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Sulzer Carbomedics, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K023185	ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800	KRH	2002-12-17	View
510(k)	K013022	SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS	DSY	2002-06-13	View
510(k)	K021051	ANNULOFLO SYSTEM, MITRAL MODEL AR700	KRH	2002-04-23	View
510(k)	K002007	SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS	DSY	2001-01-25	View
510(k)	K993288	SULZER CARBOMEDICS CARDIOFIX PERICARDIUM	DXZ	1999-12-29	View
510(k)	K992056	ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800	KRH	1999-10-12	View
510(k)	K974648	SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR	MOP	1998-08-04	View
510(k)	K972201	PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE	DXZ	1998-04-14	View

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