FDA 510(k) Decisions During August, 2011  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K110383 08/01/2011 BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 A PLUS MEDICAL THOMAS C LOESCHER
K111686 08/01/2011 A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS A&D COMPANY, LTD. JERRY WANG
K100015 08/09/2011 VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 ABBOTT MOLECULAR, INC. PAMELA L SWATKOWSKI
K091960 08/29/2011 VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 ABBOTT MOLECULAR, INC. PAMELA L SWATKOWSKI
K112239 08/31/2011 STEERABLE GUIDE CATHETER Abbott Vascular CYNTHIA MORROW
K111254 08/22/2011 RELIEVA SOLO ELITE SINUS BALLOON CATHETER ACCLARENT, INC. KIM KY
K103790 08/18/2011 ACE TRIMARK TRICAM DENTAL IMPLANT ACE SURGICAL SUPPLY COMPANY INC. DENISE WILLIAMS
K112409 08/29/2011 MATRISTEM WOUND MATRIX ACELL, INC DEBORAH A BAKER-JANIS
K111608 08/29/2011 SLIC SCREW REPAIR SYSTEM ACUMED LLC HOLLACE RHODES
K111805 08/24/2011 ECG SERIES ELECTROCARDIOGRAPH ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K112135 08/05/2011 ECG-6 SERIES ELECTROCARDIOGRAPH ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K111122 08/04/2011 AESCULAP SIBD XP SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K111945 08/05/2011 IMPAX NEXT GENERATION AGFA HEALTHCARE N.V. JODI COLEMAN
K112235 08/26/2011 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP ANDY MILLER
K102678 08/26/2011 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS ANDON MEDICAL CO., LTD. YI LIU
K101307 08/09/2011 BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 ANDON MEDICAL CO., LTD. YI LIU
K110027 08/05/2011 SURGICAL FACE MASK; SURGICAL FACE MASK ANGELINE GROUP LTD. MICHAEL LEE
K112182 08/26/2011 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. JONATHAN S KAHAN
K101204 08/31/2011 MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K103706 08/24/2011 THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR APPLIED CARDIAC SYSTEMS, INC. R. BEN GHADIMI
K111253 08/02/2011 ARTHREX DISTAL EXTREMITY PLATE SYSTEM ARTHREX, INC. COURTNEY SMITH
K111661 08/19/2011 ARTHREX SCAPHOLUNATE ANCHOR ARTHREX, INC. COURTNEY SMITH
K111044 08/09/2011 SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE ARTHROCARE CORPORATION LAURA KASPEROWICZ
K110584 08/22/2011 ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K111799 08/19/2011 NUGAIT(TM) SUBTALAR IMPLANT SYSTEM ASCENSION ORTHOPEDIC BRADLEY W STRASSER
K102760 08/03/2011 ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 ATLAS MEDICAL NOUR AL-AHWAL
K112072 08/03/2011 ATRICURE CRYO MODULE SYSTEM ATRICURE, INC. JAMES L LUCKY
K103028 08/11/2011 EEVATM PETRI DISH AUXOGYN, INC. ROBERT NEWMAN
K111338 08/11/2011 WILDCAT CATHETER AVINGER, INC. KIT CARIQUITAN
K110296 08/18/2011 AXIS-SHIELD ANTI-CCP AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE I DORA
K110719 08/11/2011 ORIGIN ZIRCONIA B&D DENTAL TECHNOLOGIES JOON HWANG
K111236 08/30/2011 INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 B. BRAUN MELSUNGEN AG ANGELA J CARAVELLA
K111991 08/11/2011 NIO COLOR 2MP BARCO NV LIEVEN DE WANDEL
K111952 08/19/2011 ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 BECKMAN COULTER, INC. KERRIE S OETTER
K110350 08/03/2011 KNEEHAB XP BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K111072 08/23/2011 BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL Bio-Rad Laboratories Juang Wang
K111347 08/12/2011 ISROBOT MONA LISA BIOBOT SURGICAL PTE LTD CHERITA JAMES
