HomeUSA3D Systems, Inc.

3D Systems, Inc.

USA · Littleton
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
27listed device types
Class I 5Class II 20Class III 2
plus 65 registration records and 21 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
6 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States65 registration records, 21 510(k), 0 PMA, 49 excluded
Brazil0 confirmed, 12 excluded
Saudi Arabia0 confirmed, 3 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: MEDICAL MODELING - A 3D SYSTEMS COMPANY · 3D SYSTEMS - LAYERWISE · VIDAR SYSTEMS CORPORATION, A 3D SYSTEMS COMPANY · 3D SYSTEMS, INC.

Company information

Country
USA
City
Littleton

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
3D SYSTEMS CORP
CIK
0000910638
Registration status
Active
Listing status
Listed (DDD)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11998
12002
12007
12008
12016
12017
22019
22020
22021
12022
12023
52024
12025
12026

FDA listed device types

showing 8 of 27
Ankle Arthroplasty Implantation System 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Screw, Fixation, Bone 1Knee Arthroplasty Implantation System 1Implant, Endosseous, Root-Form 1Washer, Bolt Nut 1Intervertebral Fusion Device With Integrated Fixation, Cervical 1System, Image Processing, Radiological 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261826VSP System (Titanium Palatal Splint)2026-06-03
USK250711VSP Orthopedics System2025-12-05
USK243173Salto Talaris Ankle PSI System2024-10-25

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