FDA 510(k) Applications Submitted by MARY MCNAMARA-CULLINANE

FDA 510(k) Number Submission Date Device Name Applicant
K050032 01/07/2005 EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS EUROMED, INC.
K960089 01/11/1996 PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR COTTRELL, LTD.
K030131 01/14/2003 OSSATURA BCP BONE VOID FILLER ISOTIS NV
K960173 01/16/1996 INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT GABRIEL MEDICAL, INC.
K050187 01/27/2005 PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES SOFRADIM PRODUCTION
K080315 02/06/2008 DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC.
K050354 02/14/2005 PERIOSCAN ULTRASONIC SCALER SIRONA DENTAL SYSTEMS GMBH
K000551 02/18/2000 IMAGE X-70 PLUS DENTAL X-RAY UNIT MEDICAL DEVICE CONSULTANTS, INC.
K090411 02/18/2009 FREEDOM METAL BACKED TIBIAL COMPONENT MAXX ORTHOPEDICS, INC.
K060507 02/27/2006 VALPLAST YAMAHACHI TEETH VALPLAST INTL. CORP.
K010711 03/09/2001 ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR ADVANCED SURGICAL CONCEPTS (ASC)
K991011 03/26/1999 ORASCOPE FIBERDENT CORP.
K020969 03/26/2002 VACURECT VACUUM CONSTRICTION DEVICE VACURECT MANUFACTURING (PTY) LTD.
K080949 04/03/2008 KERATEC WOUND DRESSINGS KERATEC LIMITED
K971369 04/14/1997 BROWNE MVI STEAM INDICATOR ALBERT BROWNE LTD.
K011183 04/18/2001 OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE ADVANCED SURGICAL CONCEPTS (ASC)
K071147 04/24/2007 NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM NEXA ORTHOPEDICS, INC.
K061166 04/27/2006 DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM BIOWAVE CORPORATION
K091280 05/01/2009 FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT MAXX ORTHOPEDICS, INC.
K061246 05/03/2006 ENDOSCOPIC SPINE SYSTEM ARTHRO KINETICS INC.
K041176 05/05/2004 URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM SOFRADIM PRODUCTION
K051160 05/05/2005 MANIPUSEAL INSITU SYSTEMS
K971791 05/15/1997 VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION LOUISVILLE LABORATORIES, INC.
K971796 05/15/1997 LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS LOUISVILLE LABORATORIES, INC.
K971797 05/15/1997 LAPAROSCOPIC BLADDER NECK SUSPENSION KIT LOUISVILLE LABORATORIES, INC.
K971801 05/15/1997 LAPAROTOMY BLADDER NECK SUSPENSION KIT LOUISVILLE LABORATORIES, INC.
K971802 05/15/1997 VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION LOUISVILLE LABORATORIES, INC.
K031584 05/21/2003 SIROTORQUE L SIRONA DENTAL SYSTEMS GMBH
K981928 06/02/1998 GALILEO DISPOSABLE ENDOSCOPES GALILEO ELECTRO-OPTICS CORP.
K051445 06/02/2005 MILLIKEN SILVER WOUND DRESSINGS MILLIKEN CHEMICAL
K981958 06/04/1998 LEISEGANG VIDEO COLPOSCOPE NETOPTIX CORP.
K081584 06/05/2008 DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC.
K981998 06/08/1998 PEDIATRIC INSTATRAK SYSTEM VISUALIZATION TECHNOLOGY, INC.
K061614 06/09/2006 TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS ESCADA INTERNATIONAL, INC.
K061615 06/09/2006 INTERDRY TEXTILE WITH SILVER MILLIKEN CHEMICAL
K021913 06/11/2002 CALSCOR SOFTWARE 3D MED CO., LTD.
K962256 06/12/1996 GALILEO HYSTEROSCOPES AND LAPAROSCOPES GALILEO ELECTRO-OPTICS CORP.
K031813 06/12/2003 OSSATURA DENTAL ISOTIS NV
K001780 06/13/2000 COPAN VIRAL TRANSYSTEM COPAN DIAGNOSTICS, INC.
K051661 06/22/2005 IMPLANT HANDPIECES SIRONA DENTAL SYSTEMS GMBH
K051709 06/27/2005 HIPPOCAMPE WHEELCHAIR VIPAMAT TECHNOLOGIE
K001971 06/28/2000 HEMODIALYSIS TUBING SETS OFI BIOMEDICA S.P.A.
K121898 06/29/2012 STAY FRESH SKIN FOLD MANAGEMENT TEXTILE QUICK-MED TECHNOLOGIES, INC.
K061862 06/30/2006 AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM AXIOM ORTHOPAEDICS, INC.
