Company ยท US
Universal Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2008. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 8 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2008 | K083535 | HEARTRAK SMART ECAT Universal Medical, Inc. | DXH |
| May 14, 2008 | K071130 | HEARTRAK AF Universal Medical, Inc. | DXH |
| Feb 5, 2004 | K033451 | HEARTRAK SMART AT/HEARTRAK SMART2 Universal Medical, Inc. | DXH |
| May 11, 1998 | K980624 | CARDIOSTATION Universal Medical, Inc. | DXH |
| Aug 6, 1996 | K960499 | HEARTRAK XL Universal Medical, Inc. | DXH |
| Apr 22, 1996 | K954495 | PACETRAK PLUS Universal Medical, Inc. | DXH |
| May 3, 1995 | K943124 | HEARTRAK Universal Medical, Inc. | DXH |
| May 3, 1995 | K943123 | PACETRAK Universal Medical, Inc. | DXH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||