ClearanceBrief
Company · US

3D Systems, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.

17510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
OYKAnkle Arthroplasty Implantation System6
DZJDriver, Wire, And Bone Drill, Manual3
PBFOrthopaedic Surgical Planning And Instrument Guides3
LLZSystem, Image Processing, Radiological2
GWOPlate, Cranioplasty, Preformed, Alterable1
IXIBlock, Beam-Shaping, Radiation Therapy1
PPTCranial Surgical Planning And Instrument Guides1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 3, 2026K261826VSP System (Titanium Palatal Splint)
3D Systems, Inc.
DZJ
Dec 5, 2025K250711VSP Orthopedics System
3D Systems, Inc.
PBF
Oct 25, 2024K243174Cadence Ankle PSI System
3D Systems, Inc.
OYK
Oct 25, 2024K243173Salto Talaris Ankle PSI System
3D Systems, Inc.
OYK
Aug 30, 2024K241326Cadence Ankle PSI System
3D Systems, Inc.
OYK
Aug 30, 2024K241148Salto Talaris Ankle PSI System
3D Systems, Inc.
OYK
Apr 4, 2024K231834VSP PEEK Cranial Implant
3D Systems, Inc.
GWO
Jun 30, 2023K231585Vantage PSI System
3D Systems, Inc.
OYK
Mar 30, 2022K214093VSP Bolus
3D Systems
IXI
Nov 10, 2021K211244VSP® Orthopedics System
3D Systems
PBF
Apr 26, 2021K210347VSP System
3D Systems
DZJ
Nov 9, 2020K193432Vantage PSI System
3D Systems
OYK
Feb 26, 2020K192192VSP System
3D Systems
DZJ
Aug 29, 2019K183489D2P
3D Systems, Inc., IL
LLZ
Aug 21, 2019K190044VSP Orthopedics System
3D Systems, Inc.
PBF
Jan 9, 2017K161841D2P
3D Systems, Inc., IL
LLZ
Sep 23, 2016K151285VSP Cranial System
3D Systems, Inc.
PPT

Latest recalls

DateFirm and productCodeLinked 510(k)
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