FDA 510(k) Applications for Medical Device Product Code "MGQ"
(Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K062795 | ACCESS PHARMACEUTICALS, INC | MUGARD MUCOADHESIVE ORAL WOUND RINSE | 12/11/2006 |
| K970693 | ACRYMED, INC. | ACRYDERM GEL WOUND DRESSING | 03/21/1997 |
| K011994 | ACRYMED, INC. | ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 | 11/08/2001 |
| K962851 | ACRYMED, INC. | ACRYNOODLES ABSORBENT WOUND DRESSING | 09/06/1996 |
| K041268 | ADRI | SILVERSITE OR CALGITROL | 09/20/2004 |
| K112568 | AEON ASTRON EUROPE B.V. | AONGEN DENTAL COLLAGEN MATRIX | 03/01/2012 |
| K010583 | AMBU, INC. | AMBU GEL, HYDROGEL BURN DRESSING | 05/25/2001 |
| K970133 | AMERX HEALTH CARE CORP. | AMERIGEL OINTMENT | 04/14/1997 |
| K971918 | AMERX HEALTH CARE CORP. | AMERIGEL OINTMENT SATURATED WOUND DRESSING | 08/12/1997 |
| K981353 | AVOCET POLYMER TECHNOLOGIES, INC. | AVOGEL | 06/01/1999 |
| K970453 | B. BRAUN MEDICAL, INC. | B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING | 04/11/1997 |
| K022995 | BIOCORE MEDICAL TECHNOLOGIES, INC. | COLLATEK HYDROGEL | 12/02/2002 |
| K130959 | BIOPLAX LIMITED | AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL | 04/04/2014 |
| K081372 | BMG PHARMA LLC. | GELX ORAL GEL | 02/04/2009 |
| K002078 | BRENNEN MEDICAL, INC. | BETA GLUCAN GEL (MACROPRO GEL) | 10/02/2000 |
| K980962 | BRENNEN MEDICAL, INC. | BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO | 07/29/1998 |
| K982825 | BRENNEN MEDICAL, INC. | BRENNEN MEDICAL BETA GLUCAN GEL | 11/06/1998 |
| K964241 | BRENNEN MEDICAL, INC. | BRENNEN MEDICAL GLUCAN II WOUND DRESSING | 12/12/1996 |
| K000519 | BRENNEN MEDICAL, INC. | GLUCANPRO | 05/01/2000 |
| K002077 | BRENNEN MEDICAL, INC. | GLUCANPRO CREAM | 10/02/2000 |
| K000518 | BRENNEN MEDICAL, INC. | MACROPRO GEL | 05/01/2000 |
| K101769 | CAMURUS AB | EPISIL | 09/13/2011 |
| K022584 | CARDIOTECH INTL. | CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING | 12/30/2002 |
| K983182 | CARRINGTON LABORATORIES, INC. | ALOE THERAPY ORAL RINSE | 12/10/1998 |
| K961758 | CARRINGTON LABORATORIES, INC. | CARASYN HYDROGEL WOUND PRODUCTS | 07/11/1996 |
| K962218 | CARRINGTON LABORATORIES, INC. | CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG | 09/12/1996 |
| K960428 | CARRINGTON LABORATORIES, INC. | CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION) | 03/21/1996 |
| K964852 | CARRINGTON LABORATORIES, INC. | RADIACARE ORAL WOUND RINSE | 03/03/1997 |
| K012126 | CARRINGTON LABORATORIES, INC. | THE SALICEPT ORAL PATCH | 10/03/2001 |
| K083024 | COLLEGIUM PHARMACEUTICAL INCORPORATED | HYLATOPIC EMOLLIENT FOAM | 03/27/2009 |
| K971597 | COLOPLAST CORP. | COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) | 07/29/1997 |
| K013525 | COLOPLAST CORP. | CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) | 10/04/2002 |
| K991202 | COLOPLAST CORP. | MODIFICATION TO WOUN'DRES | 06/04/1999 |
| K983042 | COLOPLAST CORP. | SWEEN WOUN'DRES | 11/25/1998 |
| K973806 | CONVATEC, A BRISTOL-MYERS SQUIBB CO. | DUODERM HYDROACTIVE GEL | 12/29/1997 |
| K990368 | CONVATEC, A BRISTOL-MYERS SQUIBB CO. | DUODERM HYDROACTIVE GEL WOUND DRESSING | 03/26/1999 |
| K961085 | DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES | DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING | 05/21/1996 |
| K991061 | DERMAPHYLYX, INC. | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | 06/28/1999 |
| K962089 | DERMARX CORP. | DERMAMEND GEL | 11/05/1996 |
