FDA 510(k) Applications Submitted by CONSTANCE G BUNDY

FDA 510(k) Number Submission Date Device Name Applicant
K100591 03/02/2010 SORBACT ABIGO MEDICAL AB
K101133 04/22/2010 SENSOMETRICS SOFTWARE DPCOM AS
K011438 05/10/2001 BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. ENTIFIC MEDICAL SYSTEMS, INC.
K893626 05/11/1989 FLEXMEDICS GUIDEWIRE FLEXMEDICS
K021837 06/04/2002 BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) ENTIFIC MEDICAL SYSTEMS, INC.
K042110 08/05/2004 BEAMCATH BEAMPOINT AB
K003175 10/10/2000 COMPUMEDICS SIESTA SYSTEM COMPUMEDICS LIMITED
K993802 11/09/1999 SHARPVIEW IMAGE ENHANCEMENT SYSTEM CONTEXTVISION AB
K003714 12/01/2000 OSSTELL RESONANCE FREQUENCY ANALYZER INTEGRATION DIAGNOSTICS LTD
K070055 01/04/2007 BONALIVE GRANULES AND BONALIVE PLATES VIVOXID LTD.
K000068 01/10/2000 COMPUMEDICS E-SERIES EEG SYSTEM COMPUMEDICS NEURO SCIENCE PTY LTD.
K930253 01/19/1993 CARDIO2 CTCKE ERGOMETRX, INC.
K900307 01/21/1990 KARE CHAIR I KARE CHAIR INDUSTRIES, INC.
K910280 01/23/1991 ULTRA-SELECT PTCA GUIDEWIRE MICROVENA CORP.
K050234 02/01/2005 REMOTE CARE E.CARE SOLUTIONS, INC.
K030403 02/06/2003 CEFAR REHAB 2 AND REHAB 2 PRO CEFAR MEDICAL AB
K900657 02/09/1990 UNIVERSAL DELIVERY SYSTEM CATHETER MICROVENA CORP.
K930656 02/09/1993 SULLIVAN III NASAL CPAP SYSTEM RESCARE LTD.
K950582 02/09/1995 SULLIVAN PASSOVER HUMIDIFER RESCARE, INC.
K080595 03/03/2008 CELLAVISION DM96 WITH THE BODY FLUID APPLICATION CELLAVISION AB
K020803 03/12/2002 CEFAR MEDICAL AB CEFAR PRIMO CEFAR MEDICAL AB
K130702 03/15/2013 AIRSONETT AIR-4 AIRSONETT, AB
K891672 03/21/1989 PUL-TRON 100K PROFESSIONAL SPIROMETER ADVANTAGE MEDICAL SYSTEMS, INC.
K901502 03/29/1990 AMPLATZ "GOOSE-NECK" SNARE MICROVENA CORP.
K071013 04/10/2007 REDSENSE REDSENSE MEDICAL AB
K021176 04/12/2002 COMPUMEDICS SOMTE SYSTEM COMPUMEDICS LIMITED
K861383 04/14/1986 SOLEX THERAPEUTIC PAD INTL. DIATHERMICS RESEARCH, INC.
K081062 04/14/2008 AIRSONNETT AIRSHOWER AIR 3 AIRSONETT, INC.
K931884 04/15/1993 SULLIVAN NASAL VPAP SYSTEM RESCARE LTD.
K881706 04/19/1988 PROXIMA 1 PH MONITOR TECHNOMANAGEMENT, INC. C/O C.G.
K911763 04/19/1991 LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) VASAMEDICS, L.L.C.
K871573 04/22/1987 CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS SPECTRAMED, INC.
K071165 04/26/2007 ISCALERT SENSOR SYSTEM ALERTIS MEDICAL AS
K071199 04/30/2007 BONALIVE GRANULES VIVOXID LTD.
K011355 05/03/2001 BIOLIGHT PCD BIOLIGHT INTERNATIONAL AB
K932278 05/12/1993 PFM PROFESSIONAL 7000 SPIROMETER ADVANTAGE MEDICAL SYSTEMS, INC.
