510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911407Substantially Equivalent

Harding Sternal Shield

Harding Medical Devices, Greensboro NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911407 is the FDA 510(k) clearance record for HARDING STERNAL SHIELD, a class I device, cleared for Harding Medical Devices on under FDA product code EYF (Protector, Wound, Plastic). FDA records list one 510(k) clearance for Harding Medical Devices. As of , FDA records show no recalls naming K911407.

Clearance record

Decision date
Received
(98 days to decision)
Product code
EYF Protector, Wound, Plastic
Regulation
21 CFR 878.4014
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Harding Medical Devices P.O. Box 10151, Greensboro NC
Third party review
No

Clearances, product code EYF

Trailing 12 months

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

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