510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896449Substantially Equivalent

Im Collagen Shield

Intermedical, Inc., Safety Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896449 is the FDA 510(k) clearance record for IM COLLAGEN SHIELD, a class I device, cleared for Intermedical, Inc. on under FDA product code MOE (Collagen Corneal Shield). FDA records list one 510(k) clearance for Intermedical, Inc. As of , FDA records show no recalls naming K896449.

Clearance record

Decision date
Received
(196 days to decision)
Product code
MOE Collagen Corneal Shield
Regulation
21 CFR 886.4750
Device class
Class I
Review panel
Ophthalmic
Applicant
Intermedical, Inc. 1101 Knollwood Dr., Safety Harbor FL
Third party review
No

Clearances, product code MOE

Trailing 12 months

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

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