, LLC DONOVAN MAY
K111111 06/08/2011 ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO ETHICON ENDO-SURGERY, LLC LINDA HILL
K110509 06/20/2011 EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K102917 06/17/2011 FIXTEMP C&B EXACTA DENTAL DIRECT, INC RICHARD KEEN
K111379 06/08/2011 EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT EXACTECH, INC. GRAHAM L CUTHBERT
K103655 06/30/2011 OCTANE-C INTERBODY FUSION DEVICE SYSTEM EXACTECH, INC. PATRICK HUGHES
K102412 06/23/2011 VISTA DIGITAL OPTHALMOSCOPE EYEQUICK.LLC MARC ELLMAN MD
K103783 06/16/2011 EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC FIAB S.P.A. ALBERTO CALABRO
K110275 06/03/2011 ORTHO EASY PIN FORESTADENT BERNHARD FORSTER GMBH TANYA O'BRIEN
K110518 06/24/2011 IBAG FUTURE PATH MEDICAL, LLC DANIEL KAMM
K110930 06/23/2011 ACTIVE WASTE GAS SCAVENGER G. DUNDAS CO.,INC. MICHELLE NORRIE
K110946 06/21/2011 ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE GALIL MEDICAL LTD. LYNNE DAVIES
K102856 06/30/2011 SIROCCO THERMAL REGULATING SYSTEM GALMAZ BIOTECH S.L. CHRIS ZANDER
K110823 06/17/2011 PRISMAFLEX GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K110871 06/17/2011 FIT CHECKER ADVANCED GC AMERICA, INC. MARK HEISS
K103234 06/30/2011 GC AADVA BO AC ABUTMENTS GC AMERICA, INC. CARL JENKINS
K111445 06/03/2011 DISCOVERY NM 630 GE HEALTHCARE TAL BRESLER-STRAMER
K102389 06/10/2011 NAVIGATOR APPLICATIONS SUITE GE HEALTHCARE FINLAND OY MONICA MORRISON
K103476 06/16/2011 BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX GE MEDICAL SYSTEMS, LLC NIDHI CHAUDHARY
K110968 06/27/2011 PROFLU+ ASSAY GEN-PROBE PRODESSE, INC KAREN HARRINGTON
K111219 06/30/2011 GMD UNIVERSAL URINARY INCONTINENCE SLING GENERIC MEDICAL DEVICE, INC. JEFF MORGAN
K103417 06/28/2011 HALIFAX BIOMEDICAL TANATLUM BEAD SET HALIFAX BIOMEDICAL, INC. ROBERT A POGGIE, PHD
K103641 06/16/2011 GUARDACARE HEMCON MEDICAL TECHNOLOGIES, INC. KEVIN HAWKINS
K110143 06/02/2011 HET BIPOLAR ELECTROCAUTERY FORCEPS HET SYSTEMS, LLC HOWARD L SCHRAYER
K110752 06/28/2011 HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER HIGHLAND INSTRUMENTS LEO BASTA
K100943 06/02/2011 INVADER FACTOR II HOLOGIC, INC. RANDALL COVILL
K100980 06/01/2011 INVADER FACTOR V HOLOGIC, INC. RANDALL J COVILL
K110889 06/20/2011 IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) IND DIAGNOSTICS INC. KAI LOU
K111344 06/10/2011 I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) INFIMED, INC. CATHERINE MULCAHY
K103737 06/02/2011 OMNI II PATIENT MONITOR INFINIUM MEDICAL JOHN OBRIEN
K110344 06/24/2011 INOMAX DSIR (DELIVERY SYSTEM) INO THERAPEUTICS LARRY LEPLEY
K110635 06/23/2011 INOMAX DS(IR) (DELIVERY SYSTEM) INO THERAPEUTICS LLC/DBA IKARIA LARRY LEPLEY
K102258 06/10/2011 CUSA NXT EXTENDED LENGTH TIP INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K102461 06/02/2011 FRACTORA INVASIX LTD. AMIR WALDMAN
K110810 06/21/2011 ANASCIENT BREATH MONITOR INVOY TECHNOLOGIES, LLC LUBNA M AHMAD
K102567 06/02/2011 WATCH-PAT 200S-3 (WP200S-3) ITAMAR MEDICAL LTD JONATHAN KAHN
K110826 06/23/2011 CUROS PORT PROTECTOR IVERA MEDICAL DON CANAL
K111459 06/16/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR JIANGSU ALFA GLOVE CO., LTD CHU XIAOAN
K110248 06/10/2011 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR JIANGSU DONGLING PLASTIC & RUBBER CO., LTD CHU XIAOAN
K110247 06/10/2011 POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR JIANGSU DONGLING PLASTIC & RUBBER CO., LTD CHU XIAOAN
K110843 06/22/2011 ALEUTIAN SPACER SYSTEM K2M, INC. NANCY GIEZEN
K103839 06/06/2011 BEHIND EAR GENTLE TOUCH THERMOMETER KAZ, INC. RAJ S KASBEKAR
K110747 06/14/2011 TEMPFLEX KERR CORPORATION WENDY GARMAN
K103019 06/09/2011 KJ MASK KJ MEDITECH CO., LTD PRISCILLA CHUNG
K103703 06/02/2011 REGUIS SIGMA KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSELL MUNVES
K101049 06/23/2011 WART FREEZE KONINKLIJKE UTERMOHLEN NV SHIRLEY FURESZ
K110983 06/20/2011 CENTRIMAG DRAINAGE CANNULA KIT LEVITRONIX LLC LYDIA SAKAKEENY
K110980 06/20/2011 CENTRIMAG RETURN CANNULA KIT LEVITRONIX LLC. LYDIA SAKAKEENY
K103423 06/01/2011 MIS ANTERIOR CERVICAL PLATING SYSTEM LIFE SPINE RANDY LEWIS
K102813 06/30/2011 EZONO 3000 LIFE-TECH, INC. SKIP RIMER
K110239 06/23/2011 LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K110500 06/23/2011 STAT-MAT MINOR MACPHERSON MEDICAL, INC. HOWARD HOLSTEIN
K111093 06/03/2011 BILLY BOY MALE LATEX CONDOM MAPA GMBH GERMAN FRANK
K110927 06/13/2011 MECTALIF MEDACTA INTERNATIONAL ADAM GROSS
K110243 06/28/2011 MEDART DIODE LASER SYSTEM & ACCESSORIES MEDART A/S JOANNE DAVIES
K110658 06/02/2011 APTUS CANNULATED COMPRESSION SCREWS MEDARTIS AG KEVIN A THOMAS
K110908 06/28/2011 APTUS FOOT 3.5 SYSTEM MEDARTIS AG KEVIN A THOMAS
K110630 06/24/2011 F10 MEDIANA CO., LTD. AMY M.H. KIM
K110374 06/13/2011 MAX PULSE SYSTEM MEDICORE CO., LTD. YOO BYUNG-KUK
K102177 06/30/2011 SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K110194 06/17/2011 MEDLINE EPIDURAL AND SPINAL NEEDLES MEDLINE, INDUSTRIES, INC. MATT CLAUSEN
K111471 06/10/2011 EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) MEDSHAPE SOLUTIONS, INC JACK C GRIFFIS, III
K111340 06/28/2011 HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM MEDTEC, INC. JENNY JONES
K111658 06/28/2011 AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE MEDTRONIC INC. LISA STONE
K110070 06/08/2011 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANCK USA, INC. LILA JOE
K111657 06/23/2011 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE MEDTRONIC, INC. LISA STONE
K110693 06/08/2011 PACEART OPTIMA SYSTEM SOFTWARE MEDTRONIC, INC. RACHEL U LIBI
K110284 06/08/2011 NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM MEDYSSEY CO., LTD. PATRICK MOORE
K111091 06/24/2011 MERIT MEDICAL 20 ML SYRINGE MERIT MEDICAL SYSTEMS, INC. MICHAELA RIVKOWICH
K110616 06/29/2011 THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO MICROGENICS CORP. LISA CHARTER
K111307 06/15/2011 AZUR DETACHABLE 35 PLATINUM COIL SYSTEM MICROVENTION, INC. LARAINE PANGELINA
K111007 06/08/2011 MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE MIDWEST REPROCESSING CENTER LLC SCOTT SENNER
K100313 06/14/2011 HYDROFIX SURGICAL SHEET MIMEDX GROUP, INC SALLY THORSEN
K110273 06/09/2011 AEROVENT PLUS CHC MONAGHAN MEDICAL CORPORATION CARI J REIL
K111315 06/08/2011 MULTIPURPOSE DRAINAGE CATHETER NAVILYST MEDICAL, INC. WANDA CARPINELLA
K111237 06/15/2011 MD301C4 29.8" DIAGNOSTIC IMAGING LCD MONITOR, L309TY NEC DISPLAY SOLUTIONS, LTD. ANGUS HSU
K110119 06/10/2011 PRESSURE MANOMETER NEOFORCE GROUP INC MONICA FERRANTE
K110967 06/30/2011 ENTERPRISE ELECTROPHYSIOLOGY SYSTEM NEURALYNX INC MIKE JOHNSON
K110712 06/28/2011 DRYTOUCH SUCTION STIMULATOR PROBE NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K111581 06/23/2011 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE NOBEL BIOCARE AB HERBERT CRANE
K110171 06/15/2011 NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS NOBEL BIOCARE USA LLC HERBERT CRANE
