← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

FRO — Dressing, Wound, Drug

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
33
510(K)/PMA CLEARANCES
510k: 33
0
RECALL ENTRIES

Recent clearances

K251929Silverceuticals, Inc. · 510k2026-06-24
K261023Sonoma Pharmaceuticals, Inc. · 510k2026-06-24
K261638Oneness Biotech Co., Ltd. · 510k2026-06-17
K254073Merit Medical Systems, Inc. · 510k2026-05-13
K254191InnovaCorium, Inc. · 510k2026-04-07
K252023Letus Corporation · 510k2026-03-25
K251999Solventum Germany GmbH · 510k2026-03-13
K252028Huizhou Foryou Medical Co., Ltd. · 510k2026-03-11

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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