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Prosthesis, Penile
FDA product code FAE · Class 2 · Gastroenterology, Urology
35
Registered devices
2,754
Adverse events
3
Recalls
32
510(k) clearances
Devices with this code
Spectra RTE Kit — AMERICAN MEDICAL SYSTEMS, INC.Spectra — AMERICAN MEDICAL SYSTEMS, INC.Rear Tip Extender — BOSTON SCIENTIFIC CORPORATIONRear Tip Extender — BOSTON SCIENTIFIC CORPORATIONGenesis — Coloplast A/SSpectra — AMERICAN MEDICAL SYSTEMS, INC.Spectra — AMERICAN MEDICAL SYSTEMS, INC.Spectra RTE Kit — AMERICAN MEDICAL SYSTEMS, INC.Rear Tip Extender — BOSTON SCIENTIFIC CORPORATIONRear Tip Extender — BOSTON SCIENTIFIC CORPORATIONTACTRA — BOSTON SCIENTIFIC CORPORATIONRear Tip Extender — BOSTON SCIENTIFIC CORPORATIONRIGI10 — Rigicon, Inc.RIGI10™ — Rigicon, Inc.Spectra — AMERICAN MEDICAL SYSTEMS, INC.Rear Tip Extender — BOSTON SCIENTIFIC CORPORATIONGenesis — Coloplast A/SRIGI10 — Rigicon, Inc.RIGI10™ — Rigicon, Inc.RIGI10 — Rigicon, Inc.Spectra — AMERICAN MEDICAL SYSTEMS, INC.Rear Tip Extender — BOSTON SCIENTIFIC CORPORATIONRIGI10™ — Rigicon, Inc.RIGI10 — Rigicon, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-09 | Coloplast Manufacturing US, LLC | Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The |
| 2007-02-19 | American Medical Systems | Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels. |
| 2007-02-19 | American Medical Systems | Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels. |
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