Home › Device types › FHW
Device, Impotence, Mechanical/Hydraulic
FDA product code FHW · Class 3 · Gastroenterology, Urology
86
Registered devices
38,353
Adverse events
20
Recalls
0
510(k) clearances
Devices with this code
Titan — Coloplast A/STitan® — Coloplast A/STitan — Coloplast A/STitan — Coloplast A/SAMS Ambicor — BOSTON SCIENTIFIC CORPORATIONTitan — Coloplast A/STitan — Coloplast A/STitan — Coloplast A/STitan — Coloplast A/STitan — Coloplast A/SAMS Ambicor — BOSTON SCIENTIFIC CORPORATIONTitan Touch — Coloplast A/STitan — Coloplast A/STitan® — Coloplast A/STitan — Coloplast A/SAMS Ambicor — BOSTON SCIENTIFIC CORPORATIONTitan — Coloplast A/STitan — Coloplast A/SAMS Ambicor RTE Kit — BOSTON SCIENTIFIC CORPORATIONProximal Tool — AMERICAN MEDICAL SYSTEMS, INC.Titan — Coloplast A/STitan — Coloplast A/STitan — Coloplast A/STitan — Coloplast A/S
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interaction |
| 2023-03-01 | Coloplast Manufacturing US, LLC | XXX |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interaction |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interaction |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interaction |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interaction |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interaction |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interaction |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interaction |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interaction |
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