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Data / Medical devices / Gouge, Surgical, General & Plastic Surgery / United States

FDA-registered makers of Gouge, Surgical, General & Plastic Surgery in the United States: 30 establishments

30 establishments in the United States are registered with the FDA to make Gouge, Surgical, General & Plastic Surgery (product code GDH). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Gouge, Surgical, General & Plastic Surgery
Product code
GDH
Country
United States

Makers of Gouge, Surgical, General & Plastic Surgery in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer1August 9, 1990000api.fda.gov
CovidienPonce, PR, United StatesContract manufacturer, Manufacturer1August 9, 1990000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer1August 9, 1990000api.fda.gov
Alira Medical Devices LLCRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer0000api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer0000api.fda.gov
GLW, Inc.Englewood Cliffs, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Holmed LLCAttleboro, MA, United StatesContract manufacturer, Manufacturer0000api.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
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Lenox-Maclaren Surgical Corp.Louisville, CO, United StatesManufacturer0000api.fda.gov
Life Instrument Corp.Braintree, MA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesSpecification developer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Post Surgical MFG.Bay Shore, NY, United StatesContract manufacturer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer0000api.fda.gov
Sterramed IncWeehawken, NJ, United StatesRepackager or relabeler, Specification developer0000api.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
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov

Updated November 3, 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.