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Data / Medical devices / Austria

Medical device makers in Austria: 69 FDA-registered establishments

69 establishments in Austria are registered with the FDA to make medical devices for the US market, listing 206 device types. 42 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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  • AustriaCountry

Device types made here

Device types with the most registered makers in this country.

DeviceProduct codeMakers
Frame, SpectacleHQZ6
Sunglasses (Non-Prescription Including Photosensitive)HQY5
ArticulatorsEJP4
Electrode, CutaneousGXY4
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG3
Automated Radiological Image Processing SoftwareQIH3
System, Image Processing, RadiologicalLLZ3
Activator, Ultraviolet, For PolymerizationEBZ3
Non-Normalizing Quantitative Electroencephalograph SoftwareOLT3
FacebowKCR3
Amplifier, Physiological SignalGWL3
Hearing Aid, Bone ConductionLXB3
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE2
Bit, DrillHTW2
Instrument, Manual, Surgical, General UseMDM2
Driver, Wire, And Bone Drill, ManualDZJ2
Drill, Bone, PoweredDZI2
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2
Instrument, Surgical, Sonic And Accessory/AttachmentJDX2
Needle, Hypodermic, Single LumenFMI2
Set, Administration, IntravascularFPA2
Saw, Powered, And AccessoriesHAB2
Accessories, Implant, Dental, EndosseousNDP2
Transducer, Ultrasonic, DiagnosticITX2
Motor, Surgical Instrument, Ac-PoweredGEY2
System, Imaging, Pulsed Doppler, UltrasonicIYN2
Scaler, UltrasonicELC2
Plugger, Root Canal, EndodonticEKR2
Unit, Operative DentalEIA2
Powder, PorcelainEIH2
Handpiece, Air-Powered, DentalEFB2
Handpiece, Direct Drive, Ac-PoweredEKX2
Container, Specimen Mailer And Storage, Non-SterileNNK2
Controller, Foot, Handpiece And CordEBW2
Lens, Spectacle, Non-Custom (Prescription)HQG2
Calculator/Data Processing Module, For Clinical UseJQP2
Electrode, CorticalGYC2
Introducer, Syringe NeedleKZH2
Handpiece, Contra- And Right-Angle Attachment, DentalEGS2
Full-Montage Standard ElectroencephalographGWQ2
Media, Coupling, UltrasoundMUI2
Handpiece, Rotary Bone CuttingKMW2
System, X-Ray, Tomography, ComputedJAK2
Accelerator, Linear, MedicalIYE2
Stimulator, Muscle, PoweredIPF2
Stimulator, Neuromuscular, External FunctionalGZI2
Locator, Root ApexLQY2
Handpiece, Belt And/Or Gear Driven, DentalEFA2
Normalizing Quantitative Electroencephalograph SoftwareOLU2
Screw, Fixation, BoneHWC1
Washer, Bolt NutHTN1
Electrosurgical, Cutting & Coagulation & AccessoriesGEI1
Syringe, PistonFMF1
Orthopedic Manual Surgical InstrumentLXH1
Dressing, Wound, DrugFRO1
Plate, Fixation, BoneHRS1
Nail, Fixation, BoneJDS1
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT1
Rod, Fixation, Intramedullary And AccessoriesHSB1
Pin, Fixation, ThreadedJDW1
Calibrator, PrimaryJIS1
Colorimeter, Photometer, Spectrophotometer For Clinical UseJJQ1
Slide Stainer, AutomatedKPA1
Device, Intravascular Catheter SecurementKMK1
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor LungsPHO1
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To TransplantationQBA1
Instrument, Ligature Passing And Knot TyingHCF1
Warmer, Thermal, Infusion FluidLGZ1
Gauze/Sponge, Internal, X-Ray DetectableGDY1
System And Accessories, Isolated Heart, Transport And PreservationMSB1
Culture Media, Non-Selective And Non-DifferentialJSG1
Device, Specimen CollectionLIO1
Culture Media, Non-Propagating TransportJSM1
Tourniquet, NonpneumaticGAX1
Dressing, Wound, HydrophilicNAC1
Cannula, InjectionFGY1
Component, Traction, Non-InvasiveKQZ1
Gauze / Sponge,Nonresorbable For External UseNAB1
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA1
System, Imaging, Pulsed Echo, UltrasonicIYO1
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1
Bandage, CastITG1
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double SaltKOO1
Dressing, CompressionMHW1
Cleanser, Denture, Over The CounterEFT1
Medical Glove, SpecialtyLZC1
Container, Specimen, Non-SterileNNI1
Toothbrush, PoweredJEQ1
Tray, Surgical, InstrumentFSM1
Bandage, ElasticFQM1
Carrier, LigatureGEJ1
Crown, PreformedELZ1
ScrewdriverHXX1
Instrument, Bending Or ContouringHXP1
WrenchHXC1
Instrument, CompressionHWN1
Tap, BoneHWX1
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG1
Infusor, Pressure, For I.V. BagsKZD1

