FDA.reportPublic FDA data

MATERIALISE N.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039982083003998208MATERIALISE N.V.1N2026-01-0115 TECHNOLOGIELAAN LEUVEN Vlaams Brabant BE 3001

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
169441687114807K253793Materialise TKA Guide SystemJWH2026-01-06
169441881321831K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsPPT2026-01-07
169441648626710K251964Mimics Thoracic PlannerLLZ2026-03-12
169441347529537K251554Materialise TKA Guide SystemJWH2025-07-14
169441292852037K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ2025-02-21
169441629518160K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-10-18
169441358777051K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-05-22
169441722410129K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2023-11-09
169441001029523K233217Mimics Cardiac PlannerLLZ2024-02-12
169441055088897K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2023-09-12
169441468238354K230315Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHE2023-03-06
169441287934806K223427Mimics Enlight CMFLLZ2024-05-31
169441040878518K221337Materialise TKA Guide SystemJWH2022-07-05
169441207946287K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHE2022-08-17
169441112452059K213684SurgiCase ViewerLLZ2022-06-15
169441431307421K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2022-01-12
169441776229984K202207Materialise PKA Guide SystemHSX2020-10-02
169441060352406K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerQHE2020-03-20
169441526366082K190874Materialise Mimics EnlightLLZ2019-06-05
169441609297469K190286Materialise Glenoid Positioning SystemKWS2019-07-08
169441652996576K183105Mimics MedicalLLZ2019-03-27
169441781074907K173970Materialise PKA Guide SystemHSX2018-07-06
169441587492633K173619Mimics inPrintLLZ2018-03-21
169441860212778K173445Materialise TKA Guide SystemJWH2018-02-02
169441276925818K173039TruMatch CMF Titanium 3D Printed ImplantJEY2018-07-10
169441914173473K172650Materialise PKA Guide SystemHSX2017-11-20
169441388088088K172054Materialise Glenoid Positioning SystemKWS2017-11-03
169441438126570K171068OrthoView 7.2LLZ2017-10-18
169442071211074K170893Materialise Glenoid Positioning SystemKWS2017-06-19
169442040897854K170419SurgiCase ViewerLLZ2017-05-11
169441547390648K170272TruMatch CMF Titanium 3D Printed Implant SystemJEY2017-08-08
169441326359165K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesPBF2017-01-18
169441383155258K162273Materialise TKA Guide SystemJWH2016-11-07
169441729657684K153602Materialise Glenoid Positioning SystemKWS2016-04-26
169441511725520K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesJWH2015-08-10
169441559139031K140257SIGNATURE PLANNER, SIGNATURE GUIDESMBH2014-04-02
169441111522869K140027ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNERJWH2014-05-22
169441460775197K133162ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLAJWH2014-02-25
169441525328349K132290SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDESPBF2014-04-10
169441088400091K131559MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDESKWS2013-09-27
169441043731831K121640ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEMJWH2012-12-05
169441222780485K113829ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNEJWH2012-04-02
169441334308075K113599SURGICASE CONNECTLLZ2012-04-27
169441784837376K112389SURGICASE CONNECT, SURGICASE GUIDEPBF2012-07-20
169441117931285K112301ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNERHSX2012-01-06
169441687131810K111863SIGNATURE PLANNER,SIGNATURE GUIDESJDI2012-06-15
169441665413201K111641SURGICASE ORTHOGNATHIC SOFTWARE WIZARDLLZ2011-09-26
169441869621061K111558SURGICASE GUIDEHAW2012-03-27
169441023234674K111492ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTSJWH2011-10-13
169441903702377K110415SIGNATURE PLANNER / SIGNATURE GUIDESHRY2011-05-16
169441898256055K103136SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDEJEY2011-03-18
169441954290267K102795SIGNATURE PLANNER; SIGNATURE GUIDESJWH2011-02-02
169441028644657K093533ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0MBH2010-02-17
169441920212394K091263ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)JWH2009-11-19
169441839756374K073468MIMICSLLZ2008-04-02
169441180196315K0609503MATICLLZ2006-05-18
169441661392545
169441008950202
169441352353689
169441574967996
169441813040094

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ132026-03-12
JWH132026-01-06
QHE82024-10-18
KWS52019-07-08
HSX42020-10-02
JEY32018-07-10
PBF32017-01-18
MBH22014-04-02
PPT12026-01-07
DZJ12025-02-21
JDI12012-06-15
HAW12012-03-27
HRY12011-05-16

PMN#

57 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next