Atlas FDA

NAE

29 FDA 510(k) clearances · Product code

89 daysmedian time to decision
247 days90th percentile
29clearances measured

FDA profile

Official device name
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Device class
Class I (low risk)
Regulation
21 CFR 878.4022
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2015: 17 · 2021: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MODIFICATION TO ZENIEVA (K083721)River'S Edge Pharmaceuticals, LLC2009-01-08
MODIFICATION TO ZENIEVA (K082865)Gorbec Pharmaceutical Services, Inc.2008-10-23
ZENIEVA (K073246)Gorbec Pharmaceutical Services, Inc.2008-07-23
GILTECH PLUS HYDROGEL SKIN DRESSING (K992094)Giltech Plus, Inc.1999-09-17
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (K991061)Dermaphylyx, Inc.1999-06-28
AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES (K972646)Ludlow Technical Products1997-08-21
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) (K971597)Coloplast Corp.1997-07-29
HYDROGEL SKIN DRESSING (K962352)North American Sterilization & Packaging Co.1996-08-02
AQUAFLO HYDROGEL WOUND DRESSING & PACKER (K952945)Sherwood Medical Co.1995-08-23
BIODERM MEDICAL HYDROGEL ISLAND DRESSING (K951166)Bioderm, Inc.1995-06-21
CURAGEL HYDROGEL WOUND DRESSING (K950412)Kendall Healthcare Products Co. Div.Of Tyco Health1995-03-24
BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS (K945832)Brady Medical Products Co.1995-03-01
INTRASITE (K942748)Smith & Nephew United, Inc.1994-06-29
BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING (K941019)Brady Medical Products Co.1994-05-04
ALLEVYN ISLAND WOUND DRESSING (K935705)Smith & Nephew United, Inc.1994-02-15
NDM HYDROGAUZE WOUND DRESSING (K934601)Ndm Acquisition Corp.1994-02-15
BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING (K935848)Brady Medical Products Co.1994-02-15
NU-GEL ISLAND WOUND DRESSING (K932336)Johnson & Johnson Medical, Inc.1994-02-09
DUODERM HYDROCOLLOID GEL (K931618)Convatec, A Division of E.R. Squibb & Sons1993-12-10
INTRASITE GEL (K926508)Smith & Nephew United, Inc.1993-07-13
CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI (K926202)Ndm Corp.1993-05-12
TRANSORB(TM) ULCER & WOUND DRESSING (K922666)Brady Medical Products Co.1992-11-23
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH (K915359)Medtronic Vascular1992-05-28
PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH (K915357)Medtronic Vascular1992-05-28
DEROYAL HYDROGEL DRESSING (K915182)Deroyal Industries, Inc.1992-04-21
CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION (K920677)New Dimensions IN Medicine, Inc.1992-04-21
CLEARSITE(R) STERILE WOUND CARE DRESSING (K914207)Ndm Acquisition Corp.1991-10-23
IP-758 BURN WOUND DRESSING (K810902)Exopack1981-09-11
LOMATUELL OINTMENT DRESSING (K802793)Secol Co.1980-12-18

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