Atlas FDA

MGQ

145 FDA 510(k) clearances · Product code

85 daysmedian time to decision
221 days90th percentile
145clearances measured

FDA profile

Official device name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2000: 3 · 2001: 2 · 2002: 2 · 2006: 2 · 2011: 5 · 2014: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HylaGuard Moisturizing Cream (K171879)Founders Science Group, LLC2017-10-16
HYLATOPIC EMOLLIENT FOAM (K083024)Collegium Pharmaceutical Incorporated2009-03-27
IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (K041342)Stiefel Laboratories, Inc.2005-07-19
SILVERSITE OR CALGITROL (K041268)Adri2004-09-20
SILVERSEAL (K040019)Noble Fiber Technologies2004-07-23
TENDERWET ACTIVE (K040517)Medline Industries, Inc.2004-03-25
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (K022587)Medtrade Products , Ltd.2003-08-22
SINCLAIR WOUND AND SKIN EMULSION (K024367)Sinclair Pharmaceuticals, Ltd.2003-07-28
XYLOS XCELL ANTIMICROBIAL DRESSING (K024054)Xylos Corporation2003-03-07
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (K022584)Cardiotech Intl.2002-12-30
COLLATEK HYDROGEL (K022995)Biocore Medical Technologies, Inc.2002-12-02
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) (K013525)Coloplast Corp.2002-10-04
L.A.M. IPM WOUND GEL (K020325)L.A.M. Pharmaceutical, Corp.2002-04-15
ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 (K011994)Acrymed, Inc.2001-11-08
AMBU GEL, HYDROGEL BURN DRESSING (K010583)Ambu, Inc.2001-05-25
DIAMOND ALOE VERA, STERILE (K002666)Medi-Tech Intl. Corp.2001-02-27
BURN JEL PLUS (K003396)Water-Jel Technologies, LLC2001-01-11
BETA GLUCAN GEL (MACROPRO GEL) (K002078)Brennen Medical, Inc.2000-10-02
GLUCANPRO CREAM (K002077)Brennen Medical, Inc.2000-10-02
FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN (K002129)Ferris Mfg. Corp.2000-08-25
GLUCANPRO (K000519)Brennen Medical, Inc.2000-05-01
MACROPRO GEL (K000518)Brennen Medical, Inc.2000-05-01
MEDLINE TENDER WET WOUND DRESSING (K991755)Medline Industries, Inc.2000-04-17
MPM REGENECARE WOUND GEL (K992074)Mpm Medical., Inc.1999-12-23
STERILE HYDROGEL (K993119)Dumex Medical Surgical Products, Ltd.1999-11-23
BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD (K990179)Nortrade Medical, Inc.1999-08-13
BURNFREE PAIN RELIEVING GEL, MODEL 4B (K990178)Nortrade Medical, Inc.1999-08-13
BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING (K990180)Nortrade Medical, Inc.1999-08-13
GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE (K990440)Gentell1999-08-12
MODIFICATION TO WOUN'DRES (K991202)Coloplast Corp.1999-06-04
DUODERM HYDROACTIVE GEL WOUND DRESSING (K990368)Convatec, A Bristol-Myers Squibb Co.1999-03-26
HYPERGEL 20% HYPERTONIC SALINE GEL (K984370)Molnlycke Health Care, Inc.1999-03-01
NORMLGEL 0.9% ISOTONIC SALINE GEL (K984368)Molnlycke Health Care, Inc.1999-02-22
MODIFICATION OF BIONECT HYDROGEL FOAM (K984267)Fidia Pharmaceutical Corp.1999-02-10
BIONECT HYDROGEL (K984413)Fidia Pharmaceutical Corp.1999-02-10
MODIFICATION OF BIONECT HYDROGEL GAUZE PADS (K984262)Fidia Pharmaceutical Corp.1999-02-10
MODIFICATION OF BIONECT HYDROGEL SPRAY (K984266)Fidia Pharmaceutical Corp.1999-02-10
MODIFICATION OF BIONECT CLEAR HYDROGEL (K984264)Fidia Pharmaceutical Corp.1999-02-10
BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET (K984082)Emox 911 CC1999-01-28
NU-GEL * WOUND DRESSING (K983362)Johnson & Johnson Medical, Inc.1998-12-16
SPYROGEL HYDROGEL WOUND AND BURN DRESSING (K982804)Innovative Technologies (Us), Inc.1998-12-16
SWEEN WOUN'DRES (K983042)Coloplast Corp.1998-11-25
BRENNEN MEDICAL BETA GLUCAN GEL (K982825)Brennen Medical, Inc.1998-11-06
NEUFINISH RESURFACING CREAM (K982577)Neutrogena Corp.1998-10-21
POLYTUBE (K982306)Ferris Mfg. Corp.1998-09-22
BIONECT HYDROGEL SPRAY (K973724)Fidia Pharmaceutical Corp.1998-09-22
BIONECT HYDROGEL FOAM (K973722)Fidia Pharmaceutical Corp.1998-09-22
BIONECT CLEAR HYDROGEL (K973725)Fidia Pharmaceutical Corp.1998-09-22
BIONECT HYDROGEL GAUZE PADS (K973721)Fidia Pharmaceutical Corp.1998-09-22
BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO (K980962)Brennen Medical, Inc.1998-07-29