| K980861 | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. | DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL | 05/20/1998 |
| K993119 | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. | STERILE HYDROGEL | 11/23/1999 |
| K984082 | EMOX 911 CC | BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET | 01/28/1999 |
| K002129 | FERRIS MFG. CORP. | FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN | 08/25/2000 |
| K982306 | FERRIS MFG. CORP. | POLYTUBE | 09/22/1998 |
| K973725 | FIDIA PHARMACEUTICAL CORP. | BIONECT CLEAR HYDROGEL | 09/22/1998 |
| K963004 | FIDIA PHARMACEUTICAL CORP. | BIONECT CREAM | 02/12/1997 |
| K984413 | FIDIA PHARMACEUTICAL CORP. | BIONECT HYDROGEL | 02/10/1999 |
| K973722 | FIDIA PHARMACEUTICAL CORP. | BIONECT HYDROGEL FOAM | 09/22/1998 |
| K973721 | FIDIA PHARMACEUTICAL CORP. | BIONECT HYDROGEL GAUZE PADS | 09/22/1998 |
| K973724 | FIDIA PHARMACEUTICAL CORP. | BIONECT HYDROGEL SPRAY | 09/22/1998 |
| K984264 | FIDIA PHARMACEUTICAL CORP. | MODIFICATION OF BIONECT CLEAR HYDROGEL | 02/10/1999 |
| K984267 | FIDIA PHARMACEUTICAL CORP. | MODIFICATION OF BIONECT HYDROGEL FOAM | 02/10/1999 |
| K984262 | FIDIA PHARMACEUTICAL CORP. | MODIFICATION OF BIONECT HYDROGEL GAUZE PADS | 02/10/1999 |
| K984266 | FIDIA PHARMACEUTICAL CORP. | MODIFICATION OF BIONECT HYDROGEL SPRAY | 02/10/1999 |
| K191987 | Forward Science | Orapeutic | 11/27/2019 |
| K171879 | Founders Science Group, LLC | HylaGuard Moisturizing Cream | 10/16/2017 |
| K990440 | GENTELL | GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE | 08/12/1999 |
| K992094 | GILTECH PLUS, INC. | GILTECH PLUS HYDROGEL SKIN DRESSING | 09/17/1999 |
| K060363 | HEMCON, INC. | HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12 | 07/07/2006 |
| K173196 | Huizhou Foryou Medical Devices Co., Ltd. | SUNTOUCH Dental Dressing | 01/24/2018 |
| K982804 | INNOVATIVE TECHNOLOGIES (US), INC. | SPYROGEL HYDROGEL WOUND AND BURN DRESSING | 12/16/1998 |
| K980097 | INNOVATIVE TECHNOLOGIES LTD. | FLEXIGEL-G HYDROGEL WOUND DRESSING | 03/04/1998 |
| K103054 | IZUN PHARMACEUTICALS CORPORATION | PERIOPATCH | 02/07/2011 |
| K983362 | JOHNSON & JOHNSON MEDICAL, INC. | NU-GEL * WOUND DRESSING | 12/16/1998 |
| K020325 | L.A.M. PHARMACEUTICAL, CORP. | L.A.M. IPM WOUND GEL | 04/15/2002 |
| K962917 | LANGE MEDICAL PRODUCTS, INC. | MULTIDEX HYDROPHILIC WOUND DRESSING GEL | 12/16/1996 |
| K972646 | LUDLOW TECHNICAL PRODUCTS | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES | 08/21/1997 |
| K962513 | MAXXIM MEDICAL | DERMAPLEX HYDROGEL WOUND DRESSING | 09/12/1996 |
| K002666 | MEDI-TECH INTL. CORP. | DIAMOND ALOE VERA, STERILE | 02/27/2001 |
| K964240 | MEDIX PHARMACEUTICALS AMERICAS, INC. | BIAFINE WOUND DRESSING EMULSION | 01/22/1997 |
| K991755 | MEDLINE INDUSTRIES, INC. | MEDLINE TENDER WET WOUND DRESSING | 04/17/2000 |
| K040517 | MEDLINE INDUSTRIES, INC. | TENDERWET ACTIVE | 03/25/2004 |
| K022587 | MEDTRADE PRODUCTS LTD. | MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS | 08/22/2003 |
| K961067 | MEDTRAK INTL., INC. | BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET | 05/16/1996 |
| K063148 | MERLIN GROUP DBA MCMERLIN DENTAL COMPANY | SOCK IT! ORAL PAIN GEL | 01/17/2007 |
| K110750 | MIS IMPLANTS TECHNOLOGIES LTD. | PERIOPATCH | 04/28/2011 |
| K984370 | MOLNLYCKE HEALTH CARE, INC. | HYPERGEL 20% HYPERTONIC SALINE GEL | 03/01/1999 |
