Panels › Gastroenterology, Urology › Product code EXE · Class 1
Protector, Ostomy
Regulation 876.5900
0510(k)s in 12 months (3 all time)
0recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in EXE
| Company | 510(k)s | Recalls |
|---|---|---|
| ConvaTec, Inc | 0 | 3 |
| Beckman Coulter Inc | 0 | 2 |
| Convatec, A Division of E.R. Squibb & Sons | 1 | 0 |
| Howmedica Corp. | 1 | 0 |
| Rudolfo T. Sanchez | 1 | 0 |
| T.G. Eakin Limited | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | ConvaTec, Inc Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10) Open, Classified |
EXE | None listed |
| Sep 25, 2024 | T.G. Eakin Limited eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal Open, Classified |
EXE | None listed |
| Apr 22, 2022 | ConvaTec, Inc SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers. Terminated |
EXE | None listed |
| Sep 6, 2019 | ConvaTec, Inc Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands:
1) Combihesive Natura Durahesive
2) SurFit Natura Durahesive
3) Natura
4) Varicare
Product Usage: stoma management Terminated |
EXE | None listed |
| Jul 23, 2004 | Beckman Coulter Inc Immage Antidioxyribonuclease B (DNB) reagent
part no. 447480 Terminated |
EXE | None listed |
| Jul 20, 2004 | Beckman Coulter Inc Synchron LX Clinical Systems, Operating Software, All versions. Terminated |
EXE | K011213 K014034 +2 |
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