Materialise NV

FDA 510(k) & PMA Approved 기기 — 34 products

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최신 FDA 결정

유형	번호	기기명	코드	날짜	작업
510(k)	K260802	Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner	QHE	2026-06-09	보기
510(k)	K251964	Mimics Thoracic Planner	LLZ	2026-03-12	보기
510(k)	K253308	Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models	PPT	2026-01-07	보기
510(k)	K253793	Materialise TKA Guide System	JWH	2026-01-06	보기
510(k)	K251554	Materialise TKA Guide System	JWH	2025-07-14	보기
510(k)	K243637	Materialise Personalized Guides and Models for Craniomaxillofacial Surgery	DZJ	2025-02-21	보기
510(k)	K242813	Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner	QHE	2024-10-18	보기
510(k)	K223427	Mimics Enlight CMF	LLZ	2024-05-31	보기
510(k)	K241143	Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner	QHE	2024-05-22	보기
510(k)	K233217	Mimics Cardiac Planner	LLZ	2024-02-12	보기
510(k)	K233408	Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner	QHE	2023-11-09	보기
510(k)	K231112	Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner	QHE	2023-09-12	보기
510(k)	K230315	Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner	QHE	2023-03-06	보기
510(k)	K220452	Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner	QHE	2022-08-17	보기
510(k)	K221337	Materialise TKA Guide System	JWH	2022-07-05	보기
510(k)	K213684	SurgiCase Viewer	LLZ	2022-06-15	보기
510(k)	K212569	Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner	QHE	2022-01-12	보기
510(k)	K202207	Materialise PKA Guide System	HSX	2020-10-02	보기
510(k)	K193560	Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner	QHE	2020-03-20	보기
510(k)	K190286	Materialise Glenoid Positioning System	KWS	2019-07-08	보기