K103087 08/26/2011 COVAMAX RESORBABLE COLLAGEN MEMBRANE BIOM'UP SAS VALERIE CENTIS
K111599 08/12/2011 VITEK 2 AST-ST LINEZOLID BIOMERIEUX, INC. NATHAN HARDESTY
K111957 08/19/2011 POLARIS SPINAL SYSTEM BIOMET SPINE (EBI LLC) VIVIAN KELLY, RAC
K110879 08/19/2011 BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR BIOMET SPORTS MEDICINE ELIZABETH WRAY
K110689 08/19/2011 INBODY BIOSPACE CORPORATION LIMITED DANIEL KAMM
K111609 08/22/2011 BOSTON BAND BOSTON BRACE INTL., INC. JAMES WYNNE
K111043 08/04/2011 ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER BOSTON SCIENTIFIC CORP. JANICE E BROWN, RAC
K112103 08/12/2011 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. HARLAN JONES
K110204 08/05/2011 BRAINLAB TRAUMA BRAINLAB AG ALEXANDER SCHWIERSCH
K111963 08/10/2011 BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER BRIDGEPOINT MEDICAL JILL MUNSINGER
K112137 08/26/2011 COMFORTGLIDE INTERMITENT CATHETER C.R. BARD, INC. STACCI CRONK
K112308 08/17/2011 CROSSER RECANALIZATION SYSTEM C.R. BARD, INC. TIMOTHY WADE
K102511 08/24/2011 MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT C.R. BARD, INC. Joni Creal
K111745 08/01/2011 KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER CARD GUARD SCIENTIFIC SURVIVAL, LTD. CLAY ANSELMO
K112034 08/12/2011 TECA ELITE DISPOSABLE CONCENTRIC NEEDLES CAREFUSION 209, INC. GLEN HERMANSON
K111053 08/12/2011 SENTRYSUITE PRODUCT LINE CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K110977 08/25/2011 VESOFLOW CAREMED SUPPLY, INC. EDWARD A KROLL
K111507 08/23/2011 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION CAPT HYE-JOO KIM, PHARM.D.
K103734 08/19/2011 POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE CENTRAL MEDICARE SDN BHD NICK WANG
K112376 08/31/2011 S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM CIRCA SCIENTIFIC, LLC FRED PIAZZA
K111373 08/23/2011 CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE CIRCLE CARDIOVASCULAR IMAGING INC. SHIRANTHA SAMARAPPULI
K111881 08/17/2011 VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT COLOPLAST A/S JANELL A COLLEY
K111779 08/08/2011 Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 CONMED LINVATEC JOHN CUSACK
K111365 08/19/2011 VITALA CONTINENCE CONTROL DEVICE CONVATEC INC. MARK R JAKUBOWSKI
K111911 08/04/2011 CORIN OPTIMOM MODULAR HEAD CORIN U.S.A. LUCINDA GERBER
K111917 08/24/2011 NUVANT, MOBILE CARDIAC TELEMETRY CORVENTIS, INC. MICHELE CHIN-PURCELL
K111817 08/30/2011 PALINDROME RT CHRONIC CATHETER COVIDIEN WING NG
K111372 08/04/2011 TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)... COVIDIEN WING NG
K110653 08/01/2011 CURE CATHETER CURE MEDICAL LLC. ROBYN SCOPIS
K111172 08/29/2011 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES DAAVLIN DISTRIBUTING CO. MICHELE THIEL
K093915 08/23/2011 DEKA TAC DEVICE DEKA RESEARCH & DEVELOPMENT CORP. ROBERT SWAIN
K111433 08/30/2011 DEPUY STTUNE (TM) PS KNEE SYSTEM DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K110397 08/16/2011 TRUMATCH PERSONALIZED SOLUTIONS DEPUY ORTHOPAEDICS, INC. NANCY S FRIDDLE
K111589 08/23/2011 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG DERMA CARE PLUS PRODUCTS, LLC JOSEPH NEUSER
K102188 08/09/2011 CYBOW READER, MODELS 300 & 720 DFI CO., LTD. YANG HO-DONG
K102400 08/01/2011 SYPHILIS HEALTH CHECK DIAGNOSTICS DIRECT, LLC. Gary Lehnus
K110801 08/02/2011 WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC LIKUN FU
K111376 08/03/2011 CONSTRUX EXTERNAL FIXATION DEVICE EBI, LLC MARGARET F CROWE
