Medical Device Manufacturer · US , Great Neck , NY

Crosstex Intl.

2 submissions · 2 cleared · Since 1999

Total

Cleared

Denied

Crosstex Intl. — FDA 510(k) Submissions

Crosstex Intl. has submitted 2 FDA 510(k) premarket notifications since 1999, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Gauze/sponge, Internal, Mask, Surgical . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX

K012602 · FXX Mask, Surgical · General Hospital

Jan 2002 162d

CROSSTEX NON-WOVEN SPONGES

K984187 · EFQ Gauze/sponge, Internal · General & Plastic Surgery

Feb 1999 87d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Crosstex Intl.

Crosstex Intl. — FDA 510(k) Submissions

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