DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
pma: 9
0
RECALL ENTRIES
Recent clearances
P080020Seikagaku Corp. · pma2026-04-09
P170007Bioventus, LLC · pma2025-12-23
P170016Mesoblast · pma2025-12-23
P980044Seikagaku Corp. · pma2025-12-19
P010029Ferring Pharmaceuticals, Inc. · pma2025-10-16
P160057Channel-Markers Medical, LLC · pma2025-05-20
P140005Channel-Markers Medical, LLC · pma2025-05-20
P150010Fidia Farmaceutici · pma2025-04-09
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.