510(k) K990530 ยท NAD Dressing, Wound, Occlusive
KERLIX MD ANTIMICROBIAL GAUZE DRESSING
| Applicant | The Kendall Company, L.P., Mansfield MA, US |
| Decision | Substantially Equivalent, Jan 31, 2000 |
| Received | Feb 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990530
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | 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 | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.