ClearanceBrief
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)
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Top companies in FXX

DateFirm and productCodeLinked 510(k)
Dec 20, 2024O&M HALYARD, INC.
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Open, Classified
FXXK823078
K831148
Dec 20, 2024O&M HALYARD, INC.
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Open, Classified
FXXK823078
K831148
Feb 16, 2024AMD Medicom Inc.
PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Open, Classified
FXXK051291
Feb 16, 2024AMD Medicom Inc.
HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Open, Classified
FXXK051291
Feb 16, 2024AMD Medicom Inc.
HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Open, Classified
FXXK051291
Feb 3, 2023Owens & 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
FXXK131879
Oct 11, 2019AMD Medicom Inc.
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
Terminated
FXXK051291
Oct 11, 2019AMD Medicom Inc.
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
Terminated
FXXK051291
Jun 4, 2013Maytex 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
FXXK964358
Jun 21, 2003Safco Dental Supply Co. Inc.
Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062
Terminated
FXXK801036
Feb 25, 2003Dynarex 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
FXXNone listed
Feb 25, 2003Dynarex 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
FXXNone listed

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