Data / Medical devices / Lithotriptor, Electro-Hydraulic / United States
FDA-registered makers of Lithotriptor, Electro-Hydraulic in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Lithotriptor, Electro-Hydraulic (product code FFK). 9 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Lithotriptor, Electro-Hydraulic
- Product code
- FFK
- Country
- United States
Makers of Lithotriptor, Electro-Hydraulic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Electro Medical Systems, L.L.C. | Southlake, TX, United States | Remanufacturer, Repackager or relabeler | 6 | May 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Northgate Technologies Inc. | Elgin, IL, United States | Complaint file establishment, Manufacturer | 3 | June 14, 2021 | 0 | 4 | 0 | api.fda.gov |
| Ultratellege USA Co. LTD. | Erie, PA, United States | Manufacturer | 3 | August 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 2 | August 24, 2001 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer, Repackager or relabeler | 2 | August 24, 2001 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 2 | August 24, 2001 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer, Repackager or relabeler | 1 | August 24, 2001 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | May 9, 2007 | 0 | 1 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | May 9, 2007 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nissha Medical Technologies (Ohio), Inc. | Norwalk, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | 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.