Coloplast Corp.

FDA 510(k) & PMA Approved 기기 — 25 products

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최신 FDA 결정

유형	번호	기기명	코드	날짜	작업
510(k)	K252140	Heylo™ System	EXB	2025-10-06	보기
510(k)	K251116	Luja Coudé	EZD	2025-06-27	보기
510(k)	K250270	Luja Set	EZD	2025-04-17	보기
510(k)	K242049	SureCath Set	EZD	2024-11-26	보기
510(k)	K241210	Luja Coude	EZD	2024-11-21	보기
510(k)	K242173	Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)	FED	2024-11-12	보기
510(k)	K242473	Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)	PAH	2024-10-18	보기
510(k)	K233411	Folysil Silicone Catheter	EZL	2024-04-15	보기
510(k)	K231953	Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)	FRO	2024-03-22	보기
510(k)	K233101	Luja Coude (20108 Male CH18 - large packaging)	EZD	2023-10-26	보기
510(k)	K213185	ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits	FAD	2022-06-08	보기
510(k)	K211911	Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets	LJE	2022-03-10	보기
510(k)	K213186	NovoFlow 강화된 요도 스텐트	FAD	2022-02-16	보기
510(k)	K201436	Vortek Single Loop Ureteral Stent	FAD	2021-02-25	보기
510(k)	K201165	In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath	LJE	2020-12-17	보기
510(k)	K201007	In-Ka Ureteral Balloon Dilatation Catheter	EZN	2020-06-11	보기
510(k)	K182831	SabreLine and SabreGuard Laser Fibers	GEX	2018-12-10	보기
510(k)	K180469	ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent	FAD	2018-11-06	보기
510(k)	K182122	Ureteric Catheters	EYB	2018-10-04	보기
510(k)	K180057	VORTEK URETERAL DOUBLE LOOP STENT	FAD	2018-03-09	보기