Data / Medical devices / Instrument, Ultrasonic Surgical
Instrument, Ultrasonic Surgical (LFL): 72 FDA-registered makers in 10 countries
72 establishments in 10 countries are registered with the FDA to make Instrument, Ultrasonic Surgical (product code LFL, Class U). 30 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 160 510(k) clearances under this code, the latest on October 15, 2026, and lists 32 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 46 |
| Germany | 6 |
| Mexico | 5 |
| China | 4 |
| Ireland | 3 |
| Japan | 3 |
| Dominican Republic | 2 |
| United Kingdom | 1 |
| Canada | 1 |
| Poland | 1 |
Makers of Instrument, Ultrasonic Surgical
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 |
|---|---|---|---|---|---|---|---|---|
| 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 Lifesciences (ireland) Limited | SRAGH TULLAMORE Offaly, Ireland | Manufacturer, Specification developer | 8 | July 11, 2023 | 0 | 0 | 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 |
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | KUROISHI-SHI Aomori, Japan | Manufacturer, Repackager or relabeler | 6 | August 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 6 | August 4, 2021 | 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 |
| Stryker Ireland Ltd. Instruments Division, Innovation Centre | Carrigtwohill Cork(County), Ireland | Specification developer | 4 | October 8, 2026 | 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 |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 3 | August 4, 2021 | 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 |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 1 | December 9, 2003 | 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 |
| Hunan Handlike Minimally Invasive Surgery Co., Ltd. | Changsha Hunan, China | Manufacturer | 1 | June 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Miconvey Technologies Co., Ltd. | Chongqing, China | Manufacturer | 1 | September 30, 2022 | 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 |
| SMTP Medical Co., Ltd. | Daxing District Beijing, China | Manufacturer | 1 | September 27, 2021 | 0 | 0 | 0 | api.fda.gov |
| Soering GMBH | QUICKBORN Schleswig-Holstein, Germany | Manufacturer | 1 | May 21, 2008 | 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 |
| Surgnova Healthcare Technologies (zhejiang) Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 1 | July 18, 2022 | 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 |
| Automatics Tooling Company Ltd | Salfords Surrey, United Kingdom | Contract manufacturer | 0 | 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 | |
| Cadex Electronics, Inc. | RICHMOND British Columbia, Canada | 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 | |
| Ethicon Endo-Surgery S.A. De C.V. Planta Ii | CIUDAD JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins Inpac Medizintechnik GMBH | Birkenfeld Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greatbatch Medical S. de R.L. de C.V. | Tijuana Baja California, Mexico | 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 | |
| Itd GMBH | Pfarrkirchen Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, S. de R.L. de C.V. | Mexicali Baja California, Mexico | Manufacturer | 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 | |
| Microtek Dominicana, S.A.S. | La Romana, Dominican Republic | Contract manufacturer | 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 | |
| NPA de Mexico S.de R.L. de C.V. | Tijuana Baja California, Mexico | 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 | |
| Olympus Winter & Ibe GmbH | TELTOW Brandenburg, Germany | 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 | |
| Plexus Electronica S. de R.L. de C.V.. | Zapopan Jalisco, Mexico | 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 | |
| Remington Medical, S.A. | Santo Domingo Este, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Ireland Ltd., Instruments Division | CARRIGTWOHILL, CO.CORK Munster, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | 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 Poland Manufacturing Sp. z o.o. | Skawina Malopolskie, Poland | 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 October 15, 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.