FDA 510(k) Applications Submitted by NATALIE J KENNEL

FDA 510(k) Number Submission Date Device Name Applicant
K130238 01/31/2013 NIHON KOHDEN AE-918P NEURO UNIT NIHON KOHDEN CORP.
K171685 06/07/2017 Med4 Elite Cool Systems, Inc. (dba Game Ready)
K092265 07/29/2009 VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS MEDACTA INTERNATIONAL, SA
K142624 09/16/2014 Neuromaster G1 MEE200 Nihon Kohden Corporation
K080431 02/19/2008 RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 QUANTRX BIOMEDICAL CORPORATION
K080436 02/19/2008 RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 QUANTRX BIOMEDICAL CORPORATION
K080455 02/20/2008 RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 QUANTRX BIOMEDICAL CORPORATION
K080885 03/31/2008 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION MEDACTA INTERNATIONAL, SA
K090988 04/07/2009 GMK TOTAL KNEE SYSTEM MEDACTA INTERNATIONAL, SA
K081023 04/10/2008 EVOLIS TOTAL KNEE SYSTEM MEDACTA INTERNATIONAL, SA
K091069 04/14/2009 MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT MEDACTA INTERNATIONAL, SA
K091967 07/01/2009 MEDACTA BIPOLAR HEAD MEDACTA INTERNATIONAL, SA
K102437 08/26/2010 GMK REVISION KNEE SYSTEM MEDACTA INTERNATIONAL, SA
K082792 09/23/2008 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS MEDACTA INTERNATIONAL, SA
K122975 09/26/2012 GKS PRIME FLEX CR TOTAL KNEE SYSTEM PERMEDICA
K083116 10/21/2008 VERSAFIT CUP DOUBLE MOBILITY SYSTEM MEDACTA INTERNATIONAL, SA
K103170 10/27/2010 GMK REVISION KNEE SC LINERS MEDACTA INTERNATIONAL, SA
K103189 10/28/2010 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK MEDACTA INTERNATIONAL, SA
K103352 11/16/2010 VERSAFITCUP CC TRIO MEDACTA INTERNATIONAL
K073337 11/28/2007 MECTACER BIOLOX FORTE-FEMORAL HEADS MEDACTA INTERNATIONAL, SA
K083558 12/02/2008 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C MEDACTA INTERNATIONAL, SA
K093806 12/11/2009 MYKNEE CUTTING BLOCKS MEDACTA INTERNATIONAL, SA
K103721 12/21/2010 MPACT ACETABULAR SYSTEM MEDACTA INTERNATIONAL
K063846 12/27/2006 EIGEN DSA 2000 EIGEN


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