Company ยท US
Sulzer Carbomedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2002. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 2002 | K023185 | ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 Sulzer Carbomedics, Inc. | KRH |
| Jun 13, 2002 | K013022 | SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS Sulzer Carbomedics, Inc. | DSY |
| Apr 23, 2002 | K021051 | ANNULOFLO SYSTEM, MITRAL MODEL AR700 Sulzer Carbomedics, Inc. | KRH |
| Jan 25, 2001 | K002007 | SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS Sulzer Carbomedics, Inc. | DSY |
| Dec 29, 1999 | K993288 | SULZER CARBOMEDICS CARDIOFIX PERICARDIUM Sulzer Carbomedics, Inc. | DXZ |
| Oct 12, 1999 | K992056 | ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 Sulzer Carbomedics, Inc. | KRH |
| Aug 4, 1998 | K974648 | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR Sulzer Carbomedics, Inc. | MOP |
| Apr 14, 1998 | K972201 | PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE Sulzer Carbomedics, Inc. | DXZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||