K111808 08/01/2011 SONOLITH I-MOVE EDAP TMS FRANCE HOLSTEIN HOWARD
K111705 08/03/2011 EKOSONIC ENDOVASCULAR SYSTEM EKOS CORPORATION JOCELYN KERSTEN
K111095 08/03/2011 BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025 ELECTRO KINETIC TECHNOLOGIES, LLC RAYMOND ERBE
K112029 08/30/2011 ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 ELITECHGROUP DEBRA K HUTSON
K103747 08/31/2011 ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS ELITECHGROUP SEPPIM S.A.S. DEBRA K HUTSON
K111742 08/31/2011 MDRIVE EMBLA SYSTEMS ROBERT G SCHUEPPERT
K111527 08/03/2011 MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT ERAGEN BIOSCIENCES, INC. DAVID LIM
K111195 08/03/2011 VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS ETHICON ENDO-SURGERY, INC. DENNIS HAHN
K103719 08/24/2011 LIFECARE CONDUCTIVE GARMENTS EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K111535 08/26/2011 EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K103699 08/12/2011 EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC EXACTECH, INC. SHING JEN TAI, PHD
K110316 08/19/2011 INFOSEND GSM FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K111548 08/30/2011 WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE FUJIFILM MEDICAL SYSTEM U.S.A., INC. KATHERINE Y CHOI
K103802 08/02/2011 TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR GE HEALTHCARE FINLAND OY TATJA PASANEN
K103448 08/12/2011 BRIVO XR385 GE MEDICAL SYSTEMS, LLC JOHN L SCHMIDT
K102926 08/25/2011 GEMORE MUSCLE CONDITIONER; GEMORE TECHNOLOGY CO., LTD. BODEN LAI
K102516 08/11/2011 LUCINA MODEL MELODI GENADYNE BIOTECHNOLOGIES, INC. CHIEN MING(ANDREW)GOH
K103181 08/26/2011 ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM GENORAY CO., LTD. JAE KIM
K111479 08/17/2011 REVERE CROSSTOP GLOBUS MEDICAL INC. SARAH M FITZGERALD
K111449 08/17/2011 REVOLVE ADDITIONAL IMPLANTS GLOBUS MEDICAL, INC. SARAH MARIE FITZGERALD
K110758 08/12/2011 NITRILE POWDER FREE EXAMINATION GLOVES HARTALEGA SDN BHD NURUL AISYAH KONG BT ABDULLAH
K111573 08/26/2011 MONOBLOC BM SERIES HASS CORP. Priscilla Chung
K111508 08/19/2011 TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 HOLOGIC, INC. DEBORAH THOMAS
K110301 08/19/2011 SILK'N FX HOME SKINOVATIONS LTD. AMIR WALDMAN PH. D.
K110137 08/10/2011 ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN HORIBA ABX S.A.S. CAROLINE FERRER
K102120 08/12/2011 NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 HSINER CO., LTD. TOM SHANKS
K112180 08/10/2011 I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) INFIMED, INC. CATHERINE MULCAHY
K110388 08/09/2011 COLLACARE DENTAL INNOCOLL PHARMACEUTICALS LTD AARON WYSE
K111158 08/10/2011 LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) INNOVATIVE GLOVES CO; LTD RAJEEV SOOD
K111333 08/08/2011 ANTLIA III WOUND TREATMENT SYSTEM INNOVATIVE THERAPIES, INC. JUDITH HARBOUR
K111032 08/31/2011 CMC CABLE FIX INSTRATEK, INC. Jeff Seavey
K110031 08/24/2011 HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM INSTRUMENTATION LABORATORY CO. Jacqueline Emery
K111741 08/23/2011 INTEGRA(TM) CUSA NXT(TM) BONE TIPS INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI KEVIN J O'CONNELL
K110656 08/18/2011 IMC BLOOD COLLECTION NEEDLE INTERNATIONAL MEDSURG CONNECTION PETER KIM
K110882 08/18/2011 IMC INSULIN SYRINGE INTERNATIONAL MEDSURG CONNECTION PETER KIM
K111199 08/08/2011 INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS INTRA-LOCK INTERNATIONAL, INC. ANGELA BLACKWELL
