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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 2023 | K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) Thi Total Healthcare Innovation GmbH, AT | FXY |
| Mar 21, 2020 | K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Stryker Corporation | FXY |
| Jun 26, 2014 | K140588 | FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS Stryker Corporation | FXY |
| Dec 12, 1990 | K904969 | HOOD, OPERATING, SURGICAL Chicago Assoc. For Retarded Citizens | FXY |
| Nov 21, 1990 | K904276 | DISPOSABLE BEARD COVER Anago, Inc. | FXY |
| Oct 19, 1990 | K903533 | STERI-SHIELD Biomedical Devices, Inc. | FXY |
| Aug 17, 1990 | K902677 | STERI-SHIELD Biomedical Devices, Inc. | FXY |
| Feb 24, 1988 | K880431 | CARETEX SURGEON'S HOODS James River Corp. | FXY |
| Mar 1, 1977 | K770261 | HOOD, CLARION SURGEONS Sherwood Medical Industries | FXY |
| Feb 25, 1977 | K770257 | HOOD & BEARD COVER, CLARION SURGEON'S Sherwood Medical Industries | FXY |
| Dec 30, 1976 | K761070 | P.S.M. SURGICAL HOOD The Owenby Co. | FXY |
| Nov 3, 1976 | K760865 | BARRIER FASHION BONNET Surgikos, Inc. | FXY |
| Nov 3, 1976 | K760855 | BARRIER SURGICAL HOOD Surgikos, Inc. | FXY |
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