Panels › General, Plastic Surgery › Product code FXY · Class 2
Hood, Surgical
Regulation 878.4040
0510(k)s in 12 months (13 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in FXY
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomedical Devices, Inc. | 2 | 0 |
| Sherwood Medical Industries | 2 | 0 |
| Stryker Corporation | 2 | 0 |
| Surgikos, Inc. | 2 | 0 |
| VIASYS Med Systems | 0 | 2 |
| Anago, Inc. | 1 | 0 |
| Chicago Assoc. For Retarded Citizens | 1 | 0 |
| James River Corp. | 1 | 0 |
| O&M HALYARD, INC. | 0 | 1 |
| The Owenby Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2024 | O&M HALYARD, INC. HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) Open, Classified |
FXY | None listed |
| Oct 4, 2005 | VIASYS Med Systems Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to co Terminated |
FXY | K910515 |
| Oct 4, 2005 | VIASYS Med Systems Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to co Terminated |
FXY | K910515 |
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