FDA 510(k) Applications Submitted by DAVID M LEE

FDA 510(k) Number Submission Date Device Name Applicant
K210516 02/23/2021 Clicky Cross Yomura Technologies Inc.
K122653 08/31/2012 MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES KIMBERLY-CLARK CORPORATION
K013200 09/25/2001 RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 RENNELS MEDICAL CORP.
K112562 09/26/2011 BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER KIMBERLY-CLARK
K023638 10/30/2002 CASSETTE/URINE HCG IND DIAGNOSTIC INC.
K083681 12/12/2008 BIOLAND BLOOD PRESSURE MONITOR BIOLAND TECHNOLOGY LTD.
K000195 01/21/2000 CRANIAL DRILL IMAGE-GUIDED NEUROLOGICS, INC.
K040334 02/11/2004 NAVIGUS PASSIVE PROBE, MODEL NP-1000 IMAGE-GUIDED NEUROLOGICS, INC.
K140539 03/04/2014 AERO BLUE PERFORMANCE SURGICAL GOWN KIMBERLY-CLARK CORPORATION
K080795 03/20/2008 ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN KIMBERLY-CLARK CORP.
K050772 03/25/2005 NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 IMAGE-GUIDED NEUROLOGICS, INC.
K040834 03/31/2004 NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 IMAGE-GUIDED NEUROLOGICS, INC.
K001096 04/04/2000 BURR HOLE COVER, MODEL XX IMAGE-GUIDED NEUROLOGICS, INC.
K001097 04/04/2000 ACTIVE ARRAY CATHETER, MODEL CS-2000 IMAGE-GUIDED NEUROLOGICS, INC.
K001192 04/12/2000 SELF ADHERING NAVIGUS GUIDE IMAGE-GUIDED NEUROLOGICS, INC.
K091357 05/08/2009 MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 KIMBERLY-CLARK CORP.
K031885 06/18/2003 NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX IMAGE-GUIDED NEUROLOGICS, INC.
K011971 06/25/2001 NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 IMAGE-GUIDED NEUROLOGICS, INC.
K022100 06/28/2002 NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 IMAGE-GUIDED NEUROLOGICS, INC.
K012366 07/26/2001 NAVIGUS II TRAJECTORY GUIDE IMAGE-GUIDED NEUROLOGICS, INC.
K002330 08/01/2000 NAVIGUS PEEL AWAY INTRODUCER IMAGE-GUIDED NEUROLOGICS, INC.
K012719 08/14/2001 NAVIGUS II MR IMAGE-GUIDED NEUROLOGICS, INC.
K964107 10/15/1996 OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR OSCOR MEDICAL CORP.
K993682 11/01/1999 MRI EQUIPMENT COVER IMAGE-GUIDED NEUROLOGICS, INC.
K043091 11/09/2004 NAVIGUS NEXDRIVE, MODEL MI-3000 IMAGE-GUIDED NEUROLOGICS, INC.
K033619 11/18/2003 NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 IMAGE-GUIDED NEUROLOGICS, INC.
K103406 11/19/2010 MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS KIMBERLY-CLARK CORP.
K023949 11/27/2002 NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES IMAGE-GUIDED NEUROLOGICS, INC.
K024201 12/20/2002 NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 IMAGE-GUIDED NEUROLOGICS, INC.
K173955 12/28/2017 Mic-Key* SF Over-the-Wire Stoma Measuring Device Halyard Health, Inc.
K162930 10/19/2016 Aero Chrome* Select Breathable Performance Surgical Gowns Halyard Health, Inc.
K153255 11/10/2015 Aero Chrome* Breathable Performance Surgical Gown Halyard Health, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact