FDA 510(k) Applications Submitted by CINDY DOMECUS, R.A.C. (US & EU)
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
DEN150007 |
02/10/2015 |
Magnetic Surgical System |
Levita Magnetics International Corp. |
K120665 |
03/05/2012 |
INVENT SNORING DEVICE |
VENTUS MEDICAL, INC. |
K080983 |
04/07/2008 |
PROVENT NASAL CANNULA |
VENTUS MEDICAL, INC. |
K121195 |
04/19/2012 |
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER |
NINEPOINT MEDICAL, INC |
K061210 |
05/01/2006 |
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B |
KYPHON, INC. |
K131405 |
05/15/2013 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
K071560 |
06/07/2007 |
PROVENT NASAL DILATOR, MODEL BR2 |
VENTUS MEDICAL, INC. |
K972210 |
06/11/1997 |
RESECTOSCOPE SAFETY SHEATH |
CONCEPTUS, INC. |
K041584 |
06/14/2004 |
KYPHX HV-R BONE CEMENT, MODEL C01A |
KYPHON, INC. |
DEN140020 |
06/24/2014 |
ECLIPSE SYSTEM |
PELVALON |
K122074 |
07/16/2012 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
DEN120015 |
08/24/2012 |
EEVA 2.0 |
AUXOGYN, INC. |
K092729 |
09/04/2009 |
BAXANO NEURO CHECK DEVICE |
BAXANO, INC. |
K954164 |
09/05/1995 |
HYSTEROSCOPE |
CONCEPTUS, INC. |
K112770 |
09/23/2011 |
NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER |
NINEPOINT MEDICAL, INC |
K063071 |
10/06/2006 |
DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B |
KYPHON, INC. |
K133144 |
10/17/2013 |
SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE |
CrossBay Medical, Inc. |
K123329 |
10/26/2012 |
DA VINVI SURGICAL SYSTEM |
INTUITIVE SURGICAL, INC. |
K033801 |
12/08/2003 |
KYPHX HV-R, MODEL C01A |
KYPHON, INC. |
K123850 |
12/14/2012 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
K124031 |
12/28/2012 |
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM |
INTUITIVE SURGICAL, INC. |
K141141 |
05/02/2014 |
KIVA VCF TREATMENT SYSTEM |
BENVENUE MEDICAL, INC. |
K142023 |
07/25/2014 |
LUNA INTERBODY SYSTEM |
BENVENUE MEDICAL, INC. |
K132817 |
09/09/2013 |
KIVA VCF TREATMENT SYSTEM |
BENVENUE MEDICAL, INC. |
K123642 |
11/26/2012 |
MUSCLE STIMULATION SYSTEM |
NIVEUS MEDICAL, INC. |
K120800 |
03/16/2012 |
NVISION VLE IMAGING SYSTEM |
NINEPOINT MEDICAL, INC. |
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