Data / Medical devices / Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) (DRO): 11 FDA-registered makers in 7 countries
11 establishments in 7 countries are registered with the FDA to make Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) (product code DRO, Class 2, 21 CFR 870.5550). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 84 510(k) clearances under this code, the latest on October 12, 2001, and lists 6 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- DRO
- Device class
- 2
- Regulation
- 870.5550
- Medical specialty
- Cardiovascular
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Mexico | 1 |
| Canada | 1 |
| Netherlands | 1 |
| China | 1 |
| United Kingdom | 1 |
| Switzerland | 1 |
Makers of Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
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 |
|---|---|---|---|---|---|---|---|---|
| Cardinal Health | Chicopee, MA, United States | Manufacturer | 1 | October 12, 2001 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | October 12, 2001 | 0 | 0 | 0 | api.fda.gov |
| Amphenol Alden Products Company | Hermosillo Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cadex Electronics, Inc. | RICHMOND British Columbia, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CD Leycom | Hengelo Overijssel, Netherlands | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emi (dongguan) Asia Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Physio-Control, Inc. | Redmond, WA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remote Diagnostic Technologies Ltd. | FARNBOROUGH Hampshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schiller AG | BAAR Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zoll Medical Corporation | Chelmsford, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 12, 2001. 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.