Dressing, Wound And Burn, Occlusive
FDA product code MGP · Unclassified · General, Plastic Surgery
80510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Polymedica Industries, Inc. 6
- Acutek Adhesive Specialties, Inc. 4
- Bioderm, Inc. 3
- Innovative Technologies , Ltd. 3
- Dermaphylyx, Inc. 3
- Euromed A/S 3
- Molnlycke Health Care, Inc. 2
- Bio Med Sciences, Inc. 2
- Pro-Tect Medical Products, Inc. 2
- Johnson & Johnson Medical, Div. of Ethicon, Inc. 2
- Calgon Vestal Div. 2
- Biocore Medical Technologies, Inc. 2
- Beiersdorf, Inc. 2
- Tecnol Medical Products, Inc. 2
- Hollister, Inc. 2
- Gam Industries, Inc. 1
- The Kendal Co. 1
- Wilshire Medical Products 1
- W. L. Gore & Associates, Inc. 1
- Kendall Healthcare Products Co. Div.Of Tyco Health 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012997 | Collatek FoamMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K012995 | Collatek SheetMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K001508 | Laserskin DressingMGP · Traditional | Fidia Advanced Biopolymers Srl | 07/25/2001SE |
| K990079 | Fastseal Chest Wound DressingMGP · Traditional | Greenfield Medical Technologies, Inc. | 12/23/1999SE |
| K991214 | Simplicare Transparent Wound DressingMGP · Traditional | Hollister, Inc. | 10/14/1999SE |
| K992302 | Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional | Dermaphylyx, Inc. | 09/14/1999SE |
| K992005 | Giltech Plus Transparent DressingMGP · Traditional | Giltech Plus, Inc. | 09/03/1999SE |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional | Dermaphylyx, Inc. | 05/27/1999SN |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | Dermaphylyx, Inc. | 03/25/1999SE |
| K984371 | Mepitel Non Adherent Silicone DressingMGP · Traditional | Molnlycke Health Care, Inc. | 03/03/1999SE |
| K983303 | Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound DressingsMGP · Traditional | Innovative Technologies , Ltd. | 12/09/1998SE |
| K983234 | Tielle Plus Hydropolymer Adhesive DressingMGP · Traditional | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 11/25/1998SE |
| K983394 | Modification to Tielle Hydropolmer DressingMGP · Traditional | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 11/03/1998SE |
| K983184 | MepilexMGP · Traditional | Molnlycke Health Care, Inc. | 10/28/1998SE |
| K974891 | Acutek's Hydrocolloid Wound Dressing, Tib 197013MGP · Traditional | Acutek Adhesive Specialties, Inc. | 10/21/1998SE |
| K982939 | BTF Thin Film Wound DressingMGP · Traditional | Bioderm, Inc. | 10/13/1998SE |
| K974892 | Acutek's Hydrocolloid Wound Dressing, Tib 197012MGP · Traditional | Acutek Adhesive Specialties, Inc. | 10/13/1998SE |
| K974890 | Acutek's Hydrocolloid Wound Dressing, Tib 997002MGP · Traditional | Acutek Adhesive Specialties, Inc. | 10/13/1998SE |
| K981713 | Cicanet Wound Contact Layer Dressing - 2 X 3 In. Model 59100600, Cicanet Wound Contact…MGP · Traditional | Smith & Nephew, Inc. | 07/31/1998SE |
| K981753 | Innovative Technologies Transparent Film and Intelligent Film Wound DressingMGP · Traditional | Innovative Technologies , Ltd. | 06/30/1998SE |
| K980209 | Simplicare Thin Film Wound DressingsMGP · Traditional | Hollister, Inc. | 02/20/1998SESK |
