← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

MGB — Device, Hemostasis, Vascular

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
pma: 9
0
RECALL ENTRIES

Recent clearances

P960043Abbott Vascular, Inc. · pma2026-07-14
P100013Cordis US Corporation · pma2026-06-23
P230038Cyndrx, LLC · pma2026-06-05
P040044Cordis US Corporation · pma2026-05-14
P180025Teleflex Medical, LLC · pma2026-04-23
P120016Cardiva Medical, Inc. · pma2026-04-23
P050007Abbott Vascular Devices · pma2026-04-17
P150006Vasorum, Ltd. · pma2025-12-18

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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