FDA 510(k) Applications Submitted by CYNTHIA NOLTE, PH.D

FDA 510(k) Number Submission Date Device Name Applicant
K072537 09/10/2007 CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM CREASPINE SAS
K093000 09/28/2009 EMS PIEZON MASTER 700 EMS ELECTRO MEDICAL SYSTEMS SA
K073702 12/31/2007 PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR LAZARUS MEDICAL LLC
K000565 02/22/2000 MODIFICATION TO NC-STAT NEUROMETRIX, INC.
K050710 03/18/2005 MINIMASTER ULTRASONIC SCALER E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K081388 05/19/2008 GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM PRONIA MEDICAL SYSTEM, LLC
K022328 07/18/2002 EMS PIEZON MASTER 600 ELECTRO MEDICAL SYSTEMS SA
K012335 07/24/2001 BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS ALBERT BROWNE LTD.
K063285 10/31/2006 RELIANCE CI PROCESS INDICATOR ALBERT BROWNE LTD.
K093723 12/03/2009 EMS MINIMASTER LED EMS ELECTRO MEDICAL SYSTEMS SA
K100841 03/25/2010 BONEOPTIMIZER CURASAN AG
K100960 04/07/2010 WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS CEFLA DENTAL GROUP
K002741 09/01/2000 BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK ALBERT BROWNE LTD.
K991319 04/19/1999 RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS ORFIT INDUSTRIES
K081304 05/08/2008 ALZ WEB PACS, VERSION 1.0 ALZ, INC.
K121789 06/19/2012 SHANGRING WUHU SNNA MEDICAL TREATMENT APPLIANCE TECHNOLOGY C
K132445 08/06/2013 PIEZON 250 E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K132443 08/06/2013 PIEZON 150 E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K984613 12/29/1998 BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION ALBERT BROWNE LTD.
K071418 05/22/2007 DANA 3CC SYRINGE INSULIN RESERVOIR SOOIL DEVELOPMENT CO., LTD.
K981054 03/23/1998 BROWNE GA INDICATOR FOR CIDEX PRODUCTS ALBERT BROWNE LTD.
K060066 01/09/2006 VERIFY 3-10 MIN FLASH INTEGRATOR ALBERT BROWNE LTD.
K010840 03/21/2001 SYNPLUG ISOTIS NV
K051056 04/26/2005 VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR ALBERT BROWNE LTD.
K051101 04/29/2005 VERIFY FLASH INTEGRATOR ALBERT BROWNE LTD.
K051786 07/01/2005 MELIDE FIBEROPTIC LIGHT DESIGNS FOR VISION, INC.
K032099 07/08/2003 SWISS MASTER LIGHT (EMS SA) ELECTRO MEDICAL SYSTEMS
K110173 01/20/2011 EMS AIR-FLOW MASTER PIEZON EMS ELECTRO MEDICAL SYSTEMS SA
K080860 03/27/2008 CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM CREASPINE
K091457 05/18/2009 NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM NEXSTIM OY
K001604 05/24/2000 DANA DIABECARE SOOIL DEVELOPMENT CO., LTD.
K081564 06/04/2008 CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION CREASPINE
K001742 06/08/2000 RESUSCI INFLATE-A-SHIELD CPR BARRIER LAERDAL MEDICAL CORP.
K972450 06/30/1997 FLEXTIP GRASPER ENDIUS, INC.
K071823 07/03/2007 PERMA FACIAL IMPLANTS SURGISIL
K002116 07/13/2000 S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 MEDICAL DEVICE CONSULTANTS, INC.
K092214 07/22/2009 CHIROPRO L SYSTEM BIEN-AIR DENTAL, SA
K092289 07/29/2009 EMS AIR-FLOW HANDY PERIO EMS ELECTRO MEDICAL SYSTEMS SA
K132478 08/08/2013 AIR-FLOW HANDY 3.0 E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K132480 08/08/2013 AIR-FLOW HANDY 3.0 PERIO E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K082791 09/23/2008 EMS AIR-FLOW MASTER E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K102872 09/30/2010 OSBONE DENTAL CURASAN AG
K101661 06/14/2010 MYRAY HYPERION CEFLA DENTAL GROUP
K970866 03/10/1997 FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER GEORGIA BIOMEDICAL, INC.
K971971 05/29/1997 BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK BOARD OF DIRECTORS, ALBERT BROWNE LTD.
K002118 07/13/2000 STOCKERT COMPACT SYSTEM VERSION 2.0 STOECKERT INSTRUMENTE
K013783 11/14/2001 AUTION MAX AX-4280 URINALYSIS SYSTEM INTERNATIONAL REMOTE IMAGING SYSTEMS
K060103 01/13/2006 ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS ALBERT BROWNE LTD.
K020571 02/21/2002 STOCKERT CENTRIFUGAL PUMP CONSOLE STOCKERT INSTRUMENTE GMBH
K000587 02/22/2000 SHUTTLE STOP ISOTIS NV
K030600 02/25/2003 AUTION JET AJ-4270 URINE ANALYZER INTERNATIONAL REMOTE IMAGING SYSTEMS
K970918 03/12/1997 BROWNE STEAM INDICATOR BOARD OF DIRECTORS, ALBERT BROWNE LTD.
K991418 04/23/1999 BROWNE MVI ETHYLENE OXIDE INDICATOR ALBERT BROWNE LTD.
K991709 05/19/1999 BROWNE CIDEX OPA INDICATOR ALBERT BROWNE LTD.
K991857 06/01/1999 AIRFLOW HANDY ELECTRO MEDICAL SYSTEMS, INC.
K061738 06/20/2006 ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD ALBERT BROWNE LTD.
K071722 06/22/2007 DEEP BLUE E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
K022317 07/17/2002 DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS SOOIL DEVELOPMENT CO., LTD.
K012290 07/20/2001 RAPIDIA 3D MED CO., LTD.
K032213 07/21/2003 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP STOCKERT INSTRUMENTE GMBH
K992504 07/27/1999 EMS KERMIT (EMS SA) ELECTRO MEDICAL SYSTEMS
K062155 07/28/2006 DIGITAL MXR-D FLOWMETER PORTER INSTRUMENT CO., INC.
K992599 08/03/1999 DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR DIDECO S.P.A.
K992767 08/17/1999 BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR ALBERT BROWNE LTD.
K032801 09/09/2003 MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR ALBERT BROWNE LTD.
K052532 09/15/2005 IMAX 9.5 STERILIZERS DENTAL X SRL
K002937 09/21/2000 TST CONTROL INTEGRATOR FOR STEAM STERILIZERS ALBERT BROWNE LTD.
K052665 09/27/2005 GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES GRANTON MEDICAL LTD.
K033116 09/30/2003 OPTI-RIDER DELUXE HANSUNG ECONET CO., LTD.
K053479 12/14/2005 VERIFY DRY HEAT LABEL ALBERT BROWNE LTD.
K024302 12/24/2002 PRECISION CAPILLARIES FOR MICROMANIPULATION BRINKMANN INSTRUMENTS, INC.
K984616 12/29/1998 BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION ALBERT BROWNE LTD.
K965154 12/23/1996 TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE ALBERT BROWNE LTD.
K990512 02/18/1999 STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS STOECKERT INSTRUMENTE


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