← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MQL — Media, Reproductive

DEVICE CLASS
Class II
REGULATION
21 CFR 884.6180
MEDICAL SPECIALTY
Obstetrics/Gynecology
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
14
510(K)/PMA CLEARANCES
510k: 14
0
RECALL ENTRIES

Recent clearances

K260248Kitazato Corporation · 510k2026-04-28
K252672Casebioscience, Inc. · 510k2026-02-20
K250445Fujifilm Irvine Scientific · 510k2025-09-12
K251637Donnevie Medical Technology (Shanghai) Co. , Ltd. · 510k2025-08-27
K251305Kitazato Corporation · 510k2025-08-26
K242640Fertipro NV · 510k2025-05-30
K242561Donnevie Medical Technology (Shanghai) Co. , Ltd. · 510k2025-04-10
K242089Jiangsu Ruifuda Medical Device Co., Ltd. · 510k2025-04-10

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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