Atlas FDA

MGP

80 FDA 510(k) clearances · Product code

72 daysmedian time to decision
276 days90th percentile
80clearances measured

FDA profile

Official device name
Dressing, Wound And Burn, Occlusive
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
1996: 1 · 2013: 7 · 2021: 52
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
COLLATEK SHEET (K012995)Biocore Medical Technologies, Inc.2001-10-25
COLLATEK FOAM (K012997)Biocore Medical Technologies, Inc.2001-10-25
LASERSKIN DRESSING (K001508)Fidia Advanced Biopolymers Srl2001-07-25
FASTSEAL CHEST WOUND DRESSING (K990079)Greenfield Medical Technologies, Inc.1999-12-23
SIMPLICARE TRANSPARENT WOUND DRESSING (K991214)Hollister, Inc.1999-10-14
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (K992302)Dermaphylyx, Inc.1999-09-14
GILTECH PLUS TRANSPARENT DRESSING (K992005)Giltech Plus, Inc.1999-09-03
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (K990875)Dermaphylyx, Inc.1999-05-27
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING (K990438)Dermaphylyx, Inc.1999-03-25
MEPITEL NON ADHERENT SILICONE DRESSING (K984371)Molnlycke Health Care, Inc.1999-03-03
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS (K983303)Innovative Technologies , Ltd.1998-12-09
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING (K983234)Johnson & Johnson Medical, Div. of Ethicon, Inc.1998-11-25
MODIFICATION TO TIELLE HYDROPOLMER DRESSING (K983394)Johnson & Johnson Medical, Div. of Ethicon, Inc.1998-11-03
MEPILEX (K983184)Molnlycke Health Care, Inc.1998-10-28
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 (K974891)Acutek Adhesive Specialties, Inc.1998-10-21
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 (K974890)Acutek Adhesive Specialties, Inc.1998-10-13
BTF THIN FILM WOUND DRESSING (K982939)Bioderm, Inc.1998-10-13
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 (K974892)Acutek Adhesive Specialties, Inc.1998-10-13
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 (K981713)Smith & Nephew, Inc.1998-07-31
INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING (K981753)Innovative Technologies , Ltd.1998-06-30
SIMPLICARE THIN FILM WOUND DRESSINGS (K980209)Hollister, Inc.1998-02-20
SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM (K974520)Innovative Technologies (Us), Inc.1998-02-06
N-TERFACE (K973538)Winfield Laboratories, Inc.1997-12-16
ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING (K973657)Maersk Medical, Ltd.1997-12-01
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES (K973036)3M Healthcare1997-11-12
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED (K964398)Polymedica Industries, Inc.1997-10-24
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING (K973312)Innovative Technologies , Ltd.1997-10-22
HYDRASORB STERILE DRESSING (K973260)Avitar, Inc.1997-10-21
LYOCELL WOUND DRESSING/SURGICAL SPONGE (K972458)Courtaulds Fibers, Inc.1997-09-19
OPPORTUNITY I.V. START KIT (K971093)Opportunity, Inc.1997-09-16
ALGOPLAQUE HYDROCOLLOID DRESSING (K970518)Laboratoires Urgo S.A.1997-03-21
NASP TRANSPARENT DRESSING (K963753)North American Sterilization & Packaging Co.1996-11-29
SPYROFLEX PIGMENTED WOUND DRESSING (K963623)Polymedica Industries, Inc.1996-10-25
EPIVIEW (K961319)Convatec, A Division of E.R. Squibb & Sons1996-07-08
BIO-DRESSING, STERILE ISLAND DRESSING (K961098)K. W. Griffen Co.1996-05-03
DERMASEAL (K960847)Bellingham Medical, Inc.1996-04-04
