Panels › General Hospital › Product code NGT · Class 2
Saline, Vascular Access Flush
Regulation 880.5200
1510(k)s in 12 months (40 all time)
1recalls in 12 months (61 all time)
56recalls that name a 510(k)
Top companies in NGT
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien LLC | 0 | 28 |
| Becton Dickinson | 2 | 5 |
| Excelsior Medical Corp. | 3 | 3 |
| Becton, Dickinson and Company | 5 | 0 |
| Nurse Assist, Inc. | 2 | 3 |
| Am USA | 4 | 0 |
| Medefil, Inc. | 4 | 0 |
| Medline Industries, Inc. | 2 | 2 |
| Medxl, Inc. | 4 | 0 |
| Cardinal Health | 0 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2010 | Covidien LP MONOJECT Prefill Heparin Lock Flush Syringe
100 Unit Heparin, 5 ml in 12 ml syringe
Item code 8881590125 Terminated |
NGT | K032438 |
| Dec 9, 2010 | Covidien LP MONOJECT Prefill Heparin Lock Flush Syringe
100 Unit Heparin, 3 ml in 12 ml syringe
Item code 8881590123 Terminated |
NGT | K032438 |
| Dec 9, 2010 | Covidien LP MONOJECT Prefill Heparin Lock Flush Syringe
100 Unit Heparin, 10 ml in 12 ml syringe
Item code 8881590121 Terminated |
NGT | K032438 |
| Dec 9, 2010 | Covidien LP MONOJECT Prefill Heparin Lock Flush Syringe
10 Unit Heparin, 5 ml in 12 ml syringe
Item code 8881580125 Terminated |
NGT | K032438 |
| Dec 9, 2010 | Covidien LP MONOJECT Prefill Heparin Lock Flush Syringe
10 Unit Heparin, 3 ml in 12 ml syringe
Item code 8881580123 Terminated |
NGT | K032438 |
| Dec 9, 2010 | Covidien LP MONOJECT Prefill Heparin Lock Flush Syringe
10 Unit Heparin, 10 ml in 12 ml syringe
Item code 8881580121 Terminated |
NGT | K032438 |
| Oct 20, 2010 | Excelsior Medical Corp Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride)
General hospital use Terminated |
NGT | K090882 K962938 |
| Feb 6, 2009 | Excelsior Medical Corp Sterile Field Saline Flush;
0.9% Sodium Chloride Injection, USP; Rx Only; Single Use.
Excelsior Medical, Neptune, NJ.
This product is used for the flushing of venous access devices and intravenous tu Terminated |
NGT | K053120 |
| Sep 20, 2007 | B. Braun Medical, Inc. Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton. Terminated |
NGT | K002142 |
| Sep 20, 2007 | B. Braun Medical, Inc. Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton Terminated |
NGT | K002142 |
| Oct 19, 2006 | Excelsior Medical Corp 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex. Terminated |
NGT | None listed |
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