NAE · Class I · 21 CFR 878.4022

FDA Product Code NAE: Dressing, Wound, Hydrogel Without Drug And/or Biologic

Leading manufacturers include Brady Medical Products Co., Smith & Nephew United, Inc. and Ndm Acquisition Corp..

29
Total
29
Cleared
110d
Avg days
1980
Since

FDA 510(k) Cleared Dressing, Wound, Hydrogel Without Drug And/or Biologic Devices (Product Code NAE)

29 devices
1–24 of 29
Cleared Jan 08, 2009
MODIFICATION TO ZENIEVA
K083721
River'S Edge Pharmaceuticals, LLC
General & Plastic Surgery · 24d
Cleared Oct 23, 2008
MODIFICATION TO ZENIEVA
K082865
Gorbec Pharmaceutical Services, Inc.
General & Plastic Surgery · 24d
Cleared Jul 23, 2008
ZENIEVA
K073246
Gorbec Pharmaceutical Services, Inc.
General & Plastic Surgery · 247d
Cleared Sep 17, 1999
GILTECH PLUS HYDROGEL SKIN DRESSING
K992094
Giltech Plus, Inc.
General & Plastic Surgery · 88d
Cleared Jun 28, 1999
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
K991061
Dermaphylyx, Inc.
General & Plastic Surgery · 90d
Cleared Aug 21, 1997
AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
K972646
Ludlow Technical Products
General & Plastic Surgery · 37d
Cleared Jul 29, 1997
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
K971597
Coloplast Corp.
General & Plastic Surgery · 89d
Cleared Aug 02, 1996
HYDROGEL SKIN DRESSING
K962352
North American Sterilization & Packaging Co.
General & Plastic Surgery · 45d
Cleared Aug 23, 1995
AQUAFLO HYDROGEL WOUND DRESSING & PACKER
K952945
Sherwood Medical Co.
General & Plastic Surgery · 58d
Cleared Jun 21, 1995
BIODERM MEDICAL HYDROGEL ISLAND DRESSING
K951166
Bioderm, Inc.
General & Plastic Surgery · 99d
Cleared Mar 24, 1995
CURAGEL HYDROGEL WOUND DRESSING
K950412
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 52d
Cleared Mar 01, 1995
BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS
K945832
Brady Medical Products Co.
General & Plastic Surgery · 92d
Cleared Jun 29, 1994
INTRASITE
K942748
Smith & Nephew United, Inc.
General & Plastic Surgery · 19d
Cleared May 04, 1994
BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING
K941019
Brady Medical Products Co.
General & Plastic Surgery · 62d
Cleared Feb 15, 1994
NDM HYDROGAUZE WOUND DRESSING
K934601
Ndm Acquisition Corp.
General & Plastic Surgery · 144d
Cleared Feb 15, 1994
ALLEVYN ISLAND WOUND DRESSING
K935705
Smith & Nephew United, Inc.
General & Plastic Surgery · 77d
Cleared Feb 15, 1994
BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING
K935848
Brady Medical Products Co.
General & Plastic Surgery · 69d
Cleared Feb 09, 1994
NU-GEL ISLAND WOUND DRESSING
K932336
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 271d
Cleared Dec 10, 1993
DUODERM HYDROCOLLOID GEL
K931618
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 252d
Cleared Jul 13, 1993
INTRASITE GEL
K926508
Smith & Nephew United, Inc.
General & Plastic Surgery · 195d
Cleared May 12, 1993
CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI
K926202
Ndm Corp.
General & Plastic Surgery · 154d
Cleared Nov 23, 1992
TRANSORB(TM) ULCER & WOUND DRESSING
K922666
Brady Medical Products Co.
General & Plastic Surgery · 179d
Cleared May 28, 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH
K915357
Medtronic Vascular
General & Plastic Surgery · 183d
Cleared May 28, 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
K915359
Medtronic Vascular
General & Plastic Surgery · 183d

About Product Code NAE - Regulatory Context