Panels › General, Plastic Surgery › Product code FXX · Class 2
Mask, Surgical
Regulation 878.4040
7510(k)s in 12 months (607 all time)
0recalls in 12 months (12 all time)
10recalls that name a 510(k)
Top companies in FXX
| Company | 510(k)s | Recalls |
|---|---|---|
| Tecnol New Jersey Wound Care, Inc. | 11 | 0 |
| Owens & Minor (O&M) Halyard, Inc. | 8 | 0 |
| Anago, Inc. | 7 | 0 |
| Protectaide, Inc. | 7 | 0 |
| 3M Company | 6 | 0 |
| Guangdong Kingfa Sci. & Tech.Co., Ltd. | 6 | 0 |
| AMD Medicom Inc. | 0 | 5 |
| Tecnol Medical Products, Inc. | 5 | 0 |
| Dukal Corp. | 4 | 0 |
| Kimberly-Clark | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 1978 | K780607 | MASK, SURGEONS Abco Dealers, Inc. | FXX |
| May 26, 1978 | K780609 | MASK, ISOLATION Abco Dealers, Inc. | FXX |
| Feb 13, 1978 | K780169 | MASK, SURGICAL Convertors | FXX |
| Oct 27, 1977 | K771409 | DISP. SURGICAL FACE MASK Precept, Inc. | FXX |
| Apr 29, 1977 | K770513 | MASK, SURGICAL, DISP Acme Automatic Disposable | FXX |
| Mar 23, 1977 | K770463 | MASK, SURGICAL, FACE, DISPOSABLE Precept, Inc. | FXX |
| Nov 16, 1976 | K760991 | SURGINE FACE MASK Surgikos, Inc. | FXX |
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