# Smith & Nephew United, Inc.

- Location (FDA's records): Largo, FL
- FDA decisions: 34 (1989–1996): 34 510(k) clearances
- Product codes: KMF (7), KGX (6), NAD (3), NAE (3), KOZ (3), NAB (2), EFQ (2), KOX (2), GYB (1), MGQ (1), FRO (1), FLK (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Shippert Medical Technologies Corp.: 1 (https://510kreport.com/company/shippert-medical-technologies)
- Curaline, Inc.: 1 (https://510kreport.com/company/curaline)
- 3M Company-3M Health Care: 1 (https://510kreport.com/company/3m-company-3m-health-care)
- Coloplast Corp.: 1 (https://510kreport.com/company/coloplast)
- Avocet Polymer Technologies, Inc.: 1 (https://510kreport.com/company/avocet-polymer-technologies)
- Coreleader Biotech Co., Ltd.: 1 (https://510kreport.com/company/coreleader-biotech)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Neutrogena Corp.: 1 (https://510kreport.com/company/neutrogena)

## Its most-cited devices
- K963096: Allevyn Hydro Poly Dressing ND All Trac Dressing (1996), cited by 2
- K935803: Cica-Care Silicone Gel Sheet (1994), cited by 2
- K895353: Opsite I.V. 3000 (1989), cited by 1
- K926508: Intrasite Gel (1993), cited by 1
- K932263: Solosite Dermal Wound Gel (1993), cited by 1
- K891101: Non-Absorbable Gauze, Surgical Sponge & Dressing (1989), cited by 1

## Recent decisions
- K963096: Allevyn Hydro Poly Dressing ND All Trac Dressing (Oct 25, 1996)
- K961775: Profore Four-Layer Bandage System Kit (Jul 16, 1996)
- K945330: Allevyn Adhesive (Feb 9, 1995)
- K943619: Cavi-Care Conforming Foam Dressing (Aug 19, 1994)
- K942748: Intrasite (Jun 29, 1994)
- K935705: Allevyn Island Wound Dressing (Feb 15, 1994)
- K935803: Cica-Care Silicone Gel Sheet (Feb 3, 1994)
- K932263: Solosite Dermal Wound Gel (Oct 1, 1993)

Source page: https://510kreport.com/company/smith-nephew-united