Panels › General Hospital › Product code NZW · Class 2
Heparin, Vascular Access Flush
Regulation 880.5200
0510(k)s in 12 months (7 all time)
0recalls in 12 months (44 all time)
27recalls that name a 510(k)
Top companies in NZW
| Company | 510(k)s | Recalls |
|---|---|---|
| Vygon Corporation | 0 | 12 |
| Baxter Healthcare Corp. | 0 | 10 |
| Covidien LP | 0 | 9 |
| Medefil, Inc. | 1 | 7 |
| Excelsior Medical Corp. | 3 | 2 |
| App Pharmaceuticals, LLC | 1 | 2 |
| Becton, Dickinson & CO | 1 | 0 |
| Becton, Dickinson and Company | 1 | 0 |
| Fresenius Kabi USA, LLC | 0 | 1 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2017 | K163591 | BD PosiFlush Heparin Lock Flush Syringe Becton, Dickinson and Company | NZW |
| Nov 14, 2014 | K133446 | HEPARIN LOCK / FLUSH SYRINGES Excelsior Medical Corporation | NZW |
| Jun 18, 2010 | K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 App Pharmaceuticals, LLC | NZW |
| Feb 3, 2010 | K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES Medefil, Inc. | NZW |
| Jun 10, 2009 | K090680 | HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE Becton, Dickinson & CO | NZW |
| Feb 23, 2007 | K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML Excelsior Medical Corp. | NZW |
| May 13, 2003 | K023740 | SYREX PRE-FILLED SYRINGE Excelsior Medical Corp. | NZW |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.