FDA Product Code
FDA Product Code NAE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4022
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K083721 | MODIFICATION TO ZENIEVA | River'S Edge Pharmaceuticals, LLC | 2009-01-08 | Special | PDF ↗ |
| K082865 | MODIFICATION TO ZENIEVA | Gorbec Pharmaceutical Services, Inc. | 2008-10-23 | Special | PDF ↗ |
| K073246 | ZENIEVA | Gorbec Pharmaceutical Services, Inc. | 2008-07-23 | Traditional | PDF ↗ |
| K992094 | GILTECH PLUS HYDROGEL SKIN DRESSING | Giltech Plus, Inc. | 1999-09-17 | Traditional | PDF ↗ |
| K991061 | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | Dermaphylyx, Inc. | 1999-06-28 | Traditional | PDF ↗ |
| K972646 | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES | Ludlow Technical Products | 1997-08-21 | Traditional | PDF ↗ |
| K971597 | COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) | Coloplast Corp. | 1997-07-29 | Traditional | PDF ↗ |
| K962352 | HYDROGEL SKIN DRESSING | North American Sterilization & Packaging Co. | 1996-08-02 | Traditional | PDF ↗ |
| K952945 | AQUAFLO HYDROGEL WOUND DRESSING & PACKER | Sherwood Medical Co. | 1995-08-23 | Traditional | PDF ↗ |
| K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | Bioderm, Inc. | 1995-06-21 | Traditional | PDF ↗ |
| K950412 | CURAGEL HYDROGEL WOUND DRESSING | Kendall Healthcare Products Co. Div.Of Tyco Health | 1995-03-24 | Traditional | PDF ↗ |
| K945832 | BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS | Brady Medical Products Co. | 1995-03-01 | Traditional | PDF ↗ |
| K942748 | INTRASITE | Smith & Nephew United, Inc. | 1994-06-29 | Traditional | PDF ↗ |
| K941019 | BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING | Brady Medical Products Co. | 1994-05-04 | Traditional | PDF ↗ |
| K935705 | ALLEVYN ISLAND WOUND DRESSING | Smith & Nephew United, Inc. | 1994-02-15 | Traditional | PDF ↗ |
| K934601 | NDM HYDROGAUZE WOUND DRESSING | Ndm Acquisition Corp. | 1994-02-15 | Traditional | PDF ↗ |
| K935848 | BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING | Brady Medical Products Co. | 1994-02-15 | Traditional | PDF ↗ |
| K932336 | NU-GEL ISLAND WOUND DRESSING | Johnson & Johnson Medical, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K931618 | DUODERM HYDROCOLLOID GEL | Convatec, A Division of E.R. Squibb & Sons | 1993-12-10 | Traditional | PDF ↗ |
| K926508 | INTRASITE GEL | Smith & Nephew United, Inc. | 1993-07-13 | Traditional | PDF ↗ |
| K926202 | CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI | Ndm Corp. | 1993-05-12 | Traditional | PDF ↗ |
| K922666 | TRANSORB(TM) ULCER & WOUND DRESSING | Brady Medical Products Co. | 1992-11-23 | Traditional | PDF ↗ |
| K915359 | PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH | Medtronic Vascular | 1992-05-28 | Traditional | PDF ↗ |
| K915357 | PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH | Medtronic Vascular | 1992-05-28 | Traditional | PDF ↗ |
| K920677 | CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION | New Dimensions IN Medicine, Inc. | 1992-04-21 | Traditional | PDF ↗ |
| K915182 | DEROYAL HYDROGEL DRESSING | Deroyal Industries, Inc. | 1992-04-21 | Traditional | PDF ↗ |
| K914207 | CLEARSITE(R) STERILE WOUND CARE DRESSING | Ndm Acquisition Corp. | 1991-10-23 | Traditional | PDF ↗ |
| K810902 | IP-758 BURN WOUND DRESSING | Exopack | 1981-09-11 | Traditional | PDF ↗ |
| K802793 | LOMATUELL OINTMENT DRESSING | Secol Co. | 1980-12-18 | Traditional | PDF ↗ |
Product code NAE · Class I · General, Plastic Surgery. Data: openFDA.