K111160 08/01/2011 INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) INTRICON DATRIX CORPORATION TANYA O'BRIEN
K110451 08/26/2011 ENDOWRIST ONE SUCTION/IRRIGATOR INTUITIVE SURGICAL, INC. BRANDON HANSEN
K111387 08/04/2011 LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER IQUUM INC Lingjun Chen
K111931 08/05/2011 GLIASITE RTS ISORAY MEDICAL, INC. FREDRIC G SWINDLER
K103799 08/29/2011 INQU PASTE MIX PLUS ISTO TECHNOLOGIES, INC. PATSY J TRISLER, JD, RAC
K110756 08/29/2011 BLUEPHASE STYLE IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K111439 08/24/2011 CHESAPEAKE (CERVICAL COMPONENTS) K2M, INC. NANCY GIEZEN
K110991 08/02/2011 MESA SPINAL SYSTEM (KEYSTONE RODS) K2M, INC. NANCY GIEZEN
K111135 08/17/2011 PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) K2M, INC. NANCY GIEZEN
K103027 08/19/2011 ELECTROTORQUE TLC KALTENBACH & VOIGT GMBH CLAUDIA ORTIZ
K103308 08/29/2011 AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL HAGAN
K111067 08/02/2011 JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. Glen Feye
K111288 08/02/2011 ANCHORWIRE GUIDEWIRE LAKE REGION MEDICAL MATHEW PEXA
K112231 08/19/2011 LCCS INSULATED SPINAL NEEDLE (RF CANNULA) LCCS PRODUCTS LIMITED FIELD FU
K111714 08/16/2011 HAIRMAX DUAL 12 LEXINGTON INTERNATIONAL, LLC CASPER E ULDRICKS ESQ.
K111201 08/10/2011 C7 XR IMAGING SYSTEM LIGHTLAB IMAGING,INC. BRYAN COWELL
K110598 08/18/2011 SMR REVERSE SHOULDER SYSTEM LIMACORPORATE S.P.A. CHERYL HASTINGS
K111987 08/17/2011 FIBERNET EMBOLIC PROTECTION DEVICE LUMEN BIOMEDICAL, INC. MICHELLE STRAIGHT
K110627 08/12/2011 NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER MARVAO MEDICAL DEVICES, LTD. Marybeth Gamber
K111047 08/08/2011 CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES INC. CHRIS TIHANSKY
K111145 08/16/2011 ENDO HEAD MEDACTA INTERNATIONAL ADAM GROSS
K100874 08/19/2011 LIPOSONIX SYSTEM, MODEL 1 P00XXXX MEDICIS TECHNOLOGIES CORPORATION JONATHAN KAHAN
K102406 08/23/2011 PASS ANTERIOR SPINAL SYSTEM MEDICREA TECHNOLOGIES J D WEBB
K103735 08/15/2011 MEDILED MINI MEDIX I.C.S.A. JAMES H KNAUSS
K111807 08/18/2011 MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K111319 08/05/2011 IBIS EXPLORER AND MARKUP SOFTWARE MEDQIA MAHTAB FATEMI
K101934 08/03/2011 DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 MEDSHAPE SOLUTIONS DON GRIFFIN
K111525 08/24/2011 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK MIKE SCOTT
K111942 08/30/2011 TSRH SPINAL SYSTEMS MEDTRONIC SOFAMOR DANEK USA, INC LILA JOE
K110543 08/09/2011 CRESCENT (R) SPINAL SYSTEM TITANIUM MEDTRONIC SOFAMOR DANEK USA, INC. BECKY RONNER
K100967 08/05/2011 PERIMETER C SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BRAD SHEALS
K111265 08/09/2011 METASURG SUBTALAR IMPLANT METASURG JOSHUA SCOTT
K111482 08/25/2011 SONICATOR PLUS 920 METTLER ELECTRONICS CORP. CHRISTINA CAYUELA
K110813 08/05/2011 HEADWAY 27 MICROCATHETER MICRO VENTION, INC. Naomi Gong
K112089 08/24/2011 BIOGEL ORTHOPOR BROWN SURGICAL GLOVE MOLNLYCKE HEALTHCARE, US LLC ANGELA L BUNN, RAC
K112163 08/30/2011 MONICA IF24 MONICA HEALTHCARE IAN HOW
K112124 08/19/2011 MICROCATHETER NAVILYST MEDICAL, INC. WANDA CARPINELLA
K111668 08/19/2011 CAVIOS CAVITY LINER NEO DENTAL CHEMICAL PRODUCTS CO., LTD. ROBERT SEIPLE
K110410 08/04/2011 MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) NIHON KOHDEN CORP. STEVE GEERDES
K111101 08/25/2011 NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET NORFOLK MEDICAL MICHAEL J DALTON
