ClearanceBrief
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)
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Top companies in LKK

DateFirm and productCodeLinked 510(k)
Jun 25, 2026Boston Scientific Corporation
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Completed
LKKNone listed
May 14, 2026Medtronic 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
LKKNone listed
Apr 1, 2025Medtronic Neuromodulation
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Open, Classified
LKKNone listed
Dec 27, 2024Medtronic 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
LKKNone listed
Dec 27, 2024Medtronic 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
LKKNone listed
Dec 27, 2024Medtronic 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
LKKNone listed
Dec 27, 2024Medtronic 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
LKKNone listed
Oct 21, 2024Medtronic Neuromodulation
SynchroMed II Infusion Pump. Product Number: 8637-20
Open, Classified
LKKNone listed
Jul 12, 2024Medtronic Neuromodulation
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Open, Classified
LKKNone listed
Dec 22, 2023Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637-40, Programmable pump
Open, Classified
LKKNone listed
Dec 22, 2023Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Open, Classified
LKKNone listed
Dec 9, 2023Medtronic Inc.
Medtronic SynchroMed, Model A10
Completed
LKKNone listed
Aug 22, 2022Intera Oncology, Inc.
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Terminated
LKKNone listed
May 26, 2021Flowonix 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
LKKNone listed
Jun 3, 2020Medtronic Inc.
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Terminated
LKKNone listed
Feb 10, 2020Flowonix 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
LKKNone listed
Feb 10, 2020Flowonix 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
LKKNone listed
Feb 10, 2020Flowonix Medical Inc
US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
Open, Classified
LKKNone listed
Feb 10, 2020Flowonix Medical Inc
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Open, Classified
LKKNone listed
Feb 10, 2020Flowonix Medical Inc
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
Open, Classified
LKKNone listed
Feb 10, 2020Flowonix Medical Inc
Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
Open, Classified
LKKNone listed
Dec 3, 2019Medtronic Neuromodulation
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Terminated
LKKNone listed
Mar 21, 2019Flowonix Medical Inc
Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
Terminated
LKKNone listed
Mar 21, 2019Flowonix Medical Inc
Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
Terminated
LKKNone listed
Mar 21, 2019Flowonix Medical Inc
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Terminated
LKKNone listed
Mar 21, 2019Flowonix 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
LKKNone listed
Mar 21, 2019Flowonix 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
LKKNone listed
Oct 15, 2018Smiths 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
LKKK111386
Feb 6, 2018Medtronic 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
LKKNone listed
Aug 9, 2017Medtronic 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
LKKNone listed
Jun 19, 2017Flowonix 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
LKKNone listed
Feb 9, 2017Medtronic Neuromodulation
SynchroMed II implantable drug infusion pump, Model 8637-40,
Terminated
LKKNone listed
Dec 19, 2016Medtronic 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
LKKNone listed
Mar 29, 2016Medtronic Neuromodulation
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Terminated
LKKNone listed
May 28, 2015Medtronic 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
LKKNone listed
May 28, 2015Codman & 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
LKKNone listed
Aug 8, 2014Medtronic 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
LKKNone listed
Jun 4, 2014Medtronic 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
LKKNone listed
May 9, 2014Codman & 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
LKKNone listed
May 9, 2014Codman & 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
LKKNone listed
May 8, 2014Medtronic 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
LKKNone listed
May 8, 2014Medtronic 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
LKKNone listed
Sep 30, 2013Codman & 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
LKKNone listed
Sep 30, 2013Codman & 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
LKKNone listed
Sep 30, 2013Codman & 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
LKKNone listed
Sep 30, 2013Codman & 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
LKKNone listed
Sep 30, 2013Codman & 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
LKKNone listed
Sep 30, 2013Codman & 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
LKKNone listed
Sep 30, 2013Codman & 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
LKKNone listed
Sep 30, 2013Codman & 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
LKKNone listed

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