510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K961067Substantially Equivalent

Burn-Aid Hydrogel,burn Dressing,burn Blanket

Medtrak Intl., Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961067 is the FDA 510(k) clearance record for BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET, cleared for Medtrak Intl., Inc. on under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic). FDA records list 2 510(k) clearances for Medtrak Intl., Inc., from to . As of , FDA records show no recalls naming K961067.

Clearance record

Decision date
Received
(59 days to decision)
Product code
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device class
Unclassified
Review panel
Unknown
Applicant
Medtrak Intl., Inc. 9841 Broken Land Pkwy., #107, Columbia MD
510(k) summary
Summary
Third party review
No

Clearances, product code MGQ

Trailing 12 months

FDA records hold no clearances under product code MGQ in the trailing twelve months.

FDA records show no clearances under product code MGQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MGQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260