FDA 510(k) Applications Submitted by JENNIFER LI

FDA 510(k) Number Submission Date Device Name Applicant
K121002 04/02/2012 ETEST CEFTAROLINE BIOMERIEUX, INC.
K121546 05/25/2012 VITEK 2 GRAM NEGATIVE DOXYCYCLINE BIOMERIEUX, INC.
K111976 07/12/2011 VITEK 2 STREPTOCOCCUS ERYTHROMYCIN BIOMERIEUX, INC.
K112228 08/03/2011 VITEK 2 STREPTOCOCCUS LEVOFLOXACIN BIOMERIEUX, INC.
K051586 06/15/2005 VIEWSEND MEDICAL SYSTEM KENEI CO., LTD.
K210782 03/16/2021 Tablo Cartridge Outset Medical, Inc.
K200741 03/23/2020 Tablo Hemodialysis System Outset Medical, Inc.
K190793 03/28/2019 Tablo Hemodialysis System, Tablo Cartridge Outset Medical, Inc.
K040892 04/06/2004 MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 NIDEK MEDICAL PRODUCTS, INC.
K032509 08/14/2003 MARK 5 NUVO (M5C5) NIDEK MEDICAL PRODUCTS, INC.
K082566 09/04/2008 MARK 5 NUVO LITE OCSI AND STD NIDEK MEDICAL PRODUCTS, INC.
K093308 10/22/2009 MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD NIDEK MEDICAL PRODUCTS, INC.
K120401 02/08/2012 ALAMO T ALLIANCE PARTNERS, LLC
K121181 04/18/2012 SWANNSHIDI BONE MARROW ASPIRATION NEEDLE ALLIANCE PARTNERS, LLC
K111484 05/31/2011 DISCOVERY INTUITIVE SPINE, LLC
K122047 07/12/2012 ALAMO P ALLIANCE PARTNERS, LLC
K112361 08/17/2011 ALAMO C ALLIANCE PARTNERS, LLC
K122622 08/28/2012 ENDURAMESH LUCERO MEDICAL, LLC
K093207 10/13/2009 ENDURAMESH, MODEL 762.XXX LUCERO MEDICAL, LLC
K133321 10/29/2013 ALAMO C ALLIANCE PARTNERS, LLC
K120944 03/29/2012 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER COVIDIEN
K130904 04/01/2013 TRELLIS-8 PERIPHERAL INFUSION SYSTEM COVIDIEN
K091378 05/11/2009 MAMMOSITE II RADIATION THERAPY SYSTEM HOLOGIC, INC.
K092405 08/06/2009 MAMMOSITE MULTI LUMEN HOLOGIC, INC.
K123196 10/11/2012 PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH COVIDIEN
K163055 11/01/2016 Reprocessed Kendall SCD Express Foot Cuff COVIDIEN
K131428 05/17/2013 RADVISION ACOUSTIC MEDSYSTEMS, INC.
K051753 06/29/2005 ACCU-SOURCE ONCOLOGY SYSTEMS, INC.
K092522 08/18/2009 ACU007S ONCOLOGY SYSTEMS, INC.
K010310 02/01/2001 MODIFICATION TO TRIDENT ALL POLY CUP HOWMEDICA OSTEONICS CORP.
K140548 03/04/2014 CORCAM HEART MONITOR CORCAM TECHNOLOGIA, SA
K010757 03/13/2001 LFIT V40 FEMORAL HEAD COMPONENTS HOWMEDICA OSTEONICS CORP.
K020989 03/27/2002 SUPER EON PLUS FEMORAL STEMS HOWMEDICA OSTEONICS CORP.
K141045 04/23/2014 MBD PLATE SYSTEM MBD MEDICAL, LLC
K021310 04/25/2002 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) HOWMEDICA OSTEONICS CORP.
K001385 05/02/2000 HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS HOWMEDICA OSTEONICS CORP.
K001548 05/18/2000 MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS HOWMEDICA OSTEONICS CORP.
K001886 06/21/2000 APEX FIXATION PINS HOWMEDICA OSTEONICS CORP.
K022077 06/26/2002 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) HOWMEDICA OSTEONICS CORP.
K001957 06/27/2000 MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT HOWMEDICA OSTEONICS CORP.
K012026 06/28/2001 TRIDENT ALL POLY CUP HOWMEDICA OSTEONICS CORP.
K022549 08/01/2002 RESTORATION MODULAR SYSTEM HOWMEDICA OSTEONICS CORP.
K002552 08/17/2000 HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE HOWMEDICA OSTEONICS CORP.
K002654 08/25/2000 HOWMEDICA OSTEONICS SHOULDER SCREW HOWMEDICA OSTEONICS CORP.
K993004 09/07/1999 ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW HOWMEDICA OSTEONICS CORP.
K993603 10/25/1999 WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW HOWMEDICA OSTEONICS CORP.
K013676 11/07/2001 TRIDENT HEMISPHERICAL ACETABULAR SHELLS HOWMEDICA OSTEONICS CORP.
K993768 11/08/1999 CITATION TMZF HA STEM HOWMEDICA OSTEONICS CORP.
K014226 12/26/2001 UNITRAX MODULAR UNIPOLAR SYSTEM HOWMEDICA OSTEONICS CORP.
K040362 02/13/2004 DIAPHARMA FACTOR X KIT DIAPHARMA GROUP, INC.


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