Medical Device Manufacturer · US , Boca Raton , FL

Med Gen, Inc.

2 submissions · 2 cleared · Since 2001

Total

Cleared

Denied

Med Gen, Inc. — FDA 510(k) Submissions

Med Gen, Inc. has submitted 2 FDA 510(k) premarket notifications since 2001, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Restraint, Protective, Bandage, Elastic . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE

K013244 · FQM Bandage, Elastic · General Hospital

Dec 2001 70d

COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES

K013239 · FMQ Restraint, Protective · General Hospital

Nov 2001 53d

Data Source

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

Med Gen, Inc.

Med Gen, Inc. — FDA 510(k) Submissions

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