| K974520 | Spyroflex Foam Island Wound Dressing, Spyroflex Foam Island Wound Dressing, Tinted…MGP · Traditional | Innovative Technologies (Us), Inc. | 02/06/1998SE |
| K973538 | N-TerfaceMGP · Traditional | Winfield Laboratories, Inc. | 12/16/1997SN |
| K973657 | Arglaes-Ab Antimicrobial Barrier Island DressingMGP · Traditional | Maersk Medical, Ltd. | 12/01/1997SN |
| K973036 | 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery)…MGP · Traditional | 3M Healthcare | 11/12/1997SN |
| K964398 | Spyroflex Pigmented Wound Dressing/Spyroflex Wound Dressing TintedMGP · Traditional | Polymedica Industries, Inc. | 10/24/1997SE |
| K973312 | Transparent Film Dressing, Intelligent Film DressingMGP · Traditional | Innovative Technologies , Ltd. | 10/22/1997SE |
| K973260 | Hydrasorb Sterile DressingMGP · Traditional | Avitar, Inc. | 10/21/1997SE |
| K972458 | Lyocell Wound Dressing/Surgical SpongeMGP · Traditional | Courtaulds Fibers, Inc. | 09/19/1997SE |
| K971093 | Opportunity I.V. Start KitMGP · Traditional | Opportunity, Inc. | 09/16/1997SN |
| K970518 | Algoplaque Hydrocolloid DressingMGP · Traditional | Laboratoires Urgo S.A. | 03/21/1997SN |
| K963753 | Nasp Transparent DressingMGP · Traditional | North American Sterilization & Packaging Co. | 11/29/1996SE |
| K963623 | Spyroflex Pigmented Wound DressingMGP · Traditional | Polymedica Industries, Inc. | 10/25/1996SE |
| K961319 | EpiviewMGP · Traditional | Convatec, A Division of E.R. Squibb & Sons | 07/08/1996SE |
| K961098 | Bio-Dressing, Sterile Island DressingMGP · Traditional | K. W. Griffen Co. | 05/03/1996SN |
| K960847 | DermasealMGP · Traditional | Bellingham Medical, Inc. | 04/04/1996SE |
| K960404 | Sureskin ThinMGP · Traditional | Euromed A/S | 03/01/1996SN |
| K960394 | Sureskin StandardMGP · Traditional | Euromed A/S | 03/01/1996SN |
| K960393 | Sureskin BorderMGP · Traditional | Euromed A/S | 03/01/1996SN |
| K955476 | Dukal Transparent Wound DressingMGP · Traditional | Dukal Corp. | 01/18/1996SN |
| K955383 | Spyrocolloid Wound DressingMGP · Traditional | Polymedica Industries, Inc. | 12/13/1995SN |
| K953885 | Spyroflex Skin ProtectorMGP · Traditional | Polymedica Industries, Inc. | 11/29/1995SE |
| K954738 | Dermagran Hydrophilic Wound DressingMGP · Traditional | Derma Sciences, Inc. | 11/02/1995SE |
| K954602 | Flexzan Wound DressingMGP · Traditional | Dow Hickam Pharmaceuticals, Inc. | 11/02/1995SN |
| K954033 | Tecnol Island Wound DressingMGP · Traditional | Tecnol Medical Products, Inc. | 09/22/1995SN |
| K953018 | Uni-SiteMGP · Traditional | Ttl Medical | 09/08/1995SE |
| K953618 | Spyroflex Wound DressingMGP · Traditional | Polymedica Industries, Inc. | 08/21/1995SN |
| K952449 | Transan, Transparent Film Dressing, Transparent Wound DrssingMGP · Traditional | Medical Device Development Co. | 08/07/1995SE |
| K952504 | Tecnol Transparent Wound DressingMGP · Traditional | Tecnol Medical Products, Inc. | 07/26/1995SN |
| K952217 | Mitraflex Wound Dressing Wet-StickMGP · Traditional | Polymedica Industries, Inc. | 06/22/1995SE |
| K952071 | Ultec Thin Hydrocolloid DressingMGP · Traditional | Sherwood Medical Co. | 06/22/1995SE |
| K951842 | Bioderm Medical Transparent Film DressingMGP · Traditional | Bioderm, Inc. | 06/12/1995SE |
