FDA 510(k) Applications Submitted by David Ou

FDA 510(k) Number Submission Date Device Name Applicant
K240837 03/27/2024 TOV Dental Implant System RDJ TOV Implant Ltd
K220641 03/04/2022 Barrigel Injectable Gel Palette Life Sciences
K030831 03/14/2003 LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS MODERN MEDICAL EQUIPMENT MFG., LTD.
K032327 07/28/2003 MODERN MEDICAL BIPOLAR FORCEPS MODERN MEDICAL EQUIPMENT MFG., LTD.
K032965 09/23/2003 LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE MODERN MEDICAL EQUIPMENT MFG., LTD.
K033003 09/25/2003 SUCTION COAGULATOR MODERN MEDICAL EQUIPMENT MFG., LTD.
K033095 09/29/2003 SMOKE EVACUATION ATTACHEMENT MODERN MEDICAL EQUIPMENT MFG., LTD.
K123896 12/18/2012 CCS-200 SPIROMETER BENSON MEDICAL INSTRUMENTS CO.
K240105 01/16/2024 Navigator (FMNVG15); Navigator XL (FMNVX06) Forcemech International LLC
K232331 08/04/2023 InVision Precision LVEF (LVEF) InVision Medical Technology Corporation
K243866 12/17/2024 InVision Precision Cardiac Amyloid InVision Medical Technology Corporation
K181616 06/19/2018 PSM 3-Way Silicone Foley Catheter Pathway, LLC
K192034 07/30/2019 HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc Pathway, LLC
K962228 06/10/1996 MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT OTOTECH INTL., INC.
K012455 08/01/2001 WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM WELCH ALLYN, INC.
K010186 01/22/2001 WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM WELCH ALLYN, INC.
K030075 01/08/2003 NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED) BEST MANUFACTURING COMPANY-DISTRIBUTION CENTER
K001375 05/01/2000 ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) BEST MANUFACTURING COMPANY
K022024 06/20/2002 NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN) BEST MANUFACTURING COMPANY
K992170 06/28/1999 N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE BEST MANUFACTURING COMPANY
K012166 07/11/2001 NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN) BEST MANUFACTURING COMPANY
K012899 08/29/2001 GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE BEST MANUFACTURING COMPANY
K993805 11/09/1999 NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED) BEST MANUFACTURING COMPANY
K950294 01/25/1995 FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS FLEXLENS, INC.
K981439 04/21/1998 CCA-200 BENSON MEDICAL INSTRUMENTS CO.
K963681 07/11/1996 CCA-100 (MODIFIED) BENSON MEDICAL INSTRUMENTS CO.
K982441 07/14/1998 CCA-220 BENSON MEDICAL INSTRUMENTS CO.
K991090 04/01/1999 PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3) DYNAMIC SYSTEMS, INC.
K972147 06/09/1997 PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2) DYNAMIC SYSTEMS, INC.


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