Company ยท SE
Amedic USA
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1997. Name variants (Inc, Corp, punctuation) are merged.
11510(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 30, 1997 | K955893 | EVERYTIME TRANSFUCER COVER Amedic AB, SE | ITX |
| Jan 4, 1990 | K897120 | EQUIP COVERS, STERILE Amedic USA, SE | KKX |
| Sep 5, 1989 | K892070 | GENERAL IVT NEEDLE GUIDE KIT, STERILE Amedic USA, SE | HGL |
| Aug 8, 1989 | K892071 | GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE Amedic USA, SE | KNW |
| Aug 8, 1989 | K892069 | EXTENDED COVERS, STERILE Amedic USA, SE | FFF |
| Aug 4, 1989 | K892068 | TRT (ACUSON) NEEDLE GUIDE KIT, STERILE Amedic USA, SE | FCG |
| Aug 21, 1987 | K871467 | BIOPSY NEEDLE GUIDE KIT, STERILE Amedic USA | FCG |
| Jul 15, 1987 | K871609 | ULTRASOUND TRANSDUCER SHEATHS, STERILE Amedic USA | ITX |
| Jul 15, 1987 | K871565 | ULTRASOUND TRANSDUCER GEL, STERILE Amedic USA | JOT |
| Jul 10, 1987 | K871503 | BIOPSY NEEDLE GUIDE KIT, STERILE Amedic USA | FZX |
| Mar 27, 1987 | K864219 | TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE Amedic USA | HGL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||