510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K113583Substantially Equivalent

Curad Antibacterial Bandage

MEDLINE INDUSTRIES, LP - Northfield, Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K113583 is the FDA 510(k) clearance record for CURAD ANTIBACTERIAL BANDAGE, cleared for Medline Industries, Inc. on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K113583.

Clearance record

Decision date
Received
(129 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Medline Industries, Inc. One Medline Pl., Mundelein IL
510(k) summary
Statement
Third party review
No

Clearances, product code FRO

Trailing 12 months
18 clearances under product code FRO in the twelve months to November 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FRO, trailing twelve months
MonthClearances
December 20251
January 20264
February 20261
March 20263
April 20261
May 20261
June 20263
July 20260
August 20262
September 20262
October 20260
November 20260