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) |
|---|---|---|---|
| Apr 14, 2011 | Hsmg, Inc. D/b/a Smartinfuser Usa SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S. Terminated |
MEB | K072053 |
| Mar 8, 2010 | Hsmg, Inc. D/b/a Smartinfuser Usa SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634. Terminated |
MEB | K072053 |
| Mar 8, 2010 | Hsmg, Inc. D/b/a Smartinfuser Usa SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234. Terminated |
MEB | K061409 |
| Sep 14, 2009 | I-Flow Corporation I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico.
The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusi Terminated |
MEB | K052117 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr with 2.5 in. antimicrobial silver ExFen catheter, sterile, REF 8531-200-025. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0535-626-050. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0535-626-025. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 10.0 in. catheter, sterile, REF 0535-626-010. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, sterile, REF 0535-626-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, sterile, REF 0535-600-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0535-500-050. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 1 x 10.0 in. catheter, sterile, REF 0535-500-010. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, sterile, REF 0535-500-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0535-426-050. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0535-426-025. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 10.0 in. catheter, sterile, REF 0535-426-010. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0535-426-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0535-400-250. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheters, sterile, REF 0535-400-225. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, sterile, REF 0535-400-210. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF 0535-400-200. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 550 mL AutoFuser PainPump, single site continuous, 10 mL/hr, sterile, REF 0535-100-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0532-526-050. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0532-526-025. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0532-526-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-500-050. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-500-025. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, standard catheter, sterile, REF 0532-500-001. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, sterile, REF 0532-500-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0532-400-250. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheter, sterile, REF 0532-400-225. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10 in. catheters, sterile, REF 0532-400-210. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF 0532-400-200. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0532-226-050. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0532-226-025. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0532-226-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-200-050. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-200-025. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr,standard catheter, sterile, REF 0532-200-001. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, sterile, REF 0532-200-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, 1 x 5.0 in. catheter, sterile, REF 0531-216-050. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0531-216-025. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, standard catheter, sterile, ; REF 0531-216-001. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, sterile, REF 0531-216-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, 2 x 2.5 in. catheters, sterile, REF 0531-200-250. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, sterile, REF 0531-200-200. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5" catheter, sterile, REF 0531-200-025. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, 1 x 2.5" standard catheter, sterile, Manufactured for Stryker Instruments, Kalamazoo, MI; REF 0531-200-001. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, sterile, REF 0531-200-000. Terminated |
MEB | K041585 K060258 |
| Sep 4, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 100 mL AutoFuser PainPump, single site continuous, 1.0 mL/hr, 1 x 2.5" ExFen catheter, sterile, REF 0531-100-025. Infusion pump for pain medication. Terminated |
MEB | K041585 K060258 |
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