Data / Medical devices / Instrument, Ultrasonic Surgical / United States
FDA-registered makers of Instrument, Ultrasonic Surgical in the United States: 46 establishments
46 establishments in the United States are registered with the FDA to make Instrument, Ultrasonic Surgical (product code LFL). 19 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.
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- Device
- Instrument, Ultrasonic Surgical
- Product code
- LFL
- Country
- United States
Makers of Instrument, Ultrasonic Surgical in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ethicon Endo-Surgery, LLC | Guaynabo, PR, United States | Specification developer | 15 | February 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, Inc. | Cincinnati, OH, United States | Specification developer | 13 | February 28, 2023 | 0 | 6 | 0 | api.fda.gov |
| Integra Neurosciences | Anasco, PR, United States | Manufacturer | 8 | July 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 7 | October 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Boulder, CO, United States | Manufacturer | 5 | November 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 5 | November 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Misonix, LLC | Farmingdale, NY, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 5 | May 30, 2019 | 0 | 1 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Manufacturer, Repackager or relabeler, Specification developer | 4 | March 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Integra Lifesciences Corporation | Cincinnati, OH, United States | Manufacturer | 3 | December 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Integra Pain Management | West Valley City, UT, United States | Manufacturer | 3 | December 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Tenex Health | Lake Forest, CA, United States | Contract manufacturer, Manufacturer | 3 | August 28, 2018 | 0 | 4 | 0 | api.fda.gov |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 2 | March 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Arobella Medical, LLC | Minnetonka, MN, United States | Manufacturer | 1 | January 3, 2007 | 0 | 1 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Manufacturer | 1 | August 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Microtek Medical LLC | Eagan, MN, United States | Specification developer | 1 | June 6, 2005 | 0 | 0 | 0 | api.fda.gov |
| Sonicmed Medical Technology Co., Ltd | Las Vegas, NV, United States | Manufacturer | 1 | October 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Manufacturer | 1 | April 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Trice Medical | Malvern, PA, United States | Complaint file establishment, Manufacturer | 1 | November 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| TendoNova Corporation | Atlanta, GA, United States | Manufacturer | 1 | March 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Benchmark Electronics, Inc. | Rochester, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioventus LLC | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. | Auburn Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linemaster Switch Corp. | Woodstock, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL REmmele | Big Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo Inc | Hillsboro, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo, Inc. | McMinnville, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Healthcare Baja Inc. (Albuquerque) | Albuquerque, NM, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Inc (Maple Grove) | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Corp. | Neenah, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PMC SMART Solutions, LLC | Shelbyville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.H. Cross Enterprises, Inc. | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Manufacturing Kalamazoo | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical, Inc. - Manchester | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spectrum Plastics Group | Saint Louis Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions | Tempe, AZ, United States | Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions - Chandler | Chandler, AZ, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions Lakeland | Lakeland, FL, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vesta | Franklin, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zevex, Inc. | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.