DEVICE CLASS
Class II
REGULATION
21 CFR 870.2700
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
27
510(K)/PMA CLEARANCES
510k: 27
0
RECALL ENTRIES
Recent clearances
K252821Philips Medizin Systeme Böblingen GmbH · 510k2026-05-29
K252655Shenzhen Imdk Medical Technology Co., Ltd. · 510k2026-05-11
K253887Philips Medizin Systeme · 510k2026-05-01
K260931Unimed Medical Supplies, Inc. · 510k2026-04-14
K252448Avita Corporation · 510k2026-02-27
K252805Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 510k2026-02-17
K253109Shenzhen Best Electronics Co., Ltd. · 510k2026-01-07
K251751Shenzhen Ykd Technology Co., Ltd. · 510k2025-12-19
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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