K111107 06/30/2011 SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE NORITAKE CO., INC. IVAN WASSERMAN
K111410 06/20/2011 NUVASIVE LONG LATERAL SPINAL SYSTEM NUVASIVE, INC. ELIAS KETCHUM
K110953 06/15/2011 VISENSIA, VISENSIA WITH ALERT OBS MEDICAL CHRIS WEATHERALL
K110724 06/23/2011 SURGICAL PROCEDURE PACKS OMNIA SPA JAMIE AUSTIN
K111193 06/27/2011 APEX ARC HIP STEM OMNILIFE SCIENCE INC. RADHIKA PONDICHERRY
K110947 06/16/2011 APEX K1 HIP STEM OMNILIFE SCIENCE INC. RADHIKA PONDICHERRY
K111184 06/22/2011 APEX PS KNEE SYSTEM - PS-C INSERT OMNILIFE SCIENCE INC. RADHIKA PONDICHERRY
K103266 06/03/2011 ISTAND OPTOVUE, INC. JOHN J TALARICO
K110805 06/21/2011 GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) ORTHOFIX INC. MARY BIGGERS
K111041 06/06/2011 MINI VARIABLE SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K111086 06/17/2011 ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM ORTHOPEDIATRICS, CORP MARK FOX
K103594 06/15/2011 PONTO PRO POWER OTICON MEDICAL AB ULRIKA NIELSEN
K111672 06/29/2011 MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER PACIFIC HOSPITAL SUPPLY CO., LTD IRENE LIN
K110907 06/22/2011 PALOMAR ICON (TM) AESTHETIC SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC. SHARON TIMBERLAKE
K111229 06/01/2011 JETSTREAM G3 (R) SF 1.6 SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC. CYNDY ADAMS
K111513 06/24/2011 CX50 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. PENNY GRECO
K110414 06/21/2011 QLAB 8.1 QUANTIFICATION SOFTWARE PHILIPS ULTRASOUND, INC. NANCY BURKE
K110969 06/10/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED CHU XIAOAN
K110972 06/06/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED CHU XIAOAN
K111297 06/16/2011 SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) PREMIER MEDICAL GLOVES FACTORY LIANG ZHAO
K110732 06/03/2011 EMULSION SB PRUGEN IP HOLDINGS, INC ROBERT L KNECHTEL
K102623 06/06/2011 BLUE POWDERFREE NITRILE EXAMINATION GLOVE PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K110566 06/24/2011 VIBERECT PENILE VIBRATORY STIMULATION DEVICE REFLEXONIC, LLC CAROLINE TONTINI
K111148 06/30/2011 S8 ASPEN WITH H4I PLUS RESMED CORP. DAVID D'CRUZ
K103578 06/02/2011 PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST RESPIRONICS NOVAMETRIX, LLC KEVIN MADER
K110398 06/01/2011 RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS RESPIRONICS, INC. JOSEPH E OLSAVSKY
K110405 06/06/2011 TRUBLUE NASAL MASK RESPIRONICS, INC. MICHELLE BRINKER
K111349 06/09/2011 ELECSYS SHBG CALCHECK 5 ROCHE DIAGNOSTICS KELLY FRENCH
K101733 06/06/2011 REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES SAC, LLC DBA PINNACLE MEDICAL SURGICAL DAVE STRAIN
K110625 06/17/2011 SAFETYMATE TALKING FIRST AID SAFETYMATE, INC. SHARON COHEN, PH.D
K103584 06/10/2011 ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS SHENZHEN ENVISEN INDUSTRY CO. LIMITED STEPHEN H GORSKI
K103548 06/02/2011 ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 SIEMENS HEALTHCARE DIAGNOSTICS INC. SANDRA D WHITE
K111394 06/22/2011 MICROSCAN MICROSTEP SIEMENS HEALTHCARE DIAGNOSTICS INC. SHANNON POPSON
K103429 06/08/2011 BIOGRAPH MMR SIEMENS MEDICAL SOLUTIONS USA INC. ALAINE MEDIO
K111674 06/30/2011 ACUSON SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K111292 06/03/2011 LUMINOS AGILE SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
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