SURESKIN BORDER (K960393)Euromed A/S1996-03-01
SURESKIN THIN (K960404)Euromed A/S1996-03-01
SURESKIN STANDARD (K960394)Euromed A/S1996-03-01
DUKAL TRANSPARENT WOUND DRESSING (K955476)Dukal Corp.1996-01-18
SPYROCOLLOID WOUND DRESSING (K955383)Polymedica Industries, Inc.1995-12-13
SPYROFLEX SKIN PROTECTOR (K953885)Polymedica Industries, Inc.1995-11-29
FLEXZAN WOUND DRESSING (K954602)Dow Hickam Pharmaceuticals, Inc.1995-11-02
DERMAGRAN HYDROPHILIC WOUND DRESSING (K954738)Derma Sciences, Inc.1995-11-02
TECNOL ISLAND WOUND DRESSING (K954033)Tecnol Medical Products, Inc.1995-09-22
UNI-SITE (K953018)Ttl Medical1995-09-08
SPYROFLEX WOUND DRESSING (K953618)Polymedica Industries, Inc.1995-08-21
TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSING (K952449)Medical Device Development Co.1995-08-07
TECNOL TRANSPARENT WOUND DRESSING (K952504)Tecnol Medical Products, Inc.1995-07-26
ULTEC THIN HYDROCOLLOID DRESSING (K952071)Sherwood Medical Co.1995-06-22
MITRAFLEX WOUND DRESSING WET-STICK (K952217)Polymedica Industries, Inc.1995-06-22
BIODERM MEDICAL TRANSPARENT FILM DRESSING (K951842)Bioderm, Inc.1995-06-12
CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING (K946338)Certified Safety Mfg., Inc.1995-03-29
CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING (K945977)Tri-State Hospital Supply Corp.1995-03-29
CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS (K950065)Conmedcorp1995-03-24
CUTIPLAST STERIL (K943363)Beiersdorf, Inc.1995-03-15
BIODERM MEDICAL COMPOSITE WOUND DRESSING (K946292)Bioderm, Inc.1995-02-06
PRO-TECT TRAUMA PAK (K941789)Pro-Tect Medical Products, Inc.1995-01-12
PRO-TECT SAFETY DRESSING (K941790)Pro-Tect Medical Products, Inc.1995-01-12
EPIVIEW (K940895)Convatec, A Bristol-Myers Squibb Co.1994-11-22
CUSH ISLAND DRESSING (K943424)Cush Medical Products1994-10-03
TRANSPARENT DRESSING (K943111)Acutek Adhesive Specialties, Inc.1994-09-12
PROCEL BURN COVER/PROCEL BURN TREATMENT COVER (K943280)W.L. Gore & Company, GmbH1994-08-18
ASHERMAN CHEST BANDAGE (K942757)Asherman Medical Products, LLC1994-08-01
POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING (K942774)The Kendal Co.1994-07-20
HYDRODERM BREATHABLE TRANSPARENT DRESSING (K935796)Wilshire Medical Products1994-02-02
CUTIFILM(R) FILM (K926399)Beiersdorf, Inc.1993-11-15
HYDRASORB STERILE DRESSING (K931599)Calgon Vestal Div.1993-07-08
ALUMINUM FOIL (K930401)Gam Industries, Inc.1993-05-12
EPI-LOCK WOUND DRESSING (K926034)Calgon Vestal Div.1993-04-20
KTI TRANSPARENT WOUND DRESSING (K925660)Kingston Technologies, Inc.1993-04-20
STERILE FILM WOUND DRESSING (K924008)Innovative Technology , Ltd.1992-11-24
SILON TRANSPARENT WOUND DRESSINGS (K923150)Bio Med Sciences, Inc.1992-08-27
DEROYAL TRANSPARENT FILM DRESSIGN (K920796)Deroyal Industries, Inc.1992-07-23
PROCEL BURN COVER (K915695)W. L. Gore & Associates, Inc.1992-05-29
CURITY VENTED DRESSING SYSTEM (K915635)Kendall Healthcare Products Co. Div.Of Tyco Health1992-01-31
SILON(TM) TRANSPARENT WOUND DRESSING (K912032)Bio Med Sciences, Inc.1991-08-20
MITRASHEER TRANSPLANT DRESSING (K911649)Polymint Industrial Co. , Ltd.1991-08-07
INERPAN(TM) TEMPORARY WOUND DRESSING (K911161)Laboratories Delalande1991-06-27
INTRASITE HYDROCOLLOID WOUND DRESSING (K911660)Smith & Nephew United, Inc.1991-06-17

Track MGP automatically

Every clearance here is in the API, with alerts when new ones post.