FDA 510(k) Applications Submitted by ROSINA ROBINSON

FDA 510(k) Number Submission Date Device Name Applicant
K980016 01/02/1998 MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
K060053 01/06/2006 STOCKERT S5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH
K050131 01/21/2005 INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE M.K. MEDITECH CO. LTD.
K080200 01/25/2008 WATER WORKS DOUCHING DEVICE ABBOTT RESEARCH GROUP, INC.
K950806 02/22/1995 SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS MIRA, INC.
K050474 02/24/2005 VEINNOVATIONS INFILTRATION SYSTEM VEINNOVATIONS, LLC
K020623 02/26/2002 DUOPRO SAFETY SYRINGE (DUOPROSS) M.K. MEDITECH CO. LTD.
K020647 02/28/2002 DIDECO ELECTA DIDECO S.P.A.
K090686 03/16/2009 SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS SIC BREVETTI S.R.L.
K080832 03/25/2008 STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER SORIN GROUP DEUTSCHLAND GMBH
K971146 03/28/1997 LAPARETTE RD CHUS, INC.
K030976 03/28/2003 CAREO RETRACTABLE SAFETY SYRINGE LIFE-SHIELD PRODUCTS, INC
K080902 04/02/2008 FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 LORENZ BIOTECH S.P.A.
K091007 04/09/2009 AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 SORIN GROUP DEUTSCHLAND GMBH
K091008 04/09/2009 STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 SORIN GROUP DEUTSCHLAND GMBH
K011088 04/10/2001 SIII ALARM AMPLIFIER STOCKERT INSTRUMENTE GMBH
K101046 04/14/2010 STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH
K051055 04/26/2005 INTRABEAM SYSTEM CARL ZEISS SURGICAL GMBH
K061171 04/27/2006 SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX BIOSPHERE MEDICAL, INC.
K001388 05/02/2000 DATA MASTER PERFUSION MONITORING SYSTEM DIDECO
K071318 05/10/2007 MODIFICATION TO: STOCKERT S5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH
K031594 05/21/2003 BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY M.K. MEDITECH CO. LTD.
K982014 06/08/1998 STOCKERT COMPACT SYSTEM STOECKERT INSTRUMENTE
K041558 06/10/2004 STOCKERTIR PURGE CONTROL (APC) SYSTEM STOCKERT INSTRUMENTE GMBH
K011838 06/12/2001 CENTRIFUGAL PUMP STOCKERT INSTRUMENTE GMBH
K051599 06/16/2005 NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT NEURORECOVERY, INC.
K021984 06/18/2002 PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT INCEPTIO MEDICAL TECHNOLOGIES, LC
K962365 06/19/1996 XENON LIGHTSOURCE DSP WORLDWIDE
K962371 06/19/1996 DERMTOME BLADE DSP WORLDWIDE
K972317 06/20/1997 MONTGOMERY THYROPLASTY IMPLANT SYSTEM BOSTON MEDICAL PRODUCTS, INC.
K972321 06/23/1997 S3 MAST PUMP STOECKERT INSTRUMENTE
K962544 06/28/1996 MICRO DIAMOND-POINT DISSECTION NEEDLES DSP WORLDWIDE
K061828 06/28/2006 LORENZ BIOTECH APTIVA, VERSION 2.13 LORENZ BIOTECH S.P.A.
K101794 06/28/2010 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA ADVANCED SURGICAL CONCEPTS
K002229 07/24/2000 WACKERS-LIU CQ SOFTWARE ECLIPSE SYSTEMS, INC.
K062119 07/25/2006 HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 MEDICAL PRODUCTS MFG., LLC
K072037 07/25/2007 CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML LIFE-SHIELD PRODUCTS, INC
K982650 07/30/1998 AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) DIDECO S.P.A.
K112225 08/03/2011 SORIN CENTRIFUGAL PUMP 5 (CP5) SORIN GROUP DEUTSCHLAND GMBH
K082241 08/07/2008 THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 DALE MEDICAL PRODUCTS, INC.
K022638 08/08/2002 NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT NEURORECOVERY, INC.
K062302 08/08/2006 MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM MILLICORE AB
K092463 08/11/2009 SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH
K032500 08/13/2003 MODIFICARION TO WACKERS-LIU CQ SOFTWARE ECLIPSE SYSTEMS, INC.
K082344 08/15/2008 STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) SORIN GROUP DEUTSCHLAND GMBH
K062396 08/16/2006 MODIFICATION TO STOCKERT S5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH
K963285 08/21/1996 EMS SWISS LITHOCLAST LITHOTRIPTER ELECTRO MEDICAL SYSTEMS SA
K072362 08/22/2007 NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG NOVALUNG GMBH
K022806 08/23/2002 DUOPRO SAFETY SYRINGE (DUOPROSS) M.K. MEDITECH CO. LTD.
K042374 09/01/2004 STOCKERT SCP RHYTHM STOCKERT INSTRUMENTE GMBH
K983314 09/21/1998 PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM NYCOMED AMERSHAM IMAGING
K052601 09/21/2005 STOCKERT HEATER-COOLER SYSTEM 3T SORIN GROUP DEUTSCHLAND GMBH
K052618 09/23/2005 IMAGECAST PACS IDX SYSTEMS CORP.
K052742 09/30/2005 HEPASPHERE MICROSPHERES BIOSPHERE MEDICAL, INC.
K954717 10/13/1995 SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY SODEM DIFFUSION SA
K003256 10/17/2000 PCCR DIGITAL IMAGING DEVICE OREX COMPUTED RADIOGRAPHY LTD
K042900 10/19/2004 K.E.P. CONNECTOR AND CLIP K.E.P., LLC
K103168 10/27/2010 B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) SORIN GROUP DEUTSCHLAND GMBH
K974164 11/05/1997 SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE MEDICAL DEVICE CONSULTANTS, INC.
K955152 11/13/1995 STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER STOECKERT INSTRUMENTE
K955174 11/13/1995 SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY SODEM DIFFUSION SA
K103468 11/24/2010 STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) SORIN GROUP DEUTSCHLAND GMBH
K103469 11/24/2010 STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 SORIN GROUP DEUTSCHLAND GMBH
K093813 12/11/2009 OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE IMBIOTECHNOLOGIES
K034031 12/29/2003 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE M.K. MEDITECH CO. LTD.
K123449 11/09/2012 BIOMONDE LARVAE BIOMONDE (A TRADING NAME OF ZOOBIOTIC LIMITED)
K964571 11/14/1996 VISION CARDIOPLEGIA DELIVERY SYSTEM LIFESTREAM INT'L, INC.
K131563 05/30/2013 SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM OPUS KSD, INC.
K142020 07/25/2014 LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 BIOMONDE
K093882 12/18/2009 SORIN C5 SYSTEM MODEL 58-00-00 SORIN GROUP DEUTSCHLAND GMBH
K103762 12/23/2010 SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE SORIN GROUP DEUTSCHLAND GMBH


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