FDA 510(k) Decisions During May, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K131404 05/30/2013 FLASH AR PENTA / FLASH AR PENTA QUICK 3M DEUTSCHLAND GMBH DESI W SOEGIARTO
K123115 05/20/2013 ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P ACME FILTER MASK INC. JEN KE-MIN
K130474 05/31/2013 SURGISEAL TOPICAL SKIN ADHESIVE ADHEZION BIOMEDICAL, LLC CARIDAD SMITH
K130954 05/31/2013 ARS SCREW; SLANT SCREW ADVANCED INTERVENTIONAL TECHNOLOGY, LLC EDUARDO MARCH
K123133 05/22/2013 BARLE TISSUE ADHESIVE ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD MICHAEL BROWNE
K123569 05/24/2013 ANTEGRADE FEMORAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. JULIE GLENDRANGE
K121976 05/17/2013 AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE AESCULAP, INC. KATHY A RACOSKY
K120615 05/15/2013 ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN EDWARD BREHM, PH.D.
K123953 05/02/2013 ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ PH.D.
K123322 05/21/2013 ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC HYMAN KATZ PH.D.
K131119 05/21/2013 SOLANAS POSTERIOR STABILIZATION SYSTEM ALPHATEC SPINE, INC. TREVOR DENBO
K122978 05/23/2013 SANICLAVE 102, MODEL RS-SC-102 ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT ISAAC ERICKSON
K123746 05/24/2013 AMES THERAPY DEVICE AMES TECHNOLOGY, INC. SHEILA RAMERMAN, RAC
K123823 05/31/2013 INTERLIG ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS LILIAN LLULL
K130538 05/22/2013 WINX SLEEP THERAPY SYSTEM APNICURE, INC. CHRIS DANIEL
K130192 05/10/2013 NEXTSTEP RETROGRADE ARROW INTERNATIONAL, INC. GWEN TASCHNER
K130458 05/03/2013 KNOTLESS FIBERTAK SUTURE ANCHOR ARTHREX, INC. CHRISTINA FLORES
K130129 05/31/2013 UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM ARTHREX, INC. COURTNEY SMITH
K122416 05/03/2013 ARTIGLASS L. O.R. GLASS SYRINGE ARTIGLASS SRL FEDERICO BACCARIN
K123937 05/23/2013 ATOM TRANSCAPSULE V-707 ATOM MEDICAL CORPORATION PAUL DRYDEN
K131107 05/14/2013 ATRICLIP GILLINOV-COSGROVE LAA CLIP ATRICURE, INC. REBECCA WALTERS
K130498 05/31/2013 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY BACTERIN INTERNATIONAL INC. HOWARD L SCHRAYER
K131246 05/24/2013 CORONIS 3MP BARCO N.V. LIEVEN DE WANDEL
K131295 05/29/2013 NIO COLOR 3MP LED BARCO NV LIEVEN DE WANDEL
K131199 05/30/2013 ULTRAVERSE RX PTA BALLOON DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. MARIO THOMAS
K123736 05/16/2013 CRYSTALSERT DELIVERY SYSTEM BAUSCH & LOMB JASON SMITH
K123903 05/13/2013 BD BACTEC LYTIC/10 ANAEROBIC/F (PLASTIC) BECTON DICKINSON & CO. PAUL SWIFT
K123871 05/10/2013 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K131299 05/22/2013 ANYTHINK PACS WORKSTATION BEIJING CREALIFE TECHNOLOGY CO., LTD. WEIHUA ZHOU
K123710 05/09/2013 UNITOX BOTOX SYRINGE BIO-MED USA INC YOUNG CHI
K130963 05/06/2013 LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK BIO-RAD LABORATORIES, INC. SUZANNE PARSONS
K130990 05/09/2013 VARIANT(TM) II TURBO HBA1C KIT - 2.0 BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVISION EBONY MCKINNIES
K122559 05/03/2013 BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS BIODENTA SWISS AG DAVID EILER
K123491 05/30/2013 BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT BIODENTA SWISS AG DAVID EILER
K122368 05/02/2013 WATERLASE IPLUS ALL TISSUE LASER BIOLASE TECHNOLOGY, INC. EHAB ESMAIL
K124022 05/14/2013 SPEED SHIFT BIOMEDICAL ENTERPRISES, INC JOE SOWARD
K123636 05/01/2013 H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE BIONESS, INC. KIM TOMPKINS
K131136 05/31/2013 GLUCOSE METER-CHECK SOLUTION FOR TAIDOC BIONOSTICS, INC. RANDY BYRD
K122525 05/02/2013 SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM BIOTEST MEDICAL CORP. AMANDA CHIANG
