Panels › Gastroenterology, Urology › Product code EYN · Class 2
Tray, Irrigation, Sterile
Regulation 876.5980
0510(k)s in 12 months (15 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in EYN
| Company | 510(k)s | Recalls |
|---|---|---|
| American Healthcare Corp. | 4 | 0 |
| Orion Life Systems, Inc. | 2 | 0 |
| Bci, Inc. | 1 | 0 |
| Burron Medical Products, Inc. | 1 | 0 |
| Clinical Resources, Inc. | 1 | 0 |
| Customed, Inc | 0 | 1 |
| The Healthcare Group Laboratories, Inc. | 1 | 0 |
| Intermed, Inc. | 1 | 0 |
| Kit Pak, Inc. | 1 | 0 |
| M-C Ind., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) CYSTO PACK, Pack Number DYNJ42742D;
2) CYSTO PACK, Pack Number DYNJ42799 Open, Classified |
EYN | None listed |
| Aug 9, 2019 | Medline Industries Inc Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline Open, Classified |
EYN | None listed |
| Dec 16, 2014 | Customed, Inc Irrigation Tray With Bulb Syringe, Catalog number 900-020.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
EYN | None listed |
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