Company ยท US
Dacomed Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1995. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FAE | Prosthesis, Penile | 7 |
| LIL | Monitor, Penile Tumescence | 4 |
| LKY | Device, External Penile Rigidity | 2 |
| EWL | Prosthesis, Laryngeal (Taub) | 1 |
| EXQ | Cystometer, Electrical Recording | 1 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 |
| FHA | Clamp, Penile | 1 |
| FTQ | Prosthesis, Penis, Rigid Rod | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 27, 1995 | K953640 | DUNA II PENILE PROSTHESIS Dacomed Corp. | FAE |
| Aug 25, 1994 | K941781 | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM Dacomed Corp. | LIL |
| May 11, 1992 | K920409 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE Dacomed Corp. | LKY |
| Apr 16, 1992 | K920420 | DURA II PENILE PROSTHESIS Dacomed Corp. | FAE |
| Oct 11, 1991 | K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS Dacomed Corp. | FAE |
| May 4, 1990 | K900774 | DACOMED NEGATIVE PRESSURE ERECTION DEVICE Dacomed Corp. | LKY |
| Feb 8, 1989 | K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE Dacomed Corp. | FHA |
| Apr 27, 1988 | K880391 | DACOMED CYSTOMETER Dacomed Corp. | EXQ |
| Sep 18, 1987 | K871653 | DURAPHASE PENILE PROSTHESIS Dacomed Corp. | FAE |
| Mar 17, 1987 | K870320 | DACOMED PENILE PROSTHESIS SIZER Dacomed Corp. | JLW |
| Mar 17, 1986 | K854118 | DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS Dacomed Corp. | EWL |
| Apr 9, 1985 | K850019 | OMNI PHASE PENILE PROSTHESIS Dacomed Corp. | FAE |
| Jan 18, 1985 | K843186 | ESKA MULTISTAGE ESOPHAGEAL BOUGIE Dacomed Corp. | FAT |
| Jul 6, 1984 | K841202 | DACOMED RIGISCAN SYSTEM Dacomed Corp. | LIL |
| Feb 4, 1984 | K834504 | ESKA JONAS SILICON-SILVER PENILE Dacomed Corp. | FAE |
| Oct 20, 1983 | K830667 | SILICONE-SILVER PENILE PROSTHESIS-ESK Dacomed Corp. | FTQ |
| Jul 18, 1983 | K832121 | DACOMED SNAP-GAUGE Dacomed Corp. | LIL |
| Apr 21, 1982 | K820615 | DACOMED SNAP-GAUGE Dacomed Corp. | LIL |
| Jan 25, 1982 | K820081 | ESKA JONAS SILICONE-SILVER PENILE PROST Dacomed Corp. | FAE |
| Jun 26, 1981 | K811693 | FORDER RETRACTOR Dacomed Corp. | KOA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||