FDA 510(k) Applications Submitted by JANICE M HOGAN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120964 |
03/30/2012 |
UPSTREAM GR CATHETER |
UPSTREAM PERIPHERAL TECHNOLOGIES |
| K121542 |
05/24/2012 |
PICIS WEIGHT BASED DOSE CONVERTER |
PICIS INC. |
| K071576 |
06/08/2007 |
TEXTRONICS ECG ELECTRODE |
TEXTRONICS, INC |
| K071633 |
06/14/2007 |
LANX DEFORMITY SYSTEM |
LANX, LLC |
| K141758 |
06/30/2014 |
T:SLIM INSULIN DELIVERY SYSTEM |
TANDEM DIABETES CARE, INC. |
| K132108 |
07/08/2013 |
MAXIO |
PERFINT HEALTHCARE PVT LTD |
| K122358 |
08/03/2012 |
NOVEON |
HOGAN LOVELLS US, L.L.P. |
| K133209 |
10/17/2013 |
FORESEE (4C) IMAGING SYSTEM |
DIAGNOSTIC PHOTONICS, INC |
| K133372 |
11/01/2013 |
CROSSTREES PVA POD |
CROSSTREES MEDICAL, INC. |
| K093510 |
11/12/2009 |
LUMENVU CATHETER GUIDANCE SYSTEM |
SONOSITE,INC. |
| K110048 |
01/06/2011 |
CERSR ELECTROMYOGRAPHY SYSTEM |
SPINEMATRIX, INC. |
| K140046 |
01/08/2014 |
SPINOUS PROCESS FUSION (SPF) PLATE |
SPINAL SIMPLICITY, LLC |
| K120116 |
01/13/2012 |
SERF ABLATION SYSTEM SERF ABLATION NEEDLE |
THERMEDICAL |
| K130089 |
01/14/2013 |
CROSSTREES PVA POD |
CROSSTREES MEDICAL, INC. |
| K070220 |
01/23/2007 |
OSTEOFIX BONE VOID FILLER |
CALCITEC, INC |
| K100404 |
02/16/2010 |
ASCENDX VCF REDUCTION SYSTEM |
AOI MEDICAL, INC. |
| K120564 |
02/24/2012 |
CALYPSO SYSTEM |
HOGAN LOVELLS US LLP |
| K110838 |
03/25/2011 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
| K130853 |
03/28/2013 |
IDYS(TM) C |
CLARIANCE |
| K130863 |
03/28/2013 |
FACET SCREW SYSTEM |
SPINAL USA |
| K050795 |
03/29/2005 |
IMBIBE BONE MARROW ASPIRATION NEEDLE |
ORTHOVITA, INC. |
| K081138 |
04/21/2008 |
SAFEFLO VENA CAVA FILTER |
RMT MEDICAL TECHNILOGIES INC. |
| K121541 |
05/24/2012 |
JAZZ SYSTEM |
IMPLANET S.A. |
| K121598 |
05/31/2012 |
ME HAIR2GO |
SYNERON MEDICAL LTD. |
| K131649 |
06/05/2013 |
ME |
SYNERON BEAUTY LTD. |
| K131657 |
06/06/2013 |
FLOWER SMALL AND MEDIUM IMPLANT SET |
FLOWER ORTHOPEDICS CORPORATION |
| K141507 |
06/06/2014 |
TWO SKIN TREATMENT SYSTEM |
SYNERON MEDICAL LTD. |
| K141708 |
06/24/2014 |
ULTRASHAPE SYSTEM |
SYNERON MEDICAL LTD. |
| K051826 |
07/05/2005 |
BETACONE HIP PROSTHESIS SYSTEM |
WALDEMAR LINK GMBH & CO. KG |
| K071877 |
07/09/2007 |
LANX SPINAL FIXATION SYSTEM |
LANX, LLC |
| K071905 |
07/10/2007 |
POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
LANX, LLC |
| K141956 |
07/18/2014 |
FIBERGRAFT BG MORSELS |
PROSIDYAN, INC |
| K132248 |
07/19/2013 |
FLOWER BONE SCREW SET |
FLOWER ORTHOPEDICS CORPORATION |
| K132287 |
07/23/2013 |
JAZZ SYSTEM |
HOGAN LOVELLS US LLP |
| K132303 |
07/24/2013 |
IMPLANET SPINE SYSTEM |
IMPLANET S.A. |
| K092381 |
08/05/2009 |
IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION |
IBALANCE MEDICAL, INC. |
| K092536 |
08/19/2009 |
SPINAL FIXATION SYSTEM |
LANX, INC. |
| K122725 |
09/05/2012 |
TANDA PEARL, ULTRAWYTE, PEARL |
SYNERON BEAUTY |
| K132805 |
09/06/2013 |
BG MORSELS |
PROSIDYAN, INC |
| K062739 |
09/13/2006 |
CINCH BONE ANCHOR SYSTEM |
SAPPHIRE MEDICAL, INC |
| K112887 |
09/30/2011 |
UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR |
UPSTREAM PERIPHERAL TECHNOLOGIES |
| K112886 |
09/30/2011 |
UPSTREAM SUPPORT CATHETER |
UPSTREAM PERIPHERAL TECHNOLOGIES |
| K133102 |
09/30/2013 |
FLOWER ANKLE PLATING SET |
FLOWER ORTHOPEDICS CORPORATION |
| K133238 |
10/21/2013 |
CONTOUR I V3.1 SYSTEM |
SYNERON MEDICAL LTD |
| K083184 |
10/28/2008 |
TEARLAB OSMOLARITY SYSTEM |
OCUSENSE, INC. |
| K133359 |
10/31/2013 |
ENDORINGS |
ENDO-AID, INC. |
| DEN080011 |
11/03/2008 |
SNAP WOUND CARE DEVICE |
SPIRACUR, INC. |
| K123497 |
11/13/2012 |
FACET SCREW SYSTEM |
FACET-LINK, INC. |
| K123562 |
11/19/2012 |
FLOWER SMALL AND MEDIUM BONE IMPLANTS |
FLOWER ORTHOPEDICS CORPORATION |
| K113452 |
11/21/2011 |
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM |
ASCENDX SPINE, INC. |
| K133617 |
11/25/2013 |
JAZZ SYSTEM |
IMPLANET S.A. |
| K113633 |
12/08/2011 |
MCKESSON ANESTHESIA CARE |
MCKESSON TECHNOLOGIES INC. |
| K123845 |
12/13/2012 |
ME |
SYNERON BEAUTY LTD. |
| K083825 |
12/22/2008 |
EOI SPINAL SYSTEM |
EXPANDING ORTHOPEDICS, INC. |
| K124042 |
12/28/2012 |
TANDA MINI SKINCARE SYSTEM |
SYNERON BEAUTY |
| K131178 |
04/25/2013 |
IDYS LIF CAGES |
CLARIANCE |
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