| K984368 | MOLNLYCKE HEALTH CARE, INC. | NORMLGEL 0.9% ISOTONIC SALINE GEL | 02/22/1999 |
| K962160 | MPM MEDICAL, INC. | MPM HYDROGEL DRESSING (NON-STERILE) | 06/26/1996 |
| K992074 | MPM MEDICAL, INC. | MPM REGENECARE WOUND GEL | 12/23/1999 |
| K060340 | MPM MEDICAL, INC. | ORAMAGIC PLUS ORAL WOUND RINSE | 05/10/2006 |
| K024180 | MPM MEDICAL, INC. | ORAMAGICRX ORAL WOUND RINSE | 03/14/2003 |
| K020540 | MPM MEDICAL, INC. | REGENECARE WOUND GEL | 11/01/2002 |
| K982577 | NEUTROGENA CORP. | NEUFINISH RESURFACING CREAM | 10/21/1998 |
| K040019 | NOBLE FIBER TECHNOLOGIES | SILVERSEAL | 07/23/2004 |
| K962352 | NORTH AMERICAN STERILIZATION & PACKAGING CO. | HYDROGEL SKIN DRESSING | 08/02/1996 |
| K990180 | NORTRADE MEDICAL, INC. | BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING | 08/13/1999 |
| K990179 | NORTRADE MEDICAL, INC. | BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD | 08/13/1999 |
| K990178 | NORTRADE MEDICAL, INC. | BURNFREE PAIN RELIEVING GEL, MODEL 4B | 08/13/1999 |
| K963228 | ORPHAN MEDICAL, INC. | REPLIDERM WOUND DRESSING | 12/18/1996 |
| K973693 | PCI TECHNOLOGY | AQUA PATCH | 12/18/1997 |
| K980132 | PHYTATEK LABORATORIES, INC. | PHYTACARE ALGINATE HYDROGEL WOUND DRESSING | 06/26/1998 |
| K953853 | PROCYTE CORP. | IAMIN GEL WOUND DRESSING | 02/05/1996 |
| K965005 | PROCYTE CORP. | IAMIN IMPREGNATED GAUZE DRESSING | 02/24/1997 |
| K964468 | PROCYTE CORP. | IAMIN WET DRESSING (COPPER-SALINE) | 02/03/1997 |
| K970153 | PROCYTE CORP. | LAMIN-2 HYDRATING GEL | 06/05/1997 |
| K965143 | PROCYTE CORP. | OSMOCYTE WOUND MANAGER SHEET DRESSING | 05/22/1997 |
| K955400 | QUESTOR PHARMA, INC. | QUEGEL HYDROPHILIC WOUND DRESSING | 02/09/1996 |
| K961766 | RENAISSANCE PHARMACEUTICAL, INC. | WOUND HYDROGEL & STERILE WOUND HYDROGEL | 07/15/1996 |
| K961316 | RENAISSANCE PHARMACEUTICAL, INC. | WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL | 07/15/1996 |
| K082553 | REXADERM, INC. | REXASTOM ORAL EASE | 11/21/2008 |
| K053342 | RICERFARMA SRL | GENGIGEL MOUTHRINSE | 03/13/2007 |
| K962439 | RICHARD HAMER ASSOC., INC. | DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) | 09/03/1996 |
| K953505 | RYE PHARMACEUTICALS PTY. LTD. | BURNAID BURN FIRST AID DRESSING | 02/09/1996 |
| K964620 | SAGE PHARMACEUTICALS, INC. | PANOGAUZE NON-WOVEN HYDROGEL DRESSING | 01/09/1997 |
| K040950 | SINCLAIR PHARMACEUTICALS, LTD. | ALOCLAIR ORAL GEL | 06/21/2004 |
| K023155 | SINCLAIR PHARMACEUTICALS, LTD. | ALOCLAIR ORAL RINSE | 11/25/2002 |
| K042722 | SINCLAIR PHARMACEUTICALS, LTD. | ALOCLAIR ORAL SPRAY | 01/13/2005 |
| K024367 | SINCLAIR PHARMACEUTICALS, LTD. | SINCLAIR WOUND AND SKIN EMULSION | 07/28/2003 |
| K981150 | SMITH & NEPHEW, INC. | SOLOSITE GEL CONFORMABLE DRESSING | 06/22/1998 |
| K041342 | STIEFEL LABORATORIES, INC. | IMPRUV A.I. CREAM WOUND AND SKIN EMULSION | 07/19/2005 |
| K070842 | SUNSHINE INTERNATIONAL GROUP, INC. | ULCELOOCIN ORAL ULCER PATCH | 06/07/2007 |
| K955575 | TECNOL MEDICAL PRODUCTS, INC. | TECNOL HYDROGEL WOUND DRESSING | 01/17/1996 |
| K961930 | THE HYMED GROUP CORP. | CHONDROPROTEC | 10/15/1996 |
| K960686 | THE HYMED GROUP CORP. | HYCOAT | 08/12/1996 |
| K090612 | UNICARE BIOMEDICAL | BENACEL | 07/24/2009 |
| K003396 | WATER-JEL TECHNOLOGIES, LLC. | BURN JEL PLUS | 01/11/2001 |
| K974251 | XYLOS CORPORATION | X-CELL WOUND DRESSING | 06/22/1998 |
| K024054 | XYLOS CORPORATION | XYLOS XCELL ANTIMICROBIAL DRESSING | 03/07/2003 |
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