Company · CH
Neo Medical SA
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2024. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2024 | K243693 | NEO Pedicle Screw System Neo Medical SA, CH | NKB |
| Aug 26, 2022 | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System Neo Medical SA, CH | PML |
| Oct 28, 2021 | K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System Neo Medical SA, CH | PML |
| Dec 13, 2019 | K191796 | Neo Cage System Neo Medical SA, CH | MAX |
| Jan 29, 2019 | K181048 | Neo Cage System TM Neo Medical SA, CH | MAX |
| Sep 12, 2017 | K171582 | NEO Pedicle Screw System Neo Medical SA, CH | NKB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2011 | Neo Medical, Inc. V-CATH Insertion Kits, Sterile; Product Code Number: 301-00;
Manufactured by Centurion Medical Products for Neo Medical;
42514 Albrae Street, Fremont, CA 94538 Terminated |
LRS | None listed |