Medical Device Manufacturer · GB , Deeside

Convatec Limited - FDA 510(k) Cleared Devices

10 submissions · 9 cleared · Since 2016

Recent clearances: GentleCath Air for Men, Cure Catheter Insertion Kit (K1), GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

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10

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Convatec Limited General & Plastic Surgery ✕

3 devices

1-3 of 3

Cleared Oct 19, 2018

AVELLE Negative Pressure Wound Therapy System

General & Plastic Surgery · 268d

Cleared Jul 20, 2018

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening...

General & Plastic Surgery · 232d

Cleared Jan 21, 2016

AQUACEL Ag Surgical SP Dressing

General & Plastic Surgery · 108d