Sulzer Carbomedics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K023185 | ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 | December 17, 2002 |
| K013022 | SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS | June 13, 2002 |
| K021051 | ANNULOFLO SYSTEM, MITRAL MODEL AR700 | April 23, 2002 |
| K002007 | SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS | January 25, 2001 |
| K993288 | SULZER CARBOMEDICS CARDIOFIX PERICARDIUM | December 29, 1999 |
| K992056 | ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 | October 12, 1999 |
| K974648 | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | August 4, 1998 |
| K972201 | PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE | April 14, 1998 |