510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843148Substantially Equivalent

Kodak T-Mat H Film So-118

Eastman Kodak Company, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843148 is the FDA 510(k) clearance record for KODAK T-MAT H FILM SO-118, a class III device, cleared for Eastman Kodak Company on under FDA product code LWZ (Tissue Graft Of Less Than 6mm). FDA records list 291 510(k) clearances for Eastman Kodak Company, from to . As of , FDA records show no recalls naming K843148.

Clearance record

Decision date
Received
(17 days to decision)
Product code
LWZ Tissue Graft Of Less Than 6mm
Device class
Class III
Review panel
Unknown
Applicant
Eastman Kodak Company 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LWZ

Trailing 12 months

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

FDA records show no clearances under product code LWZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWZ, 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