K111383 08/12/2011 ZIRPRIME NORITAKE CO., INC. IVAN WASSERMAN
K100602 08/17/2011 NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K110648 08/29/2011 NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K110486 08/12/2011 ACCUSOM NOVASOM, INC. ROGER K RICHARDSON
K101973 08/16/2011 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) OMEGA LABORATORIES, INC. ROBERT J BARD
K111628 08/19/2011 P200T OPTOS PLC HOWARD M HOLSTEIN
K103657 08/09/2011 SAPPHIRE ORBUSNEICH MEDICAL, INC. JOHN PAZIENZA
K110959 08/05/2011 ORTHOPEDIATRICS BLADE PLATE SYSTEM ORTHOPEDIATRICS, CORP MARK FOX
K111352 08/22/2011 TALON DISTALFIX PROXIMAL FEMORAL NAIL ORTHOPEDIC DESIGNS NORTH AMERICA, INC. SETH MASEK
K111247 08/15/2011 CRANIAL REMOLDING ORTHOSIS ORTHOTIC CARE SERVICES, LLP SCOTT HINSHON
K111176 08/15/2011 OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM OSTEOMED L.P. PIEDAD PENA
K111284 08/17/2011 FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM OSTIAL CORPORATION Mark Smutka
K111374 08/29/2011 SONO-SERIES CORNERSTONE TECHNIQUE PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K111431 08/01/2011 B1P ADHESIVE PENTRON CLINICAL Wendy Garman
K110735 08/03/2011 TANDA MAX OTC SYSTEM PHAROS LIFE CORPORATION JOHNATHAN S KAHAN
K111083 08/17/2011 PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MICHAEL ASMALSKY
K110679 08/02/2011 DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM PHYGEN, LLC HARTMUT LOCH
K111632 08/11/2011 INFILL GRAFT DELIVERY SYSTEM PINNACLE SPINE GROUP, LLC REBECCA K SPINE
K111528 08/24/2011 PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K111502 08/23/2011 STREAMLINE TL SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K111739 08/12/2011 KIDS ROCK 3 CHAIR PRIDE MOBILITY PRODUCTS CORP. KIMBERLY BLAKE
K111300 08/12/2011 SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE) PT. MAHAKARYA INTI BUANA LINA NG
K111592 08/25/2011 YOULASER CO2 LASER SYSTEM QUANTA SYSTEM, S.P.A. Maurizio Bianchi
K110856 08/10/2011 RALCO RALCO S.R.L. DANIEL KAMM
K110468 08/05/2011 FREEWAY COMFORT BITE GUARD RANDMARK DENTAL PRODUCTS, LLC NORMAN F ESTRIN
K102831 08/19/2011 RSI 4200 REIMERS SYSTEMS, INC. NAYIL ALAM
K111207 08/23/2011 RESPIRE BLUE SERIES RESPIRE MEDICAL DANIELA LEVY
K110795 08/19/2011 V200 INTELLI-TRAK OPTION RESPIRONICS CALIFORNIA, INC. ROBERT M MARSHALL
K110293 08/09/2011 OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER RESPIRONICS NEW JERSEY, INC. Lauren Ziegler
K110129 08/30/2011 RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION RIGHTMEDICAL PRODUCTS, LLC MELANIE DESLAURIERS
K112104 08/25/2011 ELECSYS N-MID OSTEOCALCIN CALCHECK 5 Roche Diagnostics JANE E PHILLIPS
K111590 08/08/2011 ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR ROG SPORTS MEDICINE, INC. CURTIS RAYMOND
K110858 08/02/2011 LO-BAK TRAX ROLAND F BERTHIAUME, DC ROLAND F BERTHIAUME
K110016 08/23/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) RONGYAO PLASTIC PRODUCE CO., LTD ZHAO GANG
K111616 08/19/2011 E-CUBE SAESHIN PRECISION CO., LTD. Y S LEE
K112339 08/29/2011 ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD KYEONG-MI PARK
K101517 08/05/2011 SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY SEDECAL S.A. DANIEL KAMM, P.E.
K110776 08/24/2011 DIGITAL THERMOMETER MT SERIES SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
K102706 08/19/2011 CKMB UDR ASSAY SENTINEL CH. SpA FABIO ROTA
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