Data / Medical devices / Transducer, Ultrasonic
Transducer, Ultrasonic (JOP): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Transducer, Ultrasonic (product code JOP, Class 2, 21 CFR 870.2880). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 72 510(k) clearances under this code, the latest on December 18, 2024, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JOP
- Device class
- 2
- Regulation
- 870.2880
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Netherlands | 2 |
| Japan | 1 |
| Israel | 1 |
| United Kingdom | 1 |
Makers of Transducer, Ultrasonic
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 |
|---|---|---|---|---|---|---|---|---|
| Hadeco, Inc. | KAWASAKI Kanagawa, Japan | Manufacturer | 5 | May 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Viasonix Ltd. | RAANANA Central, Israel | Manufacturer | 2 | December 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Corvascular | Minnetonka, MN, United States | Manufacturer | 1 | July 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Skidmore Medical Limited | Bristol Bristol, City of, United Kingdom | Exporter to the US, Manufacturer | 1 | December 20, 2007 | 0 | 0 | 0 | api.fda.gov |
| US Vascular | Beaverton, OR, United States | Manufacturer | 1 | September 27, 2013 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Ellettsville, IN, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Medical B.V. | Zutphen Gelderland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Medical B.V. Varsseveld | VARSSEVELD Gelderland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Neurology Incorporated | Middleton, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parks Medical Electronics, Inc. | Aloha, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 18, 2024. 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.