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Data / Medical devices / Rongeur, Manual / United States

FDA-registered makers of Rongeur, Manual in the United States: 24 establishments

24 establishments in the United States are registered with the FDA to make Rongeur, Manual (product code HAE). 14 have a 510(k) clearance or PMA approval on file and 0 have a recall event. 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.

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Device
Rongeur, Manual
Product code
HAE
Country
United States

Makers of Rongeur, Manual in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer4September 7, 2016000api.fda.gov
Ebner Medical LLCOrange Park, FL, United StatesSpecification developer2July 21, 2020000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler2February 29, 2016000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer2April 16, 2015000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer2April 11, 2012000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer1August 8, 2008000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer1February 29, 2016000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer1June 3, 2022000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1August 8, 2008000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer1December 6, 2013000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesComplaint file establishment, Specification developer1August 8, 2008000api.fda.gov
Steribite, LLCWooster, OH, United StatesComplaint file establishment, Specification developer1November 8, 2018000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1August 8, 2008000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1August 8, 2008000api.fda.gov
A&m Biomedical Inc.Laguna Hills, CA, United StatesContract manufacturer0000api.fda.gov
Contech Medical, Inc.Providence, RI, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Spinal Simplicity, LLCOverland Park, KS, United StatesComplaint file establishment, Specification developer0000api.fda.gov
SPINEFRONTIER, INC. DBA LESspine InnovationsBurlington, MA, United StatesManufacturer, Specification developer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer0000api.fda.gov
Surgentec LLCBoca Raton, FL, United StatesManufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, 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.