Medical Device Manufacturer · US , Raleigh , NC

Tribofilm Research, Inc.

2 submissions · 2 cleared · Since 2007

Total

Cleared

Denied

Tribofilm Research, Inc. — FDA 510(k) Submissions

Tribofilm Research, Inc. has submitted 2 FDA 510(k) premarket notifications since 2007, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Syringe, Piston, Ophthalmic Syringe . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

StaClear Syringe

K200242 · QLY Ophthalmic Syringe · General Hospital

Jul 2020 178d

TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE

K071027 · FMF Syringe, Piston · General Hospital

Jul 2007 100d

Data Source

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

Tribofilm Research, Inc.

Tribofilm Research, Inc. — FDA 510(k) Submissions

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