Iomed, Inc.
Salt Lake City, UT, US
Iomed, Inc. appears in FDA device records in Salt Lake City, UT. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Iomed, Inc. between 1990 and 2007. The busiest year on record is 1994, with 5. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 2 |
| 1994 | 5 |
| 1996 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2003 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K063465 | CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE | EGJ | Substantially Equivalent | |
| K060236 | MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE | EGJ | Substantially Equivalent | |
| K033192 | RH-950 | KTB | Substantially Equivalent | |
| K031115 | RH-900 | KTB | Substantially Equivalent | |
| K001522 | TRANSQ3 | KTB | Substantially Equivalent | |
| K001410 | PHORESOR MODEL PM2000 | KTB | Substantially Equivalent | |
| K982668 | PHORESOR II,MODEL PM900 | EGJ | Substantially Equivalent | |
| K974855 | PHORESOR II, MODEL PM900 | KTB | Substantially Equivalent for Some Indications | |
| K954126 | TRANSQ ELECTRODE PHORESOR II | KTB | Substantially Equivalent for Some Indications | |
| K934335 | PHORESOR II AUTO, MODEL PM800 MODIFICATION | EGJ | Substantially Equivalent | |
| K932621 | RH-801/GS MODEL TRANSQ(R)1 | EGJ | Substantially Equivalent | |
| K932620 | RH-806/GS MODEL TRANSQ(R)2 | EGJ | Substantially Equivalent | |
| K925806 | RH-801, MODEL TRANSQ | EGJ | Substantially Equivalent | |
| K925800 | RH-806, MODEL TRANSQ | EGJ | Substantially Equivalent | |
| K914621 | IONTOPHORESIS DEVICE, MODIFICATION | EGJ | Unknown | |
| K914264 | TRANSQ 2 | EGJ | Unknown | |
| K896444 | IONTOPHORESIS DEVICE - ELECTRODE RH 800 | EGJ | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain