3D Systems, Inc.
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3D Systems, Inc. is a medical device manufacturer, with 184 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 15 Nov 2026.
- Devices
- 184
Registry facts
- Registries
- FDA GUDID 167
- FDA 510(k) 17
- Device classes
- FDA Class II 184
- Identifiers
- DUNS 085049749
What 3D Systems, Inc. makes
The company produces custom-made orthopaedic and craniofacial surgical guides designed for precise bone-cutting procedures, as well as reusable and single-use osteotomy guides and surgical implant templates. It also manufactures custom organ and bone anatomy models for preoperative planning and reusable surgical drill guides for guided orthopaedic surgery. Additionally, the portfolio includes radiation therapy bolus materials for dose enhancement in cancer treatment and software applications for medical image segmentation.
All listed devices fall under FDA Class II regulation, with most authorised through the 510(k) pathway and some via the De Novo classification. The products are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking.
Catalogue
Search and filter all 184 devicesShowing 1-50 of 184
Company details
- DUNS number
- 085049749
- Phone
- 8446431001
Frequently asked questions
How many devices does 3D SYSTEMS, INC. have in the registry?
The registry currently lists 184 devices for 3D SYSTEMS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list 3D SYSTEMS, INC.'s devices?
Among its 50 most recently registered devices, 3D SYSTEMS, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do 3D SYSTEMS, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for 3D SYSTEMS, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from 3D SYSTEMS, INC. in the registry?
The most recently registered devices listed for 3D SYSTEMS, INC. include VSP PEEK Host Skull Model, VSP System (Titanium Palatal Splint), VSP System, VSP Cranial Perfected Full Skull Model and VSP Orthopedics Autograft Tibia Template.