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Data / Medical devices / Lithotriptor, Ultrasonic

Lithotriptor, Ultrasonic (FEO): 15 FDA-registered makers in 4 countries

15 establishments in 4 countries are registered with the FDA to make Lithotriptor, Ultrasonic (product code FEO, Class 2, 21 CFR 876.4480). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on October 23, 2023, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
FEO
Device class
2
Regulation
876.4480
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States6
Germany5
Switzerland3
Monaco1

Makers of Lithotriptor, 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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
E.M.S. Electro Medical Systems S.A.NYON Vaud, SwitzerlandComplaint file establishment, Manufacturer, Remanufacturer, Specification developer5October 23, 2023000api.fda.gov
E.M.S. Electro Medical Systems S.A.NYON Vaud, SwitzerlandManufacturer5October 23, 2023000api.fda.gov
Electro Medical Systems, L.L.C.Southlake, TX, United StatesRemanufacturer, Repackager or relabeler4October 9, 2018000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer3August 21, 2017000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer2June 22, 1998000api.fda.gov
Misonix, LLCFarmingdale, NY, United StatesComplaint file establishment, Manufacturer, Specification developer2November 22, 1999000api.fda.gov
Gyrus Acmi, Inc.Westborough, MA, United StatesSpecification developer1November 13, 2014000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer1December 7, 1992000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
Promepla S.A.MMONACO Monaco-Ville, MonacoContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov

Updated October 23, 2023. 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.