Data / Medical devices / Pump, Infusion, Implanted, Programmable
Pump, Infusion, Implanted, Programmable (LKK): 15 FDA-registered makers in 2 countries
15 establishments in 2 countries are registered with the FDA to make Pump, Infusion, Implanted, Programmable (product code LKK, Class 3). 5 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 55 recall events (9 Class I). FDA data exported November 2, 2026.
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- Product code
- LKK
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 14 |
| Malaysia | 1 |
Makers of Pump, Infusion, Implanted, Programmable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Neuromodulation | Minneapolis, MN, United States | Manufacturer | 0 | 2 | 42 | 6 | api.fda.gov | |
| Intera Oncology | Newton, MA, United States | Specification developer | 0 | 1 | 1 | 1 | api.fda.gov | |
| Infusyn Therapeutics | Hackettstown, NJ, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtec Medical | Enfield, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medron, LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Minimed | Northridge, CA, United States | Manufacturer for export | 0 | 0 | 1 | 0 | api.fda.gov | |
| NextPhase Medical Devices, LLC | Mansfield, MA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Manufacturing Sdn. Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Technologies, Inc. | St. Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services For Electronics, Inc. | Jackson, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.