Panels › General, Plastic Surgery › Product code NAD · Class 1
Dressing, Wound, Occlusive
Regulation 878.4020
1510(k)s in 12 months (107 all time)
0recalls in 12 months (19 all time)
8recalls that name a 510(k)
Top companies in NAD
| Company | 510(k)s | Recalls |
|---|---|---|
| COVIDIEN LLC | 0 | 9 |
| Chesebrough-Pond'S U.S.A. Co. | 5 | 0 |
| Smith & Nephew, Inc. | 5 | 0 |
| The Bfgoodrich Co. | 4 | 0 |
| Convatec, A Division of E.R. Squibb & Sons | 4 | 0 |
| Dermatec, Inc. | 4 | 0 |
| Fraass Survival Systems, Inc. | 4 | 0 |
| Acme United Corp. | 3 | 0 |
| ConvaTec, Inc | 0 | 3 |
| Kendall Healthcare Products Co | 0 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | ConvaTec, Inc DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas s Open, Classified |
NAD | None listed |
| Apr 4, 2025 | MEDLINE INDUSTRIES, LP - Northfield Wayson Hydrocolloid Models:
1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2;
2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2;
3) MJ BNDG HYDROCOLLOID FINGER TOE 8 Open, Classified |
NAD | None listed |
| Jan 28, 2022 | Sam Medical Products SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 Terminated |
NAD | K102403 |
| Aug 20, 2021 | ConvaTec, Inc DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) Open, Classified |
NAD | None listed |
| Aug 9, 2021 | ConvaTec, Inc DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660)
DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957)
DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955) Open, Classified |
NAD | None listed |
| Aug 1, 2018 | COVIDIEN LLC Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. Terminated |
NAD | K990530 |
| Aug 1, 2018 | COVIDIEN LLC Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. Terminated |
NAD | K990530 |
| Aug 1, 2018 | COVIDIEN LLC Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress woun Terminated |
NAD | K990530 |
| Aug 1, 2018 | COVIDIEN LLC Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress woun Terminated |
NAD | K990530 |
| Aug 1, 2018 | COVIDIEN LLC Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dres Terminated |
NAD | K990530 |
| Aug 1, 2018 | COVIDIEN LLC Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332
Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bac Terminated |
NAD | K990530 |
| Mar 27, 2017 | Covidien LLC Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile
Item Code: 3606
Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help pr Terminated |
NAD | None listed |
| Mar 27, 2017 | Covidien LLC Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile
Item Code: 3339
Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds Terminated |
NAD | None listed |
| Mar 27, 2017 | Covidien LLC Covidien Kerlix Super Sponge Saline Dressing, Sterile
Item Code: 3338
Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biolog Terminated |
NAD | None listed |
| Oct 24, 2014 | Coloplast Manufacturing US, LLC Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU.
Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low ex Terminated |
NAD | None listed |
| Apr 8, 2010 | Aplicare, Inc. Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile
Part number: A3402.
The product is used for Central Line Dressing Change. Terminated |
NAD | None listed |
| Jul 20, 2004 | Kendall Healthcare Products Co Kendall Curity Disposable Laparotomy Sponges,
12 in x 12 in, Sterile
Product Number: 6034 Terminated |
NAD | None listed |
| Jul 20, 2004 | Kendall Healthcare Products Co Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile
Product Number: 6730 Terminated |
NAD | None listed |
| Jul 20, 2004 | Kendall Healthcare Products Co Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile
6 ply-4.5 in x 4.1 yd
Product Number: 3331 Terminated |
NAD | K990530 |
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