DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
16
510(K)/PMA CLEARANCES
pma: 16
0
RECALL ENTRIES
Recent clearances
P250016Merz North America, Inc. · pma2026-07-09
P170002Teoxane S.A. · pma2026-07-02
P050052Merz North America, Inc. · pma2026-06-26
P050037Merz North America, Inc. · pma2026-06-26
P250020Merz North America, Inc. · pma2026-06-25
P030050Q-Med AB · pma2026-06-22
P250021Croma-Pharma GmbH · pma2026-06-12
P110033Allergan · pma2026-06-11
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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