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Data / Medical devices / Drills, Burrs, Trephines & Accessories (Manual) / United States

FDA-registered makers of Drills, Burrs, Trephines & Accessories (Manual) in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Drills, Burrs, Trephines & Accessories (Manual) (product code HBG). 8 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Drills, Burrs, Trephines & Accessories (Manual)
Product code
HBG
Country
United States

Makers of Drills, Burrs, Trephines & Accessories (Manual) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer2March 26, 2016000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer, Specification developer2September 20, 1990000api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer2December 30, 1991010api.fda.gov
Integra Pain ManagementWest Valley City, UT, United StatesManufacturer1June 5, 1996030api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1September 20, 1990000api.fda.gov
Natus Medical IncorporatedSan Diego, CA, United StatesComplaint file establishment, Specification developer1November 12, 2002000api.fda.gov
Phasor Health, LLCHouston, TX, United StatesComplaint file establishment, Manufacturer1November 21, 2025000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer1January 18, 2017000api.fda.gov
Ad-Tech Medical Instrument Corp.Oak Creek, WI, United StatesManufacturer0010api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
EndoplusMundelein, IL, United StatesContract manufacturer0000api.fda.gov
Hemedex IncorporatedNorth Waltham, MA, United StatesManufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.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.