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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

CountryMakers
United States46
Germany6
Mexico5
China4
Ireland3
Japan3
Dominican Republic2
United Kingdom1
Canada1
Poland1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ethicon Endo-Surgery, LLCGuaynabo, PR, United StatesSpecification developer15February 28, 2023000api.fda.gov
Ethicon Endo-Surgery, Inc.Cincinnati, OH, United StatesSpecification developer13February 28, 2023060api.fda.gov
Integra Lifesciences (ireland) LimitedSRAGH TULLAMORE Offaly, IrelandManufacturer, Specification developer8July 11, 2023000api.fda.gov
Integra NeurosciencesAnasco, PR, United StatesManufacturer8July 11, 2023000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer7October 8, 2026000api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer, Repackager or relabeler6August 4, 2021000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer6August 4, 2021000api.fda.gov
CovidienBoulder, CO, United StatesManufacturer5November 15, 2021000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer5November 15, 2021000api.fda.gov
Misonix, LLCFarmingdale, NY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer5May 30, 2019010api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer, Repackager or relabeler, Specification developer4March 26, 2018000api.fda.gov
Stryker Ireland Ltd. Instruments Division, Innovation CentreCarrigtwohill Cork(County), IrelandSpecification developer4October 8, 2026000api.fda.gov
Integra Lifesciences CorporationCincinnati, OH, United StatesManufacturer3December 7, 2018000api.fda.gov
Integra Pain ManagementWest Valley City, UT, United StatesManufacturer3December 7, 2018000api.fda.gov
Shirakawa Olympus Co., Ltd.NISHISHIRAKAWA-GUN Fukushima, JapanManufacturer3August 4, 2021000api.fda.gov
Tenex HealthLake Forest, CA, United StatesContract manufacturer, Manufacturer3August 28, 2018040api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer2March 26, 2018000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1December 9, 2003000api.fda.gov
Arobella Medical, LLCMinnetonka, MN, United StatesManufacturer1January 3, 2007010api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer1August 4, 2021000api.fda.gov
Hunan Handlike Minimally Invasive Surgery Co., Ltd.Changsha Hunan, ChinaManufacturer1June 18, 2024000api.fda.gov
Miconvey Technologies Co., Ltd.Chongqing, ChinaManufacturer1September 30, 2022000api.fda.gov
Microtek Medical LLCEagan, MN, United StatesSpecification developer1June 6, 2005000api.fda.gov
SMTP Medical Co., Ltd.Daxing District Beijing, ChinaManufacturer1September 27, 2021000api.fda.gov
Soering GMBHQUICKBORN Schleswig-Holstein, GermanyManufacturer1May 21, 2008000api.fda.gov
Sonicmed Medical Technology Co., LtdLas Vegas, NV, United StatesManufacturer1October 31, 2019000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer1April 11, 2019000api.fda.gov
Surgnova Healthcare Technologies (zhejiang) Co., Ltd.Cixi Zhejiang, ChinaManufacturer1July 18, 2022000api.fda.gov
Trice MedicalMalvern, PA, United StatesComplaint file establishment, Manufacturer1November 18, 2024000api.fda.gov
TendoNova CorporationAtlanta, GA, United StatesManufacturer1March 8, 2022000api.fda.gov
Automatics Tooling Company LtdSalfords Surrey, United KingdomContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Rochester, MN, United StatesContract manufacturer0000api.fda.gov
Bioventus LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Cadex Electronics, Inc.RICHMOND British Columbia, CanadaContract manufacturer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Ethicon Endo-Surgery S.A. De C.V. Planta IiCIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Eurofins Inpac Medizintechnik GMBHBirkenfeld Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Greatbatch Medical S. de R.L. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer0000api.fda.gov
Itd GMBHPfarrkirchen Bavaria, GermanyContract manufacturer0000api.fda.gov
Intuitive Surgical, S. de R.L. de C.V.Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Jabil Inc.Auburn Hills, MI, United StatesContract manufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Microtek Dominicana, S.A.S.La Romana, Dominican RepublicContract manufacturer0000api.fda.gov
Modo IncHillsboro, OR, United StatesContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
Modo, Inc.McMinnville, OR, United StatesContract manufacturer0000api.fda.gov
NPA de Mexico S.de R.L. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Nypro Healthcare Baja Inc. (Albuquerque)Albuquerque, NM, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Olympus Winter & Ibe GmbHTELTOW Brandenburg, GermanyManufacturer0000api.fda.gov
Plexus Corp.Neenah, WI, United StatesContract manufacturer0000api.fda.gov
PMC SMART Solutions, LLCShelbyville, IN, United StatesContract manufacturer0000api.fda.gov
Plexus Electronica S. de R.L. de C.V..Zapopan Jalisco, MexicoContract manufacturer0000api.fda.gov
R.H. Cross Enterprises, Inc.Portage, MI, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Remington Medical, S.A.Santo Domingo Este, Dominican RepublicContract manufacturer0000api.fda.gov
Stryker Ireland Ltd., Instruments DivisionCARRIGTWOHILL, CO.CORK Munster, IrelandContract manufacturer0000api.fda.gov
Stryker Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer0000api.fda.gov
Spectrum Plastics GroupSaint Louis Park, MN, United StatesContract manufacturer0000api.fda.gov
Stryker Poland Manufacturing Sp. z o.o.Skawina Malopolskie, PolandContract manufacturer0000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesReprocessor, Specification developer0000api.fda.gov
Stryker Sustainability Solutions - ChandlerChandler, AZ, United StatesReprocessor0000api.fda.gov
Stryker Sustainability Solutions LakelandLakeland, FL, United StatesReprocessor0000api.fda.gov
VestaFranklin, WI, United StatesContract manufacturer0000api.fda.gov
Zevex, Inc.Salt Lake City, UT, United StatesContract manufacturer0000api.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.