Data / Medical devices / Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (NKE): 17 FDA-registered makers in 8 countries
17 establishments in 8 countries are registered with the FDA to make Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (product code NKE, Class 3). 6 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 12 recall events (4 Class I). FDA data exported November 2, 2026.
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- Product code
- NKE
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Malaysia | 1 |
| Germany | 1 |
| Ireland | 1 |
| China | 1 |
| Singapore | 1 |
| Switzerland | 1 |
| Taiwan | 1 |
Makers of Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Medical | Sylmar, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Abbott Medical | Penang Pulau Pinang, Malaysia | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Arecibo, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Biotronik Se & Co. KG | Berlin, Germany | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 1 | 7 | 4 | api.fda.gov | |
| Boston Scientific Limited | CLONMEL Tipperary, Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotronik Apm Ii Pte. Ltd | Singapore South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Villalba | Villalba, PR, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Vascular | Danvers, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 4 | 0 | api.fda.gov | |
| Medtronic Europe Sarl | TOLOCHENAZ Vaud, Switzerland | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, 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 | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | 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.