| K946338 | Certiburn Burn/Trauma Face Dressing, Towel DressingMGP · Traditional | Certified Safety Mfg., Inc. | 03/29/1995SE |
| K945977 | Centurion(R) Site Guard(R) Transparent Dressing/Transpaent Film DressingMGP · Traditional | Tri-State Hospital Supply Corp. | 03/29/1995SE |
| K950065 | Conmed Veni-Gard(Tm I.V. Dressing-Product Line Extension and ModificationsMGP · Traditional | Conmedcorp | 03/24/1995SE |
| K943363 | Cutiplast SterilMGP · Traditional | Beiersdorf, Inc. | 03/15/1995SE |
| K946292 | Bioderm Medical Composite Wound DressingMGP · Traditional | Bioderm, Inc. | 02/06/1995SE |
| K941790 | Pro-Tect Safety DressingMGP · Traditional | Pro-Tect Medical Products, Inc. | 01/12/1995SE |
| K941789 | Pro-Tect Trauma PakMGP · Traditional | Pro-Tect Medical Products, Inc. | 01/12/1995SE |
| K940895 | EpiviewMGP · Traditional | Convatec, A Bristol-Myers Squibb Co. | 11/22/1994SN |
| K943424 | Cush Island DressingMGP · Traditional | Cush Medical Products | 10/03/1994SN |
| K943111 | Transparent DressingMGP · Traditional | Acutek Adhesive Specialties, Inc. | 09/12/1994SN |
| K943280 | Procel Burn Cover/Procel Burn Treatment CoverMGP · Traditional | W.L. Gore & Company, GmbH | 08/18/1994SN |
| K942757 | Asherman Chest BandageMGP · Traditional | Asherman Medical Products, LLC | 08/01/1994SN |
| K942774 | Polyskin(R) M.R. Moist Responsive Transparent DressingMGP · Traditional | The Kendal Co. | 07/20/1994SN |
| K935796 | Hydroderm Breathable Transparent DressingMGP · Traditional | Wilshire Medical Products | 02/02/1994SE |
| K926399 | Cutifilm(R) FilmMGP · Traditional | Beiersdorf, Inc. | 11/15/1993SE |
| K931599 | Hydrasorb Sterile DressingMGP · Traditional | Calgon Vestal Div. | 07/08/1993SE |
| K930401 | Aluminum FoilMGP · Traditional | Gam Industries, Inc. | 05/12/1993SE |
| K926034 | Epi-Lock Wound DressingMGP · Traditional | Calgon Vestal Div. | 04/20/1993SE |
| K925660 | Kti Transparent Wound DressingMGP · Traditional | Kingston Technologies, Inc. | 04/20/1993SE |
| K924008 | Sterile Film Wound DressingMGP · Traditional | Innovative Technology , Ltd. | 11/24/1992SN |
| K923150 | Silon Transparent Wound DressingsMGP · Traditional | Bio Med Sciences, Inc. | 08/27/1992SE |
| K920796 | Deroyal Transparent Film DressignMGP · Traditional | Deroyal Industries, Inc. | 07/23/1992SE |
| K915695 | Procel Burn CoverMGP · Traditional | W. L. Gore & Associates, Inc. | 05/29/1992SN |
| K915635 | Curity Vented Dressing SystemMGP · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 01/31/1992SE |
| K912032 | Silon(Tm) Transparent Wound DressingMGP · Traditional | Bio Med Sciences, Inc. | 08/20/1991SE |
| K911649 | Mitrasheer Transplant DressingMGP · Traditional | Polymint Industrial Co. , Ltd. | 08/07/1991SE |
| K911161 | Inerpan(Tm) Temporary Wound DressingMGP · Traditional | Laboratories Delalande | 06/27/1991SN |
| K911660 | Intrasite Hydrocolloid Wound DressingMGP · Traditional | Smith & Nephew United, Inc. | 06/17/1991SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1866-2011 | HydroHydrofilm is for use as a post-operative and primary dressing to protect against…Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10.… | Hartmann USA, Inc | 02/11/2011Terminated |