K122196 05/02/2013 CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY BLACKROCK NEUROMED, LLC JOHN ZIOBRO
DEN120022 05/09/2013 X-RAY ATTENUATING CREAM BLOXR CORPORATION RAI CHOWDHARY
K123422 05/09/2013 X-RAY ATTENUATING CREAM BLOXR CORPORATION RAI CHOWDHARY
K123380 05/31/2013 STRIDE UNICONDYLAR KNEE BLUE BELT TECHNOLOGIES, INC. RICK CONFER
K123821 05/17/2013 AIO HD OTOSCOPE BLUE FOCUS KI CHEOL HAN
K130909 05/16/2013 GATEWAY ADVANAGE Y-ADAPTER BOSTON SCIENTIFIC CORP. CHRISTINE SHOEMAKER
K130804 05/22/2013 UROMAX ULTRA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORPORATION LAUREN RUSSO
K130037 05/17/2013 BREATHE CPAP SYSTEM BREATHE TECHNOLOGIES, INC. CRAIG COOMBS
K130366 05/15/2013 BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT C.R. BARD, INC. JONI CREAL
K130786 05/03/2013 SLEEK OTW PTA CATHETER C.R. BARD, INC. FIONA NI MHULLAIN
K130968 05/01/2013 VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM C.R. BARD, INC. KETI SINO
K131045 05/29/2013 ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE CARDIAC DESIGNS, LLC RAYMOND J KELLY, IV
K130288 05/29/2013 STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE CARDIAC INSIGHT, INC. DEBORAH SHEFFIELD
K130411 05/29/2013 740 SELECT CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K123381 05/10/2013 HYPERION X9 CEFLA S.C. BERTHOIN CLAUDE
K130551 05/22/2013 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM, PHARM. D.
K123844 05/30/2013 CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST CHEMTRON BIOTECH, INC. JANE ZHANG
K130481 05/24/2013 SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK CIRCADIANCE LLC RYAN T KASUN
K120900 05/31/2013 I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 CLINIQA CORPORATION DAWN GAST
K131019 05/24/2013 ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K130293 05/31/2013 ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER COOK, INC. DAVID E CHADWICK
K130444 05/22/2013 H-30 HOLMIUM LASER SYSTEM COOK, INC. SUSANNE GALIN
K123202 05/30/2013 PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS COOPERVISION, INC. KARIN GASTINEAU
K131225 05/29/2013 ADROIT GUIDING CATHETER CORDIS CORP., A JOHNSON & JOHNSON CO. MARY E HOLDEN
K130634 05/24/2013 CORIN METAFIX HIP STEM CORIN U.S.A. LUCINDA GERBER
K130343 05/28/2013 CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS CORIN U.S.A. DIANA L MARTONE
K120671 05/17/2013 DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) COTRONIC TECHNOLOGY LIMITED TANI MOK
K130796 05/09/2013 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN KELSEY LEE
K123581 05/09/2013 NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. MIA M WARE
K130532 05/30/2013 IDRIVE ULTRA STERILIZATION TRAY COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE KATHERINE ROBERTSON
K122974 05/17/2013 TRYOUT-VPS HOLDING PASTE CROWN DELTA CORP. MARK KONOPKA
K120597 05/03/2013 KOMPREDA CUSTOM SPINE, INC. DAVID BRUMFIELD
K122493 05/15/2013 GENESISPLUS CUTERA, INC. CONNIE HOY
K123971 05/02/2013 CYNOSURE 1064NM DIODE LASER CYNOSURE, INC. IRINA KULINETS
K131020 05/09/2013 TEMPERATURE SENSOR CATHETER DEGANIA SILICONE, LTD. ZOYA LEE
K130216 05/01/2013 ATLANTIS STRAUMANN BONE LEVEL ABUTMENT DENTSPLY IMPLANT LINDA K SCHULZ
K123925 05/24/2013 MTM CLEAR ALIGNER IN-OFFICE DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K130169 05/01/2013 FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
K130917 05/24/2013 HEALIX ADVANCE KNOTLESS BR ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY YAYOI FUJIMAKI
K130539 05/21/2013 HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) DEPUY MITEK, A JOHNSON & JOHNSON COMPANY JULIE VAFIDES
