FDA 510(k) Applications Submitted by ELAINE DUNCAN

FDA 510(k) Number Submission Date Device Name Applicant
K950054 01/06/1995 ENDO-BEND(TM) SHAVER PALADIN MEDICAL, INC.
K060067 01/09/2006 MASKMEDIC CONCEPT NASAL MASK MASKMEDIC
K000079 01/11/2000 NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M NIKOMED U.S.A., INC.
K080106 01/15/2008 SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE LEONHARD LANG GMBH
K970347 01/27/1997 MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM PALADIN MEDICAL, INC.
K030283 01/27/2003 BABY POD PRISM ENTERPRISES, INC.
K030362 02/03/2003 SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES LEONHARD LANG GMBH
K040249 02/03/2004 SKINTACT ECG ELECTRODE LEONHARD LANG GMBH
K920548 02/06/1992 SHARPE ENDOSCALPEL PALADIN MEDICAL, INC.
K920549 02/06/1992 SHARPE ENDONEEDLE HOLDER PALADIN MEDICAL, INC.
K110384 02/10/2011 DILON 6800 ACELLA (ACELLA) DILON TECHNOLOGIES, INC.
K140340 02/11/2014 SKINTACT LEONHARD LANG GMBH
K110426 02/14/2011 DYNA-EXTOR II BK MEDITECH CO., LTD.
K980647 02/17/1998 EYE IRRIGATOR MODEL #2020 EYE-DEAL OCULAR SAFETY PRODUCTS, INC.
K030509 02/19/2003 SKINTACT ECG TAB ELECTRODE LEONHARD LANG GMBH
K090424 02/19/2009 DVX SPINE SYSTEM BK MEDITECH CO., LTD.
K060520 02/27/2006 VITAMESH MACROPOROUS PP SURGICAL MESH PROXY BIOMEDICAL LTD.
K140500 02/27/2014 SKINTACT LEONHARD LANG GMBH
K040545 03/02/2004 OTTER SAFETY SYRINGE OTTER (CHINA) TECHNOLOGY CO., LTD.
K921015 03/03/1992 SHARPE ENDOSPONGE ASPIIRATOR PALADIN MEDICAL, INC.
K140577 03/06/2014 INNESIS PEEK TL CAGE BK MEDITECH CO., LTD.
K050592 03/08/2005 SOMNOMED MAS RXA SOMNOMED LTD
K060668 03/14/2006 SAFE TIP SYRINGE DEVON SAFETY PRODUCTS, INC.
K050678 03/16/2005 MOTIFMESH SOFT TISSUE PATCH PROXY BIOMEDICAL LTD.
K080876 03/31/2008 DVX SPINE SYSTEM BK MEDITECH CO., LTD.
K140820 04/01/2014 XENOMEM WOUND MATRIX VISCUS BIOLOGICS LLC
K971290 04/07/1997 STRATASYS FDM MEDMODELER SYSTEM PALADIN MEDICAL, INC.
K121102 04/11/2012 OSTEOSYMBIONICS PEEK CRANIAL IMPLANT OSTEOSYMBIONICS, LLC
K111069 04/18/2011 OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT OSTEOSYMBIONICS, LLC
K921888 04/21/1992 SHARPE ENDODISSECTOR PALADIN MEDICAL, INC.
K111121 04/21/2011 VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH PROXY BIOMEDICAL LTD.
K041136 04/30/2004 MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS BIO-LOK INTL., INC.
K011403 05/07/2001 SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE ORTHOGEN CORP.
K081371 05/15/2008 SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL LEONHARD LANG GMBH
K051245 05/16/2005 POLYFORM SYNTHETIC MESH PROXY BIOMEDICAL LTD.
K011530 05/17/2001 VERTRAN STANDING WHEELCHAIR FENA DESIGN, INC.
K101429 05/21/2010 ECO SUPERGEL CERACARTA SPA
K061564 06/05/2006 PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD PORTLAND ORTHOPAEDICS PTY. LTD.
