FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K973036 |
3M HEALTH CARE |
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES |
11/12/1997 |
K974892 |
ACUTEK ADHESIVE SPECIALTIES, INC. |
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 |
10/13/1998 |
K974891 |
ACUTEK ADHESIVE SPECIALTIES, INC. |
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 |
10/21/1998 |
K974890 |
ACUTEK ADHESIVE SPECIALTIES, INC. |
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 |
10/13/1998 |
K991287 |
ADVANCED MEDICAL SOLUTIONS GROUP PLC |
SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA |
06/29/1999 |
K973260 |
AVITAR, INC. |
HYDRASORB STERILE DRESSING |
10/21/1997 |
K960847 |
BELLINGHAM MEDICAL, INC. |
DERMASEAL |
04/04/1996 |
K990042 |
BIO MED SCIENCES, INC. |
SILON DUAL-DRESS |
03/19/1999 |
K012997 |
BIOCORE MEDICAL TECHNOLOGIES, INC. |
COLLATEK FOAM |
10/25/2001 |
K012995 |
BIOCORE MEDICAL TECHNOLOGIES, INC. |
COLLATEK SHEET |
10/25/2001 |
K982939 |
BIODERM, INC. |
BTF THIN FILM WOUND DRESSING |
10/13/1998 |
K983173 |
COLOPLAST CORP. |
BIATAIN FOAM ADHESIVE DRESSING |
12/16/1998 |
K983163 |
COLOPLAST CORP. |
BIATAIN FOAM DRESSING |
12/16/1998 |
K982493 |
COLOPLAST CORP. |
COMPEED PSORIASIS DRESSING |
01/28/1999 |
K973688 |
CONVATEC LTD. |
DUODERM CONTROL GEL FORMULA BORDER DRESSING |
12/23/1997 |
K973689 |
CONVATEC LTD. |
DUODERM HYDROACTIVE DRESSING |
12/23/1997 |
K973717 |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
COMBIDERM ACD |
12/17/1997 |
K973716 |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
DUODERM EXTRA THIN CGF DRESSING |
12/17/1997 |
K973807 |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
DUODERM HYDROACTIVE PASTE |
12/23/1997 |
K973632 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
DUODERM CGF CONTROL GEL FORMULA DRESSING |
12/22/1997 |
K961319 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
EPIVIEW |
07/08/1996 |
K962590 |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
SIGNALDRESS |
09/20/1996 |
K972458 |
COURTAULDS FIBERS, INC. |
LYOCELL WOUND DRESSING/SURGICAL SPONGE |
09/19/1997 |
K990438 |
DERMAPHYLYX, INC. |
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING |
03/25/1999 |
K990875 |
DERMAPHYLYX, INC. |
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING |
05/27/1999 |
K990891 |
DERMAPHYLYX, INC. |
DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING |
05/27/1999 |
K992302 |
DERMAPHYLYX, INC. |
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS |
09/14/1999 |
K955476 |
DUKAL CORP. |
DUKAL TRANSPARENT WOUND DRESSING |
01/18/1996 |
K980777 |
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING |
05/04/1998 |
K960393 |
EUROMED A/S |
SURESKIN BORDER |
03/01/1996 |
K960394 |
EUROMED A/S |
SURESKIN STANDARD |
03/01/1996 |
K963039 |
EUROMED A/S |
SURESKIN STANDARD, BORDER, AND THIN |
09/23/1996 |
K960404 |
EUROMED A/S |
SURESKIN THIN |
03/01/1996 |
K992363 |
EUROMED, INC. |
SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN |
08/12/1999 |
K983249 |
EUROMED, INC. |
SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN |
11/25/1998 |
K001508 |
FIDIA ADVANCED BIOPOLYMERS SRL |
LASERSKIN DRESSING |
07/25/2001 |
K992005 |
GILTECH PLUS, INC. |
GILTECH PLUS TRANSPARENT DRESSING |
09/03/1999 |
K990079 |
GREENFIELD MEDICAL TECHNOLOGIES, INC. |
FASTSEAL CHEST WOUND DRESSING |
12/23/1999 |
K980209 |
HOLLISTER, INC. |
SIMPLICARE THIN FILM WOUND DRESSINGS |
02/20/1998 |
K991214 |
HOLLISTER, INC. |
SIMPLICARE TRANSPARENT WOUND DRESSING |
10/14/1999 |
K974520 |
INNOVATIVE TECHNOLOGIES (US), INC. |
SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM |
02/06/1998 |
K971126 |
INNOVATIVE TECHNOLOGIES LTD. |
HYDROCOLLOID WOUND DRESSINGS |
06/24/1997 |
K983303 |
INNOVATIVE TECHNOLOGIES LTD. |
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS |
12/09/1998 |
K981753 |
INNOVATIVE TECHNOLOGIES LTD. |
INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING |
06/30/1998 |
K973855 |
INNOVATIVE TECHNOLOGIES LTD. |
IT HYDROCOLLOID WITH ZINC |
12/01/1997 |
K973312 |
INNOVATIVE TECHNOLOGIES LTD. |
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING |
10/22/1997 |
K010951 |
ISLAND DRESSING, LLC. |
ISLAND WOUND DRESSING WITH MICROBAN |
06/11/2001 |
K983394 |
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. |
MODIFICATION TO TIELLE HYDROPOLMER DRESSING |
11/03/1998 |
K983234 |
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. |
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING |
11/25/1998 |
K961098 |
K. W. GRIFFEN CO. |
BIO-DRESSING, STERILE ISLAND DRESSING |
05/03/1996 |
K974348 |
LABORATOIRES URGO S.A. |
ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING |
02/13/1998 |
K970518 |
LABORATOIRES URGO S.A. |
ALGOPLAQUE HYDROCOLLOID DRESSING |
03/21/1997 |
K970566 |
MAERSK MEDICAL, LTD. |
ARGLAES FILM DRESSING |
07/29/1997 |
K973657 |
MAERSK MEDICAL, LTD. |
ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING |
12/01/1997 |
K990810 |
MAERSK MEDICAL, LTD. |
ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING |
09/17/1999 |
K004028 |
MAERSK MEDICAL, LTD. |
ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING |
03/27/2001 |
K983184 |
MOLNLYCKE HEALTH CARE, INC. |
MEPILEX |
10/28/1998 |
K984371 |
MOLNLYCKE HEALTH CARE, INC. |
MEPITEL NON ADHERENT SILICONE DRESSING |
03/03/1999 |
K963753 |
NORTH AMERICAN STERILIZATION & PACKAGING CO. |
NASP TRANSPARENT DRESSING |
11/29/1996 |
K971093 |
OPPORTUNITY, INC. |
OPPORTUNITY I.V. START KIT |
09/16/1997 |
K964701 |
POLYMEDICA INDUSTRIES, INC. |
MITRAFLEX PIGMENTED WOUND DRESSING |
02/07/1997 |
K963623 |
POLYMEDICA INDUSTRIES, INC. |
SPYROFLEX PIGMENTED WOUND DRESSING |
10/25/1996 |
K964398 |
POLYMEDICA INDUSTRIES, INC. |
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED |
10/24/1997 |
K981713 |
SMITH & NEPHEW, INC. |
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 |
07/31/1998 |
K992221 |
WESTAIM BIOMEDICAL, INC. |
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING |
06/07/2000 |
K973538 |
WINFIELD LABORATORIES, INC. |
N-TERFACE |
12/16/1997 |