DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
pma: 4
0
RECALL ENTRIES
Recent clearances
P880047ETHICON, Inc. · pma2026-06-25
P240015Womed Sas · pma2026-01-28
P950034Baxter Healthcare Corporation · pma2024-12-19
P050011Baxter Healthcare Corp · pma2024-08-23
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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