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

Drills, Burrs, Trephines & Accessories (Manual) (HBG): 37 FDA-registered makers in 7 countries

37 establishments in 7 countries are registered with the FDA to make Drills, Burrs, Trephines & Accessories (Manual) (product code HBG, Class 2, 21 CFR 882.4300). 11 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on November 21, 2025, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

HBG

Device class

2

Regulation

882.4300

Medical specialty

Neurology

Makers by country

Makers of Drills, Burrs, Trephines & Accessories (Manual)

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.

Updated November 21, 2025. 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.