FDA 510(k) Applications Submitted by STEVE DOWDLEY

FDA 510(k) Number Submission Date Device Name Applicant
K062138 07/26/2006 POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE MOLNLYCKE HEALTH CARE, INC.
K100029 01/06/2010 MEPILEX BORDER AG DRESSING MOLNLYCKE HEALTH CARE
K050250 02/03/2005 AQUIFY MULTIPURPOSE SOLUTION CIBA VISION CORPORATION
K030522 02/19/2003 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION
K000607 02/23/2000 SOLO-CARE BRAND HARD SOLUTION CIBA VISION CORPORATION
K200633 03/10/2020 Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove 0 & M Halyard, Inc
K200843 03/31/2020 Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs O&M Halyard, Inc.
K211063 04/09/2021 HALYARD Flexaprene Green Powder-Free Exam Glove O & M Halyard, Inc.
K991403 04/22/1999 SOLO-CARE BRAND MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION
K081180 04/25/2008 SKINSENSE POLYISOPRENE UNDERGLOVE MOLNLYCKE HEALTH CARE US, LLC
K031521 05/15/2003 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION
K031522 05/15/2003 SOLO-CARE PLUS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION
K071354 05/15/2007 MEPILEX AG DRESSING MONLYCKE HEALTH CARE
K021635 05/17/2002 KARATS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION
K071414 05/21/2007 BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) MOLNLYCKE HEALTH CARE US, LLC
K071465 05/29/2007 BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT MOLNLYCKE HEALTHCARE, US LLC
K031753 06/05/2003 KARATS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION
K061554 06/05/2006 MEPILEX AG ABSORBENT SILICONE-COATED DRESSING MOLNLYCKE HEALTH CARE
K071565 06/07/2007 BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT MOLNLYCKE HEALTH CARE US, LLC
K982168 06/19/1998 SOLO-CARE BRAND MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION
K071700 06/21/2007 BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT MOLNLYCKE HEALTHCARE, US LLC
K031957 06/25/2003 MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION
K041820 07/06/2004 SOLO-CARE AQUA ANTIMICROBIAL LENS CASE CIBA VISION CORPORATION
K192147 08/08/2019 Halyard ONE-STEP* Sterilization Wrap Owens & Minor (O&M) Halyard, Inc
K042176 08/11/2004 AQUIFY LENS COMFORT DROPS CIBA VISION CORPORATION
K022687 08/13/2002 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION
K012731 08/15/2001 SOLO-CARE PLUS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION
K192241 08/19/2019 Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate O & M Haylard, Inc.
K202622 09/10/2020 Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate O & M Halyard, Inc.
K983291 09/21/1998 SOLO-CARE BRAND MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION
K013204 09/25/2001 AQUIFY LENS COMFORT DROPS CIBA VISION CORPORATION
K062847 10/04/2006 BIOGEL ECLIPSE INDICATOR UNDERGLOVE MOLNLYCKE HEALTH CARE US, LLC
K023455 10/15/2002 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION
K013512 10/22/2001 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION
K003345 10/25/2000 AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION
K203177 10/26/2020 Sterisystem Dry-Base Instrument Tray O&M Halyard, Inc
K033608 11/17/2003 AQUIFY MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION
K003586 11/20/2000 FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES CIBA-GEIGY CORP.
K993949 11/22/1999 SOLO-CARE BRAND HARD SOLUTION CIBA VISION CORPORATION
K984273 11/30/1998 FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS CIBA VISION CORPORATION
K213929 12/16/2021 Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid O & M Halyard, Inc.
K213937 12/16/2021 Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution O & M Halyard, Inc.


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