Panels › General, Plastic Surgery › Product code FXX · Class 2
Mask, Surgical
Regulation 878.4040
8510(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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2024 | O&M HALYARD, INC. O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask
Product Code: 47500 Open, Classified |
FXX | K823078 K831148 |
| Dec 20, 2024 | O&M HALYARD, INC. O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask
Product Code: 47117 Open, Classified |
FXX | K823078 K831148 |
| Feb 16, 2024 | AMD Medicom Inc. PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573) Open, Classified |
FXX | K051291 |
| Feb 16, 2024 | AMD Medicom Inc. HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281) Open, Classified |
FXX | K051291 |
| Feb 16, 2024 | AMD Medicom Inc. HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) Open, Classified |
FXX | K051291 |
| Feb 3, 2023 | Owens & Minor Distribution, Inc. FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor
Product Code 47147 Open, Classified |
FXX | K131879 |
| Oct 11, 2019 | AMD Medicom Inc. MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 Terminated |
FXX | K051291 |
| Oct 11, 2019 | AMD Medicom Inc. MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 Terminated |
FXX | K051291 |
| Jun 4, 2013 | Maytex Corp Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA
Ear-loop face mask for ba Terminated |
FXX | K964358 |
| Jun 21, 2003 | Safco Dental Supply Co. Inc. Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062 Terminated |
FXX | K801036 |
| Feb 25, 2003 | Dynarex Corporation Ear Loop Procedure Masks With Plastic Shield, For one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Orangeburg, NY 10962. Terminated |
FXX | None listed |
| Feb 25, 2003 | Dynarex Corporation Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Brewster, NY 10509. Made in China.
Produc Terminated |
FXX | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.