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) |
|---|---|---|---|
| Jun 25, 2026 | Boston Scientific Corporation Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device Completed |
LKK | None listed |
| May 14, 2026 | Medtronic Neuromodulation Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices:
1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A;
2. PROG CT900B C Open, Classified |
LKK | None listed |
| Apr 1, 2025 | Medtronic Neuromodulation A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System. Open, Classified |
LKK | None listed |
| Dec 27, 2024 | Medtronic Neuromodulation SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, C Open, Classified |
LKK | None listed |
| Dec 27, 2024 | Medtronic Neuromodulation SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D Open, Classified |
LKK | None listed |
| Dec 27, 2024 | Medtronic Neuromodulation SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C Open, Classified |
LKK | None listed |
| Dec 27, 2024 | Medtronic Neuromodulation SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B Open, Classified |
LKK | None listed |
| Oct 21, 2024 | Medtronic Neuromodulation SynchroMed II Infusion Pump. Product Number: 8637-20 Open, Classified |
LKK | None listed |
| Jul 12, 2024 | Medtronic Neuromodulation Medtronic Ascenda Intrathecal Catheter, Models:
a) 8780 (114 cm);
b) 8781 (140 cm);
c) 8784 (catheter pump revision kit) Open, Classified |
LKK | None listed |
| Dec 22, 2023 | Medtronic Neuromodulation Medtronic SynchroMed II, Model 8637-40, Programmable pump Open, Classified |
LKK | None listed |
| Dec 22, 2023 | Medtronic Neuromodulation Medtronic SynchroMed II, Model 8637-20, Programmable pump Open, Classified |
LKK | None listed |
| Dec 9, 2023 | Medtronic Inc. Medtronic SynchroMed, Model A10 Completed |
LKK | None listed |
| Aug 22, 2022 | Intera Oncology, Inc. INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump. Terminated |
LKK | None listed |
| May 26, 2021 | Flowonix Medical Inc Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following:
Prometra Programmable Infusion Pump System:
MODEL/CATALOG #(s):
Catalog No. US Model Terminated |
LKK | None listed |
| Jun 3, 2020 | Medtronic Inc. Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001 Terminated |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific) Open, Classified |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific) Open, Classified |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082 Open, Classified |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242 Open, Classified |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228 Open, Classified |
LKK | None listed |
| Feb 10, 2020 | Flowonix Medical Inc Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082 Open, Classified |
LKK | None listed |
| Dec 3, 2019 | Medtronic Neuromodulation Synchromed II programmable pump, Model numbers 8637-20 and 8637-40 Terminated |
LKK | None listed |
| Mar 21, 2019 | Flowonix Medical Inc Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion. Terminated |
LKK | None listed |
| Mar 21, 2019 | Flowonix Medical Inc Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion. Terminated |
LKK | None listed |
| Mar 21, 2019 | Flowonix Medical Inc Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. Terminated |
LKK | None listed |
| Mar 21, 2019 | Flowonix Medical Inc Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. Terminated |
LKK | None listed |
| Mar 21, 2019 | Flowonix Medical Inc Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. Terminated |
LKK | None listed |
| Oct 15, 2018 | Smiths Medical ASD Inc. Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS).
Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1, v1.1.2;
MEDFUSION 400 Terminated |
LKK | K111386 |
| Feb 6, 2018 | Medtronic Neuromodulation Medtronic Ascenda(R) Intrathecal Catheter, Models:
(a) 8780, UDI: 00643169202122, 00643169783027
(b) 8781, UDI: 00643169202139
(c) 8784, UDI: 00643169202153
The Ascenda Intrathecal Catheter kits ( Terminated |
LKK | None listed |
| Aug 9, 2017 | Medtronic Neuromodulation Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter.
Product Usage:
The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system th Open, Classified |
LKK | None listed |
| Jun 19, 2017 | Flowonix Medical, Inc. PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling Terminated |
LKK | None listed |
| Feb 9, 2017 | Medtronic Neuromodulation SynchroMed II implantable drug infusion pump, Model 8637-40, Terminated |
LKK | None listed |
| Dec 19, 2016 | Medtronic Neuromodulation Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implanta Terminated |
LKK | None listed |
| Mar 29, 2016 | Medtronic Neuromodulation Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide. Terminated |
LKK | None listed |
| May 28, 2015 | Medtronic Neuromodulation Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile.
Product Usage:
The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that Terminated |
LKK | None listed |
| May 28, 2015 | Codman & Shurtleff, Inc. CODMAN 3000 Series Refill Set- Huber needles.
Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump
CATALOG NO. : AP-07014
Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gaug Terminated |
LKK | None listed |
| Aug 8, 2014 | Medtronic Neuromodulation Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784.
The Ascenda Intrathecal Catheter is part of an infusion system t Terminated |
LKK | None listed |
| Jun 4, 2014 | Medtronic Neuromodulation Medtronic Model 8780 Ascenda Intrathecal Catheter.
The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the int Terminated |
LKK | None listed |
| May 9, 2014 | Codman & Shurtleff, Inc. MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201
The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delive Terminated |
LKK | None listed |
| May 9, 2014 | Codman & Shurtleff, Inc. MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200
The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delive Terminated |
LKK | None listed |
| May 8, 2014 | Medtronic Neuromodulation Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps.
Product Usage: The Refill Kits are intended for use in refilling Medtronic Terminated |
LKK | None listed |
| May 8, 2014 | Medtronic Neuromodulation Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40.
The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a pr Terminated |
LKK | None listed |
| Sep 30, 2013 | Codman & Shurtleff, Inc. MedStream Programmable Pump; 20ml Pump EMEA 91-4200
Product Usage:
The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delive Terminated |
LKK | None listed |
| Sep 30, 2013 | Codman & Shurtleff, Inc. MedStream Programmable Pump; 40ml Pump EMEA 91-4201
Product Usage:
The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delive Terminated |
LKK | None listed |
| Sep 30, 2013 | Codman & Shurtleff, Inc. MedStream Refill Kit, U.S (6 units): 91-4288
Product Usage:
The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of M Terminated |
LKK | None listed |
| Sep 30, 2013 | Codman & Shurtleff, Inc. MedStream Refill Kit (6 units), EMEA: 91-4290
Product Usage:
The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Terminated |
LKK | None listed |
| Sep 30, 2013 | Codman & Shurtleff, Inc. MedStream Refill Kit (1 unit), EMEA: 91-4289
Product Usage:
The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of M Terminated |
LKK | None listed |
| Sep 30, 2013 | Codman & Shurtleff, Inc. MedStream Refill Kit, U.S: 91-4287
Product Usage:
The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Terminated |
LKK | None listed |
| Sep 30, 2013 | Codman & Shurtleff, Inc. MedStream Programmable Pump; 40ml - 91-4201US
Usage:
The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine Terminated |
LKK | None listed |
| Sep 30, 2013 | Codman & Shurtleff, Inc. MedStream Programmable Pump; 20ml - 91-4200US
Product Usage:
The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Terminated |
LKK | None listed |
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