ISO 13485 Certified Manufacturers

US manufacturers certified to ISO 13485 — 373 companies.

209 with online quoting · 168 ISO 9001 · 33 US-made

By state: California · Florida · Massachusetts · Illinois · Texas · Minnesota · Pennsylvania · Ohio · New York · Wisconsin · New Jersey · Connecticut · Maryland · Indiana

• ADS Biotec Inc.ISO 13485Omaha, NE
• AERO HealthcareISO 13485Valley Cottage, NY
• APS Materials, Inc.NADCAPDayton, OH
• Aalto Scientific Ltd.ISO 13485Eatonton, GA
• Abx Engineering, IncAS9100Burlingame, CA
• Access Assembly, LLCAS9100Mundelein, IL
• Acchroma, Inc.ISO 13485Cleveland, OH
• Accu TubeISO 13485Englewood, CO
• Accu-Mold, LLCISO 13485Mishawaka, IN
• Accumedix, Inc.ISO 13485Libertyville, IL
• Accumetrics Ltd.ISO 13485Royersford, PA
• Aci Medical LLCISO 13485San Marcos, CA
• Acme Monaco Corp.ISO 13485New Britain, CT
• Acra Cut, IncISO 13485Acton, MA
• Acuderm IncISO 13485Fort Lauderdale, FL
• Addev MaterialsAS9100Glenshaw, PA
• Adroit Medical Systems, IncISO 13485Loudon, TN
• Advance Medical Designs, IncISO 13485Marietta, GA
• Advanced Brain Monitoring, Inc.ISO 13485Carlsbad, CA
• Advanced Powder Products, Inc.ITARPhilipsburg, PA
• Aero-Plastics, Inc.AS9100Renton, WA
• Aimtron Systems, LLCAS9100Palatine, IL
• Alconox Inc.ISO 13485White Plains, NY
• Aldevron, LLCISO 13485Fargo, ND
• AllParts MedicalISO 13485Nashville, TN
• Altek Electronics, Inc.AS9100Torrington, CT
• Ambrit Engineering Corp.ISO 13485Santa Ana, CA
• Amend Surgical, Inc.ISO 13485Alachua, FL
• Ana Global, LLCISO 13485San Diego, CA
• Anaerobe Systems, Inc.ISO 13485Morgan Hill, CA
• Angstrom Mfg., Inc.CMMCSte. Genevieve, MO
• Antron Engineering & Machine Co IncAS9100Bellingham, MA
• Anuva Manufacturing Services, Inc.AS9100West Melbourne, FL
• Aphena Pharma Solutions, Inc.ISO 13485Cookeville, TN
• Applied Biomedical, IncISO 13485Placentia, CA
• Applied Plastics Technology, IncISO 13485Bristol, RI
• Arbour Group, LLCISO 13485Warrenville, IL
• ArcamedISO 13485Indianapolis, IN
• Arimon Technologies IncISO 13485Wautoma, WI
• Arimon Technologies, Inc.ISO 13485Montello, WI
• Armadillo Additive IncISO 13485Granbury, TX
• Asahi Crosslink Corp.ISO 13485Des Plaines, IL
• Asc Sunstone Circuits, LLCAS9100Mulino, OR
• Aspen Imaging Healthcare IncISO 13485Plano, TX
• Associated Spring Us LLCISO 13485Corry, PA
• Auer Precision Co., Inc.ISO 13485Mesa, AZ
• Azure Microdynamics, IncAS9100Foothill Ranch, CA
• BTE TechnologiesISO 13485Hanover, MD
• Banister Tool, Inc.ISO 13485Pflugerville, TX
• Baymar Solutions, LLCISO 13485Odessa, FL
• Beacon Medtech Solutions Ma LLCITARLeominster, MA
• Beam Alloy Technologies, LLCISO 13485Plain City, OH
• Befour, IncISO 13485Saukville, WI
• Betts Precision, IncAS9100Alsip, IL
• Bezwada Biomedical, LLCISO 13485Hillsborough, NJ
• Bio LinkISO 13485Liverpool, NY
• Bio-Therapeutic, Inc.ISO 13485Seattle, WA
• Bio-synthesis, IncISO 13485Lewisville, TX
• Biomerica IncISO 13485Irvine, CA
• Birk Manufacturing, Inc.AS9100East Lyme, CT
• Boedeker Plastics, IncITARShiner, TX
• Boston BioProducts, Inc.ISO 13485Milford, MA
• Boston Cell Standards IncISO 13485Sharon, MA
• Bracalente Manufacturing Co IncAS9100Trumbauersville, PA
• Brammer Engineering, Inc.ISO 13485Shreveport, LA
• Bristol Precision, IncAS9100Marlborough, MA
• Broadata CommunicationsISO 13485Torrance, CA
• Brymill CorporationISO 13485Ellington, CT
• CODAN USAISO 13485Santa Ana, CA
• CSP Technologies, Inc.ISO 13485Auburn, AL
• CT Fiberoptics, Inc.AS9100Somers, CT
• Canfield Scientific, IncISO 13485Parsippany, NJ
• Carolon Co., Inc.ISO 13485Rural Hall, NC
• Carrio Cabling Corp.ISO 13485Colorado Springs, CO
• Carwild Corp.ISO 13485New London, CT
• Casco Bay Molding, Ltd.ISO 13485Sanford, ME
• CastheonAS9100Los Angeles, CA
• Catachem, IncISO 13485Oxford, CT
• Cavero Coatings Co., LLCISO 13485Bensenville, IL
• Cellbios IncISO 13485Mckinney, TX
• Cenogenics CorporationISO 13485Morganville, NJ
• Ces Machine Products IncAS9100Reno, NV
• Challenge Machine And ManufacturingISO 13485Blaine, MN
• Chavers Gasket CorpAS9100Laguna Hills, CA
• Cision Vision, IncISO 13485Mountain View, CA
• Civatech Oncology, IncISO 13485Morrisville, NC
• Clarus Medical, LLCISO 13485Plymouth, MN
• Classic Wire Cut Co., Inc.ISO 13485Valencia, CA
• Clear Guide Medical, IncISO 13485Baltimore, MD
• Codonics IncISO 13485Cleveland, OH
• Coining Mfg LLCAS9100Clifton, NJ
• ColtTech, LLCAS9100Olathe, KS
• ComDel Innovation, Inc.ISO 13485Wahpeton, ND
• Comco Plastics, Inc.ISO 13485Huntington Station, NY
• Confirm Biosciences, Inc.ISO 13485San Diego, CA
• Contech Medical, Inc.ISO 13485Providence, RI
• Cortland BiomedicalISO 13485Cortland, NY
• Corvalent CorpISO 13485Cedar Park, TX
• Cretex MedicalISO 13485Soquel, CA
• Cvg Strategy LLCAS9100Melbourne, FL
• Danco MachineAS9100Santa Clara, CA
• Darco International, Inc.ISO 13485Huntington, WV
• DeCardy DiecastingISO 13485Chicago, IL
• Del Medical, IncISO 13485Bloomingdale, IL
• Deringer-ney IncITARBloomfield, CT
• Dermamed Coatings, LLCISO 13485Tallmadge, OH
• Design Standards Corp.ISO 13485Charlestown, NH
• Detail Mold & ManufacturingISO 13485Georgetown, TX
• DiaSys Diagnostic Systems, USA, LLCISO 13485Wixom, MI
• Diagnocine LLCISO 13485Hackensack, NJ
• Diamond Diagnostics IncISO 13485Holliston, MA
• Domico Med-device LLCISO 13485Fenton, MI
• Donson Machine Co.ISO 13485Orland Park, IL
• Drylock Technologies Ltd.ISO 13485Eau Claire, WI
• Eldon James CorpISO 13485Fort Collins, CO
• Electro Kinetic Technologies, LLCISO 13485Germantown, WI
• Electrolizing IncAS9100Providence, RI
