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Data / Medical devices / Instruments, Surgical, Cardiovascular / United States

FDA-registered makers of Instruments, Surgical, Cardiovascular in the United States: 81 establishments

81 establishments in the United States are registered with the FDA to make Instruments, Surgical, Cardiovascular (product code DWS). 9 have a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 2, 2026.

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Device
Instruments, Surgical, Cardiovascular
Product code
DWS
Country
United States

Makers of Instruments, Surgical, Cardiovascular in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer, Manufacturer3July 11, 1985000api.fda.gov
Advanced Vascular DynamicsTigard, OR, United StatesManufacturer, Specification developer1May 19, 1989000api.fda.gov
Genesee Biomedical, Inc.Denver, CO, United StatesManufacturer1September 27, 1988010api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Specification developer1July 11, 1985000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesSpecification developer1April 10, 1989010api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesManufacturer, Repackager or relabeler, Specification developer1October 9, 2002000api.fda.gov
Novosci Corp.Conroe, TX, United StatesManufacturer, Specification developer1June 30, 1980000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1June 19, 1985000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1June 19, 1985010api.fda.gov
Abbott MedicalMinnetonka, MN, United StatesManufacturer0000api.fda.gov
Abbott MedicalSylmar, CA, United StatesSpecification developer0000api.fda.gov
Abiomed, Inc.Danvers, MA, United StatesManufacturer0000api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arnold Tuber IndustriesOrchard Park, NY, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer0000api.fda.gov
Atrium Medical CorporationMerrimack, NH, United StatesSpecification developer0000api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Bear-Ent, LLCMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
BiomericsSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Biorep Technologies, Inc.Miami Lakes, FL, United StatesContract manufacturer0010api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedEllettsville, IN, United StatesContract manufacturer0000api.fda.gov
Cook Vandergrift Inc.Vandergrift, PA, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Custom Manufacturing Inc.Elbert, CO, United StatesContract manufacturer0000api.fda.gov
Donatelle Plastics, LLCNew Brighton, MN, United StatesContract manufacturer0000api.fda.gov
Eca Medical InstrumentsNewbury Park, CA, United StatesContract manufacturer0000api.fda.gov
Edwards Lifesciences LLCIrvine, CA, United StatesSpecification developer0000api.fda.gov
Edwards Lifesciences LLCDraper, UT, United StatesManufacturer0010api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Galt Medical Corp.Garland, TX, United StatesManufacturer0010api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer0000api.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
Isomedix Operations Inc.S Plainfield, NJ, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Jacobs Emerging Technologies, LLCBloomfield Hills, MI, United StatesSpecification developer0000api.fda.gov
Kapp Surgical, Inc.Cleveland, OH, United StatesManufacturer0000api.fda.gov
KDL Medical, Inc.Richardson, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Lsi Solutions Inc.Victor, NY, United StatesManufacturer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Med Michigan Holdings LLCLake Odessa, MI, United StatesManufacturer0000api.fda.gov
Medical Specialties Inc.Durham, NC, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtronic Puerto Rico Operations Co., VillalbaVillalba, PR, United StatesManufacturer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Maquet Cardiovascular LLCWayne, NJ, United StatesManufacturer, Specification developer0020api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer0000api.fda.gov
Medtronic Heart Valves DivisionSanta Ana, CA, United StatesSpecification developer0000api.fda.gov
Medtronic, Inc. (Minneapolis, MN 55447)Minneapolis, MN, United StatesManufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Omni Components CorporationHudson, NH, United StatesContract manufacturer0000api.fda.gov
On-X Life Technologies Inc.Austin, TX, United StatesManufacturer0000api.fda.gov
Pemco, Inc.Cleveland, OH, United StatesManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Princeton Medical Group, Inc.Franklin, TN, United StatesSpecification developer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Precision Medical Manufacturing LLCWheeling, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Quest Medical, Inc.Allen, TX, United StatesManufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesManufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Rultract IncIndependence, OH, United StatesSpecification developer0010api.fda.gov
Scanlan International, Inc.Saint Paul, MN, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Sterilization Services Of VirginiaRichmond, VA, United StatesContract manufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
Tedan Surgical Innovations, Inc.Sugar Land, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Terumo Cardiovascular Systems CorporationElkton, MD, United StatesSpecification developer0000api.fda.gov
Thompson Surgical Instruments, Inc.Traverse City, MI, United StatesManufacturer, Specification developer0000api.fda.gov
TechNH, INC.Merrimack, NH, United StatesContract manufacturer0000api.fda.gov
Vitalitec Int'l., Inc.Plymouth, MA, United StatesSpecification 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.