PHYTACARE ALGINATE HYDROGEL WOUND DRESSING (K980132)Phytatek Laboratories, Inc.1998-06-26
SOLOSITE GEL CONFORMABLE DRESSING (K981150)Smith & Nephew, Inc.1998-06-22
X-CELL WOUND DRESSING (K974251)Xylos Corporation1998-06-22
DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL (K980861)Dumex Medical Surgical Products, Ltd.1998-05-20
FLEXIGEL-G HYDROGEL WOUND DRESSING (K980097)Innovative Technologies , Ltd.1998-03-04
DUODERM HYDROACTIVE GEL (K973806)Convatec, A Bristol-Myers Squibb Co.1997-12-29
AQUA PATCH (K973693)Pci Technology1997-12-18
AMERIGEL OINTMENT SATURATED WOUND DRESSING (K971918)Amerx Health Care Corp.1997-08-12
LAMIN-2 HYDRATING GEL (K970153)Procyte Corp.1997-06-05
OSMOCYTE WOUND MANAGER SHEET DRESSING (K965143)Procyte Corp.1997-05-22
AMERIGEL OINTMENT (K970133)Amerx Health Care Corp.1997-04-14
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING (K970453)B.Braun Medical, Inc.1997-04-11
ACRYDERM GEL WOUND DRESSING (K970693)Acrymed, Inc.1997-03-21
IAMIN IMPREGNATED GAUZE DRESSING (K965005)Procyte Corp.1997-02-24
BIONECT CREAM (K963004)Fidia Pharmaceutical Corp.1997-02-12
IAMIN WET DRESSING (COPPER-SALINE) (K964468)Procyte Corp.1997-02-03
BIAFINE WOUND DRESSING EMULSION (K964240)Medix Pharmaceuticals Americas, Inc.1997-01-22
PANOGAUZE NON-WOVEN HYDROGEL DRESSING (K964620)Sage Pharmaceuticals, Inc.1997-01-09
MULTIDEX HYDROPHILIC WOUND DRESSING GEL (K962917)Lange Medical Products, Inc.1996-12-16
BRENNEN MEDICAL GLUCAN II WOUND DRESSING (K964241)Brennen Medical, Inc.1996-12-12
DERMAMEND GEL (K962089)Dermarx Corp.1996-11-05
CHONDROPROTEC (K961930)The Hymed Group Corp.1996-10-15
DERMAPLEX HYDROGEL WOUND DRESSING (K962513)Maxxim Medical1996-09-12
CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG (K962218)Carrington Laboratories, Inc.1996-09-12
ACRYNOODLES ABSORBENT WOUND DRESSING (K962851)Acrymed, Inc.1996-09-06
DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) (K962439)Richard Hamer Assoc., Inc.1996-09-03
HYCOAT (K960686)The Hymed Group Corp.1996-08-12
WOUND HYDROGEL & STERILE WOUND HYDROGEL (K961766)Renaissance Pharmaceutical, Inc.1996-07-15
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL (K961316)Renaissance Pharmaceutical, Inc.1996-07-15
CARASYN HYDROGEL WOUND PRODUCTS (K961758)Carrington Laboratories, Inc.1996-07-11
MPM HYDROGEL DRESSING (NON-STERILE) (K962160)Mpm Medical., Inc.1996-06-26
DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING (K961085)Debusk Knitting Mills, Div. Deroyal Industries1996-05-21
BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET (K961067)Medtrak Intl., Inc.1996-05-16
CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION) (K960428)Carrington Laboratories, Inc.1996-03-21
BURNAID BURN FIRST AID DRESSING (K953505)Rye Pharmaceuticals Pty. , Ltd.1996-02-09
QUEGEL HYDROPHILIC WOUND DRESSING (K955400)Questor Pharma, Inc.1996-02-09
IAMIN GEL WOUND DRESSING (K953853)Procyte Corp.1996-02-05
TECNOL HYDROGEL WOUND DRESSING (K955575)Tecnol Medical Products, Inc.1996-01-17
AQUAFLO BTP HYDROGEL WOUND DRESSING (K952938)Sherwood Medical Co.1995-12-08
DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING (K954664)Derma Sciences, Inc.1995-11-01
DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) (K954741)Derma Sciences, Inc.1995-11-01
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL (K954384)Renaissance Pharmaceutical, Inc.1995-10-16
DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING (K952775)Deroyal Industries, Inc.1995-10-06
PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING (K953669)Marketing Perspectives1995-09-22
DCURASOL GEL WOUND DRESSING (K953816)Dpt Laboratories, Ltd.1995-08-28
CURASOL GEL WOUND DRESSING (K953450)Dpt Laboratories, Ltd.1995-08-07
STERIGAUZE GEL DRESSING (K952419)Acacia Laboratories, Inc.1995-07-26
BURNSHIELD TRAUMA DRESSING (K952247)Golightly International Corp.1995-07-26
MULTIDEX GEL (K952774)Lange Medical Products, Inc.1995-07-24
A GEL WOUND DRESSING (K951862)Polymedica Industries, Inc.1995-07-12
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