• Electronic Source Co.AS9100Van Nuys, CA
• Electropolishing Systems, Inc.ISO 13485Plymouth, MA
• Element Biosciences, IncISO 13485San Diego, CA
• Elevate Oral Care, LLCISO 13485West Palm Beach, FL
• Enercon TechnologiesISO 13485Gray, ME
• Epitope Diagnostics, Inc.ISO 13485San Diego, CA
• Everest Biolabs, IncISO 13485Waltham, MA
• Evergait, LLCISO 13485Tampa, FL
• Eyekon Medical, Inc.ISO 13485Clearwater, FL
• Fehling Surgical Instruments, Inc.ISO 13485Kennesaw, GA
• Ferry Machine CorpISO 13485Little Ferry, NJ
• Fetzer Surgical, LLCISO 13485Schaumburg, IL
• Finishing Innovations, LLCISO 13485Atoka, TN
• Fitz-thors Manufacturing, IncAS9100Bessemer, AL
• Flintec, Inc.ISO 13485Hudson, MA
• Fluxergy, IncISO 13485Irvine, CA
• Fogg System Co., Inc.ISO 13485Aurora, CO
• Formacoat, LLCISO 13485Chaska, MN
• Fralock, LLCAS9100Valencia, CA
• Fremon Scientific IncISO 13485La Jolla, CA
• Gaishin ManufacturingAS9100Benton Harbor, MI
• Gattaco IncISO 13485Murrieta, CA
• Gauthier Biomedical, Inc.ISO 13485Grafton, WI
• Gavco Plastics, Inc.AS9100Broken Arrow, OK
• Gemini Bio-Products, Inc.ISO 13485West Sacramento, CA
• GenBioISO 13485San Diego, CA
• Genesis Plastics Welding, Inc.ISO 13485Fortville, IN
• Giles Scientific, IncISO 13485Santa Barbara, CA
• Gingi-PakISO 13485Camarillo, CA
• Globalmed Holdings, LLCISO 13485Scottsdale, AZ
• Gpa Innova America CorpISO 13485Sunrise, FL
• Graham Research, Inc.AS9100Plymouth, MN
• Granite State Plastics, IncISO 13485Hudson, NH
• Gulden Ophthalmics Inc.ISO 13485Elkins Park, PA
• Hastest Solutions, Inc.ISO 13485San Jose, CA
• Hda Technology, IncISO 13485Lake Forest, CA
• Heartland Medical Sales & Services LLCISO 13485Louisville, KY
• Hirsh Precision Products, IncAS9100Frederick, CO
• Hk Surgical IncISO 13485San Clemente, CA
• Hydromer, Inc.ISO 13485Concord, NC
• INTCO Medical Industries, Inc.ISO 13485Ontario, CA
• IOPI Medical, LLCISO 13485Woodinville, WA
• IVD Research, Inc.ISO 13485Carlsbad, CA
• Icf Mercantile LLCISO 13485Warren, NJ
• Immuno Concepts, Inc.ISO 13485Sacramento, CA
• InVitroCare, Inc.ISO 13485Frederick, MD
• Inbios International IncISO 13485Seattle, WA
• Incodema, LLCAS9100Ithaca, NY
• Indilab, Inc.ISO 13485Franklin Park, IL
• Innovaquartz, LLCISO 13485Phoenix, AZ
• Ivy Biomedical Systems, Inc.ISO 13485Branford, CT
• JACE Systems, Inc.ISO 13485Cinnaminson, NJ
• JARA Mfg., Inc.ISO 13485Butler, PA
• Jama Software, Inc.ISO 13485Portland, OR
• Janco Electronics IncISO 13485Rollinsford, NH
• KARL STORZ Industrial-America, Inc.ISO 13485El Segundo, CA
• KRONUS, Inc.ISO 13485Star, ID
• Katecho, LLC.ISO 13485Des Moines, IA
• Kawasumi Laboratories America, Inc.ISO 13485Tampa, FL
• Kaytech Industries Corp.AS9120Ronkonkoma, NY
• Kemp Proteins, LLCISO 13485Frederick, MD
• Kimera Labs IncISO 13485Miramar, FL