K130105 05/17/2013 RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM DEPUY MITEK, A JOHNSON & JOHNSON COMPANY JULIE VAFIDES
K122595 05/01/2013 HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM DERMAL LIFE LLC DIANE HORWITZ, PH.D., RAC
K122519 05/21/2013 DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM DIO CORPORATION TIMOTHY LEE
K124016 05/06/2013 EMPI PHOENIX DJO, LLC KEN FISHER
K130729 05/14/2013 EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER DORNIER MEDTECH SYSTEMS JOHN HOFFER
K123084 05/23/2013 DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD ELCAM MEDICAL A.C.A.L. AHARON COHEN
K130354 05/29/2013 MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) ENTRIGUE SURGICAL, INC. GABRIELE G NIEDERAUER
K130922 05/17/2013 ERCHONIA VERJU LASER SYSTEM WITH MASSAGER ERCHONIA MEDICAL, INC. KEVIN WALLS
K131392 05/29/2013 ETIAM PACS COMPONENTS ETIAM S.A.S.U. GERALDINE TESSENS
K121467 05/10/2013 EUROTROL HEMATOCRIT CONTROL EUROTROL B.V. PAUL B.P. KOOIJMANS
K130911 05/24/2013 RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER EV3 INC. LAURA J LIND
K130434 05/01/2013 OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC EXACTECH, INC. PATRICK HUGHES
K130524 05/22/2013 BREATHID HP SYSTEM EXALENZ BIOSCIENCE LTD. CLAY ANSELMO
K123079 05/08/2013 OLYMPIC BRAINZ MONITOR EXCEL-TECH LTD. (XLTEK) DANIEL RAMIREZ
K123041 05/29/2013 VASOSTAT HEMOSTASIS DEVICE FORGE MEDICAL INC. MASON DIAMOND
K121613 05/01/2013 AGILIA INFUSION SYSTEM FRESENIUS KABI AG CHERYL ROSCHER
K130039 05/02/2013 REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K131118 05/16/2013 4D VIEW GE HEALTHCARE BRYAN BEHN
K123603 05/17/2013 OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC GERALD BUSS
K130626 05/01/2013 MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. PHILIP MALCA
K130115 05/23/2013 DISCOVERY MR750W 3.0T GE MEDICAL SYSTEMS, LLC MICHELLE HUETTNER
K120532 05/02/2013 GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM GETINGE SOURCING LLC BARB SMITH
K122625 05/22/2013 GETINGE 800HC- SERIES STEAM STERILIZER GETINGE SOURCING LLC BARB SMITH
K130624 05/07/2013 CONI GLOBALMED NICHOLAS CAMPBELL
K124058 05/13/2013 CREO STABILIZATION SYSTEM GLOBUS MEDICAL INC. SARAH M FITZGERALD
K123913 05/13/2013 LATIS SPACER GLOBUS MEDICAL INC. CHRISTINA KICHULA
K130559 05/24/2013 MOBICATH BI-DIRECTIONAL GUIDING SHEATH GREATBATCH MEDICAL DENISE THOMPSON
K122705 05/21/2013 HUMICARE D900 GRUNDLER GMBH JIM CASSI
K130311 05/30/2013 TRANSTEK BODY FAT ANALYZER GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD LEO WANG
K131232 05/31/2013 WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K123368 05/07/2013 LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT HARTALEGA SDN BHD NURUL AISYAH KONG
K131121 05/29/2013 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR HEALTH & LIFE CO., LTD. SARAH SU
K123077 05/14/2013 VASCULAR CLAMPS HEBU MEDICAL GMBH ANGELIKA SCHERP
K130647 05/17/2013 XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML HERAEUS KULZER, LLC JAMIE MEARNA
K130870 05/02/2013 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA AMMIRATI
K130277 05/31/2013 SINGLE ENERGY (SE) FEMUR EXAMS HOLOGIC, INC. EILEEN M BOYLE
K121719 05/10/2013 SM TENS & PMS HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED DORIS DONG
K122721 05/03/2013 AG GUFFILL HOSPITECH RESPIRATION LTD. YORAM LEVY
K131099 05/13/2013 AG MASS HOSPITECH RESPIRATION LTD. YORAM LEVY
K122741 05/07/2013 HOVEROUND TEKNIQUE HOVEROUND CORP. ROBERT MUNCH
K122707 05/07/2013 HOVERROUND TEKNIQUE HOVEROUND CORP. ROBERT MUNCH
K130591 05/02/2013 SUPERA VERITAS IDEV TECHNOLOGIES, INC. DARLENE GARNER
K130338 05/31/2013 IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS IMPEDIMED LIMITED JOHN J SMITH, M.D., J.D.
