Atlas FDA

Materialise NV

61 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K260802)Materialise NV2026-06-09
Mimics Thoracic Planner (K251964)Materialise NV2026-03-12
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (K253308)Materialise NV2026-01-07
Materialise TKA Guide System (K253793)Materialise NV2026-01-06
Materialise TKA Guide System (K251554)Materialise NV2025-07-14
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (K243637)Materialise NV2025-02-21
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K242813)Materialise NV2024-10-18
Mimics Enlight CMF (K223427)Materialise NV2024-05-31
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K241143)Materialise NV2024-05-22
Mimics Cardiac Planner (K233217)Materialise NV2024-02-12
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K233408)Materialise NV2023-11-09
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K231112)Materialise NV2023-09-12
Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (K230315)Materialise NV2023-03-06
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (K220452)Materialise NV2022-08-17
Materialise TKA Guide System (K221337)Materialise NV2022-07-05
SurgiCase Viewer (K213684)Materialise NV2022-06-15
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K212569)Materialise NV2022-01-12
Materialise PKA Guide System (K202207)Materialise NV2020-10-02
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner (K193560)Materialise NV2020-03-20
Materialise Glenoid Positioning System (K190286)Materialise NV2019-07-08
Materialise Mimics Enlight (K190874)Materialise NV2019-06-05
Mimics Medical (K183105)Materialise NV2019-03-27
TruMatch CMF Titanium 3D Printed Implant (K173039)Materialise NV2018-07-10
Materialise PKA Guide System (K173970)Materialise NV2018-07-06
Mimics inPrint (K173619)Materialise NV2018-03-21
Materialise TKA Guide System (K173445)Materialise NV2018-02-02
Materialise PKA Guide System (K172650)Materialise NV2017-11-20
Materialise Glenoid Positioning System (K172054)Materialise NV2017-11-03
TruMatch CMF Titanium 3D Printed Implant System (K170272)Materialise NV2017-08-08
Materialise Glenoid Positioning System (K170893)Materialise NV2017-06-19
SurgiCase Viewer (K170419)Materialise NV2017-05-11
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides (K163156)Materialise NV2017-01-18
Materialise TKA Guide System (K162273)Materialise NV2016-11-07
Materialise Glenoid Positioning System (K153602)Materialise NV2016-04-26
Acetabular Cup Orientation System (K150780)Materialise NV2015-10-27
Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides (K150928)Materialise NV2015-08-10
ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER (K140027)Materialise NV2014-05-22
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES (K132290)Materialise NV2014-04-10
SIGNATURE PLANNER, SIGNATURE GUIDES (K140257)Materialise NV2014-04-02
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA (K133162)Materialise NV2014-02-25
MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES (K131559)Materialise NV2013-09-27
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM (K121640)Materialise NV2012-12-05
SURGICASE CONNECT, SURGICASE GUIDE (K112389)Materialise NV2012-07-20
SIGNATURE PLANNER,SIGNATURE GUIDES (K111863)Materialise NV2012-06-15
SURGICASE CONNECT (K113599)Materialise NV2012-04-27
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE (K113829)Materialise NV2012-04-02
SURGICASE GUIDE (K111558)Materialise NV2012-03-27
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER (K112301)Materialise NV2012-01-06
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS (K111492)Materialise NV2011-10-13
SURGICASE ORTHOGNATHIC SOFTWARE WIZARD (K111641)Materialise NV2011-09-26
SIGNATURE PLANNER / SIGNATURE GUIDES (K110415)Materialise NV2011-05-16
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE (K103136)Materialise NV2011-03-18
SIGNATURE PLANNER; SIGNATURE GUIDES (K102795)Materialise NV2011-02-02
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 (K093533)Materialise NV2010-02-17
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) (K091263)Materialise NV2009-11-19
SURGICASE (K073449)Materialise NV2008-04-16
MIMICS (K073468)Materialise NV2008-04-02
3MATIC (K060950)Materialise NV2006-05-18
SIMPLANT DR. JAMES (K053592)Materialise NV2006-02-08
SIMPLANT SYSTEM (K033849)Materialise NV2004-05-25
CT-MODELLER SYSTEM (K970617)Materialise NV1997-04-21

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Every clearance here is in the API, with alerts when new ones post.