DEVICE CLASS
Class II
REGULATION
21 CFR 878.4040
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
12
510(K)/PMA CLEARANCES
510k: 12
0
RECALL ENTRIES
Recent clearances
K261949New York Embroidery Studio · 510k2026-07-10
K252575New York Embroidery Studio (NYES) · 510k2026-06-04
K260725Hindernis DE Mexico, S.A.P.I. DE C.V. · 510k2026-05-12
K253243Cardinal Health 200, LLC · 510k2026-04-28
K253003Hubei Xinxin Non-Woven Co., Ltd. · 510k2026-04-20
K251860Copioumed International, Inc. · 510k2026-02-26
K252301Yadu Medical (Henan) Co., Ltd. · 510k2026-02-04
K250564Yadu Medical (Henan) Co., Ltd. · 510k2025-12-03
Related on SPEQ
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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