K041625 06/15/2004 LTD POLYAXIAL FIXATION SYSTEM U.S. SPINAL TECHNOLOGIES, LLC.
K041650 06/17/2004 MICRO PRIME INNOVX MEDICAL, INC.
K041798 07/02/2004 ATALIA TITANIUM SURGICAL MESH U.S. SPINAL TECHNOLOGIES, LLC.
K051844 07/07/2005 EQUATOR PLUS ACETABULAR CUP SYSTEM PORTLAND ORTHOPAEDICS PTY. LTD.
K992308 07/09/1999 OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138 LIFETEK MEDICAL, INC.
K041883 07/12/2004 SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 LEONHARD LANG GMBH
K092291 07/29/2009 SKINTACT AND VARIOUS OTHER TRADENAMES LEONHARD LANG GMBH
K132377 07/31/2013 OSTEOSPAN MORPHEUS BIOGENNIX, LLC
K052100 08/03/2005 MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH PROXY BIOMEDICAL LTD.
K132483 08/08/2013 INNESIS PEEK CERVICAL CAGE BK MEDITECH CO., LTD.
K072233 08/10/2007 SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS LEONHARD LANG GMBH
K032454 08/11/2003 SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) BIO-LOK INTL., INC.
K132516 08/12/2013 OXIPROBE E (OXIPROBE) BIO MEDICAL TECHNOLOGIES CO., LTD
K022909 09/03/2002 NIKOMED TRACE 1 ECG ELECTRODES NIKOMED U.S.A., INC.
K082588 09/08/2008 GAMMALOC SYSTEM, MODEL 03-00001 DILON TECHNOLOGIES LLC
K092905 09/21/2009 AUTOSTART BURETTE ANALYTICA PTY LTD
K062970 09/29/2006 I-PAD CU MEDICAL SYSTEMS, INC.
K112874 09/30/2011 EZ VEIN INFLATABLE TOURNIQUET DOMINION MEDICAL DEVICES, LLC
K935220 10/12/1993 CORE PREVENT MATTRESS MODIFICATION PALADIN MEDICAL, INC.
K063161 10/17/2006 SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL LEONHARD LANG GMBH
K023503 10/18/2002 SKINTACT ECG ELECTRODE LEONHARD LANG GMBH
K964222 10/22/1996 ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING PALADIN MEDICAL, INC.
K103186 10/29/2010 SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES LEONHARD LANG GMBH
K063278 10/31/2006 PORTLAND COBALT CHROME FEMORAL HEAD PORTLAND ORTHOPAEDICS LIMITED
K073104 11/02/2007 SKINTACT AND VARIOUS OTHER TRADENAMES LEONHARD LANG GMBH
K914967 11/05/1991 SHARP ENDOKNOT PUSHER SHARPE ENDOSURGICAL CORP.
K023920 11/25/2002 SKINTACT LEONHARD LANG GMBH
K053417 12/08/2005 M-COR HIP REPLACEMENT SYSTEM PORTLAND ORTHOPAEDICS PTY. LTD.
K063671 12/11/2006 REBOUND HRD MINNESOTA MEDICAL DEVELOPMENT, INC.
K915743 12/23/1991 SHARPE ENDOTENACULUM PALADIN MEDICAL, INC.
K915744 12/23/1991 SHARPE ENDOHEMOSTAT PALADIN MEDICAL, INC.
K915747 12/23/1991 SHARPE ENDOFORCEPS PALADIN MEDICAL, INC.
K915749 12/23/1991 SHARPE ENDOLIGATURE CARRIER PALADIN MEDICAL, INC.
K024247 12/23/2002 SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL LEONHARD LANG GMBH
K024264 12/23/2002 SKINTACT LEONHARD LANG CO.
K053623 12/28/2005 NFIX FUSION SYSTEM N-SPINE, INC.
K993306 10/04/1999 NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) PALADIN MEDICAL, INC.


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