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Data / Medical devices / Cystotome / United States

FDA-registered makers of Cystotome in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Cystotome (product code HNY). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Get makers of this device in the United StatesWatch these makers
Device
Cystotome
Product code
HNY
Country
United States

Makers of Cystotome in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Surgistar, Inc.Vista, CA, United StatesManufacturer1May 16, 1996000api.fda.gov
Anodyne SurgicalO Fallon, MO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesManufacturer, Specification developer0000api.fda.gov
BihlerMed, LLCPhillipsburg, NJ, United StatesManufacturer0000api.fda.gov
Hurricane MedicalBradenton, FL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Katena Products, Inc.Fenton, MO, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Katena Products, Inc.Parsippany, NJ, United StatesManufacturer, Specification developer0000api.fda.gov
Katena Products, Inc.Randolph, NJ, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Med-Logics, Inc.Athens, TX, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medone Surgical, Inc.Sarasota, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Oasis Medical, Inc.Glendora, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Total Titanium, Inc.Red Bud, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.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.