Company ยท US
Opus Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2004. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2004 | K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER Opus Medical, Inc. | HWC |
| Nov 12, 2004 | K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE Opus Medical, Inc. | MBI |
| Oct 19, 2004 | K042031 | OPUS SPEEDSTITCH SUTURE DEVICE Opus Medical, Inc. | GAT |
| Jun 25, 2004 | K041440 | OPUS MAGNUM ANCHOR WITH INSERTER Opus Medical, Inc. | MBI |
| Dec 30, 2003 | K033317 | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 Opus Medical, Inc. | OCW |
| Jul 28, 2003 | K030170 | REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 Opus Medical, Inc. | OCW |
| Jun 12, 2003 | K031083 | OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 Opus Medical, Inc. | HTY |
| Apr 23, 2003 | K030235 | F1 DIODE LASER SYSTEM Opus Medical, Inc. | GEX |
| Feb 14, 2003 | K023843 | SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE Opus Medical, Inc. | OCW |
| Sep 6, 2002 | K022229 | SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 Opus Medical, Inc. | OCW |
| Jul 22, 2002 | K020172 | OPUS MAGNUM ANCHOR & INSTRUMENT SET Opus Medical, Inc. | MBI |
| Sep 17, 2001 | K012125 | OPUS MAGNUM ANCHOR & INSERTER Opus Medical, Inc. | HTY |
| Mar 27, 2001 | K004021 | F1 DIODE LASER SYSTEM Opus Medical, Inc. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||