Panels › General, Plastic Surgery › Product code FZW · Class 1
Expander, Surgical, Skin Graft
Regulation 878.4800
0510(k)s in 12 months (8 all time)
0recalls in 12 months (9 all time)
0recalls that name a 510(k)
Top companies in FZW
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Inc. | 0 | 6 |
| Aesculap, Inc. | 1 | 0 |
| Cox-Uphuff Intl. | 1 | 0 |
| General Surgical Innovations | 1 | 0 |
| Inamed Development Co. | 1 | 0 |
| Lb Medical LLC | 1 | 0 |
| Linvatec Corp. dba ConMed Linvatec | 0 | 1 |
| Mentor Corp. | 1 | 0 |
| Molnlycke Health Care, Inc | 0 | 1 |
| Surgitek | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2008 | K080158 | LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM Lb Medical LLC | FZW |
| Jan 28, 1999 | K984448 | BIRCOLL BALLOON DISSECTOR Wells Johnson Co. | FZW |
| Nov 14, 1997 | K972109 | SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER General Surgical Innovations | FZW |
| Mar 10, 1994 | K936186 | AESCULAP SKIN GRAFT MESHER Aesculap, Inc. | FZW |
| Mar 6, 1991 | K904265 | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER Inamed Development Co. | FZW |
| Sep 5, 1990 | K902349 | SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER Surgitek | FZW |
| Aug 26, 1988 | K883303 | MENTOR RAPID-SPAN (TM) TISSUE EXPANDER Mentor Corp. | FZW |
| Dec 2, 1987 | K874276 | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER Cox-Uphuff Intl. | FZW |
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