3d Systems Inc

FDA Filings

This page includes the latest FDA filings for 3d Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1724955
• FEI Number: 3003142829
• Name: MEDICAL MODELING - A 3D SYSTEMS COMPANY
• Owner & Operator: 3D Systems, Inc.
• Contact Address: 5381 South Alkire Circle ; Littleton CO 80127 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 5381 SOUTH ALKIRE CIRCLE ; Littleton, CO 80127 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3008826674
• FEI Number: 3008826674
• Name: SIMBIONIX LTD, A 3D Systems Company
• Owner & Operator: 3D Systems, Inc.
• Contact Address: 5381 South Alkire Circle ; Littleton CO 80127 US
• US Agent:
  • Kim Torluemke
  • 3D Systems - Medical Modeling
  • 720 6431001
  • kim.torluemke@3dsystems.com
• Importing Logistics Registration:
  • Importer: Simbionix USA
  • Address: 7100 Euclid Avenue, Suite 180e ; Cleveland, OH 44103 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Beit Golan Corner of Golan and Hanegev St.; Airport City Tel-Aviv, 70151 IL
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00816847022781 3D SYSTEMS, INC.	Cadence Flat Cut Total Ankle System	2025-01-20
GUDID 00816847022774 3D SYSTEMS, INC.	Cadence Flat Cut Total Ankle System	2025-01-20
GUDID 00816847022767 3D SYSTEMS, INC.	Cadence Flat Cut Total Ankle System	2025-01-20
GUDID 00816847022750 3D SYSTEMS, INC.	Salto Talaris Flat Cut Total Ankle System	2025-01-20
GUDID 00816847022743 3D SYSTEMS, INC.	Salto Talaris Flat Cut Total Ankle System	2025-01-20
GUDID 00816847022736 3D SYSTEMS, INC.	Salto Talaris Flat Cut Total Ankle System	2025-01-20
GUDID 00816847022729 3D SYSTEMS, INC.	Cadence Chamfer Cut Total Ankle System	2024-09-20
GUDID 00816847022712 3D SYSTEMS, INC.	Cadence Chamfer Cut Total Ankle System	2024-09-20
GUDID 00816847022705 3D SYSTEMS, INC.	Salto Talaris Chamfer Cut Total Ankle System	2024-09-20
GUDID 00816847022699 3D SYSTEMS, INC.	Salto Talaris Chamfer Cut Total Ankle System	2024-09-20
GUDID 00816847022675 3D SYSTEMS, INC.	VSP PEEK	2024-09-20
GUDID 00816847022651 3D SYSTEMS, INC.	Salto Talaris Chamfer Cut Total Ankle System	2024-09-20
GUDID 00816847022637 3D SYSTEMS, INC.	Cadence Chamfer Cut Total Ankle System	2024-09-20
GUDID 00816847022842 3D SYSTEMS, INC.	Vantage 3D+ PSI	2024-08-13
GUDID 00816847022835 3D SYSTEMS, INC.	Vantage 3D+ PSI	2024-08-13
GUDID 00816847022828 3D SYSTEMS, INC.	Vantage 3D+ PSI	2024-08-13
GUDID 00816847022811 3D SYSTEMS, INC.	Vantage 3D PSI	2024-08-13
GUDID 00816847022804 3D SYSTEMS, INC.	Vantage 3D PSI	2024-08-13
GUDID 00816847022798 3D SYSTEMS, INC.	Vantage 3D PSI	2024-08-13
GUDID 00816847022606 3D SYSTEMS, INC.	Vantage PSI 351-80-11	2023-08-30
GUDID 00816847022576 3D SYSTEMS, INC.	Vantage PSI 351-80-00	2023-08-30
GUDID 00816847022590 3D SYSTEMS, INC.	Vantage PSI 351-80-90	2023-08-15
GUDID 00816847022583 3D SYSTEMS, INC.	Vantage PSI 351-80-10	2023-08-15
GUDID 00816847022613 3D SYSTEMS, INC.	VSP Bolus VSPRT	2023-02-15
GUDID 00816847022569 3D SYSTEMS, INC.	D2P	2020-08-11
GUDID 00816847021470 3D SYSTEMS, INC.	D2P	2020-08-11
LYU MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	3D Systems Surgical Mask	2020-04-16
PMN K183489 | LLZ SIMBIONIX LTD, A 3D Systems Company [3D Systems, Inc.]	D2P	2019-12-12
GUDID 00816847022514 3D SYSTEMS, INC.	VSP Orthopedics	2019-11-27
GUDID 00816847022507 3D SYSTEMS, INC.	VSP Orthopedics	2019-11-27
GUDID 00816847022491 3D SYSTEMS, INC.	VSP Orthopedics	2019-11-27
GUDID 00816847022484 3D SYSTEMS, INC.	VSP Orthopedics	2019-11-27
GUDID 00816847022477 3D SYSTEMS, INC.	VSP Orthopedics	2019-11-27
GUDID 00816847022460 3D SYSTEMS, INC.	VSP Orthopedics	2019-11-27
GUDID 00816847022453 3D SYSTEMS, INC.	VSP Orthopedics	2019-11-27
GUDID 00816847022446 3D SYSTEMS, INC.	VSP Orthopedics	2019-11-27
GUDID 00816847021463 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021456 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021258 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021241 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021234 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021227 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021210 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021203 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021197 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021180 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021173 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021166 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021159 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021142 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021135 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021128 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021111 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021104 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021098 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021081 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021074 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021067 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021050 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021043 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021036 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021029 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021012 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847021005 3D SYSTEMS, INC.	VSP System	2019-11-27
GUDID 00816847020992 3D SYSTEMS, INC.	VSP System, VSP Cranial	2019-11-27
GUDID 00816847021371 3D SYSTEMS, INC.	PROcedure Rehearsal Studio PROcedure Rehearsal Studio	2019-10-07
GUDID 00816847022231 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022224 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022217 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022200 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022194 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022187 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022170 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022163 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022156 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022149 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022132 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847022125 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021913 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021906 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021890 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021883 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021876 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021869 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021852 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021845 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021838 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021821 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021814 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021807 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021593 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021586 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021579 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021562 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021555 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021548 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021531 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021524 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021517 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021500 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021494 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
GUDID 00816847021487 3D SYSTEMS, INC.	VSP Orthopedics	2019-09-19
PMN K190044 | PBF MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Orthopedics	2019-09-04
PMN K183489 3D Systems, Inc.	D2P	2019-08-29
PMN K190044 3D Systems, Inc.	VSP Orthopedics System	2019-08-21
PMN K161841 | LLZ SIMBIONIX LTD, A 3D Systems Company [3D Systems, Inc.]	D2P	2017-09-15
PMN K162419 | PQC MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	FIREFLY Pedicle Screw Navigation Guide	2017-01-13
PMN K143222 | MNI MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	FIREFLY	2017-01-13
PMN K161841 3D SYSTEMS, INC.	D2P	2017-01-09
PMN K151285 | PPT MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Cranial System	2016-10-31
PMN K133907 | LLZ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Trauma	2016-09-27
PMN K133907 | LLZ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Reconstruction	2016-09-27
PMN K133907 | LLZ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Orthognathics	2016-09-27
PMN K133907 | LLZ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Distraction	2016-09-27
PMN K133907 | LLZ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	Jaw in a Day	2016-09-27
PMN K133907 | DZJ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Trauma	2016-09-27
PMN K133907 | DZJ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Reconstruction	2016-09-27
PMN K133907 | DZJ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Orthognathics	2016-09-27
PMN K133907 | DZJ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Distraction	2016-09-27
PMN K133907 | DZJ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	Jaw in a Day	2016-09-27
PMN K151285 3D Systems, Inc.	VSP Cranial System	2016-09-23
PMN K153705 | LLZ SIMBIONIX LTD, A 3D Systems Company [3D Systems, Inc.]	PROcedure Rehearsal Studio	2016-09-20
GXM MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	NTS Junior	2016-05-11
GXM MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	NTS Bandeau	2016-05-11
GXM MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	NTS Adult	2016-05-11
KTD MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	Brace	2016-01-28
IQI MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	Limb Brace	2016-01-28
IPM MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	Prosthetic Fairing	2016-01-28
PMN K123269 | LLZ SIMBIONIX LTD, A 3D Systems Company [3D Systems, Inc.]	PROcedure Rehearsal Studio?	2014-04-28
PMN K120956 | LLZ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Trauma	2013-01-16
PMN K120956 | LLZ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Reconstruction	2013-01-16
PMN K120956 | LLZ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Orthognathics	2013-01-16
PMN K120956 | LLZ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Distraction	2013-01-16
PMN K120956 | DZJ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Trauma	2013-01-16
PMN K120956 | DZJ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Reconstruction	2013-01-16
PMN K120956 | DZJ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Orthognathics	2013-01-16
PMN K120956 | DZJ MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	VSP Distraction	2013-01-16
PMN K112387 | LLZ SIMBIONIX LTD, A 3D Systems Company [3D Systems, Inc.]	PROcedure Rehearsal Studio?	2012-10-16
PMN K093269 | LLZ SIMBIONIX LTD, A 3D Systems Company [3D Systems, Inc.]	PROcedure Rehearsal Studio?	2012-10-16
HWT MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	OsteoView Anatomical Model	2002-07-19
HWT MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	ClearView Anatomical Model	2002-07-19
HWT MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	CardioView Anatomical Model	2002-07-19
HWT MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	ArthroView Anatomical Model	2002-07-19
HWT MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	AccuView Anatomical Model	2002-07-19
HWT MEDICAL MODELING - A 3D SYSTEMS COMPANY [3D Systems, Inc.]	AccuDental Anatomical Model	2002-07-19

