Panels › General Hospital › Product code MEB · Class 2
Pump, Infusion, Elastomeric
Regulation 880.5725
1510(k)s in 12 months (88 all time)
0recalls in 12 months (109 all time)
94recalls that name a 510(k)
Top companies in MEB
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Instruments Div. of Stryker Corporation | 0 | 46 |
| I-Flow Corp. | 17 | 11 |
| Baxter Healthcare Corp | 8 | 10 |
| Arrow International Inc | 0 | 17 |
| Symbios Medical Products, LLC | 3 | 12 |
| Novacon Corp. | 6 | 0 |
| Advanced Infusion, Inc. | 5 | 0 |
| Breg, Inc. | 5 | 0 |
| Hsmg, Inc. D/b/a Smartinfuser Usa | 0 | 4 |
| B.Braun Medical, Inc. | 1 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2008 | I-Flow Corporation On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around Terminated |
MEB | K063530 |
| Sep 11, 2008 | I-Flow Corporation ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) Terminated |
MEB | K063530 |
| Jan 23, 2008 | Baxter Healthcare Corp. Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
MEB | K062457 |
| Jan 18, 2007 | I-Flow Corporation I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742 Terminated |
MEB | K932740 |
| Mar 7, 2006 | I-Flow Corporation Easypump L T 60-24 infusion pump Terminated |
MEB | K052117 K932740 |
| Mar 7, 2006 | I-Flow Corporation Easypump ST 100-1 infusion pump Terminated |
MEB | K052117 K932740 |
| Jan 9, 2004 | I-Flow Corporation Easypump LT 100-200
Elastomeric Infusion Pump (100 ml x 0.5 ml/hr)
Part number: 5001120 Terminated |
MEB | None listed |
| Jan 9, 2004 | I-Flow Corporation Eclipse Infusion Pump, 250 ml X 250 ml per hour)
Part 5001247 Terminated |
MEB | K020862 |
| Mar 27, 2003 | I-Flow Corporation Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr)
Model E100500
Part No. 5001065 Terminated |
MEB | K932740 |
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