Makers in Austria

Best documented first: most 510(k) clearances and PMA approvals.

MakerLocationDevice types510(k) clearancesPMA approvalsRecall eventsSource
GE Healthcare Austria GmbH & Co OGZIPF Oberosterreich, Austria67201api.fda.gov
Greiner Bio-One GMBHKREMSMUENSTER Oberosterreich, Austria163401api.fda.gov
W&H Dentalwerk Buermoos GMBHBUERMOOS Salzburg, Austria272403api.fda.gov
W&H Dentalwerk Buermoos GMBH - Site 2BUERMOOS Salzburg, Austria272300api.fda.gov
I.T.S. GMBHLASSNITZHOEHE Steiermark, Austria132002api.fda.gov
Klema Dentalprodukte GMBHMeiningen Vorarlberg, Austria41300api.fda.gov
Amann Girrbach AGMaeder Vorarlberg, Austria201100api.fda.gov
Med-El Elektromedizinische Geraete, GMBHINNSBRUCK Tirol, Austria12823api.fda.gov
Leonhard Lang GMBHINNSBRUCK Tirol, Austria13806api.fda.gov
A.M.I. Agency For Medical Innovations GMBHFeldkirch Vorarlberg, Austria8500api.fda.gov
G.tec Medical Engineering GMBHGraz Steiermark, Austria7500api.fda.gov
G.tec Medical Engineering GMBHSCHIEDLBERG Oberosterreich, Austria7500api.fda.gov
Harps Europe ManufacturingWimpassing Niederosterreich, Austria2500api.fda.gov
Agfa HealthCare GmbHVienna Wien, Austria1400api.fda.gov
CNSYSTEMS MEDIZINTECHNIK GmbHGraz Steiermark, Austria2400api.fda.gov
Medphoton GMBHSalzburg, Austria2400api.fda.gov
Ait Austrian Institute Of Technology GMBHVienna Wien, Austria3300api.fda.gov
Greiner Bio-One GMBHRainbach im Muehlkreis Oberosterreich, Austria2300api.fda.gov
Otto Bock Healthcare Products GmbHVienna Wien, Austria16302api.fda.gov
BHM-Tech Produktionsgesellschaft mbHGrafenschachen Burgenland, Austria1200api.fda.gov
Biolux Technology GMBHAbsdorf Niederosterreich, Austria1200api.fda.gov
Croma-Pharma GMBHLeobendorf Niederosterreich, Austria1020api.fda.gov
Ib Lab GMBHVienna Wien, Austria3200api.fda.gov
ISYS Medizintechnik GmbHKitzbuehel Salzburg, Austria2200api.fda.gov
Klaxon-Mobility GMBHARNOLDSTEIN Karnten, Austria1200api.fda.gov
Piur Imaging GMBHVienna Wien, Austria1200api.fda.gov
Safersonic Medizinprodukte Handelsges.m.b.hPersenbeug Niederosterreich, Austria3200api.fda.gov
Sano Transportgeraete GMBHLICHTENBERG BEI LINZ Oberosterreich, Austria2200api.fda.gov
Silhouette International Schmied AGLinz Oberosterreich, Austria3200api.fda.gov
Thi Total Healthcare Innovation GMBHFeistritz im Rosental Karnten, Austria3200api.fda.gov
Takeda Manufacturing Austria AGVIENNA Wien, Austria4200api.fda.gov
Aha Hyperbarics GMBHVienna Wien, Austria1100api.fda.gov
Biegler GMBHMAUERBACH Niederosterreich, Austria4100api.fda.gov
