Data / Medical devices / Stethoscope, Esophageal
Stethoscope, Esophageal (BZW): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Stethoscope, Esophageal (product code BZW, Class 1, 21 CFR 868.1910). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on January 29, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- BZW
- Device class
- 1
- Regulation
- 868.1910
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| India | 3 |
| United States | 2 |
| Pakistan | 2 |
| Mexico | 1 |
Makers of Stethoscope, Esophageal
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 |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | January 7, 1983 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 1 | January 7, 1983 | 0 | 0 | 0 | api.fda.gov |
| Comfort Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 29, 1988. 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.