K871944 05/19/1987 FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) FUTURECARE SYSTEMS, INC.
K912446 06/03/1991 MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 VASAMEDICS, L.L.C.
K852694 06/26/1985 PORTALASE 200 CARBON SURGICAL LASER SYSTEM MINNESOTA LASER CORP.
K852695 06/26/1985 FOR USE IN EAR; NOSE & THROAT MICROSURGERY MINNESOTA LASER CORP.
K852696 06/26/1985 FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY MINNESOTA LASER CORP.
K071937 07/13/2007 BONALIVE GRANULES AND BONALIVE PLATES VIVOXID LTD.
K923528 07/16/1992 INLET IRRIGATION/ASPIRATION VALVE AND PROBES INLET MEDICAL, INC.
K042017 07/27/2004 BAHA DIVINO ENTIFIC MEDICAL SYSTEMS, INC.
K102111 07/28/2010 MEDICAL MAGNETIC TAPE RECORDER WPR MEDICAL AS
K112469 08/26/2011 GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM SONOWAND AS
K973318 09/04/1997 MOBIMED SYSTEM, (PEGASUS AND POLARIS) ORTIVUS US, INC.
K102595 09/09/2010 MEDISTIM VERIQC SYSTEM MEDI-STIM ASA
K873764 09/16/1987 AMBULATORY BLOOD PRESSURE MONITOR PULSETREND, INC.
K914145 09/16/1991 DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES MEDIVATORS, INC.
K002913 09/18/2000 HEADBAND FOR BAHA ENTIFIC MEDICAL SYSTEMS, INC.
K092868 09/18/2009 CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 CELLAVISION AB
K102778 09/24/2010 CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION CELLAVISION AB
K092955 09/25/2009 REDSENSE-HOME USE REDSENSE MEDICAL AB
K895899 10/06/1989 FLEXMEDICS GUIDEWIRE .012 ONLY FLEXMEDICS
K874253 10/20/1987 ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. MINNESOTA LASER CORP.
K874254 10/20/1987 ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS MINNESOTA LASER CORP.
K874255 10/20/1987 ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. MINNESOTA LASER CORP.
K896096 10/20/1989 SOLOSTICK (AMPLATZ DILATOR NEEDLE) MICROVENA CORP.
K003301 10/20/2000 DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER CELLAVISION AB
K874479 11/02/1987 MC/CPAP MANIFOLD MINNEAPOLIS CHILDREN'S SERVICES CORP.
K073099 11/02/2007 FMRI HARDWARE SYSTEM NORDICNEUROLAB
K093409 11/02/2009 POWERPUMP ARTHROSCOPY SYSTEM MEDICAL VISION AB
K103242 11/02/2010 REDSENSE-ALARM UNIT AND SENSOR REDSENSE MEDICAL AB
K854468 11/06/1985 PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC MINNESOTA LASER CORP.
K854469 11/06/1985 PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG MINNESOTA LASER CORP.
K854470 11/06/1985 PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI MINNESOTA LASER CORP.
K854471 11/06/1985 PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T MINNESOTA LASER CORP.
K854472 11/06/1985 PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG MINNESOTA LASER CORP.
K854473 11/06/1985 PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC MINNESOTA LASER CORP.
K896396 11/06/1989 MIDA SYSTEM, MODELS 1000/1100 MEDICAL GRAPHICS CORP.
K993773 11/08/1999 HUMID-HEAT HUDSON RCJ AB
K043096 11/09/2004 COMMANDER II CARDIOCOM
K915085 11/12/1991 DL100 C02 SURGICAL LASER SYSTEM MNLASE, INC.
K864507 11/14/1986 V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 SPECTRAMED, INC.
K896515 11/15/1989 LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2 TSI, INC.
K854790 11/29/1985 CERYX PACEMAKER MODELS 114, 314 & 614 VITATRON MEDICAL BV
K083597 12/05/2008 SONOWAND INVITE SONOWAND AS
K033840 12/10/2003 CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER CELLAVISION AB
K926233 12/11/1992 CARDIO2 CYCLE ERGOMETRIX, INC.


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