Data / Medical devices / Programmer, Pacemaker

Programmer, Pacemaker (KRG): 15 FDA-registered makers in 8 countries

Name: FDA-registered makers of Programmer, Pacemaker
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

15 establishments in 8 countries are registered with the FDA to make Programmer, Pacemaker (product code KRG, Class 3, 21 CFR 870.3700). 1 of them has a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on March 15, 1995, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: KRG
Device class: 3
Regulation: 870.3700
Medical specialty: Cardiovascular

Makers by country

Country	Makers
United States	8
Malaysia	1
Singapore	1
Germany	1
Ireland	1
Switzerland	1
Mexico	1
Taiwan	1

Makers of Programmer, Pacemaker

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	Recall events	Source
Medtronic, Inc.	Mounds View, MN, United States	Manufacturer, Repackager or relabeler, Specification developer	1	November 17, 1988	1	api.fda.gov
Abbott Medical	Sylmar, CA, United States	Manufacturer	0		1	api.fda.gov
Abbott Medical	Penang Pulau Pinang, Malaysia	Manufacturer	0		0	api.fda.gov
Abbott Medical	Arecibo, PR, United States	Manufacturer	0		0	api.fda.gov
Biotronik Apm Ii Pte. Ltd	Singapore South East, Singapore	Contract manufacturer	0		0	api.fda.gov
Biotronik Se & Co. KG	Berlin, Germany	Manufacturer	0		0	api.fda.gov
Boston Scientific Corporation	Saint Paul, MN, United States	Complaint file establishment, Manufacturer, Specification developer	0		5	api.fda.gov
Boston Scientific Limited	CLONMEL Tipperary, Ireland	Manufacturer	0		0	api.fda.gov
Medtronic Puerto Rico Operations Co., Villalba	Villalba, PR, United States	Manufacturer	0		0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Medtronic Europe Sarl	TOLOCHENAZ Vaud, Switzerland	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Pro-Tech Design & MFG., Inc.	Santa Fe Springs, CA, United States	Contract manufacturer	0		0	api.fda.gov
Plexus Electronica S. de R.L. de C.V..	Zapopan Jalisco, Mexico	Contract manufacturer	0		0	api.fda.gov
Technical Services For Electronics, Inc.	Jackson, MN, United States	Contract manufacturer	0		0	api.fda.gov
Technical Services for Electronics, Inc.	New Taipei City, Taiwan	Contract manufacturer	0		0	api.fda.gov

Updated March 15, 1995. 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.