Product code LKK ยท Class 3
Pump, Infusion, Implanted, Programmable
0510(k)s in 12 months (0 all time)
2recalls in 12 months (132 all time)
1recalls that name a 510(k)
Top companies in LKK
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Neuromodulation | 0 | 96 |
| Codman & Shurtleff, Inc. | 0 | 13 |
| Flowonix Medical Inc | 0 | 13 |
| Medtronic Inc, Neurological & Spinal Division | 0 | 3 |
| Medtronic Inc. | 0 | 2 |
| Medtronic Neurological | 0 | 2 |
| Boston Scientific Corporation | 0 | 1 |
| Intera Oncology, Inc. | 0 | 1 |
| Smiths Medical ASD Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic SynchroMed II Programmable Pump, model 8637-40. The contents of the inner package have been sterilized by ethylene oxide gas. 40 mL reservoir. Medtronic, Inc., 710 Medtronic Parkway NE, Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic SynchroMed II Programmable Pump, model 8637-20. The contents of the inner package have been sterilized by ethylene oxide gas. 20 mL reservoir. Medtronic, Inc., 710 Medtronic Parkway NE, Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve, screened side cathet Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve, screened side cathet Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve and screened side cath Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve and screened side cath Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve and suture loops. Me Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve and suture loops. Me Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Implantable Infusion Pump, model 8626-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve. Medtronic, Inc., 710 Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve. Medtronic, Terminated |
LKK | None listed |
| Feb 9, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pumps, Model 8627L-18, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part o Terminated |
LKK | None listed |
| Feb 9, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pumps, Model 8627-18, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part o Terminated |
LKK | None listed |
| Feb 9, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pumps, Model 8627L-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part Terminated |
LKK | None listed |
| Feb 9, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pumps, Model 8627-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of Terminated |
LKK | None listed |
| Feb 9, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pumps, Model 8626L-18, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part Terminated |
LKK | None listed |
| Feb 9, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pumps, Model 8626-18, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part o Terminated |
LKK | None listed |
| Feb 9, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pumps, Model 8626L-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part Terminated |
LKK | None listed |
| Feb 9, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pumps, Models 8626-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part Terminated |
LKK | None listed |
| Feb 2, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is par Terminated |
LKK | None listed |
| Feb 2, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8627-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is par Terminated |
LKK | None listed |
| Feb 2, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part Terminated |
LKK | None listed |
| Feb 2, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8627-10. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part Terminated |
LKK | None listed |
| Feb 2, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is pa Terminated |
LKK | None listed |
| Feb 2, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8626-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is part Terminated |
LKK | None listed |
| Feb 2, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(The implantable Medtronic SynchroMed EL Programmable Pump is par Terminated |
LKK | None listed |
| Feb 2, 2008 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8626-10. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.-- (The implantable Medtronic SynchroMed EL Programmable Pump is par Terminated |
LKK | None listed |
| Oct 20, 2006 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designe Terminated |
LKK | None listed |
| Sep 9, 2006 | Medtronic Neurological Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal section of the 8731 Intrathecal Catheter) . Medtronic, Inc., 710 Medtronic Parkway, Minneapo Terminated |
LKK | None listed |
| Sep 9, 2006 | Medtronic Neurological Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pumps) The catheter is designed for use in the intrathecal space. Medtronic, Inc., 710 Medtronic Pa Terminated |
LKK | None listed |
| Jan 13, 2005 | Medtronic Inc, Neurological & Spinal Division Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injec Terminated |
LKK | None listed |
| Sep 23, 2004 | Medtronic Inc, Neurological & Spinal Division 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer. Terminated |
LKK | None listed |
| Aug 24, 2004 | Medtronic Inc, Neurological & Spinal Division The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pum Terminated |
LKK | None listed |
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