• Kincaid Plastics, IncITARBrooksville, FL
• Kinship Precision, LLCISO 13485Melbourne, FL
• Klyo Medical Systems, Inc.ISO 13485Doral, FL
• Korvis, LLCISO 13485Corvallis, OR
• Koven Technology, Inc.ISO 13485St. Louis, MO
• LGC Clinical DiagnosticsISO 13485Cumberland Foreside, ME
• LP Aero Plastics, Inc.AS9100Jeannette, PA
• Labo America, Inc.ISO 13485Fremont, CA
• Lake Air Products, LLCAS9100Minneapolis, MN
• Lancaster Metals Science CorpITARLancaster, PA
• Lancer Orthodontics, Inc.ISO 13485Carlsbad, CA
• Laser Components Detector Group, IncISO 13485Chandler, AZ
• Laser Peripherals, LLCISO 13485Plymouth, MN
• Lattice Semiconductor Corp.ISO 13485Hillsboro, OR
• Levison Enterprises, LLCAS9100Millbury, OH
• Lincoln Diagnostics, Inc.ISO 13485Decatur, IL
• LiteCure, LLCISO 13485New Castle, DE
• Lotus International Co.AS9100Canton, MI
• Lucigen CorporationISO 13485Middleton, WI
• Lv Swiss, IncAS9100La Verkin, UT
• Lyons Manufacturing Company, IncAS9100Lyons, KS
• M Dialysis IncISO 13485North Chelmsford, MA
• MEDTOX Diagnostics, Inc.ISO 13485Burlington, NC
• MLM Biologics, Inc.ISO 13485Gainesville, FL
• MML Diagnostics Packaging, Inc.ISO 13485Troutdale, OR
• MTD Micro Molding, Inc.ISO 13485Charlton, MA
• MXR ImagingISO 13485Cary, IL
• MYCO MedicalISO 13485Apex, NC
• Machining Concepts LLCAS9100Germantown, WI
• Mack Industrial LLCITARSylvania, OH
• Mack Prototype, IncITARGardner, MA
• Maco Bag CorporationISO 13485Newark, NY
• MagentaAS9100Houston, TX
• Matrix Plastic Products IncISO 13485Wood Dale, IL
• Mawi Dna Technologies, LLCISO 13485Pleasanton, CA
• Med Fibers, Inc.ISO 13485Chandler, AZ
• Meddev Corp.ISO 13485Sunnyvale, CA
• Medi/Nuclear® Corporation, Inc.ISO 13485Baldwin Park, CA
• Medical Component Specialists, Inc.ISO 13485Bellingham, MA
• Medix Biochemica, Inc.ISO 13485Maryland Heights, MO
• Medspira, LLCISO 13485Minneapolis, MN
• Merit Cables IncorporatedITARSanta Ana, CA
• Merrill's Packaging, IncISO 13485Burlingame, CA
• Meso Scale Discovery, LLCISO 13485Rockville, MD
• Messenger Molding, Inc.ISO 13485Reno, NV
• Metalwerks, IncAS9100Aliquippa, PA
• Micron Products, Inc.ISO 13485Fitchburg, MA
• Microtech Precision, Inc.ISO 13485McMinnville, OR
• Mid-america Safety CorpISO 13485Elk Grove Village, IL
• Mikrotech LLCISO 13485Kenosha, WI
• Millar, LLCISO 13485Pearland, TX
• Millennium Precision LLCNADCAPManchester, NH
• Minnesota MedTec, Inc.ISO 13485Maple Grove, MN
• More Diagnostics IncISO 13485Los Osos, CA
• Msk Precision Products, LLCAS9100Tamarac, FL
• Multipack Solutions, LLCISO 13485Greenville, SC
• Myriad Fiber Imaging Technologies, IncISO 13485Dudley, MA
• NKT Photonics, Inc.ISO 13485Boston, MA
• Naeco, LLCAS9100Peachtree City, GA
• Natech Plastics, Inc.ISO 13485Ronkonkoma, NY
• National Power Equipment IncISO 13485Brookpark, OH
