Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Dacomed with 20 510(k) clearances. The most recent is a 510(k) clearance dated Oct 27, 1995: DUNA II PENILE PROSTHESIS.
| Oct 27, 1995 | DUNA II PENILE PROSTHESISK953640 · FAE | 510(k) clearances |
| Aug 25, 1994 | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEMK941781 · LIL | 510(k) clearances |
| May 11, 1992 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICEK920409 · LKY | 510(k) clearances |
| Apr 16, 1992 | DURA II PENILE PROSTHESISK920420 · FAE | 510(k) clearances |
| Oct 11, 1991 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESISK912344 · FAE | 510(k) clearances |
| May 4, 1990 | DACOMED NEGATIVE PRESSURE ERECTION DEVICEK900774 · LKY | 510(k) clearances |
| Feb 8, 1989 | DACOMED EXTERNAL MALE CONTINENCE DEVICEK885323 · FHA | 510(k) clearances |
| Apr 27, 1988 | DACOMED CYSTOMETERK880391 · EXQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