Related Finance Registrations

NCAGE Code	0JXE0	3D SYSTEMS, INC.
NCAGE Code	88D25	3D SYSTEMS, INC.
NCAGE Code	0PKT7	3D SYSTEMS INC
CAGE Code	0JXE0	3D SYSTEMS, INC.
CAGE Code	0PKT7	3D SYSTEMS INC
CAGE Code	1RXV6	3D SYSTEMS, INC. 3D SYSTEMS - LANGHORNE
CAGE Code	3CBV1	3D SYSTEMS, INC. 3D SYSTEMS
CAGE Code	88D25	3D SYSTEMS, INC.
S.A.M. Registration	3CBV1 [114418382]	3D SYSTEMS, INC.
S.A.M. Registration	0JXE0 [173574161]	3D SYSTEMS, INC.
S.A.M. Registration	1RXV6 [79513014]	3D SYSTEMS, INC.
S.A.M. Registration	88D25 [81118063]	3D SYSTEMS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092627754	Algeciras,Spain -> Houston, Texas	FIGURE 4 STANDALONE PRINTER SYSTEM	23 CAS
2020092318423	Rotterdam,Netherlands -> Charleston, South Carolina	RESIN MATERIAL	2016 PCS
2020092141434	Rotterdam,Netherlands -> Charleston, South Carolina	RESIN MATERIAL	849 CTN
202009218647	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	MDM TEST EQUIPMENT	3 PKG
2020091912536	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	MDM TEST EQUIPMENT	3 PKG
2020091861442	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	CRANE	1 CRT
2020091230640	Rotterdam,Netherlands -> Charleston, South Carolina	RESIN MATERIAL	941 PCS
2020091023762	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	MDM TEST EQUIPMENT	3 PKG