• Navitek Machining CorpAS9100Fairview, PA
• Neotech Products, LLCISO 13485Valencia, CA
• Nephros, IncISO 13485South Orange, NJ
• Neurasignal, IncISO 13485Los Angeles, CA
• Nikel Precision Group LLCISO 13485Saco, ME
• Nikomed USA, Inc.ISO 13485Hatboro, PA
• Norlase IncISO 13485Redwood City, CA
• Novo Surgical, Inc.ISO 13485Oak Brook, IL
• NovoSci Corp.ISO 13485Conroe, TX
• NuLine Manufacturing, Inc.ISO 13485Denver, CO
• O-rings, IncAS9100Los Angeles, CA
• OCULUS Surgical, Inc.ISO 13485Port St. Lucie, FL
• OMS Technologies, LLCNADCAPLakewood, OH
• Oasis Materials Company, LLCAS9100Poway, CA
• Oligo Factory, Inc.ISO 13485Holliston, MA
• Optikos CorporationITARWakefield, MA
• Or Specific, IncISO 13485Vancouver, WA
• P & F Machining, IncAS9100Otsego, MN
• Pace Electronics Assembly LLCISO 13485Riva, MD
• Pangaea Technologies LLCISO 13485Frederick, MD
• Paramount Mold, LLCISO 13485Fort Lauderdale, FL
• Passy Muir, Inc.ISO 13485Irvine, CA
• Pathway Precision Manufacturing LLCITARMemphis, TN
• Peko Precision Products, IncAS9100Rochester, NY
• Perry Baromedical Corp.ISO 13485Riviera Beach, FL
• Petron Automation, Inc.ISO 13485Watertown, CT
• Physcient Surgical, IncISO 13485Durham, NC
• Pivot-EDMISO 13485La Vista, NE
• Plastics Plus Technology, IncISO 13485Redlands, CA
• Plastimold Products, Inc.AS9100Delray Beach, FL
• Plexus CorpISO 13485Neenah, WI
• Polysciences IncISO 13485Warrington, PA
• Polytronix Machining & Fabrication, Inc.AS9100Richardson, TX
• Polytronix, Inc.AS9100Richardson, TX
• Precision Econowind, LLCISO 13485North Fort Myers, FL
• Precision EdgeISO 13485Angola, IN
• Precision Medical Products IncISO 13485Rocklin, CA
• Prestige Ameritech LtdISO 13485Fort Worth, TX
• Prevailing Medical IncISO 13485Plymouth, MN
• Prince & Izant Co.ITARTinley Park, IL
• Prince & Izant Manufacturing Co.ITARFranksville, WI
• Pro Scope SystemsISO 13485Blue Ash, OH
• Pro-Tech Design & Manufacturing, Inc.ISO 13485Santa Fe Springs, CA
• Probo MedicalISO 13485Tampa, FL
• Promed Molded Products, IncITARPlymouth, MN
• Prospect Life Sciences, IncISO 13485Westminster, CO
• Proto Labs, Inc.AS9100Maple Plain, MN
• Protofab EngineeringAS9100Blaine, MN
• Providien Thermoforming, Inc.ISO 13485San Diego, CA
• Prowess, Inc.ISO 13485Concord, CA
• Pulse Ism IncISO 13485Leavenworth, KS
• Purgo Scientific LLCISO 13485South Jordan, UT
• Q One Americas, IncISO 13485Fitchburg, MA
• Qt Medical, IncISO 13485Diamond Bar, CA
• Quality Aspirators, Inc.ISO 13485Duncanville, TX
• Quality CNC Machining IncAS9100Willoughby, OH
• Ranfac Corp.ISO 13485Avon, MA
• Rarecyte, IncISO 13485Seattle, WA
• Rayco Steel Process, Inc.ISO 13485Warsaw, IN
• Reich Tool & Design, IncITARMenomonee Falls, WI

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