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Data / Medical devices / Scalpel, One-Piece / United States

FDA-registered makers of Scalpel, One-Piece in the United States: 32 establishments

32 establishments in the United States are registered with the FDA to make Scalpel, One-Piece (product code GDX). 1 has 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
Scalpel, One-Piece
Product code
GDX
Country
United States

Makers of Scalpel, One-Piece in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Surgistar, Inc.Vista, CA, United StatesContract manufacturer, Manufacturer1September 9, 1992000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer0000api.fda.gov
Ansell Sandel Medical Solutions LLCChatsworth, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Apollo Renal Therapeutics, LLCOcala, FL, United StatesContract manufacturer0000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Puerto Rico Corp.Colinas de San Agustin, PR, United StatesManufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer0000api.fda.gov
Cadence Device, Inc.Cranberry Township, PA, United StatesContract manufacturer0000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dimensions Trading Inc.Oceanside, NY, United StatesSpecification developer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Ecomed Solutions, LLCLindenhurst, IL, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Exelint International, Co.Redondo Beach, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Griff Industries, Inc.Lancaster, CA, United StatesContract manufacturer0000api.fda.gov
Kluge Design Inc.Rogers, MN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
MEDBIO - Clinton TownshipClinton Township, MI, United StatesContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
Nano Surgical, IncDelray Beach, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pellecome LLCGladstone, NJ, United StatesSpecification developer0000api.fda.gov
Qsum Biopsy Disposables LLCPequot Lakes, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesSpecification developer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer0000api.fda.gov
Tacmed Solutions, LLCAnderson, SC, United StatesSpecification developer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesSpecification developer0000api.fda.gov
Treace Medical Concepts, Inc.Ponte Vedra, FL, United StatesManufacturer0000api.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 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.