Chrysalis Intelligence · Sponsors · Smith & Nephew Medical, Ltd.

Smith & Nephew Medical, Ltd.

Hull, GB · 10 510(k) clearances · 3 recalls

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Total clearances
10
2020-10-30 → 2026-05-27
Last 12 months
2
Product codes
4
Most recent
2026-05-27
Name variants in FDA filings: Smith & Nephew Medical Limited / Smith & Nephew Medical, Ltd.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OMP Negative Pressure Wound Therapy Powered Suction Pump Class II General, Plastic Surgery 7 2026-05-27
KGN Wound Dressing With Animal-Derived Material(S) Unclassified Unknown 1 2024-12-17
FRO Dressing, Wound, Drug Unclassified Unknown 1 2023-08-18
FQH Lavage, Jet Class II General Hospital 1 2023-05-16
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
3
Most recent
2024-10-02
DateSeverityStatusRecall # ProductCodeReason
2024-10-02 Class II Ongoing Z-0516-2025 RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may… — Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
2024-03-11 Class II Ongoing Z-1597-2024 RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it … — Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
2024-03-11 Class II Ongoing Z-1596-2024 RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it … — Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Filings

All 510(k) clearances (10)

Date K-number Device Code Class Specialty
2026-05-27 K260646 RENASYS EDGE (66803126) OMP Class II General, Plastic Surgery
2025-09-11 K251826 RENASYS WOUND+ Dressing Kit with AIRLOCK Technology OMP Class II General, Plastic Surgery
2025-02-18 K243576 RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port OMP Class II General, Plastic Surgery
2024-12-17 K242146 BIOBRANE Temporary Wound Dressing; BIOBRANE Glove KGN Unclassified Unknown
2024-05-24 K231939 Renasys Edge OMP Class II General, Plastic Surgery
2023-08-18 K223526 ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing FRO Unclassified Unknown
2023-05-16 K220964 VERSAJET Hydrosurgery System (III) FQH Class II General Hospital
2022-11-22 K223041 Renasys Edge (66803126) OMP Class II General, Plastic Surgery
2022-01-14 K202783 Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing OMP Class II General, Plastic Surgery
2020-10-30 K202157 PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack OMP Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence