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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2020 | Nelson Innovaions, Llc NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 )
Product #: HB66T Open, Classified |
NAE | None listed |
| Aug 22, 2018 | Safe N Simple, LLC Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345 Terminated |
NAE | None listed |
| Aug 22, 2018 | Safe N Simple, LLC Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315 Terminated |
NAE | None listed |
| Jun 22, 2017 | O-Two Medical Technologies, Inc. Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 ---
DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products Terminated |
NAE | None listed |
| Sep 1, 2016 | CellEra LLC VITALE Silicon Foam Dressings 4"x4"
Cat. No. 20144 Terminated |
NAE | None listed |
| Jan 17, 2007 | Embeem Inc. HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch. Terminated |
NAE | None listed |
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