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FDA PRODUCT CODE · CLASS III

PFZ — Ophthalmic Sealant

An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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