K123551 05/14/2013 ITCLAMP 50 INNOVATIVE TRAUMA CARE INC RICHARD WAITE
K130605 05/02/2013 INOMAX DSIR (DELIVERY SYSTEM) INO THERAPEUTICS ROBERT BOVY
K122923 05/07/2013 QUANTA FLASH ENA7 INOVA DIAGNOSTICS, INC. MICHAEL MAHLER
K130506 05/13/2013 IMSE P-TLIF INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION JOHN MORAN
K122804 05/20/2013 ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM INTAI TECHNOLOGY CORP. KEVIN WANG
K123428 05/20/2013 MIROCAM CAPSULE ENDOSCOPE SYSTEM INTROMEDIC CO., LTD STEVE KWON
K123022 05/17/2013 NEODENT IMPLANT SYSTEM JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S ALLISON C KOMIYAMA
K123662 05/22/2013 THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM JUSTRIGHT SURGICAL, LLC MICHELE LUCEY
K130699 05/30/2013 ALEUTIAN SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K130330 05/02/2013 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K131030 05/09/2013 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K122877 05/08/2013 RANGE SPINAL SYSTEM, SMALL STATURE K2M, INC. NANCY GIEZEN
K120590 05/07/2013 DILATOR TUBE SET KOROS USA, INC. GABRIEL KOROS
K131156 05/24/2013 LANX SPINAL FIXATION SYSTEM LANX, INC. MICHAEL MEDINA
K123600 05/03/2013 DIGITAL BLOOD PRESSURE MONITOR LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. SELINA QIAN
K123800 05/15/2013 WRIST AUTOMATIC BLOOD PRESSURE MONITOR LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. SELINA QIAN
K123629 05/13/2013 FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES LUCENXIA PRESCIENCE AG ROBERT HILL
K130189 05/21/2013 XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) LUMINEX MOLECULAR DIAGNOSTICS, INC. LUBNA SYED
K130639 05/16/2013 ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K130513 05/08/2013 VOLISTA 400; VOLISTA 600 MAQUET SAS TOSIN YEDESS
K121203 05/10/2013 BOSTON KERATOPROSTHESIS OR BOSTON KPRO MASSACHUSETTS EYE & EAR INFIRMARY BRIAN J EDWARDS
K121243 05/03/2013 ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER MEDA CO. LTD. KAI CHEN
K124034 05/17/2013 MECTALIF ANTERIOR MEDACTA INTERNATIONAL ADAM GROSS
K123586 05/15/2013 EASYRA CREATININE REAGENT MEDICA CORPORATION PHOTIOS MAKRIS
K123617 05/15/2013 3F PRO-PICC MEDICAL COMPONENTS INC JESSICA LEO
K130377 05/17/2013 KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM MEDICATECH USA DANIEL KAMM, P.E.