EC Certification Service GmbHSt. Veit/Glan Karnten, Austria3100api.fda.gov
Edelweiss Dentistry Products GMBHWolfurt Vorarlberg, Austria2100api.fda.gov
Ems Handels Gesellschaft M.B.H.Korneuburg Niederosterreich, Austria2100api.fda.gov
Fresenius Kabi Austria GMBHGRAZ Steiermark, Austria6100api.fda.gov
ITV Medizintechnik GmbHInnsbruck Tirol, Austria1100api.fda.gov
P.G.F. Industry Solutions GMBHElixhausen Salzburg, Austria1100api.fda.gov
Pharmazeutische Fabrik Montavit Ges.m.b.h.Absam Tirol, Austria2100api.fda.gov
Steadysense GMBHRaaba-Grambach Steiermark, Austria2100api.fda.gov
TechnocloneVienna Wien, Austria5100api.fda.gov
A. Schreiber KGWien, Austria1000api.fda.gov
Andy Wolf Fashion GMBHHartberg Steiermark, Austria2000api.fda.gov
Cadstar Technology GMBHBischofshofen Salzburg, Austria1000api.fda.gov
Eyewear Solution S GMBHHartberg Steiermark, Austria2000api.fda.gov
Fittydent Intl. GMBHVienna Wien, Austria3000api.fda.gov
Flextronics International GMBHALTHOFEN Karnten, Austria3000api.fda.gov
Gamma Medizinisch Wissenschaftliche FortbildungsgeKLOSTERNEUBURG Niederosterreich, Austria3000api.fda.gov
Geschuetzte Werkstaetten Integrative Betriebe Salzburg GMBHSt. Margareten Salzburg, Austria1000api.fda.gov
Ing. Gerhard Fildan GMBHEbenfurth Niederosterreich, Austria1000api.fda.gov
IVOCLAR VIVADENT Manufacturing GmbHBURS Vorarlberg, Austria5000api.fda.gov
Kohlbrat & BunzRadstadt Salzburg, Austria3000api.fda.gov
Lohmann & Rauscher GmbHSchoenau an der Triesting Niederosterreich, Austria5000api.fda.gov
MPG Group GmbHGraz Steiermark, Austria3000api.fda.gov
Novogenia GMBHEugendorf Salzburg, Austria1000api.fda.gov
Novartis Pharmaceutical Manufacturing GmbHLangkampfen Tirol, Austria1000api.fda.gov
On Point Medicals GMBHKlagenfurt Karnten, Austria1000api.fda.gov
PAYER International Technologies GMBHSt. Bartholomae Steiermark, Austria1000api.fda.gov
Pomberger Goisern GMBHBad Goisern Oberosterreich, Austria1000api.fda.gov
Philips Austria GmbHKlagenfurt Karnten, Austria1000api.fda.gov
Schoepf Fertigungstechnik GMBHBludesch Vorarlberg, Austria1000api.fda.gov
Stratec Consumables GMBHAnif Salzburg, Austria1000api.fda.gov
Surgebright GMBHLichtenberg Oberosterreich, Austria6000api.fda.gov
Tecan Austria GMBHGROEDIG Salzburg, Austria6000api.fda.gov
Tiger Dental GMBHHoerbranz Vorarlberg, Austria1000api.fda.gov
Tyromotion GMBHGraz Steiermark, Austria5000api.fda.gov
Wild GmbHVoelkermarkt Karnten, Austria2000api.fda.gov
rolf.produktions GmbHWeissenbach Tirol, Austria3000api.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.