Panels › General, Plastic Surgery › Product code NAE · Class 1
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Regulation 878.4022
0510(k)s in 12 months (29 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in NAE
| Company | 510(k)s | Recalls |
|---|---|---|
| Brady Medical Products Co. | 4 | 0 |
| Smith & Nephew United, Inc. | 3 | 0 |
| Gorbec Pharmaceutical Services, Inc. | 2 | 0 |
| Medtronic Vascular | 2 | 0 |
| Ndm Acquisition Corp. | 2 | 0 |
| Safe N Simple, LLC | 0 | 2 |
| Bioderm, Inc. | 1 | 0 |
| CellEra LLC | 0 | 1 |
| Coloplast Corp. | 1 | 0 |
| Convatec, A Division of E.R. Squibb & Sons | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 8, 2009 | K083721 | MODIFICATION TO ZENIEVA River'S Edge Pharmaceuticals, LLC | NAE |
| Oct 23, 2008 | K082865 | MODIFICATION TO ZENIEVA Gorbec Pharmaceutical Services, Inc. | NAE |
| Jul 23, 2008 | K073246 | ZENIEVA Gorbec Pharmaceutical Services, Inc. | NAE |
| Sep 17, 1999 | K992094 | GILTECH PLUS HYDROGEL SKIN DRESSING Giltech Plus, Inc. | NAE |
| Jun 28, 1999 | K991061 | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING Dermaphylyx, Inc. | NAE |
| Aug 21, 1997 | K972646 | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES Ludlow Technical Products | NAE |
| Jul 29, 1997 | K971597 | COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) Coloplast Corp. | NAE |
| Aug 2, 1996 | K962352 | HYDROGEL SKIN DRESSING North American Sterilization & Packaging Co. | NAE |
| Aug 23, 1995 | K952945 | AQUAFLO HYDROGEL WOUND DRESSING & PACKER Sherwood Medical Co. | NAE |
| Jun 21, 1995 | K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING Bioderm, Inc. | NAE |
| Mar 24, 1995 | K950412 | CURAGEL HYDROGEL WOUND DRESSING Kendall Healthcare Products Co. Div.Of Tyco Health | NAE |
| Mar 1, 1995 | K945832 | BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS Brady Medical Products Co. | NAE |
| Jun 29, 1994 | K942748 | INTRASITE Smith & Nephew United, Inc. | NAE |
| May 4, 1994 | K941019 | BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING Brady Medical Products Co. | NAE |
| Feb 15, 1994 | K935848 | BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING Brady Medical Products Co. | NAE |
| Feb 15, 1994 | K935705 | ALLEVYN ISLAND WOUND DRESSING Smith & Nephew United, Inc. | NAE |
| Feb 15, 1994 | K934601 | NDM HYDROGAUZE WOUND DRESSING Ndm Acquisition Corp. | NAE |
| Feb 9, 1994 | K932336 | NU-GEL ISLAND WOUND DRESSING Johnson & Johnson Medical, Inc. | NAE |
| Dec 10, 1993 | K931618 | DUODERM HYDROCOLLOID GEL Convatec, A Division of E.R. Squibb & Sons | NAE |
| Jul 13, 1993 | K926508 | INTRASITE GEL Smith & Nephew United, Inc. | NAE |
| May 12, 1993 | K926202 | CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI Ndm Corp. | NAE |
| Nov 23, 1992 | K922666 | TRANSORB(TM) ULCER & WOUND DRESSING Brady Medical Products Co. | NAE |
| May 28, 1992 | K915359 | PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH Medtronic Vascular | NAE |
| May 28, 1992 | K915357 | PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH Medtronic Vascular | NAE |
| Apr 21, 1992 | K920677 | CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION New Dimensions IN Medicine, Inc. | NAE |
| Apr 21, 1992 | K915182 | DEROYAL HYDROGEL DRESSING Deroyal Industries, Inc. | NAE |
| Oct 23, 1991 | K914207 | CLEARSITE(R) STERILE WOUND CARE DRESSING Ndm Acquisition Corp. | NAE |
| Sep 11, 1981 | K810902 | IP-758 BURN WOUND DRESSING Exopack | NAE |
| Dec 18, 1980 | K802793 | LOMATUELL OINTMENT DRESSING Secol Co. | NAE |
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