K123095 05/08/2013 MEDLINE BLOOD PRESSURE TRANSDUCER MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K130319 05/31/2013 MEDLINE CANNULATED SCREW MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K123619 05/24/2013 INTRABLOCK BIOBALL HIP SYSTEM (IBS) MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K130547 05/31/2013 ENDOFORM RECONSTRUCTIVE TEMPLATE MESYNTHE LTD RONALD WARREN
K123926 05/03/2013 METASURG NITINOL STAPLE IMPLANT METASURG JOSHUA SCOTT
K122013 05/13/2013 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K124056 05/29/2013 FREND PSA PLUS (REAGENT CARTRIDGE) NANOEN TEK, INC. JUDITH E LOEBEL
K130346 05/02/2013 SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION NATUS NEUROLOGY INCORPORATED SHANE T SAWALL
K131038 05/09/2013 NMI PICC MAXIMAL BARRIER NURSING KITS NAVILYST MEDICAL, INC. MARION W GORDON
K123082 05/16/2013 MOBILECT VIEWER NEPHOSITY, INC. MICHAEL PAN
K122214 05/21/2013 TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) NIHON KOHDEN CORP. STEVE GEERDES
K122347 05/01/2013 ELISIO-H AND ELISIO-M HEMODIALYZERS NIPRO MEDICAL CORPORATION CAROLYN GEORGE
K122343 05/07/2013 PUREFLUX-H HEMODIALYZER NIPRO MEDICAL CORPORATION CAROLYN GEORGE
K123306 05/20/2013 NORDIC TUMOREX NORDICNEUROLAB CHANDANA G BHANDARI
K122777 05/15/2013 NBX - NON BRIDGING EXTERNAL FIXATOR HAND NUTEK ORTHOPAEDICS, INC. PETER MINCIELI
K121404 05/03/2013 SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM ONSET MEDICAL CORPORATION JOSEPH BISHOP
K121702 05/06/2013 ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE ORTHO MEDICAL DAVID ROTHKOPF
K123930 05/15/2013 VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III ORTHO-CLINICAL DIAGNOSTICS, INC. MICHAEL M BYRNE
K130332 05/31/2013 VITROS CHEMISTRY PRODUCTS TRIG SLIDES ORTHO-CLINICAL DIAGNOSTICS, INC. GAOZHEN HANG
K130825 05/07/2013 AZURE ANTERIOR CERVICAL PLATE SYSTEM ORTHOFIX, INC. ALLY BADUEL
K131324 05/31/2013 MAXTORQUE SCREW SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. BRIAN HOCKETT
K130655 05/08/2013 RESPONSE SPINE SYSTEM ORTHOPEDIATRICS, CORP. MARK FOX
K122124 05/16/2013 PORTABLE X-RAY SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K130174 05/02/2013 DVTCARE CA5 OSSUR AMERICAS INC JOHN LINDAHL
K130412 05/31/2013 OSTEOMED EXTREMIFUSE SYSTEM OSTEOMED PIEDAD PENA
K130297 05/29/2013 SCANORA 3DX PALODEX GROUP OY MATTI TULIKOURA
K130250 05/03/2013 QYAG LASER SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC. NICOLE BROWN
K130159 05/13/2013 QLAB QUANTIFICATION SOFTWARE HEART MODEL PHILIPS HEALTHCARE PENNY GRECO
K130842 05/21/2013 ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. JOS VAN VROONHOVEN
K130278 05/29/2013 MR PERMEABILITY PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SUSAN QUICK
K122500 05/03/2013 NEO PS KNEE SYSTEM PIPELINE ORTHOPEDICS TERRY POWELL
K123692 05/24/2013 PIPELINE KNEE SYSTEM PIPELINE ORTHOPEDICS TERRY POWELL
K121065 05/24/2013 POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE POLYMED THERAPEUTICS, INC JJ XIA
K130924 05/16/2013 BRUXZIR SHADED PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K122700 05/31/2013 PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES PROSBEN, INC. JEN KE-MIN
K131009 05/07/2013 PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) PROTEUS DIGITAL HEALTH, INC. JAFAR SHENASA
K122801 05/24/2013 PROVIDENCE CERVICAL CAGE PROVIDENCE MEDICAL TECHNOLOGY, INC. EDWARD LIOU
K130811 05/02/2013 PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE PSYCHEMEDICS CORP. VIRGINIA HILL
K122663 05/30/2013 ORAMOIST QUANTUM, INC. FRED MA
K121898 05/24/2013 STAY FRESH SKIN FOLD MANAGEMENT TEXTILE QUICK-MED TECHNOLOGIES, INC. MARY MCNAMARA-CULLINANE
K123748 05/07/2013 ABL90 FLEX RADIOMETER MEDICAL APS SOREN BOGESTRAND
K130617 05/10/2013 RAYSTATION RAYSEARCH LABORATORIES AB DAVID HEDFORS
K130282 05/13/2013 REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT REMINGTON MEDICAL, INC. CAITLIN SENTER, MS, RAC
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