DEVICE CLASS
Class II
REGULATION
21 CFR 880.6880
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES
Recent clearances
K261055STERIS Corporation · 510k2026-06-24
K260254Enbio Group AG · 510k2026-02-26
K252307Maquet GmbH (A Getinge Group Company) · 510k2026-01-22
K250168Lucas Lifecare · 510k2025-12-30
K250164Guangzhou Ajax Medical Equipment Co., Ltd. · 510k2025-08-14
K243994Ningbo Ican Machines Co., Ltd. · 510k2025-06-06
K243801Fort Defiance Industries, LLC · 510k2025-03-07
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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