Panels › General Hospital › Product code FRN · Class 2
Pump, Infusion
Regulation 880.5725
2510(k)s in 12 months (849 all time)
24recalls in 12 months (724 all time)
672recalls that name a 510(k)
Top companies in FRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 51 | 128 |
| Hospira, Inc. | 12 | 129 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 78 |
| Abbott Laboratories | 67 | 4 |
| Carefusion 303, Inc. | 4 | 61 |
| Icu Medical, Inc. | 4 | 43 |
| Smiths Medical Asd, Inc. | 1 | 42 |
| B.Braun Medical, Inc. | 11 | 22 |
| Y | 26 | 0 |
| Zevex International, Inc. | 0 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 10.0 in. antimicrobial silver ExFen catheter kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-010-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 5.0 in. antimicrobial silver ExFen catheter kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-005-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, 2.5 in. antimicrobial silver ExFen catheter kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-002-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, standard antimicrobial silver catheter kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0555-001-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL pre-set PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 541-155. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 540-155. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2-site catheter set, sterile, Stryker Instruments, Kalamazoo, MI; REF 540-50. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile, Stryker Instruments, Kalamazoo, MI; REF 540-25. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker dual 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-225-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker dual 10.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-210-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-205-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-025-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 10.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-010-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-005-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker standard catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-001-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 ExFen 5, 5" catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-501. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 ExFen 5, 5" extended fenestration catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-500. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 ExFen 2.5, 2.5" catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-251. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 ExFen 2.5, 2.5" extended fenestration catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-250. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 2-site tube set with 5.0" ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-50. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 2-site tube set with 2.5" ExFens, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-25. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 2-site tube set with standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-2. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen catheter and luer lock tubing set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-156, REF 525-157 and REF 525-158. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-155. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with luer lock tubing set, 2.5 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-125. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-site catheter set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-50. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-25. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-10. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL pre-set PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 521-155. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump2, 250 mL pre-set PainPump with luer lock tubing set, 2.5 inch ExFen and standard catheter, sterile, Stryker Instruments, Kalamazoo, MI; REF 521-125. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL two site infusion kit with ExFen 5.0", sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-416-050. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL two site infusion kit with ExFen 2.5", sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-416-025. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL infusion kit (2.08 cc/hr) with ExFen 5.0", sterile, Stryker Instruments, Kalamazoo, MI; REF 501-140-50. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL infusion kit (4.16 mL/hr) with ExFen 2.5", sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-140-025. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL infusion kit (4.16 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-140-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-120-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 270 mL base infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 0501-100-000. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-250. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-200. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, two site infusion kit with ExFen 5.0", 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-166-50. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, two site infusion kit with ExFen 2.5", 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-166-25. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 1-day infusion kit, 120 mL infusion kit (4.16 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-140. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 2-day infusion kit with ExFen 5.0", 120 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-120-50. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 2-day infusion kit with ExFen 2.5", 120 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-120-25. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 2-day infusion kit, 120 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-120. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump, 5-day infusion kit, 120 mL infusion kit (0.83 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-110. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump base kit, 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-100. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker ExFen 5.0" extended fenestration catheter set for PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-50. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker ExFen 2.5" extended fenestration catheter set for PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-25. Terminated |
FRN | K042405 K043466 |
| Aug 19, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker PainPump catheter and split introducer needle, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-23. Terminated |
FRN | K042405 K043466 |
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