K022119 07/01/2002 EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE ELECTRO MEDICAL SYSTEMS SA
K982327 07/02/1998 INFRAMETRICS INFRACAM-MED INFRAMETRICS, INC.
K002013 07/03/2000 OMNIPORT ADVANCED SURGICAL CONCEPTS (ASC)
K032093 07/07/2003 PARIEFIX SOFRADIM PRODUCTION
K992363 07/15/1999 SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN EUROMED, INC.
K041920 07/16/2004 INFINITY PLUS ELECTROTHERAPY SYSTEM EMPI
K082019 07/16/2008 FREEDOM TOTAL KNEE SYSTEM MAXX ORTHOPEDICS, INC.
K032283 07/24/2003 DESIGNS FOR VISION FIBEROPTIC LIGHT DESIGNS FOR VISION, INC.
K042057 07/30/2004 INFINITY ELECTROTHERAPY SYSTEM EMPI
K072123 08/02/2007 HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE BIOWAVE CORPORATION
K992635 08/06/1999 INTERFACE MODULE IDDD STOECKERT INSTRUMENTE
K012746 08/16/2001 ICE BATON BEHIVE LTD
K032543 08/18/2003 SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES SIRONA DENTAL SYSTEMS GMBH
K072357 08/22/2007 NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM AFP IMAGING CORP.
K052289 08/23/2005 DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE BIOWAVE CORPORATION
K982994 08/27/1998 SKULL BASE INSTATRAK SYSTEM VISUALIZATION TECHNOLOGY, INC.
K032654 08/28/2003 PORT CASSETTE OREX COMPUTED RADIOGRAPHY LTD
K002699 08/30/2000 PARIETEX COMPOSITE (PCO) MESH MEDICAL DEVICE CONSULTANTS, INC.
K012949 09/04/2001 URETEX SUP PUBOURETHRAL SLING SOFRADIM PRODUCTION
K983144 09/08/1998 FLEXPOSURE RETRACTOR ENDIUS, INC.
K032776 09/08/2003 VACURECT VACUUM CONSTRICTION DEVICE VACURECT MANUFACTURING (PTY) LTD.
K052515 09/14/2005 SIROENDO SIRONA DENTAL SYSTEMS GMBH
K983249 09/16/1998 SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN EUROMED, INC.
K993161 09/22/1999 COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM COPAN DIAGNOSTICS, INC.
K013176 09/24/2001 MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE AFP IMAGING CORP.
K983529 10/08/1998 INSTATRAK 3000 VISUALIZATION TECHNOLOGY, INC.
K093188 10/09/2009 AFM ULTRA AG DRESSINGS MILLIKEN & CO.
K983567 10/13/1998 IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM MED IMAGES, INC.
K964111 10/15/1996 LITHOVAC SUCTION/ASPIRATION PROBE ELECTRO MEDICAL SYSTEMS SA
K993535 10/19/1999 METAPAK MULTI-PURPOSE INSTRUMENT TRAY RILEY MEDICAL, INC.
K072956 10/19/2007 MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC.
K013499 10/22/2001 DIOMED 15 PLUS AND DIOMED 30PLUS LASERS DIOMED, INC.
K033376 10/22/2003 UGYTEX MESH SOFRADIM PRODUCTION
K043055 11/05/2004 TERRAQUANT MQ2000 LASER THERAPY DEVICE ESCADA INTERNATIONAL, INC.
K073170 11/09/2007 R-PORT II LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS
K974297 11/17/1997 GALILEO DISPOSABLE HYSTEROSCOPES NETOPTIX CORP.
K033640 11/20/2003 SIROSON L AND SIROSONIC L ULTRASONIC SCALERS SIRONA DENTAL SYSTEMS GMBH
K033675 11/24/2003 PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER SIRONA DENTAL SYSTEMS GMBH
K033812 12/09/2003 SIROAIR L AIR SCALER SIRONA DENTAL SYSTEMS GMBH
K083659 12/10/2008 SILVER WOUND PAD MILLIKEN & CO.
K974619 12/11/1997 SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM AFP IMAGING CORP.
K043530 12/21/2004 DVI CURING LIGHT DESIGNS FOR VISION, INC.
K003990 12/26/2000 SOFRADIM PARIETEX SURGICAL MESHES SOFRADIM PRODUCTION
K073719 12/31/2007 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS
K970352 01/30/1997 SMARTVAC SMOKE EVACUATION SYSTEM ISOMEDIX OPERATIONS INC.
K040998 04/19/2004 MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH SOFRADIM PRODUCTION
K981828 05/22/1998 GALILEO DISPOSABLE HYSTEROSCOPES NETOPTIX CORP.


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